Thriving Beyond Breast Cancer: Post-Treatment Supportive Services Programming for Breast Cancer Survivors to Optimize Health During Survivorship
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- Community-clinical linkages
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Community-clinical linkages
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Enrollment rate(Up to 12 months)
- Retention rate(Up to 12 months)
- Acceptability of intervention(Up to 12 months)