Clinical trial NCT05645471: Together After Cancer
Official title: Comparative Effectiveness of Together After Cancer Among Breast Cancer Survivors and Their Intimate Partners
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Quality of Life
Communication
Keywords: Breast Cancer, Latino, Couples,
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: H. Lee Moffitt Cancer Center and Research Institute
name: University of Miami Sylvester Comprehensive Cancer Center
name: AdventHealth
name: University of Central Florida
First posted: 2022-12-09
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: PREVENTION

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.

Detailed description: As the fastest-growing and largest ethnic minority group, projections indicate that 128 million Latinos will reside in the United States by 2050; with one in three Latinos receiving a diagnosis of cancer during his/her lifetime. Latino cancer survivors have a lower quality of life, experience distress due to strained spousal and family relationships, have poorer physical health, and have more depression, pain, and fatigue when compared to non-Latinos. In addition, emotional and mental well-being between Latino survivors and their partners is related, with partners also experiencing increased distress and physical symptoms. Research has shown that couples-based psychosocial programs improve the quality of life and emotional and physical health of cancer survivors and their partners. Yet, much of the in this area has focused on non-Hispanic Whites. Features of Latino culture may influence and interact with social, psychosocial, health care, and clinical factors that influence cancer-related outcomes. Our goal is to add to this literature and develop a program for Latina breast cancer survivors and their partners that is culturally meaningful and relevant and responds to their needs and concerns.

Specifically, investigators plan to culturally adapt a widely-available and effective online couple intervention, OurRelationship (ORI), for Latina breast cancer survivors and their intimate partners. The online OR program - which can be done on a smartphone, tablet, or computer - was developed to serve as an online tool to help couples solve a specific relationship problem they selected. Investigators will adapt the OR program to be useful for Latina breast cancer survivors and their intimate partners using feedback from focus groups with patients, community partners, and research advisors. Once investigators have completed our adaptation, the plan to test the impact of the adapted program, Together after Cancer, using a type of study called a randomized controlled trial where participants will be randomly allocated to either receive the culturally adapted intervention or usual care. Investigators are interested in learning if couples in the group that are assigned to the intervention program report changes in their relationship functioning, psychological functioning (depression, anxiety, and perceived stress), and cancer-related quality of life (pain, fatigue, body image, and quality of life) compared to couples who are assigned to the UC group.

Through this comparative study, investigators expect to establish effective strategies that can be implemented in clinic and community settings to improve psychological functioning, relationship functioning, and quality of life. Investigators are enthusiastic about the potential for the intervention program to easily reach cancer Latina survivors around the nation, due to the online format and ease of access from any location. Throughout the project, investigators will continue to engage our local partners to ensure that the study procedures and outcomes are meaningful to all stakeholders.

Investigators are using patient-centered approaches to offer a culturally relevant web-based program that cancer survivors and their partners can access from the comfort of their homes.

Eligibility criteria: Inclusion Criteria for Latina Breast Cancer Survivors:

* 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

Inclusion criteria for Intimate Partners:

* 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

Exclusion Criteria:

-

Primary outcomes:
measure: Evaluate the changes in the quality of life of the breast cancer survivor across the pre to post to follow-up measurement time points.
timeFrame: Baseline, 2 and 5 month
measure: 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.
timeFrame: Baseline, 2 and 5 month
Secondary outcomes:
measure: 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.
timeFrame: Baseline, 2 and 5 month
measure: Evaluate the changes in cancer-related fatigue of the breast cancer across the pre to post to follow-up measurement time points.
timeFrame: Baseline, 2 and 5 month
measure: Evaluate changes in the quality of life among the intimate partner across the pre to post to follow-up measurement time points.
timeFrame: Baseline, 2 and 5 month
measure: 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.
timeFrame: Baseline, 2, 5 month
measure: 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.
timeFrame: Baseline, 2, 5 month
measure: Evaluate changes in stress among breast cancer survivors and their intimate partner across the pre to post to follow-up measurement time points.
timeFrame: Baseline, 2, 5 month
measure: Evaluate changes in feeling cared and valued as a person among breast cancer survivors and their intimate partner across the pre to post to follow-up measurement time points.
timeFrame: Baseline, 2, 5 month
measure: Evaluate changes in supportive communication among breast cancer survivors and their intimate partner across the pre to post to follow-up measurement time points.
timeFrame: Baseline, 2, 5 month
measure: Evaluate changes in negative communication between the breast cancer survivor and their intimate partner across the pre to post to follow-up measurement time points.
timeFrame: Baseline, 2, 5 month
measure: Evaluate changes in intimacy between the breast cancer survivor and their intimate partner across the pre to post to follow-up measurement time points.
timeFrame: Baseline, 2, 5 month
Other outcomes:
Locations:
city: Miami
country: United States
facility: Sylvester Comprehensive Cancer Center and University of Miami
state: Florida
city: Orlando
country: United States
facility: AdventHealth
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
References: