Improving Communication Between AYA Oncology Patients and Clinicians: A Patient-Centered Intervention

NCT06982066 | Recruiting

• 2 other identifiers: 24-081K08CA286736
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The overarching goal is to develop and demonstrate proof-of-concept of ReSPECT (Reproductive and Sexual Health Patient Education and Communication Tool), a multi-modal communication intervention to improve adolescent and young adult (AYA)- clinician sexual and reproductive health (SRH) communication in the outpatient oncology clinic setting.

Conditions

Pediatric Cancer; Adolescent and Young Adult Cancer

Keywords

adolescent young adult; sexual health communication; cancer; patient provider communication; sexual and reproductive health

Outcome Measures

Primary Outcomes (4)

• Feasibility of implementing the ReSPECT intervention.

  Feasibility will be based on patient recruitment and completion of the intervention. The intervention will be considered feasible if AYA recruitment is greater than or equal to 60% and if greater than or equal to 80% of consented AYAs complete the intervention (retention). Intervention completion will be defined as AYA completion of the pre-visit questionnaire and post-intervention survey.

  2 months

• Acceptability of the ReSPECT intervention.

  The intervention will be considered acceptable if greater than or equal to 70% of AYA and clinician participants rate ReSPECT as acceptable (average score of 4 or higher) on the Lyon Satisfaction Questionnaire, adapted for this study, which includes a 10-item satisfaction questionnaire where 1 is strongly disagree and 5 is strongly agree. Subjects will report via survey after the healthcare visit.

  2 months

• Usability of the ReSPECT intervention.

  The intervention will be considered usable/sustainable if greater than or equal to 70% of AYA and clinician participants rate ReSPECT as usable (average score of 4 or higher) on the Usability/Sustainability of Intervention Scale, adapted for this study, on a 4-item usability questionnaire where 1 is strongly disagree and 5 is completely agree. Subjects will report via survey after the healthcare visit.

  2 months

• Perceived utility of the ReSPECT intervention.

  Through qualitative interviews, participants will be asked for their perceptions on the impact of ReSPECT in promoting SRH communication in the outpatient clinic setting.

  2 months

Secondary Outcomes (9)

• Comparison of patient reported SRH communication before and after intervention implementation.

  2 months

• Comparison of clinician reported SRH communication before and after intervention implementation.

  2 months

• Comparison of patient self-efficacy in discussing SRH topics with their oncology clinician before and after intervention implementation.

  2 months

• Comparison of clinician of self-efficacy in discussing SRH topics with their AYA patient before and after intervention implementation.

  2 months

• Comparison of patient- reported outcome expectancies related to discussing SRH topics with their oncology clinician before and after intervention implementation.

  2 months

Study Arms (1)

ReSPECT

EXPERIMENTAL

Aims 2 and 3 involve a single-arm cohort study of the ReSPECT intervention using a pre-post design. Enrolled participants will complete a survey at baseline, immediately after intervention use, and at 2 months from study enrollment. All participants will also be invited to participate in a brief interview immediately after intervention use.

Behavioral: ReSPECT

Interventions

ReSPECT BEHAVIORAL

ReSPECT is an interactive, web-based digital platform that integrates (1) an AYA-centered pre-visit questionnaire (PVQ) that will discretely alert clinicians to relevant SRH questions/concerns, (2) targeted patient education on PVQ selections, and (3) clinician-centered guidance for addressing SRH issues. At enrollment, all participants will complete a baseline survey (T1). AYAs will have access to the ReSPECT digital platform and will receive the first prompt to complete the PVQ 3-5 days before their next clinic appointment. Once completed, AYAs will receive an email/text with a link to tailored information based on their PVQ selections for review. Clinicians will receive an email with a link to the patient's PVQ results on the ReSPECT platform along with clinical management recommendations. All participants will complete a brief virtual survey (T2) and interview within 48 hours of the first postintervention clinic visit and a follow-up survey 2 months after study enrollment (T3).

ReSPECT

Eligibility Criteria

• Age: 15 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adolescent and Young Adult Oncology Patients
• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• Be aged 15-25 years old at time of enrollment.
• Have a cancer diagnosis and currently be on cancer-directed therapy with at least one of the following:
• Chemotherapy: any anticancer drug to treat the cancer diagnosis, including immunotherapy.
• Radiotherapy: any radiotherapy to treat the cancer diagnosis.
• Surgery: any surgery to remove cancer including partial of total resections. Biopsies are not considered surgery.
• Be greater than or equal to 2 months from diagnosis/initiation of therapy, whichever occurred later.
• Be able to speak and read English
• Have permission to participate from a member of the patient's primary oncology team.
• Provision to sign and date the consent/assent form.
• Active study participation of primary oncology clinician
• Patient must have primary oncology care at Connecticut Children's Center for Cancer \& Blood Disorders of Children's Hospital Los Angeles Cancer \& Blood Disease Institute

You may not qualify if:

• An individual who meets and of the following criteria will be excluded from participation in this study:
• Not currently on cancer-directed therapy.
• Unable to speak and read English.
• Insufficient cognitive functioning to complete study measures (as determined by a member of the patient's primary oncology team)
• Pediatric Oncology Clinicians
• \. Be a pediatric oncology physician, clinical fellow, or advanced practice provider (including nurse practitioners and physician assistants) that provides clinical care for AYA patients with cancer

Sponsors & Collaborators

• Connecticut Children's Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms; Coitus

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior

Study Officials

• Natasha Frederick, MD, MPH

  nfrederick@connecticutchildrens.org

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natasha Frederick, MD, MPH

CONTACT

860-545-9618; nfrederick@connecticutchildrens.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 21, 2025
• Study Start: February 10, 2025
• Primary Completion (Estimated): March 15, 2029
• Study Completion (Estimated): June 29, 2029
• Last Updated: August 14, 2025

Record last verified: 2025-08

Locations

US (1)