Breast CarcinomaNCT06833255
A Post-treatment Supportive Service Program for the Transition Into Survivorship for Black Women Breast Cancer Survivors in Western New York
A study testing Interview, Questionnaire Administration and Support in people with Breast Carcinoma, run by Roswell Park Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Carcinoma
- What is being tested?
- Interview, Questionnaire Administration and Support
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2025to 30 Nov 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Roswell Park Cancer Institute
Buffalo, New York, 14263
Julia Devonish, 716-845-2300 ext. 6881, julia.devonish@roswellpark.org
Julia Devonish
About this study
Official title: Thriving Beyond Breast Cancer: Post-Treatment Supportive Services Programming for Breast Cancer Survivors to Optimize Health During Survivorship
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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:
- 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.
- Conditions
- Breast Carcinoma
- Being tested
- Interview, Questionnaire Administration, Support, Support Group Therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewOther
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
SupportOther
Also called Supportive - procedure intent
Attend 1:1 peer mentoring sessions
Support Group TherapyProcedure or surgery
Attend survivorship group support sessions
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Interview; Other: Questionnaire Administration; Other: Support; Procedure: Support Group Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: At 6 and 12 months
Secondary outcomes (3)
Enrollment rate
Will be assessed using very basic mathematical equations, no advanced level statistical analyses will be involved.
Measured: Up to 12 months
Retention rate
Will be assessed using very basic mathematical equations, no advanced level statistical analyses will be involved.
Measured: Up to 12 months
Acceptability of intervention
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.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start21 Apr 2025
- Primary completion30 Mar 2030 (estimated)
- Study completion30 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julia Devonish, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06833255
- Sponsor's protocol ID
- I-4133324
- Other IDs
- NCI-2024-10482, I-4133324
- Status last verified
- Nov 2025
- First submitted
- 12 Feb 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thriving Beyond Breast Cancer: Post-Treatment Supportive Services Programming for Breast Cancer Survivors to Optimize Health During Survivorship
- ClinicalTrials.gov ID
- NCT06833255
- Acronym / sponsor ID
- I-4133324
- Conditions
- Breast Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 21 Apr 2025 (actual)
- Primary completion
- 30 Mar 2030 (estimated)
- Study completion
- 30 Nov 2030 (estimated)
- First posted
- 18 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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:
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health services research (survivorship support) | Experimental | Other: Interview, Other: Questionnaire Administration, Other: Support, Procedure: Support Group TherapyPatients 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterviewAncillary studies | Other | Health services research (survivorship support) |
| Questionnaire AdministrationAncillary studies | Other | Health services research (survivorship support) |
| SupportAlso: Supportive - procedure intentAttend 1:1 peer mentoring sessions | Other | Health services research (survivorship support) |
| Support Group TherapyAttend survivorship group support sessions | Procedure or surgery | Health services research (survivorship support) |
Primary outcome
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.
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.
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Roswell Park Cancer Institute
Buffalo, United States
Julia Devonish principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interview, Questionnaire Administration and Support in people with Breast Carcinoma, run by Roswell Park Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Community-clinical linkages (time frame: Up to 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.