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Social Optimization Study

2026년 6월 3일 업데이트: University of Arizona

Improving the Lives of Cancer Survivors Through Enhancing Support Receptivity

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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (추정된)

30

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

    • Arizona
      • Tucson, Arizona, 미국, 85719
        • 모병
        • University of Arizona Mel and Enid Zuckerman College of Public Health
        • 연락하다:
        • 수석 연구원:
          • Scott Carvajal, PhD, MPH
        • 부수사관:
          • John Ruiz, PhD
        • 부수사관:
          • Matthias Mel, PhD
        • 부수사관:
          • Linda Garland, MD
        • 부수사관:
          • Rina Fox, PhD, MPH

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  1. Adults (18 Years or Older)
  2. History of lung cancer
  3. at least 12 months since cancer diagnosis
  4. fluent in English
  5. able to attend virtually or in person sessions at the University of Arizona.

Exclusion Criteria:

  1. Less than 12 months of cancer diagnosis at time of enrollment
  2. undergoing treatment for mood or anxiety health issues at time of enrollment
  3. unable to provide informed consent.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
A 3-week, 6-session CBT intervention that targets cognitive awareness of prosocial cues and leverages behavioral activation and social skills training
활성 비교기: Social awareness training
Participants receiving a 3-week, 6 session program designed to increase awareness of the social support already available to them.
A 3-week, 6 session program designed to increase awareness of available social support.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Feasibility assessed by recruitment and retention rates
기간: 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
Throughout the recruitment period
Acceptability assessed by study-specific survey after the intervention
기간: 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.
3 weeks - immediately after the intervention

2차 결과 측정

결과 측정
측정값 설명
기간
Change in quality of life (QOL) using the SF-36 from baseline to immediately after the intervention.
기간: 3 weeks - immediately after the intervention
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).
3 weeks - immediately after the intervention
Change in Perceived Stress using the Perceived Stress Scale (PSS) from baseline to immediately after the intervention
기간: 3 weeks - immediately after the intervention
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.
3 weeks - immediately after the intervention
Change in depression using the CES-D scale from baseline to immediately after the intervention
기간: 3 weeks - immediately after the intervention
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.
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
기간: 3 weeks - immediately after the intervention
Participants will complete the BS-SNI, which assesses network diversity, and the number of people in an individual's network.
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
기간: 3 weeks - immediately after the intervention
Participants will complete the 10-item UCLA Loneliness Scale, which measures subjective loneliness and social isolation. Higher scores represent higher levels of loneliness.
3 weeks - immediately after the intervention
Change in Multidimensional Scale of Perceived Social Support (MSPSS) scores from baseline to immediately after the intervention
기간: 3 weeks - immediately after the intervention
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.
3 weeks - immediately after the intervention

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Scott Carvajal, PhD, MPH, University of Arizona

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 4월 27일

기본 완료 (추정된)

2026년 7월 31일

연구 완료 (추정된)

2026년 7월 31일

연구 등록 날짜

최초 제출

2026년 4월 27일

QC 기준을 충족하는 최초 제출

2026년 4월 27일

처음 게시됨 (실제)

2026년 5월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 5일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 3일

마지막으로 확인됨

2026년 6월 1일

추가 정보

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개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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