Comparative Effectiveness of Together After Cancer Among Breast Cancer Survivors and Their Intimate Partners

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

To evaluate the impact of an adapted online, self-help relationship intervention (supplemented with brief coach calls) for survivors of breast cancer and their partners. Couples will be randomized to receive either the online intervention (Together after Cancer) or usual care (UC) and assessed at baseline, end of the program, and 3 months after randomization.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: t
View:

• Be 18 years of age and older

• Self-identify as Latina/Hispanic

• Spanish or English speaker

• Primary diagnosis of breast cancer in the last ten years

• Completed initial treatment

• Be married or in a committed relationship of six months duration or longer

• Willingness to be randomized and followed for approximately 5 months

• Access to the internet or a smartphone, tablet, or computer

• Be 18 years of age or older

• Be married or in a committed relationship of six months duration or longer with a Latina Breast Cancer Survivor diagnosed who was diagnosed with breast cancer in the last ten years

• Willingness to be randomized and followed for approximately 5 months

• Access to the internet or a smartphone, tablet, or computer

⁃ Couples will be eligible to participate if they also meet the following:

• Meet the inclusion criteria listed above for Latina Breast Cancer Survivors and Intimate Partners

• Both partners are willing to participate in the study

• Additionally, to be eligible, the Latina Breast Cancer Survivors must reside in Florida

Locations
United States
Florida
Sylvester Comprehensive Cancer Center and University of Miami
RECRUITING
Miami
AdventHealth
RECRUITING
Orlando
Moffitt Cancer Center
RECRUITING
Tampa
Contact Information
Primary
Dinorah Martinez Tyson, PhD
dmtyson@usf.edu
8139740723
Backup
Brian D. Doss, PhD
bdoss@miami.edu
3052841101
Time Frame
Start Date: 2023-01-01
Estimated Completion Date: 2026-03-01
Participants
Target number of participants: 480
Treatments
Experimental: Together After Cancer Intervention
Couples randomized into the intervention will participate in the program which is approximately 8-10 hours of web-based online content to be delivered over the course of 5-8 weeks. The online program can be done on a smartphone, tablet, or computer. In this program, partners complete the majority of the program on their own (to make it more flexible) and come together for 2-3 key conversations with their partner. In addition to the online content, couples will receive up to 100 minutes of scheduled research check-in/coaching calls from a research assistant to check-in. These coach calls will occur via a video chat via Zoom or, if not possible given a couple's technology limitations, over the phone. The coach calls serve several purposes: a) helping couples stay accountable to staying on the recommended schedule of activity completion; b) addressing any technical or program questions the couple has; and c) collecting research data as couples move through the program.
No_intervention: Usual Care
Participants randomized into UC, will consist of primary referral sources for breast cancer survivorship. At AdventHealth, Moffitt, and Sylvester Cancer centers, usual care consists of screening items assessing relationship/intimacy issues as a practical need. If these items are endorsed, referrals are provided to supportive oncology. At Sylvester, the Cancer Support Services offers caregiver support groups, mental well-being services (i.e., individual therapy), and an online support community for patients, caregivers, and survivors. At Moffitt, Support Services offers psychotherapy, support groups for patients, support groups for family/caregivers of cancer patients, and a program to help patients talk with their children about their diagnosis. At AdventHealth, patients are offered referrals to social services and psychoeducational programs like HEAL. However, none of the sites have services designed to focus on issues specific to patients' romantic relationships.
Related Therapeutic Areas
Sponsors
Collaborators: AdventHealth, University of Central Florida, H. Lee Moffitt Cancer Center and Research Institute, University of Miami Sylvester Comprehensive Cancer Center
Leads: University of South Florida

This content was sourced from clinicaltrials.gov