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

Trial Summary

What is the purpose of this trial?

This clinical trial studies how well a web-based dyadic intervention works to manage psychoneurological symptoms for patients with colorectal cancer and their caregivers. Patients with colorectal cancer receiving chemotherapy experience severe and distressing psychoneurological symptoms that include fatigue, depression, sleep disturbance, pain, and cognitive dysfunction. When these co-occurring symptoms are undertreated, they negatively affect functional status, survival rates, and quality of life of patients as well as decrease health outcomes of their family caregiver. A critical need exists to develop an effective and novel intervention that focuses on patients with colorectal cancer receiving chemotherapy and their caregivers. A web-based dyadic intervention holds great promise to reduce psychoneurological symptoms burden and improve quality of life for patients with colorectal cancer receiving chemotherapy and advance intervention development and implementation in cancer supportive care and health equity.

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 data supports the effectiveness of the treatment Web-Based Dyadic Intervention for Colorectal Cancer?

Research shows that web-based psychosocial interventions can improve self-efficacy (confidence in managing one's health), reduce anxiety and depression, and enhance the quality of life for colorectal cancer patients. Additionally, these interventions help both patients and their caregivers cope better with cancer together. ^{1 2 3 4 5}

Is the Internet-Based Program for Colorectal Cancer safe for humans?

The research articles reviewed do not provide specific safety data for the Internet-Based Program for Colorectal Cancer or its related interventions. ^{3 4 5 6 7}

How is the Web-Based Dyadic Intervention for Colorectal Cancer different from other treatments?

The Web-Based Dyadic Intervention for Colorectal Cancer is unique because it focuses on supporting both patients and their caregivers together, using an online platform to help them cope with cancer as a unit. This approach is different from traditional treatments that typically focus only on the patient, and it combines online and in-person support to enhance the quality of life and self-management for both parties. ^{1 4 5 7 8}

Research Team

Yufen Lin, PhD, RN

Principal Investigator

Emory University Hospital/Winship Cancer Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A feasibility study of an integrated couples-based supportive programme for Chinese couples living with colorectal cancer. [2021]

2. United States 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. [2023]

3. England pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis on the effectiveness of web-based psychosocial interventions among patients with colorectal cancer. [2022]

4. United States 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. [2022]

5. England 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. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Development and content validation of the Assessment of Burden of ColoRectal Cancer (ABCRC)-tool. [2022]

7. United States 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. [2022]

8. Canada pubmed.ncbi.nlm.nih.gov

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