Promoting Quality of Life Among Young Adult Cancer Survivors
調査の概要
詳細な説明
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).
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Georgia
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Atlanta、Georgia、アメリカ、30322
- Emory University Winship Cancer Institute
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Kentucky
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Lexington、Kentucky、アメリカ、40536
- Markey Cancer Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
他の名前：
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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Adult Trait Hope Scale Score
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in 36-Item Short Form Health Survey (SF-36) Score
時間枠：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
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Participation rate
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
スポンサー
捜査官
- 主任研究者：Carla Berg, PhD、Emory University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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