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

All Drugs and Chemicals

Immunomodulating Agents

Immunotherapy is currently a crucial cancer treatment option. Despite the development of new cancer treatment, patients and their family caregivers still experience complex psychological feelings and challenges about the effectiveness of immunotherapy, financial burden, and treatment related side effects which reflect the problems related to decision-making and the supportive care needs.

Patient Care Needs and the Decision-Making Experience of Patients With Cancer and Family Caregivers Regarding Immunotherapy: A Qualitative and Quantitative Mixed Methods Study

Patients' and family caregivers' supportive care needs will be measured by Supportive Care Needs Survey(SCNS) .It is a 5-Point Likert Scale,higher scores mean more care needs.

Patients' and family caregivers' physical and psychological symptoms will be measured by Physical and Psychological Symptom Scale.It use Numerical Rating Scale(VRS)0-10.It is a 11 Point Likert Scale(e. g. 0 is no pain; 10 is unbearable pain) .

Patients' and family caregivers' decision making process and conflict will be measured by CollaboRATE scale and SURE scale. CollaboRATE scale is a 10-Point Likert Scale (0-9), higher the score, the more effort you pay on this issues. SURE scale which base on Decisional Conflict Scale are 4 items,The question you agree that you can answer "YES" and got 1 point,if you not fit the description you have to answer "NO" and got 0 points,The lower the total score, the greater the decision conflict.

Patients' financial toxicity will be measured by COST-FACIT. It is a 5-Point Likert Scale (0-4),The higher the score for each question, the more often the problem occurs.

Patients' immunotherapy side effects will be measured by CTCAE.The severity is divided into 5 grades, the higher the grade, the higher the severity.

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
Patient Care Needs and the Decision-Making Experience of Patients With Cancer and Family Caregivers Regarding Immunotherapy: A Qualitative and Quantitative Mixed Methods Study	NCT05740800	Supportive Care... Immunotherapy		20 Years - 100 Years	National Taiwan University Hospital

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