480 Participants Needed

Together After Cancer Program for Breast Cancer

Recruiting at 2 trial locations
BD
DM
Overseen ByDinorah Martinez Tyson, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of South Florida
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

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.12345

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.12346

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.12378

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.
I have been in a committed relationship for at least six months.
See 4 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Together After Cancer InterventionExperimental Treatment1 Intervention
Group II: Usual CareActive Control1 Intervention

Find a Clinic Near You

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.
Post-Treatment Survivorship Care Needs of Spanish-speaking Latinas with Breast Cancer.Nรกpoles, 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.
Feasibility of a Mobile Phone App and Telephone Coaching Survivorship Care Planning Program Among Spanish-Speaking Breast Cancer Survivors.Nรกpoles, AM., Santoyo-Olsson, J., Chacรณn, 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.
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]

Citations

Post-Treatment Survivorship Care Needs of Spanish-speaking Latinas with Breast Cancer. [2022]
Feasibility of a Mobile Phone App and Telephone Coaching Survivorship Care Planning Program Among Spanish-Speaking Breast Cancer Survivors. [2023]
Randomized controlled trial of a clinic-based survivorship intervention following adjuvant therapy in breast cancer survivors. [2022]
Quality of cancer follow-up care: a focus on Latina breast cancer survivors. [2022]
Impact of a bilingual education intervention on the quality of life of Latina breast cancer survivors. [2021]
Adapting an evidence-based survivorship intervention for Latina breast cancer survivors. [2021]
Culturally-tailored survivorship care planning for rural Latina breast cancer patients: a pilot study. [2023]
Perceptions of Survivorship Care among Latina Women with Breast Cancer in Los Angeles County. [2021]
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