Social Optimization Study
Improving the Lives of Cancer Survivors Through Enhancing Support Receptivity
調査の概要
詳細な説明
The growing cancer survivorship population. This year, more than 1.77 million Americans will receive a life-altering cancer diagnosis. Fortunately, improvements in early detection and care have led to dramatic increases in survival. Over 18 million Americans or 5.4% of the total U.S. population now identify as cancer survivors with an expected growth to 26 million by 2040. Recognition of these immense changes in survival has led the National Cancer Institute (NCI) to found the Office of Cancer Survivorship (OCS) with a stated goal of "enhancing the quality and length of survival of all persons diagnosed with cancer…" Consistent with its mission, NCI/OCS is prioritizing research that improves the QOL of this growing survivorship population.
Social integration is a critical moderator. Social integration is one potential resilience factor that may be key to improving QOL among cancer survivors. Social integration, the degree of social embeddedness and strength of social ties, is amongst the most robust predictors of a broad range of mental and physical health outcomes. Robust, replicated research documents that people who are more socially integrated experience lower rates of depression, anxiety, and most forms of chronic illness and experience lower age-adjusted disease-specific and all-cause mortality. Decades of research show that interventions to provide more support including via support groups, community events, or provision of supportive persons can improve mental and physical health outcomes. At the same time, the improvements in these outcomes are modest, suggesting that not all relevant factors are accounted for.
Work from our team examining Hispanic advantages in mental and physical health via culturally moderated social integration suggest that support receptivity is a key element of social integration effectiveness. This revelation suggests that social integration is an interactive process not unlike effective neuronal communication. Neuron communication is moderated by both the adequacy of the signal and the sensitivity of the receptor. Both must be effective for transmission to take place. Social integration benefits may work the same way. While nearly all social integration interventions have focused on providing sufficient support, almost no interventions have sought to enhance support receptivity to enhance social integration effects in the context of physical health such as cancer survivorship.
The current goal is to test whether clinical interventions to optimize support receptivity lead to improvements in social integration and QOL amongst cancer survivor populations. A pilot randomized clinical trial is proposed to evaluate feasibility and acceptability of the intervention and assessment procedures, and to explore whether the intervention can improve QOL through optimizing survivors' social receptivity to determine proof-of-concept. We propose to enroll 30 long-term (> 12 months post-treatment) lung cancer survivors randomized to either a support receptivity intervention or attention-control condition. Our intervention draws on the large body of cognitive behavioral therapy (CBT) interventions to reduce social anxiety, improve social awareness, and promote social integration for a wide range of mental health conditions. The proposed 3-week, 6 session CBT intervention specifically targets cognitive awareness of prosocial cues coupled with Behavioral Activation and Social Skills Training to improve target person social engagement. Building on our ongoing, NCI-funded work on social engagement in lung cancer patients, we will use two novel in vivo sampling methods using a mobile phone platform to assess social engagement and QOL improvements: 1) recording via the Electronically Activated Recorder (EAR)17 to capture frequency of daily social interactions, and 2) repeated self-report sampling (ecological momentary assessments) where participants will be prompted to answer questions about their social engagement experiences via their personal cell phone.
The following aims are proposed:
Aim 1: Explore whether a CBT intervention targeting social receptivity can improve QOL in cancer survivors compared to an attention control condition to determine proof-of-concept. Hypothesis: We expect that the intervention will produce improvements via the targeted mechanism with sustained differences at 2 months post.
Aim 2: Explore the degree to which the CBT intervention increases objectively assessed social engagement as a putative mechanism. Hypothesis: We expect to demonstrate proof-of-concept that social engagement is malleable with implications for survivor mental and social health in alignment with NCI survivorship priorities.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Francis Morales-Lozada
- 電話番号:(520) 621-0563
- メール:fmoraleslozada@arizona.edu
研究場所
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Arizona
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Tucson、Arizona、アメリカ、85719
- 募集
- University of Arizona Mel and Enid Zuckerman College of Public Health
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コンタクト:
- Francis Morales-Lozada
- 電話番号:(520) 621-0563
- メール:fmoraleslozada@arizona.edu
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主任研究者:
- Scott Carvajal, PhD, MPH
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副調査官:
- John Ruiz, PhD
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副調査官:
- Matthias Mel, PhD
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副調査官:
- Linda Garland, MD
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副調査官:
- Rina Fox, PhD, MPH
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Adults (18 Years or Older)
- History of lung cancer
- at least 12 months since cancer diagnosis
- fluent in English
- able to attend virtually or in person sessions at the University of Arizona.
Exclusion Criteria:
- Less than 12 months of cancer diagnosis at time of enrollment
- undergoing treatment for mood or anxiety health issues at time of enrollment
- unable to provide informed consent.
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:Social support receptivity training
Participants will receive a 3-week, 6 session CBT intervention targeting cognitive awareness of prosocial cues coupled with behavioral activation and social skills training to improve target person social engagement.
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A 3-week, 6-session CBT intervention that targets cognitive awareness of prosocial cues and leverages behavioral activation and social skills training
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アクティブコンパレータ:Social awareness training
Participants receiving a 3-week, 6 session program designed to increase awareness of the social support already available to them.
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A 3-week, 6 session program designed to increase awareness of available social support.
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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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Feasibility assessed by recruitment and retention rates
時間枠:Throughout the recruitment period
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Given the pilot nature of this work, the intervention/study will be deemed feasible if 20% of eligible potential participants approached enroll and 50% of enrolled participants are retained at post-intervention
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Throughout the recruitment period
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Acceptability assessed by study-specific survey after the intervention
時間枠:3 weeks - immediately after the intervention
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The intervention/study will be deemed acceptable if, on average, participants report satisfaction with the overall program/study as ≥2 on a 0-4 scale.
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3 weeks - immediately after the intervention
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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 quality of life (QOL) using the SF-36 from baseline to immediately after the intervention.
時間枠:3 weeks - immediately after the intervention
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Participants will complete the 36-item SF-36, which evaluates eight health domains-physical functioning, pain, vitality, social functioning, and mental health-covering physical and mental components.
Scores on each domain range from 0-100, with higher scores indicating better quality of life (QOL).
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3 weeks - immediately after the intervention
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Change in Perceived Stress using the Perceived Stress Scale (PSS) from baseline to immediately after the intervention
時間枠:3 weeks - immediately after the intervention
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Participants will complete a 10-item PSS, which evaluates an individual's stress level.
Scores range from 0-40, with higher scores indicating higher perceived stress.
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3 weeks - immediately after the intervention
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Change in depression using the CES-D scale from baseline to immediately after the intervention
時間枠:3 weeks - immediately after the intervention
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Participants will complete a 10-item CES-D, which evaluates an individual's self-reported symptoms of depression.
The total score is calculated by totaling all items scored after reversing the positive mood items.
Possible range for scores is 0-11 with higher scores representing greater degrees of depressed mood.
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3 weeks - immediately after the intervention
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Change in network diversity using the Berkman-Syme Social Network Index (BS-SNI) from baseline to immediately after the intervention
時間枠:3 weeks - immediately after the intervention
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Participants will complete the BS-SNI, which assesses network diversity, and the number of people in an individual's network.
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3 weeks - immediately after the intervention
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Change in subject loneliness and social isolation using the UCLA-Loneliness Scale from baseline to immediately after the intervention
時間枠:3 weeks - immediately after the intervention
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Participants will complete the 10-item UCLA Loneliness Scale, which measures subjective loneliness and social isolation.
Higher scores represent higher levels of loneliness.
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3 weeks - immediately after the intervention
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Change in Multidimensional Scale of Perceived Social Support (MSPSS) scores from baseline to immediately after the intervention
時間枠:3 weeks - immediately after the intervention
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Participants will complete a 12-item MSPSS, which measures an individual's perception of support.
A sum through all scores can range from 12-84, with higher scores noting a higher perceived support.
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3 weeks - immediately after the intervention
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Scott Carvajal, PhD, MPH、University of Arizona
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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
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