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AYA-PeerConnect: Uma Intervenção de Coaching de Comunicação para Sobreviventes de Cancro Adolescentes/Jovens Adultos (AYACS)

2 de novembro de 2026 atualizado por: Pooja Rao, Milton S. Hershey Medical Center

AYA-PeerConnect: Uma Intervenção de Coaching de Comunicação para Sobreviventes Adolescentes/Jovens Adultos de Cancro (AYACS)

This research is being done to test a communication coaching intervention pilot designed to improve communication quality between adolescent/young adult cancer survivors (AYACS) and their friends/peers. The results of the study will help to understand how to best support adolescent/young adult cancer survivors, and may inform the development or future implementation of similar programs for cancer survivor populations.

Visão geral do estudo

Descrição detalhada

This study is being done to test a communication coaching intervention designed to improve communication quality between adolescent/young adult cancer survivors (AYACS) and their friends/peers. The results of the study will help to understand how to best support adolescent/young adult cancer survivors, and may inform the development or future implementation of similar programs for cancer survivor populations.

Tipo de estudo

Intervencional

Inscrição (Real)

11

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.

Locais de estudo

    • Pennsylvania
      • Hershey, Pennsylvania, Estados Unidos, 17033
        • Milton S. Hershey Medical Center

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

18 anos a 35 anos (Adulto)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Participant is currently ≥18-35 years old
  • Participant is receiving cancer-directed care at Penn State Cancer Institute or Penn State Children's Hospital
  • Participant has completed all cancer-directed therapy and is at least 1 year from end of cancer treatment (based on date of last cancer-directed treatment)
  • Participant has access to a computer with internet capability
  • Participant is fluent in written and spoken English

Exclusion Criteria:

  • Participant is not fluent in written and spoken English
  • Participant with cognitive inability to participant in the study as determined by the study team
  • Participants with history of relapsed cancer

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: Cuidados de suporte
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Asynchronous coaching and artificial intelligence (AI) Yoodli coach sessions

The intervention will use a combination of asynchronous communication coaching sessions, and AI Yoodli coach sessions.

Participants will complete asynchronous individual sessions for Visits 2-4. Each visit will include a 60-minute interactive didactic session using Rise 360 software, with a 20-minute Yoodli AI coaching session (both Rise 360 and Yoodli will be accessed via website). Rise 360 sessions will cover topics related to communication style, multiple goals theory and how to apply concepts learned in being good communicators. Yoodli AI coaching session will be completed for the corresponding Rise 360 session before moving to the next visit's session.

The 20-minute Yoodli AI coaching sessions will include coaching from the Yoodli AI coach and practicing various peer conversation situations. These sessions will consolidate and reinforce concepts learned in the didactic sessions. The Yoodli AI coach is programmed with input on relationship style (a communication tool to assess communication style) to deliver personalized coaching.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Intervention Feasibility (Quantitative)
Prazo: Post intervention follow up visit (Up to a month)

Quantitative feasibility will be collected based on visit attendance.

Post intervention follow up visit (Up to a month)
Intervention Feasibility (Qualitative)
Prazo: Post intervention follow up visit (Up to a month)

Qualitative feasibility data will be collected from post-module mixed methods assessments, and exit interviews and focus groups.

Post intervention follow up visit (Up to a month)
Intervention Acceptability (Quantitative)
Prazo: Post intervention follow up visit (Up to a month)

Quantitative acceptability will be collected using an acceptability questionnaire. Quantitative acceptability will be integrated with qualitative data from post-module mixed methods assessments, and exit interviews and focus groups to understand intervention acceptability.

Post intervention follow up visit (Up to a month)
Intervention Acceptability (Qualitative)
Prazo: Post intervention follow up visit (Up to a month)

Qualitative acceptability data will be collected from post-module mixed methods assessments, and exit interviews and focus groups.

Post intervention follow up visit (Up to a month)
Communication quality Multiple Goals Score
Prazo: Baseline

Rating process for communication quality analysis (CQA) domains. A domain score is calculated for each of the six communication quality domains (content, emotion, accommodation, engagement, relationship, and face). Using the emotion domain as an example, the neutral score is assigned as a "1," and as participants express emotion (as per the definition above and further detailed in the CQA codebook) the score increases with the highest quality score being "7". A domain score is assigned every five minutes for each of the six domains. The full range for each measure is 6 (most neutral)-42 (highest quality).

Baseline
Communication quality Multiple Goals Score
Prazo: Post intervention follow up visit (Up to a month)

Rating process for communication quality analysis (CQA) domains. A domain score is calculated for each of the six communication quality domains (content, emotion, accommodation, engagement, relationship, and face). Using the emotion domain as an example, the neutral score is assigned as a "1," and as participants express emotion (as per the definition above and further detailed in the CQA codebook) the score increases with the highest quality score being "7". A domain score is assigned every five minutes for each of the six domains. The full range for each measure is 6 (most neutral)-42 (highest quality).

Post intervention follow up visit (Up to a month)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Anxiety
Prazo: Baseline

Anxiety will be measured using the Anxiety (Emotional Distress-Anxiety-Short Form 8a) measure from the Patient Reported Outcomes Measurement Information System (PROMIS). It is an 8-item self-report questionnaire assessing anxiety symptoms over the past 7 days, including fear, tension, and worry. It is scored on a 5-point Likert scale (1=Never, 2=Rarely, 3=Sometimes, 4=Often, 5=Always).

Baseline
Anxiety
Prazo: Post intervention follow up visit (Up to a month)

Anxiety will be measured using the Anxiety (Emotional Distress-Anxiety-Short Form 8a) measure from the Patient Reported Outcomes Measurement Information System (PROMIS). It is an 8-item self-report questionnaire assessing anxiety symptoms over the past 7 days, including fear, tension, and worry. It is scored on a 5-point Likert scale (1=Never, 2=Rarely, 3=Sometimes, 4=Often, 5=Always).

Post intervention follow up visit (Up to a month)
Depression
Prazo: Baseline

Depression will be measured using the Depression (Emotional Distress-Depression-Short Form 8b) measure from the Patient Reported Outcomes Measurement Information System (PROMIS). It is an 8-item, self-report questionnaire assessing negative mood, views of self, and social cognition over the past seven days. It uses a 5-point scale (1=Never, 5=Always) to measure severity.

Baseline
Depression
Prazo: Post intervention follow up visit (Up to a month)

Depression will be measured using the Depression (Emotional Distress-Depression-Short Form 8b) measure from the Patient Reported Outcomes Measurement Information System (PROMIS). It is an 8-item, self-report questionnaire assessing negative mood, views of self, and social cognition over the past seven days. It uses a 5-point scale (1=Never, 5=Always) to measure severity.

Post intervention follow up visit (Up to a month)
Social isolation
Prazo: Baseline

Social isolation will be measured by the validated Patient Reported Outcomes Measurement Information System (PROMIS) Social Isolation Form 8a.The PROMIS Social Isolation 8a short form is a 8-item, self-report tool measuring perceived loneliness and detachment from others. It uses a 5-point Likert scale (1=Never to 5=Always) to assess feelings of being avoided, excluded, or disconnected.

Baseline
Social isolation
Prazo: Post intervention follow up visit (Up to a month)

Social isolation will be measured by the validated Patient Reported Outcomes Measurement Information System (PROMIS) Social Isolation Form 8a.The PROMIS Social Isolation 8a short form is a 8-item, self-report tool measuring perceived loneliness and detachment from others. It uses a 5-point Likert scale (1=Never to 5=Always) to assess feelings of being avoided, excluded, or disconnected.

Post intervention follow up visit (Up to a month)

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Pooja Rao, MD MSCE, Penn State College of Medicine

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)

14 de abril de 2026

Conclusão Primária (Real)

13 de maio de 2026

Conclusão do estudo (Real)

4 de setembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

2 de março de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

2 de março de 2026

Primeira postagem (Real)

6 de março de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

3 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

2 de novembro de 2026

Última verificação

1 de novembro de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

Aggregate participant data that underlie the results reported in the study, after de-identification.

Prazo de Compartilhamento de IPD

1 years to 3 years following final publication.

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • CIF

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

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 .

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