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Effectiveness of Exercise Program in Improving Quality of Life in Patients With Gastric Cancer Undergoing Gastrectomy

Primary Purpose

Gastric Cancer

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
exercise group
Sponsored by
Taipei Veterans General Hospital, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gastric Cancer focused on measuring gastrectomy, fatigue, anxiety, depression, sleep quality, Quality of Life

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. After undergoing surgery and clinically diagnosed as gastric cancer.
  2. Adults over 20 years old.
  3. Hemoglobin (above 10 g/dL).
  4. Clear consciousness and could communicate in either Mandarin or Taiwanese, and were not cognitively impaired were included.
  5. No lower limb disability and able to walk on their own.

Exclusion Criteria:

  1. Suspected or confirmed bone metastasis.
  2. Poorly controlled cardiovascular disease such as heart failure, arrhythmia, angina, myocardial infarction, chest pain during activities or rest in the past three months, and valvular heart disease using anticoagulants.
  3. Poorly diabetes controlled, glycosylated hemoglobin (HbA1C)>9%, blood sugar higher than 250mg/dl or lower than 80mg/dl.
  4. Those with poor blood pressure control, systolic blood pressure greater than 160mmHg or diastolic blood pressure than 100mmHg when quiet, and heart rate is greater than 100bpm when quiet.
  5. Diagnosed as recurrent depression.
  6. Regular exercise above moderate intensity, such as 150 minutes per week in the past three months.

Sites / Locations

  • Taipei Veterans General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

exercise group

usual-care group

Arm Description

A 12-week regimen of home-based walking exercises, comprising walking at a moderate intensity for 40 min, three times a Week.

These participants follows the standard post-surgery follow-up consisting of counseling by dietitians, nurses and doctors.

Outcomes

Primary Outcome Measures

Quality of Life (EORTC QLQ-C30 )
The EORTC QLQ-C30 :This scale is measured by the respondent self-assessed the frequency of various problems in the past week. The EORTC QLQ-C30 consists of three subscales with 30 questions. The EORTC QLQ-C30 have three subscales in the scale include functioning scales (15 questions), symptom scales (13 questions), and global health status (2 questions). The reliability and validity of Cronbach'α was 0.81-0.94. The functional scale and the global health status , the higher the total score, the better the quality of life; the lower the score in the symptom scale, the better the quality of life.
Quality of Life (EORTC QLQ-C30 )
The EORTC QLQ-C30 :This scale is measured by the respondent self-assessed the frequency of various problems in the past week. The EORTC QLQ-C30 consists of three subscales with 30 questions. The EORTC QLQ-C30 have three subscales in the scale include functioning scales (15 questions), symptom scales (13 questions), and global health status (2 questions). The reliability and validity of Cronbach'α was 0.81-0.94. The functional scale and the global health status , the higher the total score, the better the quality of life; the lower the score in the symptom scale, the better the quality of life.
Quality of Life (EORTC QLQ-C30)
The EORTC QLQ-C30 :This scale is measured by the respondent self-assessed the frequency of various problems in the past week. The EORTC QLQ-C30 consists of three subscales with 30 questions. The EORTC QLQ-C30 have three subscales in the scale include functioning scales (15 questions), symptom scales (13 questions), and global health status (2 questions). The reliability and validity of Cronbach'α was 0.81-0.94. The functional scale and the global health status , the higher the total score, the better the quality of life; the lower the score in the symptom scale, the better the quality of life.
Quality of Life (EORTC QLQ-C30)
The EORTC QLQ-C30 :This scale is measured by the respondent self-assessed the frequency of various problems in the past week. The EORTC QLQ-C30 consists of three subscales with 30 questions. The EORTC QLQ-C30 have three subscales in the scale include functioning scales (15 questions), symptom scales (13 questions), and global health status (2 questions). The reliability and validity of Cronbach'α was 0.81-0.94. The functional scale and the global health status , the higher the total score, the better the quality of life; the lower the score in the symptom scale, the better the quality of life.
Quality of Life (EORTC QLQ-C30)
The EORTC QLQ-C30 :This scale is measured by the respondent self-assessed the frequency of various problems in the past week. The EORTC QLQ-C30 consists of three subscales with 30 questions. The EORTC QLQ-C30 have three subscales in the scale include functioning scales (15 questions), symptom scales (13 questions), and global health status (2 questions). The reliability and validity of Cronbach'α was 0.81-0.94. The functional scale and the global health status , the higher the total score, the better the quality of life; the lower the score in the symptom scale, the better the quality of life.
Quality of Life (EORTC QLQ-C30)
The EORTC QLQ-C30 :This scale is measured by the respondent self-assessed the frequency of various problems in the past week. The EORTC QLQ-C30 consists of three subscales with 30 questions. The EORTC QLQ-C30 have three subscales in the scale include functioning scales (15 questions), symptom scales (13 questions), and global health status (2 questions). The reliability and validity of Cronbach'α was 0.81-0.94. The functional scale and the global health status , the higher the total score, the better the quality of life; the lower the score in the symptom scale, the better the quality of life.
Quality of Life (EORTC QLQ-C30)
The EORTC QLQ-C30 :This scale is measured by the respondent self-assessed the frequency of various problems in the past week. The EORTC QLQ-C30 consists of three subscales with 30 questions. The EORTC QLQ-C30 have three subscales in the scale include functioning scales (15 questions), symptom scales (13 questions), and global health status (2 questions). The reliability and validity of Cronbach'α was 0.81-0.94. The functional scale and the global health status , the higher the total score, the better the quality of life; the lower the score in the symptom scale, the better the quality of life.
Quality of Life (EORTC QLQ-C30)
The EORTC QLQ-C30 :This scale is measured by the respondent self-assessed the frequency of various problems in the past week. The EORTC QLQ-C30 consists of three subscales with 30 questions. The EORTC QLQ-C30 have three subscales in the scale include functioning scales (15 questions), symptom scales (13 questions), and global health status (2 questions). The reliability and validity of Cronbach'α was 0.81-0.94. The functional scale and the global health status , the higher the total score, the better the quality of life; the lower the score in the symptom scale, the better the quality of life.
Quality of Life (EORTC QLQ-STO22)
The EORTC QLQ-STO22:This scale is measured by the respondent self-assessed the frequency of various problems in the past week. The EORTC QLQ-STO22 consists of one subscale with 22 questions.The EORTC QLQ-STO22 scale include symptom scales (22 questions) The Cronbach'α was 0.70-0.94.The lower the score in the symptom scale, the better the quality of life.
Quality of Life (EORTC QLQ-STO22)
The EORTC QLQ-STO22:This scale is measured by the respondent self-assessed the frequency of various problems in the past week. The EORTC QLQ-STO22 consists of one subscale with 22 questions.The EORTC QLQ-STO22 scale include symptom scales (22 questions) The Cronbach'α was 0.70-0.94.The lower the score in the symptom scale, the better the quality of life.
Quality of Life (EORTC QLQ-STO22)
The EORTC QLQ-STO22:This scale is measured by the respondent self-assessed the frequency of various problems in the past week. The EORTC QLQ-STO22 consists of one subscale with 22 questions.The EORTC QLQ-STO22 scale include symptom scales (22 questions) The Cronbach'α was 0.70-0.94.The lower the score in the symptom scale, the better the quality of life.
Quality of Life (EORTC QLQ-STO22)
The EORTC QLQ-STO22:This scale is measured by the respondent self-assessed the frequency of various problems in the past week. The EORTC QLQ-STO22 consists of one subscale with 22 questions.The EORTC QLQ-STO22 scale include symptom scales (22 questions) The Cronbach'α was 0.70-0.94.The lower the score in the symptom scale, the better the quality of life.
Quality of Life (EORTC QLQ-STO22)
The EORTC QLQ-STO22:This scale is measured by the respondent self-assessed the frequency of various problems in the past week. The EORTC QLQ-STO22 consists of one subscale with 22 questions.The EORTC QLQ-STO22 scale include symptom scales (22 questions) The Cronbach'α was 0.70-0.94.The lower the score in the symptom scale, the better the quality of life.
Quality of Life (EORTC QLQ-STO22)
The EORTC QLQ-STO22:This scale is measured by the respondent self-assessed the frequency of various problems in the past week. The EORTC QLQ-STO22 consists of one subscale with 22 questions.The EORTC QLQ-STO22 scale include symptom scales (22 questions) The Cronbach'α was 0.70-0.94.The lower the score in the symptom scale, the better the quality of life.
Quality of Life (EORTC QLQ-STO22)
The EORTC QLQ-STO22:This scale is measured by the respondent self-assessed the frequency of various problems in the past week. The EORTC QLQ-STO22 consists of one subscale with 22 questions.The EORTC QLQ-STO22 scale include symptom scales (22 questions) The Cronbach'α was 0.70-0.94.The lower the score in the symptom scale, the better the quality of life.
Quality of Life (EORTC QLQ-STO22)
The EORTC QLQ-STO22:This scale is measured by the respondent self-assessed the frequency of various problems in the past week. The EORTC QLQ-STO22 consists of one subscale with 22 questions.The EORTC QLQ-STO22 scale include symptom scales (22 questions) The Cronbach'α was 0.70-0.94.The lower the score in the symptom scale, the better the quality of life.

Secondary Outcome Measures

fatigue(Brief Fatigue Inventory-Taiwan , BFI-T)
The scale is measured by the respondent self-assessed the frequency of various problems with activities of daily living in 24 hours. BFI-T has 9 questions in total； it is a self-reported 11-Point Likert Scale. Retest reliability was 0.89-0.97.
fatigue(Brief Fatigue Inventory-Taiwan , BFI-T)
The scale is measured by the respondent self-assessed the frequency of various problems with activities of daily living in 24 hours. BFI-T has 9 questions in total；it is a self-reported 11-Point Likert Scale. Retest reliability was 0.89-0.97.
fatigue(Brief Fatigue Inventory-Taiwan , BFI-T)
The scale is measured by the respondent self-assessed the frequency of various problems with activities of daily living in 24 hours. BFI-T has 9 questions in total；it is a self-reported 11-Point Likert Scale. Retest reliability was 0.89-0.97.
fatigue(Brief Fatigue Inventory-Taiwan , BFI-T)
The scale is measured by the respondent self-assessed the frequency of various problems with activities of daily living in 24 hours. BFI-T has 9 questions in total； it is a self-reported 11-Point Likert Scale. Retest reliability was 0.89-0.97.
fatigue(Brief Fatigue Inventory-Taiwan , BFI-T)
The scale is measured by the respondent self-assessed the frequency of various problems with activities of daily living in 24 hours. BFI-T has 9 questions in total； it is a self-reported 11-Point Likert Scale. Retest reliability was 0.89-0.97.
fatigue(Brief Fatigue Inventory-Taiwan , BFI-T)
The scale is measured by the respondent self-assessed the frequency of various problems with activities of daily living in 24 hours. BFI-T has 9 questions in total； it is a self-reported 11-Point Likert Scale. Retest reliability was 0.89-0.97.
fatigue(Brief Fatigue Inventory-Taiwan , BFI-T)
The scale is measured by the respondent self-assessed the frequency of various problems with activities of daily living in 24 hours. BFI-T has 9 questions in total； it is a self-reported 11-Point Likert Scale. Retest reliability was 0.89-0.97.
fatigue(Brief Fatigue Inventory-Taiwan , BFI-T)
The scale is measured by the respondent self-assessed the frequency of various problems with activities of daily living in 24 hours. BFI-T has 9 questions in total； it is a self-reported 11-Point Likert Scale. Retest reliability was 0.89-0.97.
Emotional distress( Hospital Anxiety and Depression Scale, HADS)
Emotional distress including anxiety and depression (Hospital Anxiety and Depression Scale). The Hospital Anxiety and Depression Scale include anxiety and depression subscales, a total of 7 questions, each subscale is a four-point scoring method, 0 point for "not at all", 3 points for "always do", each subscale scores is between 0 and 21, that a score of 7 or less for non-cases, scores of 8-10 for doubtful cases and scores of 11 or more for definite cases.
Emotional distress( Hospital Anxiety and Depression Scale, HADS)
Emotional distress including anxiety and depression (Hospital Anxiety and Depression Scale). The Hospital Anxiety and Depression Scale include anxiety and depression subscales, a total of 7 questions, each subscale is a four-point scoring method, 0 point for "not at all", 3 points for "always do", each subscale scores is between 0 and 21, that a score of 7 or less for non-cases, scores of 8-10 for doubtful cases and scores of 11 or more for definite cases.
Emotional distress( Hospital Anxiety and Depression Scale, HADS)
Emotional distress including anxiety and depression (Hospital Anxiety and Depression Scale). The Hospital Anxiety and Depression Scale include anxiety and depression subscales, a total of 7 questions, each subscale is a four-point scoring method, 0 point for "not at all", 3 points for "always do", each subscale scores is between 0 and 21, that a score of 7 or less for non-cases, scores of 8-10 for doubtful cases and scores of 11 or more for definite cases.
Emotional distress( Hospital Anxiety and Depression Scale, HADS)
Emotional distress including anxiety and depression (Hospital Anxiety and Depression Scale). The Hospital Anxiety and Depression Scale include anxiety and depression subscales, a total of 7 questions, each subscale is a four-point scoring method, 0 point for "not at all", 3 points for "always do", each subscale scores is between 0 and 21, that a score of 7 or less for non-cases, scores of 8-10 for doubtful cases and scores of 11 or more for definite cases.
Emotional distress( Hospital Anxiety and Depression Scale, HADS)
Emotional distress including anxiety and depression (Hospital Anxiety and Depression Scale). The Hospital Anxiety and Depression Scale include anxiety and depression subscales, a total of 7 questions, each subscale is a four-point scoring method, 0 point for "not at all", 3 points for "always do", each subscale scores is between 0 and 21, that a score of 7 or less for non-cases, scores of 8-10 for doubtful cases and scores of 11 or more for definite cases.
Emotional distress( Hospital Anxiety and Depression Scale, HADS)
Emotional distress including anxiety and depression (Hospital Anxiety and Depression Scale). The Hospital Anxiety and Depression Scale include anxiety and depression subscales, a total of 7 questions, each subscale is a four-point scoring method, 0 point for "not at all", 3 points for "always do", each subscale scores is between 0 and 21, that a score of 7 or less for non-cases, scores of 8-10 for doubtful cases and scores of 11 or more for definite cases.
Emotional distress( Hospital Anxiety and Depression Scale, HADS)
Emotional distress including anxiety and depression (Hospital Anxiety and Depression Scale). The Hospital Anxiety and Depression Scale include anxiety and depression subscales, a total of 7 questions, each subscale is a four-point scoring method, 0 point for "not at all", 3 points for "always do", each subscale scores is between 0 and 21, that a score of 7 or less for non-cases, scores of 8-10 for doubtful cases and scores of 11 or more for definite cases.
Emotional distress( Hospital Anxiety and Depression Scale, HADS)
Emotional distress including anxiety and depression (Hospital Anxiety and Depression Scale). The Hospital Anxiety and Depression Scale include anxiety and depression subscales, a total of 7 questions, each subscale is a four-point scoring method, 0 point for "not at all", 3 points for "always do", each subscale scores is between 0 and 21, that a score of 7 or less for non-cases, scores of 8-10 for doubtful cases and scores of 11 or more for definite cases.
sleep quality(Pittsburgh Sleep Quality Index and using Actigraph)
The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if one is available). Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. Actigraph is the gold standard for evaluating sleep disorders. As the name suggests, it is an electrophysiological recording of multiple parameters, including total sleep time(TST), sleep efficiency(SE), and sleep onset latency(SOL) which help to score various sleep stages.
sleep quality(Pittsburgh Sleep Quality Index and using Actigraph)
The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if one is available). Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. Actigraph is the gold standard for evaluating sleep disorders. As the name suggests, it is an electrophysiological recording of multiple parameters, including total sleep time(TST), sleep efficiency(SE), and sleep onset latency(SOL) which help to score various sleep stages.
sleep quality(Pittsburgh Sleep Quality Index and using Actigraph)
The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if one is available). Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. Actigraph is the gold standard for evaluating sleep disorders. As the name suggests, it is an electrophysiological recording of multiple parameters, including total sleep time(TST), sleep efficiency(SE), and sleep onset latency(SOL) which help to score various sleep stages.
sleep quality(Pittsburgh Sleep Quality Index and using Actigraph)
The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if one is available). Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. Actigraph is the gold standard for evaluating sleep disorders. As the name suggests, it is an electrophysiological recording of multiple parameters, including total sleep time(TST), sleep efficiency(SE), and sleep onset latency(SOL) which help to score various sleep stages.
sleep quality(Pittsburgh Sleep Quality Index and using Actigraph)
The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if one is available). Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. Actigraph is the gold standard for evaluating sleep disorders. As the name suggests, it is an electrophysiological recording of multiple parameters, including total sleep time(TST), sleep efficiency(SE), and sleep onset latency(SOL) which help to score various sleep stages.
sleep quality(Pittsburgh Sleep Quality Index and using Actigraph)
The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if one is available). Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. Actigraph is the gold standard for evaluating sleep disorders. As the name suggests, it is an electrophysiological recording of multiple parameters, including total sleep time(TST), sleep efficiency(SE), and sleep onset latency(SOL) which help to score various sleep stages.
Circadian rhythms(using Actigraph)
Circadian rhythms including 24-h autocorrelation coefficient (r24) and in bed less than out of bed dichotomy index (I<O) collection from actigraphy.
Circadian rhythms(using Actigraph)
Circadian rhythms including 24-h autocorrelation coefficient (r24) and in bed less than out of bed dichotomy index (I<O) collection from actigraphy.
Circadian rhythms(using Actigraph)
Circadian rhythms including 24-h autocorrelation coefficient (r24) and in bed less than out of bed dichotomy index (I<O) collection from actigraphy.
Circadian rhythms(using Actigraph)
Circadian rhythms including 24-h autocorrelation coefficient (r24) and in bed less than out of bed dichotomy index (I<O) collection from actigraphy.
Circadian rhythms(using Actigraph)
Circadian rhythms including 24-h autocorrelation coefficient (r24) and in bed less than out of bed dichotomy index (I<O) collection from actigraphy.
Circadian rhythms(using Actigraph)
Circadian rhythms including 24-h autocorrelation coefficient (r24) and in bed less than out of bed dichotomy index (I<O) collection from actigraphy.

Full Information

First Posted
September 21, 2020
Last Updated
December 19, 2021
Sponsor
Taipei Veterans General Hospital, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT04593134
Brief Title
Effectiveness of Exercise Program in Improving Quality of Life in Patients With Gastric Cancer Undergoing Gastrectomy
Official Title
The Effect of Home Based Walking Exercise on Fatigue, Anxiety, Depression, Sleep Quality, Circadian Rhythms and Quality of Life in Patients With Gastric Cancer Undergoing Gastrectomy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 10, 2020 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
October 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study will investigate the effectiveness of a rehabilitation program in improving fatigue, negative emotions , sleep quality, circadian rhythms and quality of life in patients with gastric cancer undergoing gastrectomy in Taiwan. Hypothesis: The fatigue in exercise group is significant improving than usual-care group at 1st, 2nd, 3rd, 6th, 12th, 24th and 36th month. The negative emotions in exercise group is significant improving than usual-care group at 1st, 2nd, 3rd, 6th, 12th, 24th and 36th month. The sleep quality in exercise group is significant improving than usual-care group at 1st, 2nd, 3rd, 6th, 12th, 24th and 36th month. The quality of life in exercise group is significant improving than usual-care group at 1st, 2nd,3rd, 6th, 12th, 24th and 36th month.
Detailed Description
This study will investigate the effectiveness of a rehabilitation program in improving fatigue, negative emotions , sleep quality, circadian rhythms and quality of life in patients with gastric cancer undergoing gastrectomy in Taiwan.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
gastrectomy, fatigue, anxiety, depression, sleep quality, Quality of Life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
exercise group
Arm Type
Experimental
Arm Description
A 12-week regimen of home-based walking exercises, comprising walking at a moderate intensity for 40 min, three times a Week.
Arm Title
usual-care group
Arm Type
No Intervention
Arm Description
These participants follows the standard post-surgery follow-up consisting of counseling by dietitians, nurses and doctors.
Intervention Type
Behavioral
Intervention Name(s)
exercise group
Intervention Description
exercise education: A 12-week regimen of homebased walking exercises, include moderate intensity for 40 min, three times a week. We explained the participants how to perform the exercises, according to an instruction manual for the exercise regimen. Participants were instructed that the exercises would be effective only if they reached 40%-60% of the heart rate reserve, as determined by the Karvonen method, or 13-14 on the RPE. Exercise education: Weekly telephone or mobile application "LINE" consultations concerning exercise.we discussed whether participants' exercise fulfilled the prescribed intensity, duration, frequency and whether the participants experienced any adverse effects.
Primary Outcome Measure Information:
Title
Quality of Life (EORTC QLQ-C30 )
Description
The EORTC QLQ-C30 :This scale is measured by the respondent self-assessed the frequency of various problems in the past week. The EORTC QLQ-C30 consists of three subscales with 30 questions. The EORTC QLQ-C30 have three subscales in the scale include functioning scales (15 questions), symptom scales (13 questions), and global health status (2 questions). The reliability and validity of Cronbach'α was 0.81-0.94. The functional scale and the global health status , the higher the total score, the better the quality of life; the lower the score in the symptom scale, the better the quality of life.
Time Frame
baseline (one week after recruited)
Title
Quality of Life (EORTC QLQ-C30 )
Description
The EORTC QLQ-C30 :This scale is measured by the respondent self-assessed the frequency of various problems in the past week. The EORTC QLQ-C30 consists of three subscales with 30 questions. The EORTC QLQ-C30 have three subscales in the scale include functioning scales (15 questions), symptom scales (13 questions), and global health status (2 questions). The reliability and validity of Cronbach'α was 0.81-0.94. The functional scale and the global health status , the higher the total score, the better the quality of life; the lower the score in the symptom scale, the better the quality of life.
Time Frame
1st month after recruited
Title
Quality of Life (EORTC QLQ-C30)
Description
The EORTC QLQ-C30 :This scale is measured by the respondent self-assessed the frequency of various problems in the past week. The EORTC QLQ-C30 consists of three subscales with 30 questions. The EORTC QLQ-C30 have three subscales in the scale include functioning scales (15 questions), symptom scales (13 questions), and global health status (2 questions). The reliability and validity of Cronbach'α was 0.81-0.94. The functional scale and the global health status , the higher the total score, the better the quality of life; the lower the score in the symptom scale, the better the quality of life.
Time Frame
2nd month after recruited
Title
Quality of Life (EORTC QLQ-C30)
Description
The EORTC QLQ-C30 :This scale is measured by the respondent self-assessed the frequency of various problems in the past week. The EORTC QLQ-C30 consists of three subscales with 30 questions. The EORTC QLQ-C30 have three subscales in the scale include functioning scales (15 questions), symptom scales (13 questions), and global health status (2 questions). The reliability and validity of Cronbach'α was 0.81-0.94. The functional scale and the global health status , the higher the total score, the better the quality of life; the lower the score in the symptom scale, the better the quality of life.
Time Frame
3rd month after recruited
Title
Quality of Life (EORTC QLQ-C30)
Description
The EORTC QLQ-C30 :This scale is measured by the respondent self-assessed the frequency of various problems in the past week. The EORTC QLQ-C30 consists of three subscales with 30 questions. The EORTC QLQ-C30 have three subscales in the scale include functioning scales (15 questions), symptom scales (13 questions), and global health status (2 questions). The reliability and validity of Cronbach'α was 0.81-0.94. The functional scale and the global health status , the higher the total score, the better the quality of life; the lower the score in the symptom scale, the better the quality of life.
Time Frame
6th month after recruited
Title
Quality of Life (EORTC QLQ-C30)
Description
The EORTC QLQ-C30 :This scale is measured by the respondent self-assessed the frequency of various problems in the past week. The EORTC QLQ-C30 consists of three subscales with 30 questions. The EORTC QLQ-C30 have three subscales in the scale include functioning scales (15 questions), symptom scales (13 questions), and global health status (2 questions). The reliability and validity of Cronbach'α was 0.81-0.94. The functional scale and the global health status , the higher the total score, the better the quality of life; the lower the score in the symptom scale, the better the quality of life.
Time Frame
12th month after recruited
Title
Quality of Life (EORTC QLQ-C30)
Description
The EORTC QLQ-C30 :This scale is measured by the respondent self-assessed the frequency of various problems in the past week. The EORTC QLQ-C30 consists of three subscales with 30 questions. The EORTC QLQ-C30 have three subscales in the scale include functioning scales (15 questions), symptom scales (13 questions), and global health status (2 questions). The reliability and validity of Cronbach'α was 0.81-0.94. The functional scale and the global health status , the higher the total score, the better the quality of life; the lower the score in the symptom scale, the better the quality of life.
Time Frame
24th month after recruited
Title
Quality of Life (EORTC QLQ-C30)
Description
The EORTC QLQ-C30 :This scale is measured by the respondent self-assessed the frequency of various problems in the past week. The EORTC QLQ-C30 consists of three subscales with 30 questions. The EORTC QLQ-C30 have three subscales in the scale include functioning scales (15 questions), symptom scales (13 questions), and global health status (2 questions). The reliability and validity of Cronbach'α was 0.81-0.94. The functional scale and the global health status , the higher the total score, the better the quality of life; the lower the score in the symptom scale, the better the quality of life.
Time Frame
36th month after recruited
Title
Quality of Life (EORTC QLQ-STO22)
Description
The EORTC QLQ-STO22:This scale is measured by the respondent self-assessed the frequency of various problems in the past week. The EORTC QLQ-STO22 consists of one subscale with 22 questions.The EORTC QLQ-STO22 scale include symptom scales (22 questions) The Cronbach'α was 0.70-0.94.The lower the score in the symptom scale, the better the quality of life.
Time Frame
baseline (one week after recruited)
Title
Quality of Life (EORTC QLQ-STO22)
Description
The EORTC QLQ-STO22:This scale is measured by the respondent self-assessed the frequency of various problems in the past week. The EORTC QLQ-STO22 consists of one subscale with 22 questions.The EORTC QLQ-STO22 scale include symptom scales (22 questions) The Cronbach'α was 0.70-0.94.The lower the score in the symptom scale, the better the quality of life.
Time Frame
1st month after recruited
Title
Quality of Life (EORTC QLQ-STO22)
Description
The EORTC QLQ-STO22:This scale is measured by the respondent self-assessed the frequency of various problems in the past week. The EORTC QLQ-STO22 consists of one subscale with 22 questions.The EORTC QLQ-STO22 scale include symptom scales (22 questions) The Cronbach'α was 0.70-0.94.The lower the score in the symptom scale, the better the quality of life.
Time Frame
2nd month after recruited
Title
Quality of Life (EORTC QLQ-STO22)
Description
The EORTC QLQ-STO22:This scale is measured by the respondent self-assessed the frequency of various problems in the past week. The EORTC QLQ-STO22 consists of one subscale with 22 questions.The EORTC QLQ-STO22 scale include symptom scales (22 questions) The Cronbach'α was 0.70-0.94.The lower the score in the symptom scale, the better the quality of life.
Time Frame
3rd month after recruited
Title
Quality of Life (EORTC QLQ-STO22)
Description
The EORTC QLQ-STO22:This scale is measured by the respondent self-assessed the frequency of various problems in the past week. The EORTC QLQ-STO22 consists of one subscale with 22 questions.The EORTC QLQ-STO22 scale include symptom scales (22 questions) The Cronbach'α was 0.70-0.94.The lower the score in the symptom scale, the better the quality of life.
Time Frame
6th month after recruited
Title
Quality of Life (EORTC QLQ-STO22)
Description
The EORTC QLQ-STO22:This scale is measured by the respondent self-assessed the frequency of various problems in the past week. The EORTC QLQ-STO22 consists of one subscale with 22 questions.The EORTC QLQ-STO22 scale include symptom scales (22 questions) The Cronbach'α was 0.70-0.94.The lower the score in the symptom scale, the better the quality of life.
Time Frame
12th month after recruited
Title
Quality of Life (EORTC QLQ-STO22)
Description
The EORTC QLQ-STO22:This scale is measured by the respondent self-assessed the frequency of various problems in the past week. The EORTC QLQ-STO22 consists of one subscale with 22 questions.The EORTC QLQ-STO22 scale include symptom scales (22 questions) The Cronbach'α was 0.70-0.94.The lower the score in the symptom scale, the better the quality of life.
Time Frame
24th month after recruited
Title
Quality of Life (EORTC QLQ-STO22)
Description
The EORTC QLQ-STO22:This scale is measured by the respondent self-assessed the frequency of various problems in the past week. The EORTC QLQ-STO22 consists of one subscale with 22 questions.The EORTC QLQ-STO22 scale include symptom scales (22 questions) The Cronbach'α was 0.70-0.94.The lower the score in the symptom scale, the better the quality of life.
Time Frame
36th month after recruited
Secondary Outcome Measure Information:
Title
fatigue(Brief Fatigue Inventory-Taiwan , BFI-T)
Description
The scale is measured by the respondent self-assessed the frequency of various problems with activities of daily living in 24 hours. BFI-T has 9 questions in total； it is a self-reported 11-Point Likert Scale. Retest reliability was 0.89-0.97.
Time Frame
baseline (one week after recruited)
Title
fatigue(Brief Fatigue Inventory-Taiwan , BFI-T)
Description
The scale is measured by the respondent self-assessed the frequency of various problems with activities of daily living in 24 hours. BFI-T has 9 questions in total；it is a self-reported 11-Point Likert Scale. Retest reliability was 0.89-0.97.
Time Frame
1st month after recruited
Title
fatigue(Brief Fatigue Inventory-Taiwan , BFI-T)
Description
The scale is measured by the respondent self-assessed the frequency of various problems with activities of daily living in 24 hours. BFI-T has 9 questions in total；it is a self-reported 11-Point Likert Scale. Retest reliability was 0.89-0.97.
Time Frame
2nd month after recruited
Title
fatigue(Brief Fatigue Inventory-Taiwan , BFI-T)
Description
The scale is measured by the respondent self-assessed the frequency of various problems with activities of daily living in 24 hours. BFI-T has 9 questions in total； it is a self-reported 11-Point Likert Scale. Retest reliability was 0.89-0.97.
Time Frame
3rd month after recruited
Title
fatigue(Brief Fatigue Inventory-Taiwan , BFI-T)
Description
The scale is measured by the respondent self-assessed the frequency of various problems with activities of daily living in 24 hours. BFI-T has 9 questions in total； it is a self-reported 11-Point Likert Scale. Retest reliability was 0.89-0.97.
Time Frame
6th month after recruited
Title
fatigue(Brief Fatigue Inventory-Taiwan , BFI-T)
Description
The scale is measured by the respondent self-assessed the frequency of various problems with activities of daily living in 24 hours. BFI-T has 9 questions in total； it is a self-reported 11-Point Likert Scale. Retest reliability was 0.89-0.97.
Time Frame
12th month after recruited
Title
fatigue(Brief Fatigue Inventory-Taiwan , BFI-T)
Description
The scale is measured by the respondent self-assessed the frequency of various problems with activities of daily living in 24 hours. BFI-T has 9 questions in total； it is a self-reported 11-Point Likert Scale. Retest reliability was 0.89-0.97.
Time Frame
24th month after recruited
Title
fatigue(Brief Fatigue Inventory-Taiwan , BFI-T)
Description
The scale is measured by the respondent self-assessed the frequency of various problems with activities of daily living in 24 hours. BFI-T has 9 questions in total； it is a self-reported 11-Point Likert Scale. Retest reliability was 0.89-0.97.
Time Frame
36th month after recruited
Title
Emotional distress( Hospital Anxiety and Depression Scale, HADS)
Description
Emotional distress including anxiety and depression (Hospital Anxiety and Depression Scale). The Hospital Anxiety and Depression Scale include anxiety and depression subscales, a total of 7 questions, each subscale is a four-point scoring method, 0 point for "not at all", 3 points for "always do", each subscale scores is between 0 and 21, that a score of 7 or less for non-cases, scores of 8-10 for doubtful cases and scores of 11 or more for definite cases.
Time Frame
baseline (one week after recruited)
Title
Emotional distress( Hospital Anxiety and Depression Scale, HADS)
Description
Emotional distress including anxiety and depression (Hospital Anxiety and Depression Scale). The Hospital Anxiety and Depression Scale include anxiety and depression subscales, a total of 7 questions, each subscale is a four-point scoring method, 0 point for "not at all", 3 points for "always do", each subscale scores is between 0 and 21, that a score of 7 or less for non-cases, scores of 8-10 for doubtful cases and scores of 11 or more for definite cases.
Time Frame
1st month after recruited
Title
Emotional distress( Hospital Anxiety and Depression Scale, HADS)
Description
Emotional distress including anxiety and depression (Hospital Anxiety and Depression Scale). The Hospital Anxiety and Depression Scale include anxiety and depression subscales, a total of 7 questions, each subscale is a four-point scoring method, 0 point for "not at all", 3 points for "always do", each subscale scores is between 0 and 21, that a score of 7 or less for non-cases, scores of 8-10 for doubtful cases and scores of 11 or more for definite cases.
Time Frame
2nd month after recruited
Title
Emotional distress( Hospital Anxiety and Depression Scale, HADS)
Description
Emotional distress including anxiety and depression (Hospital Anxiety and Depression Scale). The Hospital Anxiety and Depression Scale include anxiety and depression subscales, a total of 7 questions, each subscale is a four-point scoring method, 0 point for "not at all", 3 points for "always do", each subscale scores is between 0 and 21, that a score of 7 or less for non-cases, scores of 8-10 for doubtful cases and scores of 11 or more for definite cases.
Time Frame
3rd month after recruited
Title
Emotional distress( Hospital Anxiety and Depression Scale, HADS)
Description
Emotional distress including anxiety and depression (Hospital Anxiety and Depression Scale). The Hospital Anxiety and Depression Scale include anxiety and depression subscales, a total of 7 questions, each subscale is a four-point scoring method, 0 point for "not at all", 3 points for "always do", each subscale scores is between 0 and 21, that a score of 7 or less for non-cases, scores of 8-10 for doubtful cases and scores of 11 or more for definite cases.
Time Frame
6th month after recruited
Title
Emotional distress( Hospital Anxiety and Depression Scale, HADS)
Description
Emotional distress including anxiety and depression (Hospital Anxiety and Depression Scale). The Hospital Anxiety and Depression Scale include anxiety and depression subscales, a total of 7 questions, each subscale is a four-point scoring method, 0 point for "not at all", 3 points for "always do", each subscale scores is between 0 and 21, that a score of 7 or less for non-cases, scores of 8-10 for doubtful cases and scores of 11 or more for definite cases.
Time Frame
12th month after recruited
Title
Emotional distress( Hospital Anxiety and Depression Scale, HADS)
Description
Emotional distress including anxiety and depression (Hospital Anxiety and Depression Scale). The Hospital Anxiety and Depression Scale include anxiety and depression subscales, a total of 7 questions, each subscale is a four-point scoring method, 0 point for "not at all", 3 points for "always do", each subscale scores is between 0 and 21, that a score of 7 or less for non-cases, scores of 8-10 for doubtful cases and scores of 11 or more for definite cases.
Time Frame
24th month after recruited
Title
Emotional distress( Hospital Anxiety and Depression Scale, HADS)
Description
Emotional distress including anxiety and depression (Hospital Anxiety and Depression Scale). The Hospital Anxiety and Depression Scale include anxiety and depression subscales, a total of 7 questions, each subscale is a four-point scoring method, 0 point for "not at all", 3 points for "always do", each subscale scores is between 0 and 21, that a score of 7 or less for non-cases, scores of 8-10 for doubtful cases and scores of 11 or more for definite cases.
Time Frame
36th month after recruited
Title
sleep quality(Pittsburgh Sleep Quality Index and using Actigraph)
Description
The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if one is available). Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. Actigraph is the gold standard for evaluating sleep disorders. As the name suggests, it is an electrophysiological recording of multiple parameters, including total sleep time(TST), sleep efficiency(SE), and sleep onset latency(SOL) which help to score various sleep stages.
Time Frame
baseline (one week after recruited)
Title
sleep quality(Pittsburgh Sleep Quality Index and using Actigraph)
Description
The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if one is available). Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. Actigraph is the gold standard for evaluating sleep disorders. As the name suggests, it is an electrophysiological recording of multiple parameters, including total sleep time(TST), sleep efficiency(SE), and sleep onset latency(SOL) which help to score various sleep stages.
Time Frame
3rd month after recruited
Title
sleep quality(Pittsburgh Sleep Quality Index and using Actigraph)
Description
The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if one is available). Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. Actigraph is the gold standard for evaluating sleep disorders. As the name suggests, it is an electrophysiological recording of multiple parameters, including total sleep time(TST), sleep efficiency(SE), and sleep onset latency(SOL) which help to score various sleep stages.
Time Frame
6th month after recruited
Title
sleep quality(Pittsburgh Sleep Quality Index and using Actigraph)
Description
The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if one is available). Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. Actigraph is the gold standard for evaluating sleep disorders. As the name suggests, it is an electrophysiological recording of multiple parameters, including total sleep time(TST), sleep efficiency(SE), and sleep onset latency(SOL) which help to score various sleep stages.
Time Frame
12th month after recruited
Title
sleep quality(Pittsburgh Sleep Quality Index and using Actigraph)
Description
The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if one is available). Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. Actigraph is the gold standard for evaluating sleep disorders. As the name suggests, it is an electrophysiological recording of multiple parameters, including total sleep time(TST), sleep efficiency(SE), and sleep onset latency(SOL) which help to score various sleep stages.
Time Frame
24th month after recruited
Title
sleep quality(Pittsburgh Sleep Quality Index and using Actigraph)
Description
The Pittsburgh Sleep Quality Index (PSQI) contains 19 self-rated questions and 5 questions rated by the bed partner or roommate (if one is available). Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. Actigraph is the gold standard for evaluating sleep disorders. As the name suggests, it is an electrophysiological recording of multiple parameters, including total sleep time(TST), sleep efficiency(SE), and sleep onset latency(SOL) which help to score various sleep stages.
Time Frame
36th month after recruited
Title
Circadian rhythms(using Actigraph)
Description
Circadian rhythms including 24-h autocorrelation coefficient (r24) and in bed less than out of bed dichotomy index (I<O) collection from actigraphy.
Time Frame
baseline (one week after recruited)
Title
Circadian rhythms(using Actigraph)
Description
Circadian rhythms including 24-h autocorrelation coefficient (r24) and in bed less than out of bed dichotomy index (I<O) collection from actigraphy.
Time Frame
3rd month after recruited
Title
Circadian rhythms(using Actigraph)
Description
Circadian rhythms including 24-h autocorrelation coefficient (r24) and in bed less than out of bed dichotomy index (I<O) collection from actigraphy.
Time Frame
6th month after recruited
Title
Circadian rhythms(using Actigraph)
Description
Circadian rhythms including 24-h autocorrelation coefficient (r24) and in bed less than out of bed dichotomy index (I<O) collection from actigraphy.
Time Frame
12th month after recruited
Title
Circadian rhythms(using Actigraph)
Description
Circadian rhythms including 24-h autocorrelation coefficient (r24) and in bed less than out of bed dichotomy index (I<O) collection from actigraphy.
Time Frame
24th month after recruited
Title
Circadian rhythms(using Actigraph)
Description
Circadian rhythms including 24-h autocorrelation coefficient (r24) and in bed less than out of bed dichotomy index (I<O) collection from actigraphy.
Time Frame
36th month after recruited

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: After undergoing surgery and clinically diagnosed as gastric cancer. Adults over 20 years old. Hemoglobin (above 10 g/dL). Clear consciousness and could communicate in either Mandarin or Taiwanese, and were not cognitively impaired were included. No lower limb disability and able to walk on their own. Exclusion Criteria: Suspected or confirmed bone metastasis. Poorly controlled cardiovascular disease such as heart failure, arrhythmia, angina, myocardial infarction, chest pain during activities or rest in the past three months, and valvular heart disease using anticoagulants. Poorly diabetes controlled, glycosylated hemoglobin (HbA1C)>9%, blood sugar higher than 250mg/dl or lower than 80mg/dl. Those with poor blood pressure control, systolic blood pressure greater than 160mmHg or diastolic blood pressure than 100mmHg when quiet, and heart rate is greater than 100bpm when quiet. Diagnosed as recurrent depression. Regular exercise above moderate intensity, such as 150 minutes per week in the past three months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pei-Shan Ho, BSN
Phone
886-933937197
Email
psho@vghtpe.gov.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Hui-Mei Chen, PhD
Phone
886-939654302
Email
alice@ntunhs.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui-Mei Chen, PhD
Organizational Affiliation
National Taipei University of Nursing and Health Sciences, Taipei, Taiwan
Official's Role
Study Chair
Facility Information:
Facility Name
Taipei Veterans General Hospital
City
Taipei county
ZIP/Postal Code
112
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taipei Veterans General Hospital
Phone
+886-2-2875-7808

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD Sharing Time Frame
Beginning 12 months following article publication
IPD Sharing Access Criteria
Researchers who provide a methodologically sound proposal and receive the authors consent.

Learn more about this trial

Effectiveness of Exercise Program in Improving Quality of Life in Patients With Gastric Cancer Undergoing Gastrectomy

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