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

NCT06833255 | Recruiting

• 2 other identifiers: I-4133324NCI-2024-10482
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Carcinoma

Outcome Measures

Primary Outcomes (3)

• Community-clinical linkages

  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.

  Up to 12 months

• Facilitators to implementation

  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.

  At 6 and 12 months

• Barriers to implementation

  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.

  At 6 and 12 months

Secondary Outcomes (3)

• Enrollment rate

  Up to 12 months

• Retention rate

  Up to 12 months

• Acceptability of intervention

  Up to 12 months

Study Arms (1)

Health services research (survivorship support)

EXPERIMENTAL

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.

Other: Interview; Other: Questionnaire Administration; Other: Support; Procedure: Support Group Therapy

Interventions

Interview OTHER

Ancillary studies

Health services research (survivorship support)

Questionnaire Administration OTHER

Ancillary studies

Health services research (survivorship support)

Support OTHER

Attend 1:1 peer mentoring sessions

Also known as: Supportive - procedure intent

Health services research (survivorship support)

Support Group Therapy PROCEDURE

Attend survivorship group support sessions

Health services research (survivorship support)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Interviews as Topic; Palliative Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Julia Devonish

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: February 18, 2025
• Study Start: April 21, 2025
• Primary Completion (Estimated): March 30, 2030
• Study Completion (Estimated): November 30, 2030
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

US (1)