Breast Cancer Clinical Trial

Together After Cancer

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.

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Full 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.

View Eligibility Criteria

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:

-

Study is for people with:

Breast Cancer

Estimated Enrollment:

480

Study ID:

NCT05645471

Recruitment Status:

Recruiting

Sponsor:

University of South Florida

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There are 3 Locations for this study

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Sylvester Comprehensive Cancer Center and University of Miami
Miami Florida, 33136, United States More Info
Brian Doss, PhD
Contact
305-284-1101
[email protected]
Frank Penedo, PhD
Contact
[email protected]
AdventHealth
Orlando Florida, 32803, United States More Info
Amber Orman, MD
Contact
812-236-0695
[email protected]
Amber Orman, MD
Principal Investigator
Moffitt Cancer Center
Tampa Florida, 33612, United States More Info
Laura Oswald, PhD
Contact
Laura Oswald, PhD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

480

Study ID:

NCT05645471

Recruitment Status:

Recruiting

Sponsor:


University of South Florida

How clear is this clinincal trial information?

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