Supportive Services for Breast Cancer Survivors

Age: 18+

Sex: Female

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

Trial Summary

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 data supports the effectiveness of the Post-treatment Supportive Service Program for breast cancer survivors?

Research highlights the importance of addressing both physical and emotional needs in breast cancer survivors, as they often face challenges like fear of recurrence and other post-treatment symptoms. Implementing comprehensive care pathways and multidisciplinary support can empower survivors and improve their overall well-being. ^{1 2 3 4 5}

Is the Supportive Services for Breast Cancer Survivors program safe for participants?

The available research does not provide specific safety data for the Supportive Services for Breast Cancer Survivors program, but it focuses on lifestyle education and wellness activities, which are generally considered safe for participants. ^{6 7 8 9 10}

How is the Post-treatment Supportive Service Program different from other treatments for breast cancer survivors?

The Post-treatment Supportive Service Program is unique because it focuses on providing comprehensive supportive care for breast cancer survivors, addressing both physical and emotional needs after treatment. It emphasizes self-management, education on recognizing disease recurrence, and lifestyle modifications, which are not typically the focus of standard cancer treatments. ^{11 12 13 14 15}

What is the purpose of this trial?

This clinical trial studies whether a post-treatment supportive service program can be used to help Black women breast cancer survivors in Western New York (WNY) transition into post-treatment life (survivorship). Programming for Black cancer survivors in WNY is crucially needed. Poverty and cancer have affected the region for years. The post-treatment supportive service program is delivered to Black women breast cancer survivors of WNY. It combines group support sessions and one-on-one (1:1) peer mentoring sessions. The group support sessions include traditional support groups, educational topics/lessons, activities, such as cooking lessons, celebrations, or facility tours, and guest speakers. The 1:1 peer mentoring sessions are held with a long-term breast cancer survivor mentor. The long-term breast cancer survivor mentor helps the mentee get in the practice of performing once monthly self-assessments and create plans to help improve any identified modifiable risk factors. The long-term breast cancer survivor mentor can also help connect the mentee to providers or resources as needed. A post-treatment supportive service program may help Black women breast cancer survivors in WNY transition into survivorship.

Research Team

Julia Devonish

Principal Investigator

Roswell Park Cancer Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

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

Implementing a PROACTive Care Pathway to Empower and Support Survivors of Breast Cancer. [2023]

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

Impact of post-treatment symptoms on supportive care needs among breast cancer survivors in South Korea. [2023]

3. France pubmed.ncbi.nlm.nih.gov

Psychological and physical impact in women treated for breast cancer: Need for multidisciplinary surveillance and care provision. [2021]

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

Explaining Postdischarge Care Needs of Cancer Patients: A Qualitative Study. [2022]

5. England pubmed.ncbi.nlm.nih.gov

A mixed-methods study to explore the supportive care needs of breast cancer survivors. [2019]

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

PAVING the Path to Wellness for Breast Cancer Survivors: Lifestyle Medicine Education and Group Interventions. [2022]

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

Catalyzing Navigation for Breast Cancer Survivorship (CaNBCS) in Safety-Net Settings: A Mixed Methods Study. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Barriers and engagement in breast cancer survivorship wellness activities. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Wellness Beyond Cancer Program: building an effective survivorship program. [2018]

10. Denmark pubmed.ncbi.nlm.nih.gov

Attention to cancer patients' safety after primary treatment is needed. [2015]

11. Scotland pubmed.ncbi.nlm.nih.gov

Survivors' preferences for the organization and delivery of supportive care after treatment: An integrative review. [2021]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Supportive care after curative treatment for breast cancer (survivorship care): resource allocations in low- and middle-income countries. A Breast Health Global Initiative 2013 consensus statement. [2021]

13. Thailand pubmed.ncbi.nlm.nih.gov

Qualitative experiences of breast cancer survivors on a self-management intervention: 2-year post-intervention. [2017]

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

Evidence-Based Guidance for Breast Cancer Survivorship. [2023]

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

Utilization of cancer survivorship services during the COVID-19 pandemic in a tertiary referral center. [2023]