- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07564960
Social Optimization Study
Improving the Lives of Cancer Survivors Through Enhancing Support Receptivity
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Francis Morales-Lozada
- Número de telefone: (520) 621-0563
- E-mail: fmoraleslozada@arizona.edu
Locais de estudo
-
-
Arizona
-
Tucson, Arizona, Estados Unidos, 85719
- Recrutamento
- University of Arizona Mel and Enid Zuckerman College of Public Health
-
Contato:
- Francis Morales-Lozada
- Número de telefone: (520) 621-0563
- E-mail: fmoraleslozada@arizona.edu
-
Investigador principal:
- Scott Carvajal, PhD, MPH
-
Subinvestigador:
- John Ruiz, PhD
-
Subinvestigador:
- Matthias Mel, PhD
-
Subinvestigador:
- Linda Garland, MD
-
Subinvestigador:
- Rina Fox, PhD, MPH
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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
|
|
Comparador Ativo: 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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Feasibility assessed by recruitment and retention rates
Prazo: 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
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in quality of life (QOL) using the SF-36 from baseline to immediately after the intervention.
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Scott Carvajal, PhD, MPH, University of Arizona
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- STUDY00007008
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .