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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06353178
Other study ID # 20240314
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 8, 2024
Est. completion date April 1, 2025

Study information

Verified date April 2024
Source Color Health, Inc.
Contact Cecilia M Votta, PhD
Email cecilia.votta@color.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date April 1, 2025
Est. primary completion date February 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Cancer Connect Program
Online group peer program where participants learn evidence based skills for managing stressors and emotions related to their cancer experience.

Locations

Country Name City State
United States Color Health Burlingame California

Sponsors (1)

Lead Sponsor Collaborator
Color Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quality of Life 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)
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