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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

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.


Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Behavioral: colorectal cancer self-management Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
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
Official Title: Developing and Testing a Self-management Support Intervention in Colorectal Cancer Survivors: A Mixed-methods Study
Actual Study Start Date : January 15, 2018
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.

No Intervention: No intervention control group
The control group will receive health education leaflets.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03853278


Contacts
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Contact: Tsae Jyy Wang, PhD +886911246130 tsaejyy@ntunhs.edu.tw
Contact: En Yue Lin +886983725320 judy757320@gmail.com

Locations
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Taiwan
Mackay Memorial Hospital Recruiting
Taipei, Taiwan, 104
Sub-Investigator: Wen Chien Huang, PhD         
Cathay General Hospital Recruiting
Taipei, Taiwan, 106
Sub-Investigator: Shih Chang Chang         
Sponsors and Collaborators
National Taipei University of Nursing and Health Sciences
Ministry of Science and Technology, Taiwan
Mackay Memorial Hospital
Cathay General Hospital
Investigators
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Principal Investigator: Tsae Jyy Wang, PhD National Taipei University of Nursing and Health Sciences

Publications:
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Responsible Party: Tsae Jyy, Wang, RN PhD Professor, National Taipei University of Nursing and Health Sciences
ClinicalTrials.gov Identifier: NCT03853278     History of Changes
Other Study ID Numbers: 107-2314-B-227-001-MY2
First Posted: February 25, 2019    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tsae Jyy, Wang, National Taipei University of Nursing and Health Sciences:
Colorectal Neoplasms
self-management support
cancer survivor
healthy life styles

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases