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NCT Number: NCT06833255

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

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.

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Key information

Conditions

Breast Carcinoma Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location status: Recruiting

Location contact

Julia Devonish

CONTACT

[email protected]

716-845-2300 ext. 6881

Julia Devonish

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

interview

Other

Ancillary studies

Questionnaire Administration

Other

Ancillary studies

SUPPORT

Other

Attend 1:1 peer mentoring sessions

Other names: Supportive - procedure intent

support group therapy

Procedure

Attend survivorship group support sessions

Primary outcomes

  1. Community-clinical linkages

    Time frame: Up to 12 months

    Will assess the number of community-clinical linkages between organizations that support enrollment of breast cancer survivors who are Black into grant survivorship services. This will include formal agreements with at least: 1 cancer center, 2 primary care facilities, and 4 community organizations.

  2. Facilitators to implementation

    Time frame: At 6 and 12 months

    Will be assessed using semi-structured interviews conducted at focus groups. An integrated (i.e., both deductive and inductive) approach to data analysis will be used. Qualitative data analyses techniques will be used to identify key themes within and across the interviewee groups. A structured summary template will be created using key elements from the interviewee guides to organize and condense data based on Consolidated Framework for Implementation Research (CFIR) domains. At least two implementation evaluation team members will participate in the initial coding of interviews and synthesis of summary sheets. Summary sheets will be transferred into matrix displays by the main coder (Devonish) and categorized into barriers and facilitators within each CFIR domain for each interviewee group. Group matrices will then be compared to determine cross-cutting themes and explore differences across groups.

  3. Barriers to implementation

    Time frame: At 6 and 12 months

    Will be assessed using semi-structured interviews conducted at focus groups. An integrated (i.e., both deductive and inductive) approach to data analysis will be used. Qualitative data analyses techniques will be used to identify key themes within and across the interviewee groups. A structured summary template will be created using key elements from the interviewee guides to organize and condense data based on CFIR domains. At least two implementation evaluation team members will participate in the initial coding of interviews and synthesis of summary sheets. Summary sheets will be transferred into matrix displays by the main coder (Devonish) and categorized into barriers and facilitators within each CFIR domain for each interviewee group. Group matrices will then be compared to determine cross-cutting themes and explore differences across groups.

Secondary outcomes

  1. Enrollment rate

    Time frame: Up to 12 months

    Will be assessed using very basic mathematical equations, no advanced level statistical analyses will be involved.

  2. Retention rate

    Time frame: Up to 12 months

    Will be assessed using very basic mathematical equations, no advanced level statistical analyses will be involved.

  3. Acceptability of intervention

    Time frame: Up to 12 months

    Feedback will be compiled into a quarterly summary report that will be distributed during the execution phase of the proposed programming. Quarterly reports will be available for board members' quarterly meetings during the execution phase to guide shared decision making about content changes, adjustments, and guest facilitators.

Sponsors and collaborators

Lead sponsor

Roswell Park Cancer Institute

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Feb 18, 2025
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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