Internet-Based Program for Colorectal Cancer

(CRCweb Trial)

Overseen By Canhua Xiao, PhD, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Karnofsky < 50, Severe diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

56 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a web-based program designed to help people with colorectal cancer and their caregivers manage challenging symptoms like fatigue, depression, and pain. These symptoms can complicate daily life and affect health outcomes for both patients and caregivers. The program, called the Web-Based Dyadic Intervention, aims to improve quality of life by reducing these symptoms through supportive online sessions. To join, patients must have colorectal cancer, be undergoing chemotherapy, and experience at least two of the mentioned symptoms, along with having a primary caregiver. Both patients and caregivers need internet access and must be comfortable using it. As an unphased trial, this study offers a unique opportunity to access supportive resources that could enhance daily life and well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on a web-based program to help manage symptoms for colorectal cancer patients receiving chemotherapy.

What prior data suggests that this web-based dyadic intervention is safe for patients with colorectal cancer and their caregivers?

Research shows that online programs for two people, like the one under study, are safe and easy to use. In past studies, patients and caregivers using similar online programs experienced fewer issues such as tiredness, depression, and trouble sleeping. Importantly, these online tools have not been associated with major side effects. This indicates that the program is not only safe but also helpful in managing symptoms related to colorectal cancer and its treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Web-Based Dyadic Intervention for colorectal cancer because it offers a new way to support patients and their caregivers together, rather than focusing solely on medical treatments like surgery, chemotherapy, or radiation. This program is unique because it provides an online platform for both patients and caregivers to engage in supportive care over eight weeks, making it more accessible and flexible than traditional in-person support groups. By integrating interviews and surveys, the intervention aims to enhance the emotional and psychological well-being of participants, which is often overlooked in standard care.

What evidence suggests that this web-based dyadic intervention is effective for managing psychoneurological symptoms in colorectal cancer patients?

This trial will evaluate an online program, the CRCweb intervention, designed to support patients with colorectal cancer and their caregivers. Studies have shown that online programs can significantly reduce symptoms in these patients. Early results indicate that such programs help manage common issues like tiredness, depression, and sleep problems during chemotherapy. Research suggests this approach improves patients' quality of life and benefits their caregivers. By addressing these symptoms, the program may enhance overall health and help both patients and caregivers cope more effectively. This intervention shows promise for managing the difficult symptoms associated with colorectal cancer treatment. ^{1 2 4 5 6}

Who Is on the Research Team?

Yufen Lin, PhD, RN

Principal Investigator

Emory University Hospital/Winship Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adults over 18 with colorectal cancer who are currently undergoing chemotherapy and have a life expectancy of more than 12 months. Participants must experience at least two psychoneurological symptoms, have a primary caregiver willing to join the study, be fluent in English, and have internet access. Those with severe conditions or very poor performance status (Karnofsky Scale <50) cannot participate.

Inclusion Criteria

Patients must have a life expectancy of more than 12 months

Patients must have access to the Internet

I have been diagnosed with colorectal cancer.

Exclusion Criteria

I need considerable assistance and medical care.

I am a caregiver with a severe illness like cancer or heart disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Patients and caregivers attend a CRCweb intervention to manage psychoneurological symptoms

8 weeks

Web-based sessions

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Web-Based Dyadic Intervention

Trial Overview The study is testing a web-based program designed to help patients with colorectal cancer and their caregivers manage distressing symptoms like fatigue, depression, sleep issues, pain, and cognitive problems during chemotherapy treatment. It involves online interventions along with interviews and surveys.

How Is the Trial Designed?

Group I: Supportive care (CRCWeb intervention) Experimental Treatment 4 Interventions

Patients and caregivers attend a CRCweb intervention over 8 weeks. Patients and caregivers complete interviews and surveys throughout the trial.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Oncology Nursing Society

Collaborator

Trials

11

Recruited

510+

Published Research Related to This Trial

The 'Caring for Couples Coping with Colorectal Cancer' (4Cs: CRC) program is a six-week integrated supportive intervention that combines web-based and face-to-face sessions, showing preliminary feasibility and acceptability for couples dealing with colorectal cancer.

Initial evaluations indicate that the program is effective in supporting these couples, but further improvements are needed, and a full-scale randomized controlled trial is necessary to confirm its effectiveness in a larger population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The development and evaluation of a web-based complex intervention: The caring for couples coping with colorectal cancer "4Cs: CRC" program. Chen, M., Gong, J., Cao, Q., et al.[2022]

The study reviewed 18 observational studies involving 2,757 colorectal cancer patients and 2,601 caregivers, revealing that the psychological distress of CRC patients significantly impacts the distress and burden experienced by their caregivers.

It identified three key actor effects: patients' social support reduces their own distress, patients' distress negatively affects their health-related quality of life (HRQL), and caregivers' social support helps lower their distress, highlighting the importance of dyadic interventions to improve overall well-being for both patients and caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dyadic Effects of Psychological Health on Quality of Life in Patients with Colorectal Cancer and Caregivers: A Systematic Review and Meta-Analysis. Kim, YM., Lee, JE.[2023]

The integrated online and in-person support program for colorectal cancer patients and their spousal caregivers showed strong feasibility, with a recruitment rate of 70.6% and a retention rate of 83.3% over six weeks.

Participants reported positive engagement and evaluations of the program, indicating it was acceptable, and preliminary results showed small-to-medium improvements in coping outcomes, suggesting potential efficacy for couples dealing with colorectal cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A feasibility study of an integrated couples-based supportive programme for Chinese couples living with colorectal cancer. Luo, X., Li, J., Cao, Q., et al.[2021]

The ABCRC-tool was developed to assess the burden of colorectal cancer (CRC) on patients, incorporating patient-reported outcomes (PROs) to guide follow-up care, and was validated through interviews with 11 patients and 22 healthcare professionals.

This tool includes a generic module and three CRC-specific modules, providing tailored treatment advice based on patient experiences and lifestyle factors, demonstrating good face and content validity for improving oncological care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and content validation of the Assessment of Burden of ColoRectal Cancer (ABCRC)-tool. Boome, IT., Somers, AMJ., Graupner, C., et al.[2022]

Web-based dyadic interventions for cancer survivors and their caregivers have shown positive effects on self-efficacy, quality of life, and mental health, based on a review of 13 studies.

The interventions primarily focused on providing information support, psychotherapy, and self-management skills, indicating that these elements are crucial for enhancing the well-being of both survivors and caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The application of eHealth in cancer survivorship care: A review of web-based dyadic interventions for post-treatment cancer survivors and caregivers. Chen, M., Gong, J., Li, Q.[2022]

Web-based interventions for cancer patient-caregiver dyads have shown positive impacts on various health outcomes, including physical health (effect size d = 0.17-0.75) and psychological health (d = 0.04-0.80), based on a systematic review of 17 studies.

These interventions typically include components like information support and skills-building, and they can enhance the overall quality of life (d = 0.20-0.68) and strengthen the dyadic relationship (d = 0.30-0.95) between patients and caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A critical literature review of dyadic web-based interventions to support cancer patients and their caregivers, and directions for future research. Luo, X., Gao, L., Li, J., et al.[2020]

Web-based psychosocial interventions, particularly cognitive-behavioral therapy, significantly reduce anxiety and depression in colorectal cancer survivors, as shown in a systematic review of 19 studies with 1386 participants.

However, these interventions did not show a positive effect on self-efficacy and had minimal benefits on quality of life, indicating the need for further research to improve these outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis on the effectiveness of web-based psychosocial interventions among patients with colorectal cancer. Wan, SW., Chng, YJD., Lim, SH., et al.[2022]

Patients with colorectal cancer (CRC) often lack guidance from healthcare professionals on reliable online resources for their condition, which can hinder their ability to make informed decisions about their treatment.

An effective eHealth service for CRC patients should focus on personalized education, health monitoring, and communication, taking into account the patient's age and digital skills to enhance self-management and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stakeholders' Perspectives on eHealth Support in Colorectal Cancer Survivorship: Qualitative Interview Study. Husebø, AML.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10365620/

A Web-Based Dyadic Intervention to Manage ... The purposes of this study are to (1) develop a web-based dyadic intervention for patients with CRC receiving chemotherapy and their caregivers (CRCweb)

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05663203

A Web-Based Dyadic Intervention for Colorectal Cancer This clinical trial studies how well a web-based dyadic intervention works to manage psychoneurological symptoms for patients with colorectal cancer and ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05663203/a-web-based-dyadic-intervention-for-colorectal-cancer

A Web-Based Dyadic Intervention for Colorectal Cancer A web-based dyadic intervention holds great promise to reduce psychoneurological symptoms burden and improve quality of life for patients with ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37379055/

A Web-Based Dyadic Intervention to Manage ... Objective: The purposes of this study are to (1) develop a web-based dyadic intervention for patients with CRC receiving chemotherapy and their ...

5. cancernursingtoday.com cancernursingtoday.com/post/mobile-app-addresses-health-related-disparities-in-patients-with-colorectal-cancer-and-their-caregivers

Dyadic Intervention Promotes Health Equity in Patients ... According to a preliminary analysis, the intervention significantly reduced psychoneurological symptoms among patients with colorectal cancer ...

6. trialx.com trialx.com/clinical-trials/listings/233095/a-web-based-dyadic-intervention-for-colorectal-cancer/?&geo_lat=33.8398171&geo_lng=-84.3769691&radius=10&place=Additional%20Locations&user_country=United%20States

A Web-Based Dyadic Intervention for Colorectal Cancer This clinical trial studies how well a web-based dyadic intervention works to manage psychoneurological symptoms for patients with colorectal ...