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

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ClinicalTrials.gov Identifier: NCT03853278
Recruitment Status : Recruiting
First Posted : February 25, 2019
Last Update Posted : February 25, 2019
Sponsor:
Collaborators:
Ministry of Science and Technology, Taiwan
Mackay Memorial Hospital
Cathay General Hospital
Information provided by (Responsible Party):
Tsae Jyy, Wang, National Taipei University of Nursing and Health Sciences

Tracking Information
First Submitted Date  ICMJE February 20, 2019
First Posted Date  ICMJE February 25, 2019
Last Update Posted Date February 25, 2019
Actual Study Start Date  ICMJE January 15, 2018
Estimated Primary Completion Date October 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 22, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 22, 2019)
  • International Physical Activity Questionnaire [ Time Frame: Change from Baseline to 6 months ]
    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 [ Time Frame: Change from Baseline to 6 months ]
    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 [ Time Frame: Change from Baseline to 6 months ]
    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 [ Time Frame: Change from Baseline to 6 months ]
    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 [ Time Frame: Change from Baseline to 6 months ]
    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 [ Time Frame: Change from Baseline to 6 months ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Self-management Support for Colorectal Cancer Survivors Colorectal Cancer Survivors: A Mixed-methods Study
Official Title  ICMJE Developing and Testing a Self-management Support Intervention in Colorectal Cancer Survivors: A Mixed-methods Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
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.
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
Condition  ICMJE Colorectal Neoplasms
Intervention  ICMJE Behavioral: colorectal cancer self-management
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.
Study Arms  ICMJE
  • Experimental: 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: Behavioral: colorectal cancer self-management
  • No Intervention: No intervention control group
    The control group will receive health education leaflets.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 22, 2019)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2020
Estimated Primary Completion Date October 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tsae Jyy Wang, PhD +886911246130 tsaejyy@ntunhs.edu.tw
Contact: En Yue Lin +886983725320 judy757320@gmail.com
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03853278
Other Study ID Numbers  ICMJE 107-2314-B-227-001-MY2
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Tsae Jyy, Wang, National Taipei University of Nursing and Health Sciences
Study Sponsor  ICMJE National Taipei University of Nursing and Health Sciences
Collaborators  ICMJE
  • Ministry of Science and Technology, Taiwan
  • Mackay Memorial Hospital
  • Cathay General Hospital
Investigators  ICMJE
Principal Investigator: Tsae Jyy Wang, PhD National Taipei University of Nursing and Health Sciences
PRS Account National Taipei University of Nursing and Health Sciences
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP