Neoplasms

Digestive System Diseases

All Conditions

Behaviors and Mental Disorders

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Quality of Life

The experimental group will receive the web-based interactive self-management support intervention.

The control group will receive usual care and regular patients education.

The intervention group will receive a 60-90 minute introduction to the web-based interactive self-management support program. They will be instructed to do the weekly online self-assessment on symptoms, emotion, and health behaviors and how to use the web-based program to manage their health by applying self-manage skills and behavior change techniques. The contents of the interactive colorectal cancer self-management website include the following five main components: Health Support Station, Knowledge Supply Station, Sharing Stories, My Dear Friend, and Asking a Nurse.

Web-based interactive self-management support program

Tsae Jyy Wang, PhD

Ting Ru Lin, MS

Yi-Chiu Li, MSN

Wen Chien Huang, PhD

Shih-Chang Chang, Dr.

Shih Chang Chang

The study aims to test the efficacy of a web-based interactive self-management support intervention on the primary outcome, quality of life, secondary outcomes, symptom distress, emotional distress, physical activity, and the mediation effects of self-efficacy, and supportive care needs in colorectal cancer patients.

Colorectal cancer is the most commonly diagnosed cancer in Taiwan. With proper treatments, most patients can be long-term survivors. However, patients often suffered long-term consequences of the disease and its treatment side effects. In addition, unhealthy lifestyles will further impact on patient's prognosis and quality of life. Face-to-face or web-based self-management support interventions can help colorectal cancer patients to achieve a healthy lifestyle and better adjustment. However, they are costly and may not be assessable for a certain population. Therefore, it is necessary to develop the most cost-effective interventions for patients with colorectal cancer.

Aim: The study aims is to test the efficacy of a web-based interactive self-management support intervention on the primary outcome, quality of life, and secondary outcomes, symptom distress, emotional distress, physical activity, nutrition intake, and the mediation effects of self-efficacy, social support, and supportive care needs in colorectal cancer patients.

Design: A multi-center randomized six-month follow-up parallel-group superiority design will be used to test the intervention efficacy. A convenient sample of 160 post-operative colorectal cancer patients (stage I-III) will be recruited and randomized to the control or intervention group. Outcome variables will be assessed on the baseline, 2nd, 4th, and 6th month in both groups.

Instruments: The study instruments include Cancer Behavior Inventory-Brief Version, 34-item Supportive Care Needs Survey, M.D. Anderson Symptom Inventory, The Center for Epidemiologic Studies Depression Scale, International Physical Activity Questionnaire, 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 Linear Mixed Model will be used to test the efficacy of the study interventions.

Significance: The study results will provide evidence for the efficacy of the web-based interactive self-management support intervention for enhancing a healthy lifestyle and quality of life in colorectal cancer patients.

The study participants will be randomly assigned 1:1 to the intervention or the control group by the stratified permuted block randomization and block 4, 6, 8 will be used. The randomization will be stratified by cancer stage (stage I-IIA; stage IIB-III). The Sealed Envelope software (Sealed Envelope Ltd., 2016) will be used to generate the random sequences and sealed envelopes will be used to conceal the assignment of each participant.

Efficacy of Web-based Self-management Support Intervention on Health Outcomes in Patients With Colorectal Cancer

Efficacy of an Interactive Web-based Self-management Support Intervention on Health Outcomes in Patients With Colorectal Cancer: A Mixed-methods Study

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.

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.

There are 12 questions in total. It measures cancer patients 1) maintain independence and a positive attitude, 2) participate in medical care, (3) respond to and manage stress, and 4) Four aspects of self-efficacy, such as managing emotions. Each question is scored from 1 point "very unconfident" to 9 points "very confident". The total score of each question is the total score of the scale, and the possible range of scores Between 12 and 108 points, the higher the score, the higher the self-efficacy.

34-item Supportive Care Needs Survey (SCNS-SF34) measures the supportive care needs of research subjects. This scale mainly to assess cancer patients' psychological (10 questions), health system and information (11 questions), body and daily life (5 questions), medical care and support ( 5 questions) and sex (3 questions) and other five aspects of support and care needs, each question is scored on a Lick-style scale ranging from 1 point "not necessary" to 5 points "very necessary", and the total score of each question is added. The total score in the table, the possible score ranges from 34 to 170 points, the higher the score, the higher the need for support and care.

MDASI (M.D. Anderson Symptom Inventory) measures the symptom distress and consists of a 13-item symptom scale and a 6-item interference scale. The 13 symptoms were pain, fatigue, nausea, interrupted sleep, depression, shortness of breath, difficulty in remembering, loss of appetite, lethargy, dry mouth, sadness, vomiting, numbness/tingling. The interference scales for 6 questions are interference with walking, mobility, working ability (including housework), relationship with others, enjoying life, and mood. Each question is scored on a Lick-style scale ranging from 0 points "not at all" to 10 points "very bad". The average score of each question is the total score of the scale. The possible score ranges from 0 to 10 points. The higher the score, the more the symptom. The more serious the trouble, the average score of 1 to 4 means mild symptom distress, 5-6 means moderate symptom distress, and 7-10 means severe symptom distress.

Ministry of Science and Technology, Taiwan

Mackay Memorial Hospital

Cathay General Hospital

National Taipei University of Nursing and Health Sciences

Director, School of Nursing, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan

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.

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.

colorectal cancer self-management

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.

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.

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.

The randomization procedure was handled by an independent research assistant. Participants, care providers, investigator and outcomes assessors are blind to the group assignment.

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

Developing and Testing a Self-management Support Intervention in Colorectal Cancer Survivors: A Mixed-methods Study

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.

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.

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.

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Efficacy of Web-based Self-management Support Intervention on Health Outcomes in Patients With Colorectal Cancer	NCT05045976	Colorectal Neop...	Web-based inter...	20 Years - 75 Years	National Taipei University of Nursing and Health Sciences
Self-management Support for Colorectal Cancer Survivors Colorectal Cancer Survivors: A Mixed-methods Study	NCT03853278	Colorectal Neop...	colorectal canc...	20 Years -	National Taipei University of Nursing and Health Sciences

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