Promoting Follow-Up Care Self-Management for Adolescent and Young Adult (AYA) Childhood Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Mentor Training Satisfaction
研究概览
简要总结
This pilot trial studies a peer mentoring and online self-management program to see how well it works in promoting follow-up care self-management in younger childhood cancer survivors. Childhood cancer survivors require lifelong follow-up care to identify, monitor, and treat medical and psychosocial late effects stemming from their cancer, its treatment, and lifestyle factors. A peer mentoring program + self-management may improve disease knowledge, health motivation, problem-solving skills, stress management, and communication with caregivers and providers in adolescent and young adult cancer survivors.
详细描述
PRIMARY OBJECTIVES:
I. Evaluate the feasibility of the self-management + peer mentoring program in a pilot trial.
II. Assess preliminary outcomes of the peer mentoring program.
OUTLINE:
All Participants will be asked to complete online self-management educational modules and 6 weekly peer mentor calls to facilitate engagement with the online modules and offer specialized support. We will also recruit and train peer Mentors.
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 29 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PEER MENTOR ELIGIBILITY:
- •Age 21-29
- •At least 1.5 years from treatment
- •Self-reported primary responsibility for care and "complete readiness" using the Readiness for Transition Questionnaire
- •PATIENT ELIGIBILITY:
- •Age 18-25
- •At least 1.5 years from treatment
- •Currently does not independently self-manage follow-up care according to self-report to assume total responsibility for care (i.e., reports low readiness [score of 1 or 2 out of 4] OR scores <3 on any of the 10-item responsibility scale from the Readiness for Transition Questionnaire)
排除标准
- •PATIENT EXCLUSION CRITERIA: Physician- or self-reported cognitive delay or impairment that would prevent self-management of healthcare
结局指标
主要结局
Mentor Training Satisfaction
时间窗: Time of enrollment, after completing mentor training.
Mentor 6-item Training Satisfaction measured on a scale from 1 "strongly disagree" to 4 "strongly agree" (higher score=high satisfaction). Administered to Group Intervention Mentors only. Total average score is reported.
Satisfaction With Intervention, Measured by 1) General Satisfaction, 2) Intervention Utility Questionnaire, 3) Impact Questionnaire (i.e., Effectiveness), and 4) Adherence Questionnaire ( i.e., Barriers to Engagement).
时间窗: 6 weeks (post-intervention)
1. General Satisfaction: Average of each item reported separately. 1: Program; 2: Online educational materials; 3: Discussion with mentor; 4: Frequency of calls; 5: Program duration; 6: Material read. Items 1, 2, 3, \& 6 are rated on a 1 "not at all" to 5 "very" scale (higher=higher satisfaction). Item 4 uses a 1 "not frequent enough" to 3 "too frequent" scale. Item 5 uses a 1 "way too short" to 5 "way too long" scale. 2. 12-items adapted from Internet Intervention Utility Questionnaire; measures perceived usefulness on 1 "not at all" to 5 "very" scale, higher=higher usefulness. Average total score reported. 3. 16-item Impact Questionnaire measures perceived effectiveness in improving targeted skills using 1 "not at all" to 5 "very" scale (higher=greater perceived effectiveness). Average total score reported. 4. 6-item Adherence Questionnaire measures barriers to engagement using 1 "not a problem" to 3 "major problem" scale. (higher=bigger barrier). Average total score reported.
Feasibility as Measured by Study Enrollment Rates, Retention Rates, Adherence to the Intervention, and Reasons for Study Drop Out.
时间窗: 6 weeks
Descriptive analyses will be used to evaluate expected enrollment (\> 50%), retention (\> 80%), and completion of intervention sessions (\> 75%).
次要结局
- Impact of Cancer, as Measured by Three Subscales of the Impact of Cancer - Childhood Cancer Survivors Scale(Baseline to up to 6 weeks)
- Transition Readiness, as Measured by the Transition Readiness Inventory (Phase 2).(Baseline to up to 6 weeks)
- Symptoms of Anxiety, as Measured by the PROMIS Anxiety Short-Form (v1.0 8a)(Baseline to up to 6 weeks)
- Barriers to Follow-up Care & Adherence(Up to 6 weeks)
- Transition Readiness, as Measured by the Readiness for Transition Questionnaire - Survivor Version(Baseline to up to 6 weeks)
- Symptoms of Depression, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short-Form (v1.0 8b).(Baseline to up to 6 weeks)
- Short Grit Scale(Baseline to up to 6 weeks)
- Cancer Related Worry Scale(Baseline to up to 6 weeks)
研究者
Katie Devine, PhD, MPH
Assistant Professor of Medicine
Rutgers, The State University of New Jersey