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

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

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. ^{1 2 3 4 5}

Is 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. ^{1 2 3 6 7}

How 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. ^{1 2 3 6 8}

Eligibility 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.

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Post-Treatment Survivorship Care Needs of Spanish-speaking Latinas with Breast Cancer. [2022]

2. Canada pubmed.ncbi.nlm.nih.gov

Feasibility of a Mobile Phone App and Telephone Coaching Survivorship Care Planning Program Among Spanish-Speaking Breast Cancer Survivors. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of a clinic-based survivorship intervention following adjuvant therapy in breast cancer survivors. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Quality of cancer follow-up care: a focus on Latina breast cancer survivors. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Impact of a bilingual education intervention on the quality of life of Latina breast cancer survivors. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Adapting an evidence-based survivorship intervention for Latina breast cancer survivors. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Culturally-tailored survivorship care planning for rural Latina breast cancer patients: a pilot study. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Perceptions of Survivorship Care among Latina Women with Breast Cancer in Los Angeles County. [2021]