Recruiting

Observational Study

Sponsor:

Connecticut Children's Medical Center

Code:

NCT06982066

Conditions

Pediatric Cancer

Adolescent and Young Adult Cancer

Eligibility Criteria

Sex: All

Age: 15 - 25

Healthy Volunteers: Not accepted

Interventions

ReSPECT

Study Details

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

Study ID

NCT06982066

Start date

Feb 10, 2025

Status verified date

Aug, 2025

Completion date

Jun 29, 2029

Anticipated

Primary completion date

Mar 15, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15 - 25

Healthy Volunteers: Not accepted

Inclusion Criteria

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:

1. Be aged 15-25 years old at time of enrollment.
2. Have a cancer diagnosis and currently be on cancer-directed therapy with at least one of the following:

1. Chemotherapy: any anticancer drug to treat the cancer diagnosis, including immunotherapy.
2. Radiotherapy: any radiotherapy to treat the cancer diagnosis.
3. Surgery: any surgery to remove cancer including partial of total resections. Biopsies are not considered surgery.
3. Be greater than or equal to 2 months from diagnosis/initiation of therapy, whichever occurred later.
4. Be able to speak and read English
5. Have permission to participate from a member of the patient's primary oncology team.
6. Provision to sign and date the consent/assent form.
7. Active study participation of primary oncology clinician
8. 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

Exclusion Criteria

An individual who meets and of the following criteria will be excluded from participation in this study:

1. Not currently on cancer-directed therapy.
2. Unable to speak and read English.
3. Insufficient cognitive functioning to complete study measures (as determined by a member of the patient's primary oncology team)

Pediatric Oncology Clinicians

1\. 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

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: ReSPECT

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.

Interventions

ReSPECT

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).

Primary outcome measure

  • Feasibility of implementing the ReSPECT intervention. [ Time Frame: 2 months ]
  • Acceptability of the ReSPECT intervention. [ Time Frame: 2 months ]
  • Usability of the ReSPECT intervention. [ Time Frame: 2 months ]
  • Perceived utility of the ReSPECT intervention. [ Time Frame: 2 months ]

Central Contacts and Locations

Central contacts

Locations

Connecticut Children's Medical Center

Recruiting

Hartford, Connecticut, United States, 06106

Contacts

More Information

Sponsor

Connecticut Children's Medical Center

Last update posted

Aug 14, 2025

Last verified

Aug, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Connecticut Children's Medical Center on 2025-08-14.