ReSPECT for Cancer

Overseen By Natasha Frederick, MD, MPH

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Connecticut Children's Medical Center

Must be taking: Chemotherapy, Immunotherapy

Disqualifiers: Not on therapy, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Natasha Frederick, MD, MPH

Principal Investigator

[e-mail]

Eligibility Criteria

This trial is for adolescent and young adult oncology patients who need better communication with their clinicians about sexual and reproductive health. Specific eligibility criteria are not provided, but typically participants would be within a certain age range and undergoing cancer treatment.

Inclusion Criteria

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

Exclusion Criteria

I am not currently undergoing treatment for cancer.

My doctor thinks I can't fully understand or participate in the study due to cognitive issues.

Unable to speak and read English

Timeline

Development and Refinement

Development and refinement of the ReSPECT intervention by integrating feedback from AYAs and pediatric oncology clinicians.

Not specified

Proof-of-Concept Testing

Single-arm cohort study of the ReSPECT intervention using a pre-post design. Participants complete surveys at baseline, immediately after intervention use, and at 2 months from study enrollment.

2 months

3 surveys (baseline, post-intervention, 2 months)

Follow-up

Participants are monitored for the impact of the intervention on SRH communication and related outcomes.

2 months

Treatment Details

Interventions

• ReSPECT

Trial Overview The study is testing ReSPECT, an intervention designed to enhance the way young cancer patients and their doctors talk about sexual and reproductive health in outpatient clinics. It's a proof-of-concept trial to see if this tool can improve communication.

Participant Groups

Group I: ReSPECT Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Connecticut Children's Medical Center

Lead Sponsor

Trials

76

Recruited

30,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+