Clinical trial NCT03853278: 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
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Neoplasms
Keywords: Colorectal Neoplasms
self-management support
cancer survivor
healthy life styles
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Taiwan
name: Mackay Memorial Hospital
name: Cathay General Hospital
First posted: 2019-02-25
Enrollment: 165
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional Assessment of Cancer Therapy- Colorectal
timeFrame: Change from Baseline to 6 months
Secondary outcomes:
measure: International Physical Activity Questionnaire
timeFrame: Change from Baseline to 6 months
measure: Eating at America's Table Study-Quick Food Scan
timeFrame: Change from Baseline to 6 months
measure: Body weight scale
timeFrame: Change from Baseline to 6 months
measure: Pittsburgh Sleep Quality Index
timeFrame: Change from Baseline to 6 months
measure: Hospital Anxiety and Depression Scale
timeFrame: Change from Baseline to 6 months
measure: The Functional Assessment of Chronic Illness Therapy-Fatigue
timeFrame: Change from Baseline to 6 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
city: Taipei
country: Taiwan
facility: Cathay General Hospital
Study officials:
affiliation: National Taipei University of Nursing and Health Sciences
name: Tsae Jyy Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.