Improving Sexual and Reproductive Health Communication for Adolescent and Young Adult Oncology Patients (ReSPECT)
3 de agosto de 2026 atualizado por: Connecticut Children's Medical Center
Improving Sexual and Reproductive Health Communication Between Adolescent and Young Adult Oncology Patients and Clinicians: ReSPECT Intervention Proof-of-Concept Testing
The goal of this clinical trial is to learn if ReSPECT, which includes a pre-visit checklist for patients to complete and an informational website, can work well in practice to help adolescent and young adult oncology patients communicate with their clinicians about sexual and reproductive health (SRH). SRH includes topics such as how cancer may impact puberty and development, best methods for contraception during cancer treatment, fertility risk and fertility preservation strategies, and dating/relationships during and after cancer. The study will also help researchers better understand how to best measure the impact of ReSPECT on improving SRH communication for future testing of ReSPECT.
The main questions the study aims to answer are:
How well does ReSPECT work in practice? Do patients and clinicians like ReSPECT, and do they find it helpful? What are the best ways to test ReSPECT and measure whether it works?
Participants will:
Use ReSPECT to support a conversation about SRH during an outpatient oncology clinic appointment Complete surveys before and after using ReSPECT Provide feedback on their experience using ReSPECT in a short interview
Visão geral do estudo
Status
Ainda não está recrutando
Intervenção / Tratamento
Descrição detalhada
Psychosexual development is a key aspect of adolescence and young adulthood, which may be significantly disrupted by a cancer diagnosis. Adolescent and young adult (AYA) cancer patients are at risk for complications that can detrimentally impact their sexual and reproductive health (SRH) during and after cancer treatment. Prior research has shown that pediatric oncologists rarely discuss many important aspects of SRH, and AYA cancer patients repeatedly report unmet communication needs related to these topics.
To address these needs, we have developed ReSPECT, an interactive, web-based digital platform designed to improve communication about insufficiently addressed SRH topics. ReSPECT integrates (1) a pre-visit questionnaire (PVQ) that will allow AYA patients to discreetly alert clinicians to relevant SRH questions/concerns (2) targeted patient education based on PVQ selections, and (3) clinician-centered guidance for addressing specific SRH questions/concerns. Previous stages of this research involved developing and refining a prototype of ReSPECT based on stakeholder feedback. Utilizing this prototype, this proof-of-concept study will assess the feasibility, acceptability, and perceived usefulness of ReSPECT with AYA patients on active cancer treatment and their oncology clinicians. In addition to assessing operational viability, this study will also assess the feasibility of collecting secondary outcomes measures. Data collected will lay the foundation for a future randomized controlled trial to assess ReSPECT intervention efficacy, with the ultimate goal of improving HRQOL communication for AYAs across the cancer continuum.
Primary Aim: Evaluate the feasibility, acceptability, usability, and perceived usefulness of ReSPECT in the outpatient setting with AYA oncology patients and clinicians.
ReSPECT will undergo proof-of-concept testing with AYAs (n=30) and their oncology clinicians (n~10-30) to determine if the intervention is feasible (recruitment >60%, retention >80%), acceptable (>70% with an average score ≥4 on the Lyon Satisfaction Questionnaire), and perceived useful (>70% with an average score ≥4 on the Usability/Sustainability of Intervention scale). Qualitative interviews with participants will provide additional information on acceptability, perceived usefulness, and opportunities for intervention improvement.
Secondary Aim: Collect and examine descriptive data on preliminary outcomes of ReSPECT and assess feasibility of procedures for a future randomized controlled trial.
Pre- and post-intervention questionnaires (T1: pre-visit, T2: within 48 hrs post-visit, T3: 8 weeks post-visit) to assess signals of intervention efficacy will include communication behavior, self-efficacy, outcome expectancies, decision-making, therapeutic alliance, distress/bother, and developmentally relevant health risk behaviors.
Tipo de estudo
Intervencional
Inscrição (Estimado)
30
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
- Nome: Natasha N Frederick, MD, MPH
- Número de telefone: 8605459630
- E-mail: nfrederick@connecticutchildrens.org
Estude backup de contato
- Nome: Rachel Perry, BS
- E-mail: rperry01@connecticutchildrens.org
Locais de estudo
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California
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Los Angeles, California, Estados Unidos, 90027
- Children's Hospital Los Angeles
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Contato:
- David R Freyer, DO, MS
- Número de telefone: (323) 361-4624
- E-mail: DFreyer@chla.usc.edu
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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
- Filho
- Adulto
Aceita Voluntários Saudáveis
Não
Descrição
Inclusion Criteria:
- Age 15-25 years old
- Has a cancer diagnosis
- ≥2 months from diagnosis/initiation of therapy, whichever occurred later
- Currently on cancer-directed therapy
- Speaks and reads English
- Approval from primary oncology team
- Study participation by primary oncology clinician
Exclusion Criteria:
- Not able to provide informed consent/assent
- Insufficient cognitive functioning to complete study measures, as determined by a member of the patient's primary oncology team
- Exceeds primary oncologist's participant limit (3 patients/clinician)
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 |
|---|---|
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Experimental: ReSPECT Intervention Arm
AYA oncology patients and their primary oncology clinicians who will receive the ReSPECT intervention
|
ReSPECT is a multi-modal digital intervention that integrates a pre-visit questionnaire and targeted patient and clinician education to support SRH communication in the outpatient oncology clinic setting.
For the purposes of this study it will be used in conjunction with a single regularly scheduled clinic visit.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Feasibility
Prazo: From enrollment until T3 survey completion (8 weeks post-visit)
|
Feasibility will be evaluated based on intervention enrollment (% of participants that complete consent/assent that complete all enrollment procedures, including the T1 survey), completion (% of enrolled AYAs completing the PVQ and the T2 survey) and retention (% of enrolled AYAs and clinicians completing all steps through the T3 survey).
ReSPECT will be deemed feasible if intervention enrollment, completion and retention rates are ≥80%, ≥80%, and ≥70%, respectively
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From enrollment until T3 survey completion (8 weeks post-visit)
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Acceptability
Prazo: From enrollment until T2 survey completion (within 48 hours post-visit)
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Acceptability will include usability.
Acceptability measures will be modeled on the Theoretical Framework of Acceptability, and include the rating of seven statements on a 5-point Likert scale (Strongly Disagree to Strongly Agree).
Acceptability will be defined as ≥70% of AYA and clinician participants rating the intervention acceptable (average score 4 or higher).
Usability will be assessed by the Intervention Usability Scale (IUS), a 10-item survey that measures responses to statements on a 5-point Likert scale ("strongly disagree" to "strongly agree".
Scores are converted and averaged to produce a total score from 0 to 100, with a score of 70 or higher set as the threshold for satisfactory usability.
ReSPECT will be deemed usable if ≥70% of AYA and clinician participants rate the intervention usable (average score 70 or higher).
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From enrollment until T2 survey completion (within 48 hours post-visit)
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Perceived Usefulness
Prazo: Timepoint 2
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Perceived usefulness will be evaluated in post-encounter semi-structured qualitative interviews with AYAs and clinicians.
Sample questions include, "Was the SRH conversation helpful?
Why or why not?" and, "What is the most useful part of ReSPECT?
What is the least useful?".
Additional questions will also cover perceived potential impact of ReSPECT improving SRH, barriers encountered using ReSPECT, and opportunities for improvement.
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Timepoint 2
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SRH Communication
Prazo: From enrollment until T3 survey completion (8 weeks post-visit)
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Participants will be asked if the sexual health topic(s) selected on the PVQ were discussed during the clinic visit (yes/no) and about who initiated the conversation (AYA patient/clinician).
They will also complete a brief survey listing each of the 7 sexual health subtopics and indicate whether or not the topic was discussed, who initiated the topic conversation, and (for patients) whether they asked their clinician any questions about the specific topic.
AYA patient participants will also be asked if there were topics/information not addressed or inadequately addressed during the visit along with whether or not additional people were in the room during the conversation.
Data to be collected were adapted from an instrument used for similar sexual health communication research in adult cancer populations
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From enrollment until T3 survey completion (8 weeks post-visit)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Self-Efficacy
Prazo: From enrollment until T3 survey completion (8 weeks post-visit)
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Self-efficacy will be measured by a two-item scale assessing AYA and clinician confidence (1) initiating and (2) participating in discussions about SRH topics.
Responses range from 0 (not at all confident) to 10 (extremely confident) for each topic.
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From enrollment until T3 survey completion (8 weeks post-visit)
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Decisional Confidence (Decision Making)
Prazo: From enrollment until T3 survey completion (8 weeks post-visit)
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Decisional confidence will be assessed by a single-item survey measure to assess whether ReSPECT helped AYAs make an informed decision about a SRH question/concern.
Participants will be asked to respond with yes/no, then to describe why/why not.
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From enrollment until T3 survey completion (8 weeks post-visit)
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Distress/Bother
Prazo: From enrollment until T3 survey completion (8 weeks post-visit)
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The Level of Bother Scale is a single-item scale assessing the extent to which participants have been bothered by specific SRH concerns in the last month.
Responses are scored on a 4-point Likert scale, with higher scores indicating greater levels of bother.
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From enrollment until T3 survey completion (8 weeks post-visit)
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Outcome Expectancies
Prazo: From enrollment until T3 survey completion (8 weeks post-visit)
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The Outcome Expectancy Scale is a 6-item scale assessing AYA's perception of the extent to which outcomes may result from discussing SRH topics with their oncology clinician.
Potential outcomes include answering question(s), finding a solution to a problem, giving peace of mind, helping play an active role in one's health care, improving SRH, and helping make decisions.
For each item, responses range from 0 (not at all) to 10 (very much).
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From enrollment until T3 survey completion (8 weeks post-visit)
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Risk Behaviors (Decision Making)
Prazo: From enrollment until T3 survey completion (8 weeks post-visit)
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A 9-item questionnaire adapted from the National Youth Risk Behavior Survey will be used to characterize quality and frequency of health risk behaviors among AYA participants.
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From enrollment until T3 survey completion (8 weeks post-visit)
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Therapeutic Alliance
Prazo: From enrollment until T3 survey completion (8 weeks post-visit)
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The Human Connection (THC) scale is a 16-item scale measuring therapeutic alliance (TA) between AYAs and clinicians.
Items are scored on a 4-point Likert scale, with response categories based on question content, and higher scores indicating greater TA.
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From enrollment until T3 survey completion (8 weeks post-visit)
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Health Literacy
Prazo: Timepoint 1
|
The Chew Health Literacy Screen is a validated 3-item questionnaire designed to identify individuals with inadequate health literacy.
Items are scored on a 5-point Likert scale, with higher scores indicating greater health literacy
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Timepoint 1
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Depression and Anxiety
Prazo: From enrollment until T3 survey completion (8 weeks post-visit)
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The Hospital Anxiety and Depression Scale (HADS) is a 14-item scale with subscales for anxiety and depression (7 items each).
Items were validated in the outpatient medical clinic setting and do not assess somatic complaints.
Each item is rated on a 4-point scale ranging from 0 (absence) to 3 (extreme presence), with higher scores indicating greater levels of anxiety and depression
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From enrollment until T3 survey completion (8 weeks post-visit)
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Sexual Health
Prazo: From enrollment until T3 survey completion (8 weeks post-visit)
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The COG Sexual Health Task Force Sexual Health Assessment is an 8-item survey designed to assess SH outcomes among AYAs with cancer and includes sexual history, sexual function, body image, and romantic relationships.
Question types include Likert scales, yes/no questions, and multiple-response checklists.
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From enrollment until T3 survey completion (8 weeks post-visit)
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Natasha N Frederick, MD, MPH, Connecticut Children's Medical
Publicações e links úteis
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- Klosky JL, Simmons JL, Russell KM, Foster RH, Sabbatini GM, Canavera KE, Hodges JR, Schover LR, McDermott MJ. Fertility as a priority among at-risk adolescent males newly diagnosed with cancer and their parents. Support Care Cancer. 2015 Feb;23(2):333-41. doi: 10.1007/s00520-014-2366-1. Epub 2014 Aug 2.
- Vrancken Peeters NJMC, Vlooswijk C, Bijlsma RM, Kaal SEJ, Kerst JM, Tromp JM, Bos MEMM, van der Hulle T, Lalisang RI, Nuver J, Kouwenhoven MCM, van der Ploeg IMC, van der Graaf WTA, Husson O. Sexual quality of life of adolescents and young adult breast cancer survivors. ESMO Open. 2024 Feb;9(2):102234. doi: 10.1016/j.esmoop.2024.102234. Epub 2024 Jan 27.
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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 (Estimado)
15 de novembro de 2026
Conclusão Primária (Estimado)
30 de junho de 2028
Conclusão do estudo (Estimado)
30 de junho de 2029
Datas de inscrição no estudo
Enviado pela primeira vez
2 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
15 de junho de 2026
Primeira postagem (Real)
22 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
5 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
3 de agosto de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 26-029 (The Cleveland Clinic Foundation Institutional Review Board)
- K08CA286736-01A1 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
Given the relatively small sample size and the rarity of pediatric cancer, even after removal of identifiers we believe a risk remains of deductive identification of participants.
Consequently, we are not planning to share IPD.
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 .