Together After Cancer Program for Breast Cancer

Recruiting at 2 trial locations

Overseen By Dinorah Martinez Tyson, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of South Florida

Disqualifiers: Reside outside Florida, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 5-8 weeks

480 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how an online self-help program, the Together After Cancer program, can support Latina breast cancer survivors and their partners. The program aims to improve relationship dynamics after cancer treatment, with couples either participating in the program or receiving standard care. It is ideal for Latina breast cancer survivors diagnosed in the past ten years who are in a committed relationship and live in Florida. Participants need internet access and must be willing to engage in the study for about five months. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative support solutions for cancer survivors and their partners.

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 prior data suggests that the Together After Cancer program is safe for breast cancer survivors and their partners?

Research has shown that the "Together After Cancer" program is based on a program tested with over 5,000 couples. This indicates that the program is safe and well-received by participants. Previous studies did not report any negative effects, suggesting that participants can join without significant risk. The program aims to help breast cancer survivors and their partners by strengthening their relationships through online content and coaching calls. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Together After Cancer program because it's a fresh approach to supporting breast cancer survivors and their partners, focusing on romantic relationships, which traditional survivorship care often overlooks. Unlike standard care options that emphasize individual therapy or general support groups, this program offers a tailored, web-based experience that partners can complete at their own pace. The inclusion of scheduled coaching calls ensures couples stay engaged and receive personalized guidance, potentially leading to more meaningful improvements in relationship dynamics. This innovative method could fill a critical gap in survivorship care by addressing intimacy and relationship challenges that are typically left unaddressed.

What evidence suggests that the Together After Cancer program is effective for breast cancer survivors?

Research has shown that the Together After Cancer program, available to participants in this trial, has been used by over 5,000 couples, receiving very positive feedback. An impressive 94% of participants expressed satisfaction with the program, and 97% would recommend it to others. This online self-help program aims to help Latina breast cancer survivors and their partners strengthen their relationships and adjust to life after cancer. It offers tools to enhance closeness and communication, which can be challenging post-cancer. Evidence suggests that couples generally find it helpful in improving their relationship dynamics. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

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 was diagnosed with breast cancer within the last 5 years.

I have finished my first round of treatment.

You identify yourself as being of Latina/Hispanic descent.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Together After Cancer

Trial Overview 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.

How Is the Trial Designed?

Group I: Together After Cancer Intervention Experimental Treatment 1 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 Care Active Control 1 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.

Who Is Running the Clinical Trial?

University of South Florida

Lead Sponsor

Trials

433

Recruited

198,000+

University of Central Florida

Collaborator

Trials

101

Recruited

1,191,000+

University of Miami Sylvester Comprehensive Cancer Center

Collaborator

Trials

11

Recruited

2,700+

AdventHealth

Collaborator

Trials

118

Recruited

31,800+

H. Lee Moffitt Cancer Center and Research Institute

Collaborator

Trials

576

Recruited

145,000+

Published Research Related to This Trial

A study involving 118 telephone surveys and 25 in-person interviews with Spanish-speaking breast cancer survivors revealed that common physical symptoms include joint pain, fatigue, and hot flashes, while emotional challenges include anxiety about recurrence and feelings of abandonment after treatment ends.

The findings highlight a significant need for culturally appropriate survivorship care programs that address both physical symptom management and psychosocial support, particularly during the transition from active treatment to follow-up care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-Treatment Survivorship Care Needs of Spanish-speaking Latinas with Breast Cancer. Nápoles, AM., Ortiz, C., Santoyo-Olsson, J., et al.[2022]

The Nuevo Amanecer Survivorship Care Planning Program, designed for Spanish-speaking Latina breast cancer survivors, showed high acceptability and feasibility, with 83% of participants completing all coaching calls and 81% rating the app as 'very good' or 'excellent'.

After the 2-month intervention, participants experienced significant reductions in fatigue and health distress, improved knowledge of follow-up care, enhanced emotional well-being, and increased daily physical activity, indicating the program's potential effectiveness in supporting this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a Mobile Phone App and Telephone Coaching Survivorship Care Planning Program Among Spanish-Speaking Breast Cancer Survivors. Nápoles, AM., Santoyo-Olsson, J., Chacón, L., et al.[2023]

An evidence-based intervention for breast cancer education was successfully adapted for Latina breast cancer survivors, addressing cultural relevance through certified translation and cognitive interviews.

Out of 40 participants, 30 completed the intervention, and 14 provided positive feedback on its usefulness and relevance, indicating potential for improving quality of life and reducing disparities among Latina breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapting an evidence-based survivorship intervention for Latina breast cancer survivors. Meneses, K., Gisiger-Camata, S., Schoenberger, YM., et al.[2021]

Proyecto Mariposa, a survivorship care program for rural Latina breast cancer patients, showed promising feasibility and acceptability among 18 participants, despite challenges posed by the COVID-19 pandemic.

Participants reported the program as useful for gaining information and improving proactive health behaviors, with modest improvements in self-efficacy regarding disease management, highlighting the need for further research with a larger sample size.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Culturally-tailored survivorship care planning for rural Latina breast cancer patients: a pilot study. Ko, E., Woodruff, SI., Zúñiga, ML., et al.[2023]

English-speaking Latina breast cancer survivors reported receiving higher quality follow-up care compared to Spanish-speaking survivors, with significant differences in care settings and provider access.

Factors such as language proficiency, seeing a cancer specialist, and receiving follow-up care at a doctor's office were linked to better quality of care, highlighting the need for improved access for Spanish-speaking survivors to reduce health disparities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of cancer follow-up care: a focus on Latina breast cancer survivors. Rosales, M., Ashing, K., Napoles, A.[2022]

A study involving 126 women with early-stage breast cancer found that a survivorship intervention (SI) did not significantly improve overall patient-reported outcomes compared to a control group, but it did lead to reduced health worry among participants in the SI group.

Hispanic women reported higher levels of health worry and social-life interference compared to non-Hispanic women, highlighting the need for tailored survivorship care plans that address the specific concerns of diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of a clinic-based survivorship intervention following adjuvant therapy in breast cancer survivors. Hershman, DL., Greenlee, H., Awad, D., et al.[2022]

A bilingual education intervention for Latina breast cancer survivors showed a slight increase in quality of life (QOL) after treatment, although the results were not statistically significant, indicating potential benefits that need further exploration.

The study highlighted the ongoing QOL concerns among Latina breast cancer survivors, particularly in social and psychological well-being, suggesting a need for more culturally tailored interventions to effectively support this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a bilingual education intervention on the quality of life of Latina breast cancer survivors. Juarez, G., Hurria, A., Uman, G., et al.[2021]

A study involving 74 Latinas highlighted significant gaps in breast cancer survivorship care, including issues with finances, continuity of care, and a lack of information and symptom management support.

Participants emphasized the importance of support systems, such as patient navigators, and expressed a need for tailored interventions to address their specific survivorship needs, suggesting that enhancing support services and implementing survivorship care plans could improve their experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceptions of Survivorship Care among Latina Women with Breast Cancer in Los Angeles County. Tisnado, DM., Mendez-Luck, C., Metz, J., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05645471

Study Details | NCT05645471 | Together After Cancer Investigators will adapt the OR program to be useful for Latina breast cancer survivors and their intimate partners using feedback from focus groups with ...

2. health.usf.edu health.usf.edu/publichealth/research/tac/overview

Together After Cancer - USF Health - University of South Florida Our research can help Latina breast cancer survivors and their partners: Strengthen their relationship and intimacy; Use effective tools to navigate ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40229582/

Después del Cáncer: a qualitative exploration of navigating ... This study aimed to explore how breast cancer shapes Latino couples' relationships throughout the cancer care continuum.

4. health.usf.edu health.usf.edu/publichealth/research/tac/lbcs

For the Latina Breast Cancer Survivor | USF Health The original program has been tested with over 5,000 couples – 94% of whom were satisfied with the program and 97% of whom would recommend the program to their ...

5. trialx.com trialx.com/clinical-trials/listings/222087/together-after-cancer/?&geo_lat=28.5978&geo_lng=-81.3534&radius=10&place=Winter%20Park&user_country=United%20States

Together After Cancer | Clinical Research Trial Listing ... Our goal is to add to this literature and develop a program for Latina breast cancer survivors and their partners that is culturally meaningful ...