Improving the Lives of Cancer Survivors Through Enhancing Support Receptivity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Feasibility assessed by recruitment and retention rates
研究概览
简要总结
This study tests whether clinical interventions to optimize support receptivity lead to improvements in social integration and quality of life (QOL) amongst long-term lung cancer survivors. The feasibility and acceptability of the intervention and assessment procedures will be examined. Thirty long-term lung cancer survivors will be randomized to a support receptivity intervention or an attention-control condition. Our intervention draws on cognitive behavioral therapy (CBT) strategies to reduce social anxiety, improve social awareness, and promote social integration. 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 to capture daily social interactions, and 2) repeated self-report sampling where participants answer questions about their social engagement experiences via their personal cell phone.
详细描述
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:
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 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Social support receptivity training (Behavioral)
Social awareness training
Participants receiving a 3-week, 6 session program designed to increase awareness of the social support already available to them.
干预措施: Social awareness training (Behavioral)
结局指标
主要结局
Feasibility assessed by recruitment and retention rates
时间窗: Throughout the recruitment period
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
Acceptability assessed by study-specific survey after the intervention
时间窗: 3 weeks - immediately after the intervention
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.
次要结局
- Change in quality of life (QOL) using the SF-36 from baseline to immediately after the intervention.(3 weeks - immediately after the intervention)
- Change in Perceived Stress using the Perceived Stress Scale (PSS) from baseline to immediately after the intervention(3 weeks - immediately after the intervention)
- Change in depression using the CES-D scale from baseline to immediately after the intervention(3 weeks - immediately after the intervention)
- Change in network diversity using the Berkman-Syme Social Network Index (BS-SNI) from baseline to immediately after the intervention(3 weeks - immediately after the intervention)
- Change in subject loneliness and social isolation using the UCLA-Loneliness Scale from baseline to immediately after the intervention(3 weeks - immediately after the intervention)
- Change in Multidimensional Scale of Perceived Social Support (MSPSS) scores from baseline to immediately after the intervention(3 weeks - immediately after the intervention)
