Building Empowerment and Coping Outcomes for CaNcer Patients, Survivors and Their Caregivers

NCT06353178 | Completed

• 1 other identifier: 20240314
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer; Caregiving Stress; Caregiver Burnout; Survivorship

Keywords

cancer; caregiving; emotional support; psychology

Outcome Measures

Primary Outcomes (1)

• Depression

  Patient Health Questionnaire-9 (PHQ-9)

  Multiple time points across 8 months (waitlist; baseline, 2 months post waitlist, 3 months post waitlist, 2 months post program start, 3 months post program start) or 5 months (intervention; baseline, 2 months post program start, 3 months post program)

Study Arms (2)

Cancer Connect Program

EXPERIMENTAL

Participants assigned to this arm will be able to attend the online peer program upon entering the study.

Behavioral: Cancer Connect Program

Waitlist

PLACEBO COMPARATOR

Participants assigned to this arm will be on a waitlist and will be invited to join the online peer program in 3 months.

Behavioral: Cancer Connect Program

Interventions

Cancer Connect Program BEHAVIORAL

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

Cancer Connect Program; Waitlist

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Severe mental illness that is disruptive to other group members

Sponsors & Collaborators

• Color Health, Inc.: lead

Study Sites (1)

Color Health

Burlingame, California, 94010, United States

Location

MeSH Terms

Conditions

Neoplasms; Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants will be notified of a waitlist assignment upon enrolling. Those on the waitlist will receive the intervention after 3 months.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to waitlist or intervention group. Those in intervention group will receive the peer program; those on the waitlist will receive it after being on the waitlist for 3 months.

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 8, 2024
• Study Start: April 8, 2024
• Primary Completion: January 25, 2025
• Study Completion: January 25, 2025
• Last Updated: January 28, 2025

Record last verified: 2025-01

Locations

US (1)