Clinical trial NCT06833255: 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 Black Women to Alleviate Disparities During Survivorship
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Carcinoma
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2025-02-18
Enrollment: 125
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

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 Black women who are breast cancer survivors in WNY during their transitions into post-treatment life.

SECONDARY OBJECTIVES:

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

II. Prepare for 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.

Eligibility criteria: Inclusion Criteria:

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

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)

Primary outcomes:
measure: Community-clinical linkages
timeFrame: Up to 12 months
measure: Facilitators to implementation
timeFrame: At 6 and 12 months
measure: Barriers to implementation
timeFrame: At 6 and 12 months
Secondary outcomes:
measure: Enrollment rate
timeFrame: Up to 12 months
measure: Retention rate
timeFrame: Up to 12 months
measure: Acceptability of intervention
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Julia Devonish
role: PRINCIPAL_INVESTIGATOR
References: