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
- 60
- 试验地点
- 2
- 主要终点
- Feasibility: Completion of the Intervention (Young Adult Survivors): Percentage
研究概览
简要总结
The goal of this project is to evaluate the feasibility of the "Managing Your Health" online self-management skills+peer mentoring intervention that focuses on overcoming survivor barriers to self-management of their survivorship care. We will conduct a pilot randomized controlled trial (RCT) of the intervention versus usual care with adolescent and young adult survivors of childhood cancer ages 18-25 years. Participants will complete survey measures at baseline, Time 2 (about 2 months after baseline), Time 3 (about 5 months after baseline), and Time 4 (about 12 months after baseline).
详细描述
PRIMARY OBJECTIVES:
I. Evaluate the feasibility of the online self-management+peer mentoring program in a pilot RCT.
II. Assess preliminary efficacy of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Young Adult Survivors:
- •age 18-25;
- •at least 2 years from treatment for any pediatric cancer diagnosed at age 0-19;
- •low self-reported responsibility for healthcare as indicated by reporting parent is primarily responsible for healthcare or low score (1 or 2) on two or more items from Readiness for Transition Questionnaire - Survivor Version.
- •Peer Mentor:
- •age 21-29;
- •at least 2 years from treatment for any pediatric cancer diagnosed at age 0-19;
- •self-reported primary responsibility for healthcare and "complete" readiness to assume responsibility or high scores (3 or 4) on all items from Readiness for Transition Questionnaire - Survivor Version.
排除标准
- •Documented or self-reported cognitive delay to prevent self-management of healthcare.
结局指标
主要结局
Feasibility: Completion of the Intervention (Young Adult Survivors): Percentage
时间窗: Time 2, about 2 months since baseline.
Mean percent completed per task: (a) On-line self-management educational modules and (b) Weekly calls with peer mentor.
Feasibility Measure: Retention in Study (Young Adult Survivors): Percent of Consented Patients Who Are Retained in the Study and Complete Time 3 Follow-up
时间窗: Time 3 at about 5 months since Baseline.
Retention in study (Young Adult Survivors). Determined by the percent of consented patients who are retained in the study and complete Time 3 follow-up. Hypothesis: \>80%.
Feasibility: Impact of the Online Self-Management Modules (Young Adult Survivors): Questionnaire
时间窗: Time 2, about 2 months since baseline.
The Impact Questionnaire is a 13-item scale that measures perceived effectiveness of the online program using a 5-point scale, (minimum 1, and maximum 5) with higher scores indicating greater perceived effectiveness. An overall mean of all items will be calculated.
Acceptance of Peer Mentors (Young Adult Survivors and Peer Mentors): Questionnaire
时间窗: Time 2, about 2 months since baseline
Acceptance will be evaluated by young adult survivors' and peer mentors' report on perceived alliance with each other using the Working Alliance Inventory - Short Form Revised (Hatcher \& Gillaspy, 2006), a validated measure of the quality and strength of the relationship. Items are rated on a 5-point scale. The measure yields 3 subscales summary scores that can range from 5 to 20, with higher scores indicating more positive relationships. Sum scores on each sub-scale with be calculated: Bond, Goal, and Task.
Feasibility: Satisfaction With Intervention (Young Adult Survivors): Mean
时间窗: Time 2, about 2 months since baseline.
Five items assess satisfaction with each aspect of the intervention: a. Overall program satisfaction; b. Content of online modules; c. Discussions with peer mentor; d. Frequency of calls with peer mentor; and e. Duration of program. First 3 items (a, b and c) were evaluated using a 5-point scale, (Minimum 1, Maximum 5) with higher scores indicating greater satisfaction. Item c evaluated on a scale from 1 "not frequent enough" to 3 "too frequent". Item d uses a 1 "way too short" to 5 "way too long" scale. The sample mean will be examined.
Feasibility: Utility of the Online Self-Management Modules (Young Adult Survivors): Questionnaire
时间窗: Time 2, about 2 months since baseline.
The Utility Questionnaire is an 11-item scale that measures perceived ease of use and convenience of the online program using a 5-point scale, (minimum 1, maximum 5) with higher scores indicating greater perceived utility. An overall mean of all items will be calculated.
Feasibility Measure: Enrollment (Young Adult Survivors) - Number of Eligible Patients Consented and Completing Baseline
时间窗: Baseline
Determined by number of eligible patients consented and completing baseline. Hypothesis: \>50% of eligible will consent and complete the baseline.
Feasibility: Adherence Barriers to the Online Self-Management Modules (Young Adult Survivors): Questionnaire
时间窗: Time 2, about 2 months since baseline.
The Adherence Barriers Questionnaire is a 6-item scale that measures perceived barriers to using the online program using a 5-point scale, (minimum 1 and maximum 5) with higher scores indicating greater perceived barriers. An overall mean of all items will be calculated.
次要结局
- Self-Management Goals (Young Adult Survivors)(Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline))
- Healthcare Responsibility (Young Adult Survivors)(Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).)
- Knowledge (Young Adult Survivors)(Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline))
- Self-efficacy for Managing Emotions (Young Adult Survivors): Scale(Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline))
- Self-efficacy for Communicating With Physician (Young Adult Survivors): Scale(Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).)
- Health Insurance Self-efficacy (Young Adult Survivors): Scale(Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).)
- Self-Management Skills/Self-Efficacy (Young Adult Survivors)(Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline))
- Self-efficacy for Survivorship Care Planning (Young Adult Survivors): Scale(Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).)
- Self-Management Beliefs (Young Adult Survivors)(Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline))
- Self-efficacy for Managing Late Effects (Young Adult Survivors): Scale(Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).)
- Emotional Support (Young Adult Survivors)(Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).)
- Informational Support (Young Adult Survivors)(Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).)
- Self-efficacy for Communicating With Family About Healthcare (Young Adult Survivors): Scale(Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).)
- Survivorship Care Attitudes (Young Adult Survivors)(Baseline, Time 2 (about 2 months since baseline), Time 3 (about 5 months since baseline), Time 4 (about 12 months since baseline).)
研究者
Katie Devine, PhD, MPH
Assistant Professor of Medicine
Rutgers, The State University of New Jersey