Supportive Services for Breast Cancer Survivors

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Roswell Park Cancer Institute

Must not be taking: Neoadjuvant, Adjuvant therapies

Disqualifiers: Pregnant, Nursing, Others

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

Compensation: Varies

Number of Visits: 1

125 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist breast cancer survivors in Western New York as they transition into post-treatment life through a supportive service program. The program includes group support sessions and one-on-one mentoring with long-term survivors, focusing on self-assessments and resource connections. Women who have completed their primary breast cancer treatments and are not currently undergoing chemotherapy or radiation may find this program beneficial, particularly those who identify as African American. As an unphased trial, this study provides a unique opportunity to receive personalized support and resources tailored to the post-treatment journey.

Do I have to stop taking my current medications for this trial?

The trial does not require you to stop taking your current medications. If you are on ongoing hormonal therapies or awaiting breast reconstruction surgery, you can still participate.

What prior data suggests that this post-treatment supportive service program is safe for breast cancer survivors?

Research has shown that programs supporting breast cancer survivors are very safe. Studies have found that these programs help survivors manage their health and improve their quality of life. They often include group support and education, which many find helpful.

No reports of harmful effects have emerged from joining these programs. They focus on mental and emotional support, without involving any physical treatments or medications, so the risk of side effects remains very low. Participants often feel more supported and connected to others who understand their experiences.

Overall, these programs are well-received and provide a safe way for breast cancer survivors to adjust to life after treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Post-treatment Supportive Service Program for breast cancer survivors because it offers a unique blend of group support and peer mentoring, which is not a common focus in standard care. Unlike typical post-treatment options that may emphasize medical follow-ups and physical rehabilitation, this program prioritizes emotional and social recovery. By providing regular group sessions and one-on-one mentoring with long-term survivors, it aims to foster a sense of community and personal growth. This holistic approach addresses mental and emotional health, which are crucial yet often underserved aspects of survivorship care.

What evidence suggests that this post-treatment supportive service program is effective for breast cancer survivors?

Research shows that programs supporting breast cancer survivors after treatment can be very helpful. In this trial, participants will attend survivorship group support sessions and one-on-one peer mentoring sessions. Survivors who joined group medical visits (GMVs) felt more informed and confident about their care. Survivorship care plans (SCPs) have also clarified who is responsible for their follow-up care. Studies have found that these programs improve the quality of life and health of survivors by addressing ongoing health and life challenges. These programs are especially important because they help survivors manage the long-term effects of cancer and its treatment. ^{6 7 8 9 10}

Who Is on the Research Team?

Julia Devonish

Principal Investigator

Roswell Park Cancer Institute

Are You a Good Fit for This Trial?

This trial is for Black women in Western New York who have survived breast cancer and are transitioning into post-treatment life. It aims to support them through group sessions, educational activities, and one-on-one mentoring with long-term survivors.

Inclusion Criteria

Self-identify as Black or African American but may include other breast cancer survivors

I have finished all my initial breast cancer treatments.

I finished my cancer treatment over a year ago.

Exclusion Criteria

Are pregnant or nursing

Are unwilling or unable to follow protocol requirements

I am on hormonal therapy or waiting for breast reconstruction after finishing my primary breast cancer treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Survivorship Support Program

Participants attend group support sessions and 1:1 peer mentoring sessions to aid transition into post-treatment life

12 months

Bi-weekly group sessions and bi-weekly 1:1 mentoring sessions

Follow-up

Participants are monitored for program effectiveness and sustainability

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Post-treatment Supportive Service Program

Trial Overview The study tests a supportive service program combining group therapy, educational lessons, peer mentoring, and self-assessment training to aid survivorship transition for these women.

How Is the Trial Designed?

Group I: Health services research (survivorship support) Experimental Treatment 4 Interventions

Patients attend survivorship group support sessions over 2 hours on the 1st and 3rd Thursday of each month and 1:1 peer mentoring sessions with long-term breast cancer survivors on the 2nd and 4th Thursday of each month for up to 12 months.

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+

Published Research Related to This Trial

A retrospective analysis of 724 adverse events (AEs) after primary cancer treatment revealed that 46% of these events resulted in physical harm, with 4% leading to severe harm or death, highlighting significant safety concerns in post-treatment care.

The study found that 50% of AEs were related to care transitions, indicating that improvements in administrative practices, communication, and clarity in patient responsibility could greatly reduce these adverse events and enhance patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attention to cancer patients' safety after primary treatment is needed. Christiansen, AH., Lipczak, H., Knudsen, JL.[2015]

A 4-week self-management intervention for breast cancer survivors led to positive experiences and increased self-efficacy, with benefits reported even two years later by the 21 participants in the study.

Despite the success of the program in fostering community and self-management skills, a significant gap was identified in bereavement support for women who lost friends, highlighting the need for comprehensive emotional support in survivorship care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Qualitative experiences of breast cancer survivors on a self-management intervention: 2-year post-intervention. Loh, SY., Ong, L., Ng, LL., et al.[2017]

The PAVING the Path to Wellness Program is a 12-week initiative designed for breast cancer survivors, focusing on evidence-based lifestyle medicine to enhance well-being and reduce the risk of cancer recurrence.

Participants in the program reported significant improvements in their attitude and overall well-being, highlighting the program's effectiveness in supporting survivors post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PAVING the Path to Wellness for Breast Cancer Survivors: Lifestyle Medicine Education and Group Interventions. Comander, A., Frates, B., Tollefson, M.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10314024/

Breast cancer survivors–supportive care needs: systematic ... Increased survival rates in patients with breast cancer have led to a growth in the number of survivors with disease-related problems that require ongoing post- ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1526820925002162

Preferences for Breast Cancer Survivorship Programs ... These data show differences in provider referrals to clinical survivorship resources for different age groups and White compared to Black women.

3. nature.com nature.com/articles/bjc2014505

Survivorship care plans in cancer: a systematic review of ... Breast cancer survivors with SCPs were better able to correctly identify the clinician responsible for their follow-up care. One study suggested ...

4. link.springer.com link.springer.com/article/10.1007/s13187-024-02429-6

Acceptability and Feasibility of Survivorship Group Medical ... The BCS who completed the post-survey reported that GMVs increased their awareness, confidence, and knowledge of survivorship care. GMVs were ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/prm2.12042

The improvement in continuity and integrity of survivorship ... For a long term, breast cancer and the side effects of cancer treatments affect health and life quality of cancer survivors. With the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6443226/

Are patient-reported outcomes useful in post-treatment ... This review aims to determine the effects and feasibility of using PROs proactively during follow-up care in early breast cancer.

7. ascopubs.org ascopubs.org/doi/10.1200/EDBK-25-473472

Long-Term Follow-Up Care After Treatment for Primary ... This article explores the most prevalent symptoms and concerns experienced by BCS, particularly those arising from systemic and local therapies during post- ...

8. cancer.jmir.org cancer.jmir.org/2022/1/e31756

Evaluation of the Pathways for Survivors Program to Address ... After active treatment ends, patients with breast cancer may feel a loss of a safety net. A comprehensive review of breast cancer survivors (≥1 ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12088642/

Outcomes for breast cancer survivors with metastatic ... This study examined the effectiveness and feasibility of the Active Living After Cancer (ALAC) program for metastatic breast cancer (MBC) ...

10. dana-farber.org dana-farber.org/newsroom/news-releases/2024/breast-cancer-research-new-studies-show-how-post-treatment-lifestyle-choices-shape-long-term-outcomes-after-diagnosis

Breast cancer research: New studies show how post- ... "These studies provide the first evidence on the safety of breastfeeding after breast cancer in both young patients carrying BRCA variations ...