[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06833255":3,"trial-entities:NCT06833255":114,"trial-summary:NCT06833255":117},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":48,"secondary_outcomes":60,"sex":69,"minimum_age":70,"maximum_age":71,"healthy_volunteers":15,"eligibility_criteria":72,"std_ages":88,"locations":91,"central_contacts":109,"overall_officials":110,"references":112,"see_also_links":113},"NCT06833255","I-4133324","A Post-treatment Supportive Service Program for the Transition Into Survivorship for Black Women Breast Cancer Survivors in Western New York","Thriving Beyond Breast Cancer: Post-Treatment Supportive Services Programming for Breast Cancer Survivors to Optimize Health During Survivorship","RECRUITING","2030-11-30","2025-11","2025-11-24","2025-04-21","Roswell Park Cancer Institute","OTHER",false,"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\u002Flessons, 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.","PRIMARY OBJECTIVE:\n\nI. 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\u002For self-identify as African American.\n\nSECONDARY OBJECTIVES:\n\nI. Determine the feasibility and acceptability of the newly generated survivorship programming.\n\nII. Prepare for possible future dissemination and implementations at other National Witness Project® (NWP) sites.\n\nEXPLORATORY OBJECTIVES:\n\nI. Examinations of:\n\nIa. 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 \u002F modification \u002F improvement etc.\n\nOUTLINE:\n\nPatients 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.",[19],"Breast Carcinoma",[],"INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[24],"NA",{"count":26,"type":27},125,"ESTIMATED",[29,34,37,43],{"type":14,"name":30,"description":31,"armGroupLabels":32},"Interview","Ancillary studies",[33],"Health services research (survivorship support)",{"type":14,"name":35,"description":31,"armGroupLabels":36},"Questionnaire Administration",[33],{"type":14,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Support","Attend 1:1 peer mentoring sessions",[33],[42],"Supportive - procedure intent",{"type":44,"name":45,"description":46,"armGroupLabels":47},"PROCEDURE","Support Group Therapy","Attend survivorship group support sessions",[33],[49,53,57],{"measure":50,"description":51,"timeFrame":52},"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",{"measure":54,"description":55,"timeFrame":56},"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",{"measure":58,"description":59,"timeFrame":56},"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.",[61,64,66],{"measure":62,"description":63,"timeFrame":52},"Enrollment rate","Will be assessed using very basic mathematical equations, no advanced level statistical analyses will be involved.",{"measure":65,"description":63,"timeFrame":52},"Retention rate",{"measure":67,"description":68,"timeFrame":52},"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.","ALL","18 Years",null,{"inclusion":73,"exclusion":81,"raw_text":87},[74,75,76,77,78,79,80],"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\u002For 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",[82,83,84,85,86],"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 \u002For self-identify as African American","Currently receiving neoadjuvant and\u002For adjuvant systemic and\u002For radiations therapies","Unwilling or unable to complete the assessment in English","Are pregnant or nursing","Are unwilling or unable to follow protocol requirements","Inclusion Criteria:\n\n* Ability to speak and read English\n* At least 18 years of age or older\n* Live in the Western New York area\n* Has been diagnosed with breast cancer (any stage)\n* Has completed primary breast cancer treatments (i.e., systemic, radiation, and\u002For surgical interventions other than breast reconstruction surgeries)\n\n  * Mentors are at least one-year post-treatment completion\n  * Mentees are less than one-year post-treatment completion\n  * Note: Individuals who have completed primary breast cancer treatments who are being managed with ongoing hormonal therapies and\u002For are awaiting breast reconstruction surgery may participate in this study (i.e., these therapies do not meet exclusion criteria)\n\n    * 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 \u002For self-identify as African American\n\nExclusion Criteria:\n\n* Currently receiving neoadjuvant and\u002For adjuvant systemic and\u002For radiations therapies\n* Unwilling or unable to complete the assessment in English\n* Are pregnant or nursing\n* Are unwilling or unable to follow protocol requirements\n\n  * Note: Individuals who have completed primary breast cancer treatments who are being managed with ongoing hormonal therapies and\u002For are awaiting breast reconstruction surgery may participate in this study (i.e., these therapies do not meet exclusion criteria)",[89,90],"ADULT","OLDER_ADULT",[92],{"facility":13,"status":8,"city":93,"state":94,"zip":95,"country":96,"contacts":97,"geoPoint":106},"Buffalo","New York","14263","United States",[98,104],{"name":99,"role":100,"phone":101,"phoneExt":102,"email":103},"Julia Devonish","CONTACT","716-845-2300","6881","julia.devonish@roswellpark.org",{"name":99,"role":105},"PRINCIPAL_INVESTIGATOR",{"lat":107,"lon":108},42.88645,-78.87837,[],[111],{"name":99,"affiliation":13,"role":105},[],[],{"nct_id":4,"conditions":115,"biomarkers":116},[19],[],{"nct_id":4,"found":118,"summary":119,"prompt_version":129},true,{"design":120,"status":121,"heading":122,"summary":123,"follow_up":124,"word_count":125,"commitments":126,"compensation":127,"drugs_mentioned":128},"This interventional study plans to enroll 125 participants. It combines group support sessions and one-on-one peer mentoring.","completed","Support Program for Black Women Breast Cancer Survivors in Western New York","This study is testing a supportive service program to help Black women breast cancer survivors in Western New York (WNY) adjust to life after treatment. The program includes both group support sessions and one-on-one (1:1) mentoring with a long-term breast cancer survivor. You might be able to join if you are at least 18 years old, live in WNY, have been diagnosed with breast cancer, and have finished your main treatments (like chemotherapy, radiation, or surgery, not including breast reconstruction). The study aims to see how well this program works and if it can be used in other places. The current status of this study is unclear, and it plans to enroll 125 people.","The study will look at community-clinical linkages for up to 12 months, and facilitators and barriers to implementation at 6 and 12 months.",114,"You would attend survivorship group support sessions for 2 hours twice a month and 1:1 peer mentoring sessions twice a month for up to 12 months.","Not stated in the trial record.",[38],"v2"]