Together After Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05645471
• Other study ID #: 004181
• Secondary ID: AD-2020C3-21171
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: March 1, 2026

Study information

• Verified date: April 2023
• Source: University of South Florida
• Contact: Dinorah Martinez Tyson, PhD
• Phone: 8139740723
• Email: dmtyson[@]usf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: March 1, 2026
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 five 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 five 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: -

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Communication
• Quality of Life

Intervention

Behavioral:
• Together After Cancer
This is an online couples intervention for Latina breast cancer survivors and their intimate partners.

Locations

Country	Name	City	State
United States	Sylvester Comprehensive Cancer Center and University of Miami	Miami	Florida
United States	AdventHealth	Orlando	Florida
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (5)

Lead Sponsor	Collaborator
University of South Florida	AdventHealth, H. Lee Moffitt Cancer Center and Research Institute, University of Central Florida, University of Miami Sylvester Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 a=.90, with subscale alpha coefficients ranging from .63 to .86.	Baseline, 2 and 5 month
Primary	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 a=0.92.	Baseline, 2 and 5 month
Secondary	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.	The Body Image Scale is a 10-item measure developed to measure cognitive, affective, and evaluative variables of an individual's concept of body image and reflects relatively time-stable physical aspects, rather than current physical conditions. Each question is rated on a four-point scale from 1=Not at all to 4=Very much. The scale has an internal consistency is a=.90.	Baseline, 2 and 5 month
Secondary	Evaluate the changes in cancer-related fatigue of the breast cancer across the pre to post to follow-up measurement time points.	The Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue is a 7-item scale that assess a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. Each question is rated on a four-point scale from 1=Not at all to 4=Very much. The scale has an internal consistency is a=0.79.	Baseline, 2 and 5 month
Secondary	Evaluate changes in the quality of life among the intimate partner across the pre to post to follow-up measurement time points.	The Functional Assessment of Cancer Therapy-General Pop. (FACT-GP) a shortened, 21-item that assess the perceived levels of health-related quality of life in the partner. Each question is rated on a five-point scale from 0=Not at all to 4=Very much. The scale has an internal consistency is a=0.89.	Baseline, 2 and 5 month
Secondary	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.	The PROMIS: Emotional Distress-Depression is an 8-item survey related to depressed mood in the past 7 days. Each question is rated on a five-point scale from 1=Never to 5=Always. The internal consistency is a=0.97.	Baseline, 2, 5 month
Secondary	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.	The PROMIS: Emotional Distress - Anxiety is a 6-item survey that assess self-reported fear, anxious misery, hyperarousal and somatic symptoms related to arousal. Each question is rated on a five-point scale from 1=Never to 5=Always. The internal consistency is a=0.96.	Baseline, 2, 5 month
Secondary	Evaluate changes in stress among breast cancer survivors and their intimate partner across the pre to post to follow-up measurement time points.	The Perceived Stress Scale (PSS) is a 10-item that measures the degree to which situations in one's life are appraised as stressful. Items were designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. Each question is rated on a five-point scale from 0=never to 4 very often. The internal consistency is a=0.74.	Baseline, 2, 5 month
Secondary	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.	The PROMIS: Emotional Support is a 4-item that assess perceived feelings of being cared and valued as a person; having confidant relationships. Each question is rated on a five-point scale from 1=Never to 5=Always. The internal consistency is a=0.98.	Baseline, 2, 5 month
Secondary	Evaluate changes in supportive communication among breast cancer survivors and their intimate partner across the pre to post to follow-up measurement time points.	The Dyadic Coping Inventory is a 37-item instrument designed to measure perceived communication and dyadic coping (supportive, delegated, negative, and joint) that occurs in close relationships when one or both partners are stressed. The internal consistency is a=0.86.	Baseline, 2, 5 month
Secondary	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.	The Conflictual Communication Index is a 7-item measure developed to assess negative communication. Participants were asked to report how often communication conflict occurred during the past month on a Likert-type scale from 1=Never to 4= Often. The internal consistency is a=0.89.	Baseline, 2, 5 month
Secondary	Evaluate changes in intimacy between the breast cancer survivor and their intimate partner across the pre to post to follow-up measurement time points.	The Personal Assessment of Intimacy in Relationships (PAIR) is a 6-item measure of that assesses comfort, intimacy, and satisfaction with sexual relationship of a couple. Each question is rated on a five-point scale from 1=Very rarely to 5=Very often. The internal consistency is a=0.86.	Baseline, 2, 5 month