Self-management Support for Colorectal Cancer Survivors Colorectal Cancer Survivors: A Mixed-methods Study
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Colorectal Neoplasms
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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: 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.Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 20 years and 125 years
- Gender
- Both males and females
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 tre...
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.
Tracking Information
- NCT #
- NCT03853278
- Collaborators
- Ministry of Science and Technology, Taiwan
- Mackay Memorial Hospital
- Cathay General Hospital
- Investigators
- Principal Investigator: Tsae Jyy Wang, PhD National Taipei University of Nursing and Health Sciences