Together After Cancer

NCT05645471 | Active Not Recruiting DMC

• 2 other identifiers: 004181AD-2020C3-21171
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Breast Cancer; Quality of Life; Communication

Keywords

Breast Cancer, Latino, Couples,

Outcome Measures

Primary Outcomes (2)

• Evaluate the changes in the quality of life of the breast cancer survivor across the pre to post to follow-up measurement time points.

  The FACT-B is a 37-item instrument designed to measure five domains of HRQOL in breast cancer patients which focuses on physical, social, emotional, functional well-being as well as a breast-cancer subscale. Each question is rated on a four-point scale from 0=Not at all to 4=Very Much. The scale has an internal consistency of an α=.90, with subscale alpha coefficients ranging from .63 to .86.

  Baseline, 2 and 5 month

• Evaluate the changes in the satisfaction of the relationship between couples who are married across the pre to post to follow-up measurement time points.

  The Couples Satisfaction Index (CSI) is a 32- item instrument assess one's satisfaction in a relationship which assess the presence of problems between individuals and the intensity of such problems. Each question is rated on a six-point scale from 0=Extremely Unhappy to 6=Perfect. The scale as an internal consistency α=0.92.

  Baseline, 2 and 5 month

Secondary Outcomes (10)

• Evaluate the changes in the cancer-related body image of the breast cancer survivor across the pre to post to follow-up measurement time points.

  Baseline, 2 and 5 month

• Evaluate the changes in cancer-related fatigue of the breast cancer across the pre to post to follow-up measurement time points.

  Baseline, 2 and 5 month

• Evaluate changes in the quality of life among the intimate partner across the pre to post to follow-up measurement time points.

  Baseline, 2 and 5 month

• Evaluate changes in emotional distress-depression among breast cancer survivor and their intimate partner across the pre to post to follow-up measurement time points.

  Baseline, 2, 5 month

• Evaluate changes in emotional distress-anxiety among breast cancer survivors and their intimate partner across the pre to post to follow-up measurement time points.

  Baseline, 2, 5 month

Study Arms (2)

Together After Cancer Intervention

EXPERIMENTAL

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.

Behavioral: Together After Cancer

Usual Care

NO INTERVENTION

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.

Interventions

Together After Cancer BEHAVIORAL

This is an online couples intervention for Latina breast cancer survivors and their intimate partners.

Together After Cancer Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Both partners are willing to participate in the study
• Additionally, to be eligible, the Latina Breast Cancer Survivors must reside in Florida

Sponsors & Collaborators

• University of South Florida: lead
• AdventHealth: collaborator
• H. Lee Moffitt Cancer Center and Research Institute: collaborator
• University of Miami Sylvester Comprehensive Cancer Center: collaborator
• University of Central Florida: collaborator

Study Sites (3)

Sylvester Comprehensive Cancer Center and University of Miami

Miami, Florida, 33136, United States

Location

AdventHealth

Orlando, Florida, 32803, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Communication

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The study aims to test the impact of the adapted Together After Cancer intervention using a cluster randomized controlled trial (cRCT), with individuals nested within couples and randomization occurring at the couple level to see if it is more effective than usual care (UC).

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: December 9, 2022
• Study Start: January 1, 2023
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)