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Self-management Support for Colorectal Cancer Survivors Colorectal Cancer Survivors: A Mixed-methods Study

Primary Purpose

Colorectal Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
colorectal cancer self-management
Sponsored by
National Taipei University of Nursing and Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colorectal Neoplasms focused on measuring Colorectal Neoplasms, self-management support, cancer survivor, healthy life styles

Eligibility Criteria

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

Inclusion Criteria:

  1. Diagnose with Colonrectal cancer (ICD-10 code: C18-C20, C21.8)
  2. Stage I-III Colonrectal cancer
  3. One month post curative cancer incision surgery for patients with cancer stage I-IIA
  4. One month chemotherapy for patients with cancer stage IIB-III
  5. Aged 20 and above
  6. With the permission of the patient's doctor
  7. Able to understand and sign the study inform consent

Exclusion Criteria:

  1. The Eastern Cooperative Oncology Group ,( ECOG) performance score greater or equal to 3.
  2. Diagnose with severe psychological diseases.
  3. Life expectancy less than 3 month.
  4. Had cancers before
  5. Not able to communicate verbally or with writing

Sites / Locations

  • Mackay Memorial Hospital
  • Cathay General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

colorectal cancer self-management

No intervention control group

Arm Description

The intervention includes a colorectal cancer self-management information booklet, a DVD, two individual skill trainings and 12 follow-up telephone calls.These are to establish participants' self-management skills and healthy lifestyle, including physical activity and healthy eating fruits and vegetables.

The control group will receive health education leaflets.

Outcomes

Primary Outcome Measures

Functional Assessment of Cancer Therapy- Colorectal
There are two subscales, 27 items of FACT-General and 9 items of Colorectal Cancer Subscale. Each item is rated on a 5-point Likert scale (0-4). The total score of the 36 items represents the score of the scale. The possible score for the scale ranges from 0 to 136. The higher values represent better quality of life.

Secondary Outcome Measures

International Physical Activity Questionnaire
The Taiwan Version of International Physical Activity Questionnaire is used to measure a patient's physical activity. The scale has 7 items, asking patients the time they spent on walking, moderate, and vigorous physical activities during the past 7 days. The amounts of time spent on walking, moderate and vigorous physical activities are then multiplied by 3.3, 4.0, and 8.0 MET, respectively. The sum of the METs-min/wk for three types physically actives is the total score of the scale.
Eating at America's Table Study-Quick Food Scan
The scale measures a patient's intake of vegetables and fruits in the past month. There are 10 items in the scale, asking the amount and frequency of eating nine different types of vegetables and fruits. The frequency multiplied by the amount represents the total amount of vegetables and fruits consumed in the past month. The higher values indicate more vegetables and fruits patient consumed.
Body weight scale
The Body Mass Index (BMI) is calculated by the patient's body weight (kilograms) divided by height (meters) to the second power. Underweight is the BMI lower than18.5. Normal weight is the BMI higher or equal than18.5 and lower than 24. The overweight is the BMI higher or equal than 24 and lower than 27. The obese is the BMI higher or equal than 35.
Pittsburgh Sleep Quality Index
There are 10 items in the scale. Each item is rated on a 4-point Likert scale (0-3). The 10 items consist 7 dimensions. The total score of seven dimensions represents the scale score. The possible score for the scale ranges from 0 to 21. The higher values represent worse sleep quality.
Hospital Anxiety and Depression Scale
There are two subscales, HADS Anxiety and HADS Depression. Each subscale has 7 items. The possible score for each subscale scale ranges from 0 to 21. The higher values represent more anxiety or depression.
The Functional Assessment of Chronic Illness Therapy-Fatigue
There are 13 items in the scale. Each item is rated on a 5-point Likert scale (0-4). The total score of the 13 items represents the score of the scale. The possible score for the scale ranges from 0 to 52. The higher values represent more fatigue.

Full Information

First Posted
February 20, 2019
Last Updated
August 30, 2021
Sponsor
National Taipei University of Nursing and Health Sciences
Collaborators
Ministry of Science and Technology, Taiwan, Mackay Memorial Hospital, Cathay General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03853278
Brief Title
Self-management Support for Colorectal Cancer Survivors Colorectal Cancer Survivors: A Mixed-methods Study
Official Title
Developing and Testing a Self-management Support Intervention in Colorectal Cancer Survivors: A Mixed-methods Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 15, 2018 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
August 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Taipei University of Nursing and Health Sciences
Collaborators
Ministry of Science and Technology, Taiwan, Mackay Memorial Hospital, Cathay General Hospital

4. Oversight

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

5. Study Description

Brief Summary
Background: Survivors of colorectal cancer have to face long-term consequences of the disease and its treatment side effects, which in turn affect mood and psychological well-being. Self-management support may help colorectal cancer survivors to achieve healthy lifestyle and better adjustment. However, there is little research evidence to support it and also no theory-based self-management support interventions specifically designed for colorectal cancer survivors in Taiwan. Aim: The study aims is to test the efficacy of the Acceptance and Commitment Therapy -based self-management support program on the primary outcome, quality of life, and secondary outcomes, physical activity, fruit and vegetative intake, body mass index, sleep quality, emotion distress, and fatigue in colorectal cancer survivors . Design: An experimental design with repeated measures will be used to test the intervention efficacy. A convenient sample of 250 colorectal cancer (stage I-III) survivors who has completed initial treatments will be recruited and randomized to the control or intervention group. The intervention includes a colorectal cancer self-management information booklet, a DVD, two individual skill trainings and 12 follow-up telephone calls. These are to establish participants' self-management skills and healthy lifestyle, including physical activity and healthy eating fruits and vegetables. The control group will receive health education leaflets. Outcome variables will be assessed on the baseline, 2th, 4th, and 6th month in both groups. Descriptive analysis will be used to describe patients' demographics, disease variables, and outcome variables. The Chi-square, t-test, and General Linear Mix-effect Model will be used to test the efficacy of the study interventions.
Detailed Description
Background: Colorectal cancer is the second most commonly diagnosed cancer in Taiwan. The five year relative survival rate of colorectal cancer is 61% and has become the third largest cancer survivor group. Survivors of colorectal cancer have to face long-term consequences of the disease and its treatment side effects, which in turn affect mood and psychological well-being. Overweight and unhealthy lifestyles will further impact on patient's prognosis and quality of life. The current follow-up systems often fail to adequately address patients' complex physical and mental needs. Self-management support may help colorectal cancer survivors to achieve healthy lifestyle and better adjustment. However, there is little research evidence to support it and also no theory-based self-management support interventions specifically designed for colorectal cancer survivors in Taiwan. Aim: The study aims is to test the efficacy of the Acceptance and Commitment Therapy -based self-management support program on the primary outcome, quality of life, and secondary outcomes, physical activity, fruit and vegetative intake, body mass index, sleep quality, emotion distress, and fatigue in colorectal cancer survivors . Design: An experimental design with repeated measures will be used to test the intervention efficacy. A convenient sample of 250 colorectal cancer (stage I-III) survivors who has completed initial treatments will be recruited and randomized to the control or intervention group. The intervention includes a colorectal cancer self-management information booklet, a DVD, two individual skill trainings and 12 follow-up telephone calls. These are to establish participants' self-management skills and healthy lifestyle, including physical activity and healthy eating fruits and vegetables. The control group will receive health education leaflets. Outcome variables will be assessed on the baseline, 2th, 4th, and 6th month in both groups. Instruments: The study instruments include a body weight scale, Hospital Anxiety and Depression Scale, International Physical Activity Questionnaire, Eating at America's Table Study-Quick Food Scan, Pittsburgh Sleep Quality Index, FACIT-Fatigue, and FACT-C. Data analysis: Descriptive analysis will be used to describe patients' demographics, disease variables, and outcome variables. The Chi-square, t-test, and General Linear Mix-effect Model will be used to test the efficacy of the study interventions. Significance: The study results will provide evidence for the efficacy of the self-management support intervention for enhancing healthy life style and quality of life in colorectal cancer survivors.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
Keywords
Colorectal Neoplasms, self-management support, cancer survivor, healthy life styles

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The intervention includes a colorectal cancer self-management information booklet, a DVD, two individual skill training and 12 follow-up telephone calls. These are to establish participants' self-management skills and healthy lifestyle, including physical activity and healthy eating fruits and vegetables. The control group will receive health education leaflets.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The randomization procedure was handled by an independent research assistant. Participants, care providers, investigator and outcomes assessors are blind to the group assignment.
Allocation
Randomized
Enrollment
165 (Actual)

8. Arms, Groups, and Interventions

Arm Title
colorectal cancer self-management
Arm Type
Experimental
Arm Description
The intervention includes a colorectal cancer self-management information booklet, a DVD, two individual skill trainings and 12 follow-up telephone calls.These are to establish participants' self-management skills and healthy lifestyle, including physical activity and healthy eating fruits and vegetables.
Arm Title
No intervention control group
Arm Type
No Intervention
Arm Description
The control group will receive health education leaflets.
Intervention Type
Behavioral
Intervention Name(s)
colorectal cancer self-management
Intervention Description
The intervention includes a colorectal cancer self-management information booklet, a DVD, two individual skill training and 12 follow-up telephone calls. These are to establish participants' self-management skills and healthy lifestyle, including physical activity and healthy eating fruits and vegetables.
Primary Outcome Measure Information:
Title
Functional Assessment of Cancer Therapy- Colorectal
Description
There are two subscales, 27 items of FACT-General and 9 items of Colorectal Cancer Subscale. Each item is rated on a 5-point Likert scale (0-4). The total score of the 36 items represents the score of the scale. The possible score for the scale ranges from 0 to 136. The higher values represent better quality of life.
Time Frame
Change from Baseline to 6 months
Secondary Outcome Measure Information:
Title
International Physical Activity Questionnaire
Description
The Taiwan Version of International Physical Activity Questionnaire is used to measure a patient's physical activity. The scale has 7 items, asking patients the time they spent on walking, moderate, and vigorous physical activities during the past 7 days. The amounts of time spent on walking, moderate and vigorous physical activities are then multiplied by 3.3, 4.0, and 8.0 MET, respectively. The sum of the METs-min/wk for three types physically actives is the total score of the scale.
Time Frame
Change from Baseline to 6 months
Title
Eating at America's Table Study-Quick Food Scan
Description
The scale measures a patient's intake of vegetables and fruits in the past month. There are 10 items in the scale, asking the amount and frequency of eating nine different types of vegetables and fruits. The frequency multiplied by the amount represents the total amount of vegetables and fruits consumed in the past month. The higher values indicate more vegetables and fruits patient consumed.
Time Frame
Change from Baseline to 6 months
Title
Body weight scale
Description
The Body Mass Index (BMI) is calculated by the patient's body weight (kilograms) divided by height (meters) to the second power. Underweight is the BMI lower than18.5. Normal weight is the BMI higher or equal than18.5 and lower than 24. The overweight is the BMI higher or equal than 24 and lower than 27. The obese is the BMI higher or equal than 35.
Time Frame
Change from Baseline to 6 months
Title
Pittsburgh Sleep Quality Index
Description
There are 10 items in the scale. Each item is rated on a 4-point Likert scale (0-3). The 10 items consist 7 dimensions. The total score of seven dimensions represents the scale score. The possible score for the scale ranges from 0 to 21. The higher values represent worse sleep quality.
Time Frame
Change from Baseline to 6 months
Title
Hospital Anxiety and Depression Scale
Description
There are two subscales, HADS Anxiety and HADS Depression. Each subscale has 7 items. The possible score for each subscale scale ranges from 0 to 21. The higher values represent more anxiety or depression.
Time Frame
Change from Baseline to 6 months
Title
The Functional Assessment of Chronic Illness Therapy-Fatigue
Description
There are 13 items in the scale. Each item is rated on a 5-point Likert scale (0-4). The total score of the 13 items represents the score of the scale. The possible score for the scale ranges from 0 to 52. The higher values represent more fatigue.
Time Frame
Change from Baseline to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnose with Colonrectal cancer (ICD-10 code: C18-C20, C21.8) Stage I-III Colonrectal cancer One month post curative cancer incision surgery for patients with cancer stage I-IIA One month chemotherapy for patients with cancer stage IIB-III Aged 20 and above With the permission of the patient's doctor Able to understand and sign the study inform consent Exclusion Criteria: The Eastern Cooperative Oncology Group ,( ECOG) performance score greater or equal to 3. Diagnose with severe psychological diseases. Life expectancy less than 3 month. Had cancers before Not able to communicate verbally or with writing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tsae Jyy Wang, PhD
Organizational Affiliation
National Taipei University of Nursing and Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mackay Memorial Hospital
City
Taipei
ZIP/Postal Code
104
Country
Taiwan
Facility Name
Cathay General Hospital
City
Taipei
ZIP/Postal Code
106
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28280612
Citation
Aminisani N, Nikbakht H, Asghari Jafarabadi M, Shamshirgaran SM. Depression, anxiety, and health related quality of life among colorectal cancer survivors. J Gastrointest Oncol. 2017 Feb;8(1):81-88. doi: 10.21037/jgo.2017.01.12.
Results Reference
background
PubMed Identifier
28248415
Citation
Siegel RL, Miller KD, Fedewa SA, Ahnen DJ, Meester RGS, Barzi A, Jemal A. Colorectal cancer statistics, 2017. CA Cancer J Clin. 2017 May 6;67(3):177-193. doi: 10.3322/caac.21395. Epub 2017 Mar 1.
Results Reference
background
PubMed Identifier
29052663
Citation
Kim SH, Kim K, Mayer DK. Self-Management Intervention for Adult Cancer Survivors After Treatment: A Systematic Review and Meta-Analysis. Oncol Nurs Forum. 2017 Nov 1;44(6):719-728. doi: 10.1188/17.ONF.719-728.
Results Reference
background

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Self-management Support for Colorectal Cancer Survivors Colorectal Cancer Survivors: A Mixed-methods Study

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