Promoting Quality of Life Among Young Adult Cancer Survivors
研究概览
详细说明
Young adulthood is a critical time for negotiating several life transitions and establishing and pursuing important life goals. Unfortunately, a cancer diagnosis disrupts this period of life for more than 60,000 people annually in the U.S. Compared to those without a history of cancer, young adult cancer survivors report poorer mental and physical health; moreover, they report significantly greater disruption in their goal pursuits than cancer survivors diagnosed at a later age. However, this high-risk group has been underserved and understudied, particularly in terms of intervention research to address these sequelae. Hope, a positive psychology construct that taps the ways in which people choose and pursue goals, is particularly relevant to this population. Additionally, higher hope is related to engaging in health promoting behaviors and living healthier lifestyles, which reduces risk of disease and adverse late effects and ultimately increase quality of life (QOL). The research team has pioneered a app-based behavioral intervention called Achieving Wellness After Kancer in Early life (AWAKE), aimed at promoting healthy lifestyles - specifically targeting mental health and positive health behaviors - among young adult cancer survivors. The proposed study will refine the intervention messaging to focus on goal-oriented thinking, include a coach, and extend the prior pilot work to a larger sample of young adult cancer survivors (aged 18-39 years) recruited from two NCI-designated cancer centers (Emory's Winship Cancer Institute in Atlanta; University of Kentucky's Markey Cancer Center in Lexington). In this randomized controlled trial, recipients of the AWAKE intervention will be compared to an attention control group.
The specific aims of this study are to:
Aim 1. Test the feasibility and acceptability of AWAKE among intervention participants. The primary feasibility indicators are participation rates and retention rates. The primary acceptability indicators are use of and satisfaction with intervention components.
Aim 2. Estimate effect sizes of AWAKE vs. control at 2 and 6 months to inform sample size calculations for the subsequent efficacy trial. The primary outcome is changes in hope, per the Trait Hope Scale. The secondary outcome is changes in quality of life, per the 36-Item Short Form Health Survey (SF-36) and the Functional Assessment of Cancer Therapy - General (FACT-G).
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Georgia
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Atlanta、Georgia、美国、30322
- Emory University winship Cancer Institute
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Kentucky
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Lexington、Kentucky、美国、40536
- Markey Cancer Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Aged 18 to 39, as of January 15th, 2017
- Speak English
- Be within two years of cancer treatment completion (since January 15th, 2015)
- Have a functioning smartphone and reliable internet access
- Be willing to complete study activities
Exclusion Criteria:
- Cancer recurrence since treatment completion
- Diagnosis of a central nervous system cancer (to ensure requisite mental/emotional functioning to engage in the program)
- Diagnosis of a thyroid cancer
- History of alcohol or drug dependency in the past year, or psychosis, bipolar disorder, or major depressive disorder
- In hospice
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：App-based behavioral intervention
Participants randomized to this study arm will take part in the Achieving Wellness After Kancer in Early life (AWAKE) behavioral intervention for 8 weeks.
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Achieving Wellness After Kancer in Early life (AWAKE) is a behavioral intervention that includes a smartphone app and coaching.
AWAKE contains eight modules, and participants will complete the one module every week.
App functioning will facilitate weekly homework assignments and include health education messaging, the ability to track progress toward goals over time via self-monitoring and graphical depictions of progress, audio-recordings of guided imagery exercises and relaxation exercises (e.g., progressive muscle relaxation), videos of topic-related inspirational material, and a portal for interacting with the coach.
The coach will call each intervention participant weekly.
Each coaching session will last roughly 30 minutes and involve four segments that will correspond to the module for the week.
The coach will send daily text messages to participants encouraging their goal pursuits and providing other sources of support related to that week's homework.
其他名称：
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有源比较器：Attention control group
Participants randomized to this study arm will take part in a behavioral intervention and coaching for 8 weeks.
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The attention control group will receive the same components as the intervention group, but the educational modules will contain different content than those receiving the AWAKE intervention.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Adult Trait Hope Scale Score
大体时间：Baseline, Month 2, Month 6
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The Adult Trait Hope Scale is a 12-item survey where respondents indicate how true a statement is on a scale of 1 (definitely false) to 8 (definitely true).
The Hope Scale includes two subscales of four items each plus four distracter items.
Higher scores on the Pathways subscale (example question: "I can think of many ways to get out of a jam") indicate higher levels of pathways thinking.
Higher scores on the Agency subscale (example question: "I energetically pursue my goals") indicate higher levels of agency thinking.
The subscales will be summed to obtain a total hope score.
Total scores can range from 8 to 64 with higher scores indicating higher levels of hope.
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Baseline, Month 2, Month 6
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in 36-Item Short Form Health Survey (SF-36) Score
大体时间：Baseline, Month 2, Month 6
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The 36-Item Short-Form Health Survey (SF-36) asks respondents to rate their health and abilities to do their usual tasks. The SF-36 uses a variety of questions and response options and includes 8 subscales (physical functioning, role limitations due to physical health, role limitations due to emotional health, energy/fatigue, emotional well-being, social functioning, pain, and general health). Responses are coded on a scale of 0 to 100 where 0 is the worst possible health and 100 is the most favorable health score. The coded responses will be summed and averaged to obtain a mean score for the entire survey. The SF-36 is standardized to the general population with a mean of 50 and a standard deviation of 10. Scores above 50 indicate better than average health while scores below 50 are worse than average health scores. |
Baseline, Month 2, Month 6
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Change in Functional Assessment of Cancer Therapy - General (FACT-G) Score
大体时间：Baseline, Month 2, Month 6
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The FACT-G is a 27-item quality of life (QOL) measure specific to cancer patients to provide insight into cancer specific factors in four dimensions (physical, social/family, emotional, functional well-being).
Participants respond to a list of statements that tend to impact people with cancer by indicating how much they are impacted on a scale of 0 (not at all) to 4 (very much).
Scores for negatively worded statements are reversed so that higher scores indicate positive health.
Scores from the four dimensions can be summed to create a total score.
Total possible scores range from 0 to 108, with higher scores indicating increased well being.
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Baseline, Month 2, Month 6
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
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Participation rate
大体时间：Baseline
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The participation rate will be recorded to assess feasibility of the intervention.
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Baseline
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Retention rate
大体时间：Month 2, Month 6
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The retention rate will be recorded to assess feasibility of the intervention.
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Month 2, Month 6
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Use of AWAKE
大体时间：Month 2
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Acceptability will be assessed by evaluating the number of participants in the intervention who use the AWAKE app.
Participants will be asked about use of specific components of the app, such as watching the videos, recording health behaviors and mood, and completing homework.
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Month 2
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Satisfaction with AWAKE
大体时间：Month 2
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Participants randomized to AWAKE will receive a survey to assess their satisfaction with the intervention.
Participants will indicate the usefulness of the different components of the AWAKE program as well as overall satisfaction with the program.
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Month 2
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合作者和调查者
调查人员
- 首席研究员：Carla Berg, PhD、Emory University
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- IRB00086979
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
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