- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06353178
Building Empowerment and Coping Outcomes for caNcer Patients, Survivors and Their Caregivers (BEACON)
April 5, 2024 updated by: Color Health, Inc.
BEACON Study: Virtual Coping Skills Groups for Cancer Patients, Survivors and Their Caregivers
Cancer has a psychological, emotional and social impact beyond a patient's physical health.
This study examines three new online peer mental-wellness support program for cancer patients, survivors or their caregivers.
Each program teaches evidence-based skills, in the context of that groups lived experience, to manage the emotional impact of cancer.
This study examines the impact of that program.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Cancer has a psychological, emotional and social impact beyond a patient's physical health.
These problems often ripple beyond the individual with the diagnosis, to their broader community, and also beyond a cancer treatment course into survivorship.
As a result, there are a wide range of socioemotional needs in those who have been impacted by cancer.
Further, these emotional impacts have a direct impact on morbidity and mortality of cancer.
A new peer mental-wellness support program, called Color Cancer Connect (CCC) supports cancer patients, survivors and their caregivers by teaching them evidence-based skills to manage the emotional impact of cancer.
This study will examine all three programs (i.e., patient, survivor, caregiver) to gather data to measure the impact of the program on emotional well-being, quality of life and health behaviors.
Study Type
Interventional
Enrollment (Estimated)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Cecilia M Votta, PhD
- Email: cecilia.votta@color.com
Study Contact Backup
- Name: Cynthia Neben, PhD
- Email: cynthia@color.com
Study Locations
-
-
California
-
Burlingame, California, United States, 94010
- Recruiting
- Color Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Lived experience as either a current cancer patient, cancer survivor or caregiver of someone with cancer
- Adult - 18+
- Has health insurance provided by employer or union (can be dependent of person on insurance)
- Read/speak English
- Have access to internet and personal email account
Exclusion Criteria:
- Severe mental illness that is disruptive to other group members
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cancer Connect Program
Participants assigned to this arm will be able to attend the online peer program upon entering the study.
|
Online group peer program where participants learn evidence based skills for managing stressors and emotions related to their cancer experience.
|
Placebo Comparator: Waitlist
Participants assigned to this arm will be on a waitlist and will be invited to join the online peer program in 3 months.
|
Online group peer program where participants learn evidence based skills for managing stressors and emotions related to their cancer experience.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Life
Time Frame: Multiple time points across 8 months (waitlist) or 5 months (intervention)
|
Patients: EORTC Core Quality of Life (CLC-C30), Survivors: Quality of Life Adult Cancer Survivors (QLACS), Caregivers: WHO Quality of Life Scale (WHO-QOL)
|
Multiple time points across 8 months (waitlist) or 5 months (intervention)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
April 8, 2024
Primary Completion (Estimated)
February 1, 2025
Study Completion (Estimated)
April 1, 2025
Study Registration Dates
First Submitted
April 2, 2024
First Submitted That Met QC Criteria
April 5, 2024
First Posted (Actual)
April 8, 2024
Study Record Updates
Last Update Posted (Actual)
April 8, 2024
Last Update Submitted That Met QC Criteria
April 5, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20240314
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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