Together After Cancer Program for Breast Cancer
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of South Florida
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the Together After Cancer treatment for Latina breast cancer survivors?
The Together After Cancer treatment may be effective as similar survivorship care planning programs have been shown to help Latina breast cancer survivors manage their condition and receive better follow-up care. Additionally, a survivorship intervention was associated with decreased health worry among participants, suggesting potential benefits in addressing concerns specific to Latina breast cancer survivors.
12345Is the Together After Cancer Program safe for breast cancer survivors?
The available research does not provide specific safety data for the Together After Cancer Program or its variations, but it does not report any safety concerns for similar survivorship interventions in breast cancer survivors.
12367How is the Together After Cancer treatment different from other treatments for breast cancer survivors?
The Together After Cancer treatment is unique because it is specifically adapted for Latina breast cancer survivors, focusing on their cultural and language needs, which are often underserved in traditional survivorship care programs.
12368Eligibility Criteria
This trial is for Latina/Hispanic breast cancer survivors, aged 18+, who've finished initial treatment within the last five years. Participants must be in a committed relationship for at least six months, willing to follow the study for about 5 months, and have internet access. They must reside in Florida.Inclusion Criteria
I speak English or Spanish.
I am 18 years old or older.
I was diagnosed with breast cancer within the last 5 years.
+6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive the Together After Cancer intervention, which includes approximately 8-10 hours of web-based online content delivered over 5-8 weeks, supplemented with up to 100 minutes of coaching calls.
5-8 weeks
2-3 key conversations with partner, multiple online sessions
Follow-up
Participants are monitored for changes in relationship functioning, psychological functioning, and quality of life at 2 and 5 months post-randomization.
3 months
Assessments at 2 and 5 months
Participant Groups
The trial tests an online self-help program called 'Together After Cancer,' which includes brief coaching calls, versus usual care. Couples are randomly assigned to either group and evaluated at the start, after completing the program, and three months post-randomization.
2Treatment groups
Experimental Treatment
Active Control
Group I: Together After Cancer InterventionExperimental Treatment1 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.
Group II: Usual CareActive Control1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
AdventHealthOrlando, FL
Sylvester Comprehensive Cancer Center and University of MiamiMiami, FL
Moffitt Cancer CenterTampa, FL
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Who Is Running the Clinical Trial?
University of South FloridaLead Sponsor
University of Central FloridaCollaborator
University of Miami Sylvester Comprehensive Cancer CenterCollaborator
AdventHealthCollaborator
H. Lee Moffitt Cancer Center and Research InstituteCollaborator
References
Post-Treatment Survivorship Care Needs of Spanish-speaking Latinas with Breast Cancer. [2022]A comprehensive assessment of Spanish-speaking breast cancer survivors' (SSBCS) survivorship needs is lacking.
Feasibility of a Mobile Phone App and Telephone Coaching Survivorship Care Planning Program Among Spanish-Speaking Breast Cancer Survivors. [2023]Spanish-speaking Latina breast cancer survivors experience disparities in knowledge of breast cancer survivorship care, psychosocial health, lifestyle risk factors, and symptoms compared with their white counterparts. Survivorship care planning programs (SCPPs) could help these women receive optimal follow-up care and manage their condition.
Randomized controlled trial of a clinic-based survivorship intervention following adjuvant therapy in breast cancer survivors. [2022]In 2006, the IOM released a report citing the importance of "survivorship plans" to improve quality of life and care coordination for cancer survivors, but little has been done to evaluate their efficacy. Women with early-stage breast cancer were randomized within 6 weeks of completing adjuvant therapy to a survivorship intervention group (SI) or control group (CG). All subjects were given the NCI publication, "Facing Forward: Life after Cancer Treatment." The SI also met with a nurse/nutritionist to receive a treatment summary, surveillance, and lifestyle recommendations. Both groups completed questionnaires on the impact of cancer (IOC), patient satisfaction (FACIT-TS-PS), and assessment of survivor concerns (ASC) at baseline, 3 and 6 months. Within and between group t tests and linear regression analyses were performed. Among 126 women (60 CG, 66 SI), mean age was 54 years, 48 % were Hispanic, and the groups were well-balanced by baseline characteristics. No significant differences between the CG and SI on the FACIT-TS-PS or IOC at 3 and 6 months were seen. The ASC health worry subscale was lower (less worry) in the SI compared to CG (p = 0.02). At all time-points, Hispanic women had higher (worse) health worry (p = 0.0008), social-life interference (p = 0.009), and meaning of cancer scales (p = 0.0004), and more trust in medical professionals (p = 0.03) compared to non-Hispanic women. While the SI did not lead to significant improvements in most patient-reported outcomes, it was associated with decreased health worry. Future interventions should determine the most efficient and effective method for delivering survivorship care plans.
Quality of cancer follow-up care: a focus on Latina breast cancer survivors. [2022]Receiving quality cancer follow-up care influences survivorship outcomes. Among Latinas, breast cancer is the number one cause of cancer death; yet Latinas do not receive adequate follow-up care. This study examined quality of cancer follow-up care among Latina breast cancer survivors (BCS) and whether it differs by participant language and healthcare system variables (provider specialty, and medical setting).
Impact of a bilingual education intervention on the quality of life of Latina breast cancer survivors. [2021]To test the effectiveness of a bilingual education intervention to improve the quality of life (QOL) of Latina breast cancer survivors (BCSs) after completing primary treatment for breast cancer.
Adapting an evidence-based survivorship intervention for Latina breast cancer survivors. [2021]About 120,000 Latina breast cancer survivors (LBCS) live in the USA with the numbers expected to increase. LBCS experience survivorship disparities and report poor quality of life outcomes. Despite poor outcomes, few survivorship interventions for LBCS are available. Adapting evidence-based interventions for Latinas may be one strategy to reduce disparities.
Culturally-tailored survivorship care planning for rural Latina breast cancer patients: a pilot study. [2023]Label="OBJECTIVE" NlmCategory="UNASSIGNED">To explore the feasibility and acceptability of Proyecto Mariposa, a culturally-tailored survivorship care program for rural Latina breast cancer patients.
Perceptions of Survivorship Care among Latina Women with Breast Cancer in Los Angeles County. [2021]Cancer "survivorship" is a distinct and important aspect of the cancer experience. More research is needed about survivorship care in underserved populations such as Latinas. This study examined issues of breast cancer survivorship care among Latinas to understand their experiences and needs, to inform the design of future programs.