Actively Recruiting

Phase Not Applicable
Age: 15Years - 25Years
All Genders
ID06982066

Improving Health-Related Quality of Life Communication Between Adolescent and Young Adult Oncology Patients and Clinicians: A Patient-Centered Intervention

Led by Connecticut Children's Medical Center · Updated on 2025-08-14

60

Participants Needed

1

Research Sites

15 weeks

Total Duration

On this page

Sponsors

C

Connecticut Children's Medical Center

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating a new web-based tool called ReSPECT (Reproductive and Sexual Health Patient Education and Communication Tool) aimed at improving communication about sexual and reproductive health between adolescent and young adult (AYA) cancer patients and their clinicians during outpatient oncology visits. The project includes developing, refining, and testing this patient-centered intervention to enhance discussions on these important health topics within cancer care. The study involves a single group of AYA oncology patients aged 15 to 25 who will use the ReSPECT platform. This interactive digital tool includes a pre-visit questionnaire for patients that alerts clinicians to relevant sexual and reproductive health concerns, targeted patient education based on questionnaire responses, and guidance for clinicians on addressing these issues. Participants will complete surveys before using the tool, shortly after, and again two months later. They will also be invited to a brief interview after their first post-intervention clinic visit. During the study, participants will complete baseline and follow-up surveys plus interviews to evaluate the tool's feasibility, acceptability, usability, and perceived usefulness. Researchers will measure changes in patient and clinician communication, self-efficacy in discussing sexual and reproductive health, decision-making impact, distress related to these topics, risk behaviors, and therapeutic alliance. The study is conducted with active involvement from patients' oncology clinicians, and participation lasts at least two months after enrollment.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 15Years - 25Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 15 to 25 years old at time of enrollment
  • Diagnosed with cancer and currently receiving cancer-directed therapy, including chemotherapy, radiotherapy, or surgery (excluding biopsies)
  • At least 2 months have passed since diagnosis or start of therapy, whichever is later
  • Able to speak and read English
  • Permission to participate granted by primary oncology team
  • Signed consent or assent form
  • Active participation of primary oncology clinician
  • Primary oncology care at Connecticut Children's Center for Cancer & Blood Disorders or Children's Hospital Los Angeles Cancer & Blood Disease Institute
Not Eligible

You will not qualify if you...

  • Not currently receiving cancer-directed therapy
  • Unable to speak or read English
  • Insufficient cognitive function to complete study measures, as determined by primary oncology team

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person or virtual)

Outpatient Treatment

Duration - From enrollment through the first post-intervention clinic visit

Participants use the ReSPECT digital platform to complete a pre-visit questionnaire and receive tailored sexual and reproductive health education before their clinic appointment. Clinicians receive the participant's questionnaire results with guidance on addressing concerns.

1 baseline survey, 1 post-intervention survey and interview within 48 hours of the first post-intervention clinic visit

Follow-up

Duration - Up to 2 months from enrollment

Participants complete a follow-up survey to assess the impact of the intervention on communication and related outcomes.

1 follow-up survey visit (virtual)

Trial Site Locations

Total: 1 location

1

Connecticut Children's Medical Center

Hartford, Connecticut, United States, 06106

Actively Recruiting

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Research Team

N

Natasha Frederick, MD, MPH

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

1

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