Supporting Black Breast Cancer Survivors: Feasibility Trial of Health Coaching-Based Navigation at the Conclusion of Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Dropout rate
研究概览
简要总结
This clinical trial evaluates the feasibility of coaching-based navigation for black breast cancer survivors including recruitment, dropout, and survey completion rates. A coaching-based navigation may perform a needs assessment and coach the participant to access relevant supportive content including physical rehabilitation, emotional and psychosocial support, and nutrition and exercise programming. This trial aims to see whether this navigation program may improve the quality of life of black breast cancer survivors.
详细描述
PRIMARY OBJECTIVE:
I. To evaluate the feasibility of coaching-based navigation for black breast cancer survivors including recruitment, dropout, and survey completion rates.
SECONDARY OBJECTIVES:
I. To evaluate the preliminary impact of health coaching on completion of scheduled survivorship related referrals and participation in support services.
II. To determine the preliminary impact on quality of life and self-efficacy pre and post coaching.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Black women > 18 years of age with stage I-III primary breast cancer who have completed definitive breast cancer treatment
排除标准
- 未提供
研究组 & 干预措施
Health services research (patient navigator)
Patients are assigned a Black patient navigator for racial concordance and receive coaching from patient navigator over 30 minutes every other week for 3 months and then monthly for 3 months.
干预措施: Patient Navigation (Behavioral)
Health services research (patient navigator)
Patients are assigned a Black patient navigator for racial concordance and receive coaching from patient navigator over 30 minutes every other week for 3 months and then monthly for 3 months.
干预措施: Quality-of-Life Assessment (Other)
Health services research (patient navigator)
Patients are assigned a Black patient navigator for racial concordance and receive coaching from patient navigator over 30 minutes every other week for 3 months and then monthly for 3 months.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Dropout rate
时间窗: Up to 6 months
Will be calculated as the percentage of women who are enrolled in the study but withdraw before the conclusion of the study.
Patient-Reported Outcomes Measurement Information System score
时间窗: Up to 6 months
Differences in scoring at the start of the study period and at the end of the trial will also be summarized by mean, standard deviation, and range.
Recruitment rate
时间窗: Up to 6 months
Will be calculated as the number of new eligible women per month.
Consent rate
时间窗: Up to 6 months
Will be calculated as the number of consented women (set to 40 for this study) divided by the total number of women approached.
European Organization for Research and Treatment of Cancer Quality of Life-30 score
时间窗: Up to 6 months
Differences in scoring at the start of the study period and at the end of the trial will also be summarized by mean, standard deviation, and range.
Breast Cancer Self Efficacy Scale score
时间窗: Up to 6 months
A self reported, unidimensional, 11 item scale designed to show the differences in scoring at the start of the study period and at the end of the trial will also be summarized by mean, standard deviation, and range.
次要结局
未报告次要终点
研究者
Bridget Oppong
Principal Investigator
Ohio State University Comprehensive Cancer Center