Developing and Testing a Self-management Support Intervention in Colorectal Cancer Survivors: A Mixed-methods Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 165
- Locations
- 2
- Primary Endpoint
- Functional Assessment of Cancer Therapy- Colorectal
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes 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.
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Diagnose with severe psychological diseases.
- •Life expectancy less than 3 month.
- •Had cancers before
- •Not able to communicate verbally or with writing
Arms & Interventions
colorectal cancer self-management
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.
Intervention: colorectal cancer self-management (Behavioral)
No intervention control group
The control group will receive health education leaflets.
Outcomes
Primary Outcomes
Functional Assessment of Cancer Therapy- Colorectal
Time Frame: Change from Baseline to 6 months
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 Outcomes
- Body weight scale(Change from Baseline to 6 months)
- Pittsburgh Sleep Quality Index(Change from Baseline to 6 months)
- International Physical Activity Questionnaire(Change from Baseline to 6 months)
- Eating at America's Table Study-Quick Food Scan(Change from Baseline to 6 months)
- Hospital Anxiety and Depression Scale(Change from Baseline to 6 months)
- The Functional Assessment of Chronic Illness Therapy-Fatigue(Change from Baseline to 6 months)
Investigators
Tsae Jyy, Wang
RN PhD Professor
National Taipei University of Nursing and Health Sciences