Participation Restrictions in Young-Middle Adult Rural Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Feasibility
研究概览
简要总结
This project will develop and preliminarily evaluate an intervention to assist young-middle adult rural breast cancer survivors to overcome functional impairments related to their cancer treatment. Younger breast cancer survivors (below age 60) have ongoing family, social and vocational responsibilities and recreational interests and are at increased risk of developing long-term difficulties performing these valued activities (participation restrictions). Rural cancer survivors are medically underserved and due to distance and geographic isolation face significant barriers to accessing traditional rehabilitation services. Alternative rehabilitation approaches are sorely needed for this population. Based on previous research with cancer and other medical populations a working draft of a treatment manual using a telephone-delivered Behavioral Activation and Problem Solving (BA/PS) intervention has been designed. Prior to testing the intervention in a randomized clinical trial, additional work must be completed. The specific aims of this study are to a. refine the BA/PS treatment manual, b. develop and apply treatment integrity measures for the BA/PS manual, c. assess participation restrictions and associated outcomes, d. preliminarily assess the immediate and maintenance effects of BA/PS, and e. examine mediators and moderators of BA/PS effects based on our "Self Regulation" model of functional recovery. 188 young-middle adult breast cancer survivors will be screened for participation restrictions following cancer treatment and 40 survivors with participation restrictions will receive BA/PS delivered by phone. BA/PS participants will be assessed for treatment effectiveness and interviewed regarding their experiences during treatment to provide information for refining the manual. The long-term objective of this line of research is to develop effective and feasible treatments for the medical and psychosocial consequences of cancer and its treatment in medically underserved cancer survivors (e.g., rural populations).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female breast cancer patient stages I-III.
- •Completion of definitive breast cancer treatment (i.e., subsequent to loco-regional surgical treatment and completion of adjuvant or neo-adjuvant chemotherapy with or without radiation) within the past 3-6 months.
- •Screen positive for a moderate or worse level of participation restriction (Work and Social Adjustment Scale score > 10) within 6 months following cancer treatment.
- •English speaking.
- •Have a land-based phone or reliable cell phone reception.
排除标准
- •Non-correctable hearing loss.
- •Moderate-severe cognitive impairment indicated by a score < 3 on a 6-item cognitive screener.
- •Medical record documentation of severe mental illness (i.e., schizophrenia or bipolar disorder) or active substance abuse.
- •Medical record documentation of a physical disorder with associated functional impairment (e.g., Parkinson's disease, stroke, congestive heart failure, etc.).
结局指标
主要结局
Feasibility
时间窗: six weeks
* of patients evaluated for enrollment / # of patients approached. * of patients meeting eligibility criteria / # of patients evaluated. * of patients enrolled / # of patients meeting eligibility criteria * of patients completing 6 weeks of BA/PS treatment. * of patients completing each study assessment point (T1, T2, T3, T4).
次要结局
- Affective symptoms(baseline, six weeks, 12 weeks, 18 weeks)
- Quality of life(baseline, six weeks, 12 weeks, 18 weeks)
- Functional status(baseline, six weeks, 12 weeks, 18 weeks)