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Effectiveness of a Rehabilitation Program in Improving Quality of Life in Patients With Esophageal Cancer

Primary Purpose

Esophageal Cancer

Status
Active
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
exercise and dietary education
weekly telephone consultations concerning exercise and diet.
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 Esophageal Cancer

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with esophageal cancer who were aged ≥20 years, could communicate in either Mandarin or Taiwanese, and were not cognitively impaired were included.

Exclusion Criteria:

-

Sites / Locations

  • National Taipei University of Nursing and Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

exercise group

usual-care group

Arm Description

The rehabilitation program was composed of two parts: an exercise program and a diet-teaching program. The exercise program was a 12-week home-based program that comprised moderate-intensity brisk walking for 40 min per session, with 3 sessions per week; in addition, weekly exercise counseling was provided through telephone. The diet teaching program was provided to the patients by using a diet booklet at baseline (same timing as the exercise program), and its contents were used to instruct the patients regarding dietary principles to be followed.

The control group (CG) received usual care, whereas a nurse, the manager for esophageal cancer treatment, provided routine care, conducted follow-ups, and offered information on esophageal cancer to the experimental group (EG).

Outcomes

Primary Outcome Measures

Quality of life (EORTC QLQ-C30 )
using European Organization for Research and Treatment cancer QLQ-C30 (EORTC) to measure quality of life.
Quality of life (EORTC QLQ-C30 )
using European Organization for Research and Treatment cancer QLQ-C30 (EORTC) to measure quality of life.
Quality of life (EORTC QLQ-C30 )
using European Organization for Research and Treatment cancer QLQ-C30 (EORTC) to measure quality of life.
Quality of life (EORTC QLQ-C30 )
using European Organization for Research and Treatment cancer QLQ-C30 (EORTC) to measure quality of life.
Quality of life (EORTC QLQ-C30 )
using European Organization for Research and Treatment cancer QLQ-C30 (EORTC) to measure quality of life.
Quality of life (EORTC QLQ-C30 )
using European Organization for Research and Treatment cancer QLQ-C30 (EORTC) to measure quality of life.
Quality of life (EORTC QLQ-OES 18 )
using European Organization for Research and Treatment cancer QLQ-OES 18 (EORTC) to measure quality of life.
Quality of life (EORTC QLQ-OES 18 )
using European Organization for Research and Treatment cancer QLQ-OES 18 (EORTC) to measure quality of life.
Quality of life (EORTC QLQ-OES 18 )
using European Organization for Research and Treatment cancer QLQ-OES 18 (EORTC) to measure quality of life.
Quality of life (EORTC QLQ-OES 18 )
using European Organization for Research and Treatment cancer QLQ-OES 18 (EORTC) to measure quality of life.
Quality of life (EORTC QLQ-OES 18 )
using European Organization for Research and Treatment cancer QLQ-OES 18 (EORTC) to measure quality of life.
Quality of life (EORTC QLQ-OES 18 )
using European Organization for Research and Treatment cancer QLQ-OES 18 (EORTC) to measure quality of life.

Secondary Outcome Measures

Subjective sleep quality
using Pittsburgh Sleep Quality Index
Subjective sleep quality
using Pittsburgh Sleep Quality Index
Subjective sleep quality
using Pittsburgh Sleep Quality Index
Subjective sleep quality
using Pittsburgh Sleep Quality Index
Subjective sleep quality
using Pittsburgh Sleep Quality Index
Subjective sleep quality
using Pittsburgh Sleep Quality Index
Objective sleep quality
using Actigraph for measure Objective sleep quality
Objective sleep quality
using Actigraph for measure Objective sleep quality
Objective sleep quality
using Actigraph for measure Objective sleep quality
Objective sleep quality
using Actigraph for measure Objective sleep quality
Objective sleep quality
using Actigraph for measure Objective sleep quality
Objective sleep quality
using Actigraph for measure Objective sleep quality
Emotional distress
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.
Circadian rhythms
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
May 17, 2017
Last Updated
August 21, 2023
Sponsor
Taipei Veterans General Hospital, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT03161535
Brief Title
Effectiveness of a Rehabilitation Program in Improving Quality of Life in Patients With Esophageal Cancer
Official Title
Effectiveness of a Rehabilitation Program in Improving Sleep Quality, Emotional Distress, Circadian Rhythms, and Quality of Life in Patients With Esophageal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 19, 2017 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (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 sleep quality, emotional distress, circadian rhythms, and quality of life in patients with esophageal cancer in Taiwan. Hypothesis: The quality of life in exercise group is significant improving than usual-care group at 3rd, 6th, 12th, 24th, and 36th month. The quality of sleep in exercise group is significant improving than usual-care group at 3rd, 6th, 12th, 24th, and 36th month. The emotional distress in exercise group is significant improving than usual-care group at 3rd, 6th, 12th, 24th, and 36th month. The circadian rhythms in exercise group is significant improving than usual-care group at 3rd, 6th, 12th, 24th, and 36th month.
Detailed Description
This study will investigate the effectiveness of a rehabilitation program in improving sleep quality, emotional distress, circadian rhythms, and quality of life in patients with esophageal cancer in Taiwan.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
exercise group
Arm Type
Experimental
Arm Description
The rehabilitation program was composed of two parts: an exercise program and a diet-teaching program. The exercise program was a 12-week home-based program that comprised moderate-intensity brisk walking for 40 min per session, with 3 sessions per week; in addition, weekly exercise counseling was provided through telephone. The diet teaching program was provided to the patients by using a diet booklet at baseline (same timing as the exercise program), and its contents were used to instruct the patients regarding dietary principles to be followed.
Arm Title
usual-care group
Arm Type
No Intervention
Arm Description
The control group (CG) received usual care, whereas a nurse, the manager for esophageal cancer treatment, provided routine care, conducted follow-ups, and offered information on esophageal cancer to the experimental group (EG).
Intervention Type
Other
Intervention Name(s)
exercise and dietary education
Intervention Description
A 12-week regimen of home-based walking exercises, comprising walking at a moderate intensity for 40 min, three times a week, was administered along with weekly exercise counseling. After collecting pretrial measurements, we explained the participants how to perform the exercises, according to an instruction manual for the exercise regimen. The detailed instructions, provided at the hospital clinics, included the determination of activity intensity, demonstration of pulse measurement, criteria for scores of 6-20 on the Borg's rating of perceived exertion (RPE), prevention of exercise-related injuries, and conditions necessitating termination of an exercise session. Participants were instructed that the exercises would be effective only if they reached 60%-80% of the target heart rate, as determined by the Karvonen method, and 13-15 on the RPE. Diet-teaching program (using dietary education booklet).
Intervention Type
Other
Intervention Name(s)
weekly telephone consultations concerning exercise and diet.
Intervention Description
For each participant, we discussed exercise regimen-related issues and diet weekly through the telephone. For instance, we discussed whether participants' exercise fulfilled the prescribed intensity, duration, or frequency and whether the participants experienced any adverse effects.
Primary Outcome Measure Information:
Title
Quality of life (EORTC QLQ-C30 )
Description
using European Organization for Research and Treatment cancer QLQ-C30 (EORTC) to measure quality of life.
Time Frame
baseline
Title
Quality of life (EORTC QLQ-C30 )
Description
using European Organization for Research and Treatment cancer QLQ-C30 (EORTC) to measure quality of life.
Time Frame
3rd month after recruited
Title
Quality of life (EORTC QLQ-C30 )
Description
using European Organization for Research and Treatment cancer QLQ-C30 (EORTC) to measure quality of life.
Time Frame
6th month after recruited
Title
Quality of life (EORTC QLQ-C30 )
Description
using European Organization for Research and Treatment cancer QLQ-C30 (EORTC) to measure quality of life.
Time Frame
12th month after recruited
Title
Quality of life (EORTC QLQ-C30 )
Description
using European Organization for Research and Treatment cancer QLQ-C30 (EORTC) to measure quality of life.
Time Frame
24th month after recruited
Title
Quality of life (EORTC QLQ-C30 )
Description
using European Organization for Research and Treatment cancer QLQ-C30 (EORTC) to measure quality of life.
Time Frame
36th month after recruited
Title
Quality of life (EORTC QLQ-OES 18 )
Description
using European Organization for Research and Treatment cancer QLQ-OES 18 (EORTC) to measure quality of life.
Time Frame
baseline
Title
Quality of life (EORTC QLQ-OES 18 )
Description
using European Organization for Research and Treatment cancer QLQ-OES 18 (EORTC) to measure quality of life.
Time Frame
3rd month after recruited
Title
Quality of life (EORTC QLQ-OES 18 )
Description
using European Organization for Research and Treatment cancer QLQ-OES 18 (EORTC) to measure quality of life.
Time Frame
6th month after recruited
Title
Quality of life (EORTC QLQ-OES 18 )
Description
using European Organization for Research and Treatment cancer QLQ-OES 18 (EORTC) to measure quality of life.
Time Frame
12th month after recruited
Title
Quality of life (EORTC QLQ-OES 18 )
Description
using European Organization for Research and Treatment cancer QLQ-OES 18 (EORTC) to measure quality of life.
Time Frame
24th month after recruited
Title
Quality of life (EORTC QLQ-OES 18 )
Description
using European Organization for Research and Treatment cancer QLQ-OES 18 (EORTC) to measure quality of life.
Time Frame
36th month after recruited
Secondary Outcome Measure Information:
Title
Subjective sleep quality
Description
using Pittsburgh Sleep Quality Index
Time Frame
baseline
Title
Subjective sleep quality
Description
using Pittsburgh Sleep Quality Index
Time Frame
3rd month after recruited
Title
Subjective sleep quality
Description
using Pittsburgh Sleep Quality Index
Time Frame
6th month after recruited
Title
Subjective sleep quality
Description
using Pittsburgh Sleep Quality Index
Time Frame
12th month after recruited
Title
Subjective sleep quality
Description
using Pittsburgh Sleep Quality Index
Time Frame
24th month after recruited
Title
Subjective sleep quality
Description
using Pittsburgh Sleep Quality Index
Time Frame
36th month after recruited
Title
Objective sleep quality
Description
using Actigraph for measure Objective sleep quality
Time Frame
baseline
Title
Objective sleep quality
Description
using Actigraph for measure Objective sleep quality
Time Frame
3rd month after recruited
Title
Objective sleep quality
Description
using Actigraph for measure Objective sleep quality
Time Frame
6th month after recruited
Title
Objective sleep quality
Description
using Actigraph for measure Objective sleep quality
Time Frame
12th month after recruited
Title
Objective sleep quality
Description
using Actigraph for measure Objective sleep quality
Time Frame
24th month after recruited
Title
Objective sleep quality
Description
using Actigraph for measure Objective sleep quality
Time Frame
36th month after recruited
Title
Emotional distress
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, 3rd month, 6th month, 12th month, 24th month, and 36th month after recruited
Title
Circadian rhythms
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, 3rd month, 6th month, 12th month, 24th month, and 36th month after recruited

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with esophageal cancer who were aged ≥20 years, could communicate in either Mandarin or Taiwanese, and were not cognitively impaired were included. Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui-Mei Chen, PhD
Organizational Affiliation
National Taipei University of Nursing and Health Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
YU-CHUNG WU, M.D.
Organizational Affiliation
Taipei Veterans General Hospital, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taipei University of Nursing and Health Sciences
City
Taipei
ZIP/Postal Code
112
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
33813524
Citation
Chen HM, Lin YY, Wu YC, Huang CS, Hsu PK, Chien LI, Lin YJ, Huang HL. Effects of Rehabilitation Program on Quality of Life, Sleep, Rest-Activity Rhythms, Anxiety, and Depression of Patients With Esophageal Cancer: A Pilot Randomized Controlled Trial. Cancer Nurs. 2022 Mar-Apr 01;45(2):E582-E593. doi: 10.1097/NCC.0000000000000953.
Results Reference
derived

Learn more about this trial

Effectiveness of a Rehabilitation Program in Improving Quality of Life in Patients With Esophageal Cancer

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