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Keep Social Randomized Controlled Trial for Young Adults With Cancer

28 de outubro de 2026 atualizado por: UNC Lineberger Comprehensive Cancer Center

The main purpose of this Keep Social randomized controlled trial is to examine the effectiveness of our social connectedness intervention to improve social and emotional well-being among young adults with cancer. The investigators will conduct a randomized controlled trial with a sample of up to 395 US young adults (ages 22-39) who previous had a cancer diagnosis as an adolescent or young adult (diagnosed at age 15-39).

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

This trial aims to examine the effectiveness of our social connectedness intervention to improve social and emotional well-being among young adults with cancer. The investigators will enroll up to 395 young adults ages 22-39 who had received a cancer diagnosis as an adolescent or young adult (diagnosed at age 15-39). Participants will complete our 7-week protocol, which includes a 4-week intervention phase. During weeks 1 and 2, we will gather information about daily life as usual (e.g., social interactions). At the beginning of week 3, participants will be randomized to trial arm (experimental or control) and introduced to a beta version of a simulated social media site. Participants who do not take the week 3 survey will not be randomized and will be dropped from the study. During weeks 3-6, participants will interact with a simulated social media platform, branded as Invibe. Participants will have passive exposure to intervention or control stimuli in the social media feeds. Participants also had forced exposure to stimuli posts (intervention messages vs. control messages) in the online survey after interacting with Invibe. During week 7, participants will complete the final weekly survey.

Tipo de estudo

Intervencional

Inscrição (Estimado)

395

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

    • North Carolina
      • Chapel Hill, North Carolina, Estados Unidos, 27599
        • Recrutamento
        • University of North Carolina at Chapel Hill
        • Contato:
        • Investigador principal:
          • Allison Lazard, PhD

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

22 anos a 39 anos (Adulto)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Are ages 22-39
  • Received a cancer diagnosis between ages 15-39
  • Use social media
  • Reside in the United States

Exclusion Criteria:

  • Report high psychosocial health (≥4.5 mean of two mental health quality of life items)
  • Report being unable to take the study surveys because their schedule will not allow, they are not interested in taking the study surveys, or do not intend to complete the study surveys

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Outro
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Social connectedness intervention

See intervention description.

Participants view a brief psychoeducational video about the value of connecting in-person with others and receive guided instructions for creating if-then behavioral plans for increasing moments of high-quality social connection. Over the next four weeks, they view messages to encourage in-person connections with strangers and acquaintances on our simulated social media platform called Invibe. During the 4-week intervention phase with Invibe (weeks 3-6), participants will view the Invibe simulated social media feed in each survey. Participant exposure to each intervention message will be both passive, via that day's feed, and forced, via inclusion on the following pages of that survey. Participants will see 12 intervention messages during this 4-week phase, each shown within the first five posts of the Invibe feed.

Sem intervenção: Control

To rule out placebo and nonspecific effects, the Keep Social RCT engenders positive expectations in all participants by promoting the use of Invibe to build and maintain social ties, a framing that mirrors information-as-usual for well-being through social media connections. Those in the placebo control condition receive no further social connectedness education (view no psychoeducational video, no if/then plan) and encounter all background content on Invibe (all intervention messages excluded) with control posts that feature unrelated content.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Social well-being
Prazo: Up to 7 weeks

Measured with 8 items from the General Belongingness Scale. Participants will complete a 4-item acceptance/inclusion subscale and 4-item rejection/exclusion subscale weekly, up to 5 times, during the intervention phase of the RCT (weeks 3-7). Rejection/exclusion items will be reverse coded. We will average responses to the 8 items each week. Social well-being scores will range from 1-5, with higher scores representing better social well-being.

Up to 7 weeks
Emotional well-being
Prazo: Up to 7 weeks

Measured with the 9-item Positive Affect and Well-Being assessment from the Neuro-QOL Item Bank v1.0. Emotional wellbeing will be measured weekly, up to 5 times, during the intervention phase of the RCT (weeks 3-7). We will average responses to the 9 items each week. Emotional well-being scores will range from 1-5, with higher scores representing better emotional well-being.

Up to 7 weeks

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Resilience
Prazo: Up to 7 weeks

Measured with the 11-item ego-resiliency short form (ER-11) focused on the time-varying subscales (active engagement with the world, integrated performance under stress, repertoire of problem-solving strategies) from the 14-item ego-resiliency scale (ER-89). Resilience will be measured weekly, up to 5 times, during the intervention phase of the RCT (weeks 3-7). We will average responses to the 11 items each week. Resilience scores will range from 1-4, with higher scores representing more resilience.

Up to 7 weeks
Loneliness
Prazo: Up to 7 weeks

Measured with 5 items from the Loneliness (Ages 18+) - Fixed Form in the National Institutes of Health (NIH) Toolbox® Item Bank v3.0 for adult social relationship scales. Loneliness will be measured weekly, up to 5 times, during the intervention phase of the RCT (weeks 3-7). We will average responses to the 5 items each week. Loneliness scores will range from 1-5, with higher scores representing more loneliness.

Up to 7 weeks
Perceived stress
Prazo: Up to 7 weeks

Measured with 3 selected items that focus on feeling stressed, inability to cope, and feeling that difficulties are piling high from the 14-item perceived stress scale (PSS). Perceived stress will be measured weekly, up to 5 times, during the intervention phase of the RCT (weeks 3-7). We will average responses to the 3 items each week. Perceived stress scores will range from 1-5, with higher scores representing more stress.

Up to 7 weeks
Anxiety
Prazo: Up to 7 weeks

Measured with 4 items from the PROMIS-29 Profile v2.0. Anxiety will be measured weekly, up to 5 times, during the intervention phase of the RCT (weeks 3-7). We will average responses to the 4 items each week. Anxiety scores will range from 1-5, with higher scores representing more anxiety.

Up to 7 weeks
Depression
Prazo: Up to 7 weeks

Measured with 4 items from the PROMIS-29 Profile v2.0. Depression will be measured weekly, up to 5 times, during the intervention phase of the RCT (weeks 3-7). We will average responses to the 4 items each week. Depression scores will range from 1-5, with higher scores representing more depression.

Up to 7 weeks
Behavioral adherence
Prazo: Up to 7 weeks

Measured with 3 items about participants' 1) social opportunity, 2) openness to and 3) initiation of in-person connections. Behavioral adherence will be measured in up to 13 times in each weekly survey and day report (weeks 1-7), including up to 4 assessments during the intro/baseline period and up to 9 assessments for the intervention period. We will analyze each type of behavioral adherence separately. Behavioral adherence (social opportunity) scores will be binary, with 1 representing social opportunity and 0 representing no opportunity. Behavioral adherence (openness, initiation) scores will range from 1-5, with higher scores representing more behavioral adherence.

Up to 7 weeks
Positivity resonance
Prazo: Up to 7 weeks

Measured with 2 adapted items for stranger interactions and 2 adapted items for acquaintance interactions from the Perceived Positivity Resonance Scale. Positivity resonance will be measured up to 13 times in each weekly survey and day report (weeks 1-7), including up to 4 assessments during the intro/baseline period and up to 9 assessments for the intervention period. We will average the responses to the 2 items for each type of interaction (stranger, acquaintance) from each weekly survey and day report. Positivity resonance scores will range from 0-10, with higher scores representing more positivity resonance.

Up to 7 weeks

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Colaboradores

Investigadores

  • Investigador principal: Allison Lazard, PhD, UNC Lineberger Comprehensive Cancer Center

Publicações e links úteis

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

15 de setembro de 2026

Conclusão Primária (Estimado)

1 de março de 2027

Conclusão do estudo (Estimado)

1 de março de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

21 de agosto de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

21 de agosto de 2026

Primeira postagem (Real)

26 de agosto de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

30 de outubro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

28 de outubro de 2026

Última verificação

1 de outubro de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 26-0723-RCT
  • R01CA276176 (Concessão/Contrato do NIH dos EUA)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

Researchers may request de-identified data 1 year after publication.

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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