A Post-treatment Supportive Service Program for the Transition Into Survivorship for Black Women Breast Cancer Survivors in Western New York

Official title

Thriving Beyond Breast Cancer: Post-Treatment Supportive Services Programming for Breast Cancer Survivors to Optimize Health During Survivorship

Overview

This clinical trial studies whether a post-treatment supportive service program can be used to help breast cancer survivors in Western New York (WNY) transition into post-treatment life (survivorship). The post-treatment supportive service program is delivered to 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.

Detailed description

PRIMARY OBJECTIVE:

I. Design, develop, and deliver a no-cost, culturally appropriate, community-engaged, evidence-based, easily accessible, multilevel program to one hundred individuals who are breast cancer survivors in WNY prioritzing those who have most recently transitioned into their post-treatment life and/or self-identify as African American.

SECONDARY OBJECTIVES:

I. Determine the feasibility and acceptability of the newly generated survivorship programming.

II. Prepare for possible future dissemination and implementations at other National Witness Project® (NWP) sites.

EXPLORATORY OBJECTIVES:

I. Examinations of:

Ia. Program participants overall health, wellbeing, and quality of life; Ib. Program participants breast cancer recurrence rates; Ic. Factors that influence the program's self-sustainability potential; Id. Processes involved in programming revision / modification / improvement etc.

OUTLINE:

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.

Interventions

• Other Interview
  Ancillary studies
• Other Questionnaire Administration
  Ancillary studies
• Other Support
  Attend 1:1 peer mentoring sessions
• Procedure Support Group Therapy
  Attend survivorship group support sessions

Primary outcome measures

• Community-clinical linkages [Time frame: Up to 12 months]
• Facilitators to implementation [Time frame: At 6 and 12 months]
• Barriers to implementation [Time frame: At 6 and 12 months]

Secondary outcome measures (3)

• Enrollment rate [Time frame: Up to 12 months]
• Retention rate [Time frame: Up to 12 months]
• Acceptability of intervention [Time frame: Up to 12 months]

Eligibility criteria

Inclusion criteria

• Ability to speak and read English
• At least 18 years of age or older
• Live in the Western New York area
• Has been diagnosed with breast cancer (any stage)
• Has completed primary breast cancer treatments (i.e., systemic, radiation, and/or surgical interventions other than breast reconstruction surgeries)

• Mentors are at least one-year post-treatment completion
• Mentees are less than one-year post-treatment completion
• Note: Individuals who have completed primary breast cancer treatments who are being managed with ongoing hormonal therapies and/or are awaiting breast reconstruction surgery may participate in this study (i.e., these therapies do not meet exclusion criteria)

• Note: Although any breast cancer survivor may participate, priority will be given to those who have most recently transitioned into their post-treatment life (or those who report that support was either not offered or was unavailable to them during their less recent transition into post-treatment life) and /or self-identify as African American

Exclusion criteria

• Currently receiving neoadjuvant and/or adjuvant systemic and/or radiations therapies
• Unwilling or unable to complete the assessment in English
• Are pregnant or nursing
• Are unwilling or unable to follow protocol requirements

• Note: Individuals who have completed primary breast cancer treatments who are being managed with ongoing hormonal therapies and/or are awaiting breast reconstruction surgery may participate in this study (i.e., these therapies do not meet exclusion criteria)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Health services research

Study locations

United States · 1 center

• Roswell Park Cancer Institute — Buffalo

Identifiers

NCT: NCT06833255 · I-4133324 · NCI-2024-10482 · I-4133324

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗