Improving Sexual and Reproductive Health Communication for Adolescent and Young Adult Oncology Patients (ReSPECT)
3 de agosto de 2026 actualizado 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
Descripción general del estudio
Estado
Aún no reclutando
Intervención / Tratamiento
Descripción detallada
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 estudio
Intervencionista
Inscripción (Estimado)
30
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Natasha N Frederick, MD, MPH
- Número de teléfono: 8605459630
- Correo electrónico: nfrederick@connecticutchildrens.org
Copia de seguridad de contactos de estudio
- Nombre: Rachel Perry, BS
- Correo electrónico: rperry01@connecticutchildrens.org
Ubicaciones de estudio
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California
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Los Angeles, California, Estados Unidos, 90027
- Children's Hospital Los Angeles
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Contacto:
- David R Freyer, DO, MS
- Número de teléfono: (323) 361-4624
- Correo electrónico: DFreyer@chla.usc.edu
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
No
Descripción
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)
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: ReSPECT Intervention Arm
AYA oncology patients and their primary oncology clinicians who will receive the ReSPECT intervention
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Feasibility
Periodo de tiempo: From enrollment until T3 survey completion (8 weeks post-visit)
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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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Self-Efficacy
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Health Literacy
Periodo de tiempo: Timepoint 1
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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
Periodo de tiempo: 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
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Natasha N Frederick, MD, MPH, Connecticut Children's Medical
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
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Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
15 de noviembre de 2026
Finalización primaria (Estimado)
30 de junio de 2028
Finalización del estudio (Estimado)
30 de junio de 2029
Fechas de registro del estudio
Enviado por primera vez
2 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
15 de junio de 2026
Publicado por primera vez (Actual)
22 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
5 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
3 de agosto de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 26-029 (The Cleveland Clinic Foundation Institutional Review Board)
- K08CA286736-01A1 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .