Improving Sexual and Reproductive Health Communication for Adolescent and Young Adult Oncology Patients

NCT07658937 | Not Yet Recruiting

• 2 other identifiers: 26-029K08CA286736-01A1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Health-Related Quality-of-Life; Cancer; Health Communication

Keywords

Health-Related Quality-of-Life; Adolescent; Young Adult; Psychosocial Intervention; Health Communication; Cancer

Outcome Measures

Primary Outcomes (3)

• Feasibility (as assessed by intervention completion and retention rates)

  Feasibility will be evaluated based on intervention completion (% of AYAs completing all steps through T2) and retention (% of enrolled AYAs and clinicians completing all steps through T3). ReSPECT will be deemed feasible if intervention completion and retention rates are ≥80% and ≥70%, respectively.

  From enrollment until T3 survey completion (8 weeks post-visit)

• Acceptability (as assessed by Lyon Satisfaction Questionnaire)

  Acceptability will be measured using the 11-item Lyon Satisfaction Questionnaire, included in the T2 survey, with a threshold of ≥70% of AYA and clinician participants rating the intervention acceptable (average score 4 or higher).

  From enrollment until T2 survey completion (within 48 hours post-visit)

• Perceived Usefulness (as assessed by Intervention Usability/Sustainability Scale, qualitative interviews)

  Perceived Usefulness will encompass usability and utility. Usability will be assessed by the 4-item Intervention Usability/Sustainability Scale, included in the T2 and T3 surveys, with a threshold of ≥70% of AYA and clinician participants rating the intervention usable (average score 4 or higher). Utility will be evaluated in post-encounter qualitative interviews with AYAs and clinicians.

  From enrollment until T3 survey completion (8 weeks post-visit)

Secondary Outcomes (7)

• Exchange of Information

  From enrollment until T3 survey completion (8 weeks post-visit)

• Self-Efficacy

  From enrollment until T3 survey completion (8 weeks post-visit)

• Fostering Healing Relationships (Therapeutic Alliance)

  From enrollment until T3 survey completion (8 weeks post-visit)

• Decisional Confidence (Decision Making)

  From enrollment until T3 survey completion (8 weeks post-visit)

• Distress/Bother

  From enrollment until T3 survey completion (8 weeks post-visit)

Study Arms (1)

ReSPECT Intervention Arm

EXPERIMENTAL

AYA oncology patients and their primary oncology clinicians who will receive the ReSPECT intervention

Behavioral: ReSPECT

Interventions

ReSPECT BEHAVIORAL

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.

ReSPECT Intervention Arm

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

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MeSH Terms

Conditions

Neoplasms

Study Officials

• Natasha N Frederick, MD, MPH

  Connecticut Children's Medical

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natasha N Frederick, MD, MPH

CONTACT

8605459630; nfrederick@connecticutchildrens.org

Rachel Perry, BS

CONTACT

rperry01@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: June 2, 2026
• First Posted: June 22, 2026
• Study Start (Estimated): November 15, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)