Improving Sexual and Reproductive Health Communication Between Adolescent and Young Adult Oncology Patients and Clinicians: ReSPECT Intervention Proof-of-Concept Testing
Improving Sexual and Reproductive Health Communication Between Adolescent and Young Adult Oncology Patients and Clinicians: ReSPECT Intervention Proof-of-Concept Testing
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
Psychosexual development is a key aspect of adolescence and young adulthood, which may be significantly disrupted by a cancer diagnosis. Adolescent and young adult (AYA) cancer patients are at risk for complications that can detrimentally impact their sexual and reproductive health (SRH) during and after cancer treatment. Prior research has shown that pediatric oncologists rarely discuss many important aspects of SRH, and AYA cancer patients repeatedly report unmet communication needs related to these topics.
To address these needs, we have developed ReSPECT, an interactive, web-based digital platform designed to improve communication about insufficiently addressed SRH topics. ReSPECT integrates (1) a pre-visit questionnaire (PVQ) that will allow AYA patients to discreetly alert clinicians to relevant SRH questions/concerns (2) targeted patient education based on PVQ selections, and (3) clinician-centered guidance for addressing specific SRH questions/concerns. Previous stages of this research involved developing and refining a prototype of ReSPECT based on stakeholder feedback. Utilizing this prototype, this proof-of-concept study will assess the feasibility, acceptability, and perceived usefulness of ReSPECT with AYA patients on active cancer treatment and their oncology clinicians. In addition to assessing operational viability, this study will also assess the feasibility of collecting secondary outcomes measures. Data collected will lay the foundation for a future randomized controlled trial to assess ReSPECT intervention efficacy, with the ultimate goal of improving HRQOL communication for AYAs across the cancer continuum.
Primary Aim: Evaluate the feasibility, acceptability, usability, and perceived usefulness of ReSPECT in the outpatient setting with AYA oncology patients and clinicians.
ReSPECT will undergo proof-of-concept testing with AYAs (n=30) and their oncology clinicians (n~10-30) to determine if the intervention is feasible (recruitment >60%, retention >80%), acceptable (>70% with an average score ≥4 on the Lyon Satisfaction Questionnaire), and perceived useful (>70% with an average score ≥4 on the Usability/Sustainability of Intervention scale). Qualitative interviews with participants will provide additional information on acceptability, perceived usefulness, and opportunities for intervention improvement.
Secondary Aim: Collect and examine descriptive data on preliminary outcomes of ReSPECT and assess feasibility of procedures for a future randomized controlled trial.
Pre- and post-intervention questionnaires (T1: pre-visit, T2: within 48 hrs post-visit, T3: 8 weeks post-visit) to assess signals of intervention efficacy will include communication behavior, self-efficacy, outcome expectancies, decision-making, therapeutic alliance, distress/bother, and developmentally relevant health risk behaviors.
Inclusion Criteria:
Exclusion Criteria:
nfrederick@connecticutchildrens.org8605459630
rperry01@connecticutchildrens.org