Improving Communication Between AYA Oncology Patients and Clinicians: A Patient-Centered Intervention
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-25
SponsorConnecticut Children's Medical Center
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Be aged 15-25 years old at time of enrollment.
Chemotherapy: any anticancer drug to treat the cancer diagnosis, including immunotherapy.
Radiotherapy: any radiotherapy to treat the cancer diagnosis.
Surgery: any surgery to remove cancer including partial of total resections. Biopsies are not considered surgery.
Disqualifiers
Not currently on cancer-directed therapy.
Unable to speak and read English.
Insufficient cognitive functioning to complete study measures (as determined by a member of the patient's primary oncology team)
Trial design
Design model
Single group
Treatments tested in this trial
ReSPECT
BehavioralReSPECT 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).
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: ReSPECTExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of implementing the ReSPECT intervention.
Feasibility will be based on patient recruitment and completion of the intervention. The intervention will be considered feasible if AYA recruitment is greater than or equal to 60% and if greater than or equal to 80% of consented AYAs complete the intervention (retention). Intervention completion will be defined as AYA completion of the pre-visit questionnaire and post-intervention survey.
Time frame
2 months2
Acceptability of the ReSPECT intervention.
The intervention will be considered acceptable if greater than or equal to 70% of AYA and clinician participants rate ReSPECT as acceptable (average score of 4 or higher) on the Lyon Satisfaction Questionnaire, adapted for this study, which includes a 10-item satisfaction questionnaire where 1 is strongly disagree and 5 is strongly agree. Subjects will report via survey after the healthcare visit.
Time frame
2 months3
Usability of the ReSPECT intervention.
The intervention will be considered usable/sustainable if greater than or equal to 70% of AYA and clinician participants rate ReSPECT as usable (average score of 4 or higher) on the Usability/Sustainability of Intervention Scale, adapted for this study, on a 4-item usability questionnaire where 1 is strongly disagree and 5 is completely agree. Subjects will report via survey after the healthcare visit.
Time frame
2 months4
Perceived utility of the ReSPECT intervention.
Through qualitative interviews, participants will be asked for their perceptions on the impact of ReSPECT in promoting SRH communication in the outpatient clinic setting.
Time frame
2 monthsSecondary outcomes
1
Comparison of patient reported SRH communication before and after intervention implementation.
Comparison of pre- and post- intervention percentage of patients reporting that their clinician talked to them about a SRH topic during the most recent clinic visit. Subjects will report via survey (yes/no) at baseline and after their healthcare visit.
Time frame
2 months2
Comparison of clinician reported SRH communication before and after intervention implementation.
Comparison of pre- and post- intervention percentage of clinicians reporting that they talked to their AYA patient about a SRH topic during the most recent clinic visit. Subjects will report (yes/no) via survey at baseline and after the healthcare visit.
Time frame
2 months3
Comparison of patient self-efficacy in discussing SRH topics with their oncology clinician before and after intervention implementation.
Comparison of pre- and post- intervention patient report of confidence in talking to their oncology clinician about SRH. Patients will complete a multi-item questionnaire adapted for this study on confidence where 0 is "not at all confident" and 10 is "extremely confident." Subjects will report via survey at baseline and after the healthcare visit.
Time frame
2 months4
Comparison of clinician of self-efficacy in discussing SRH topics with their AYA patient before and after intervention implementation.
Comparison of pre- and post- intervention clinician report of confidence in talking to their AYA clinician about SRH. Patients will complete a multi-item questionnaire adapted for this study on confidence where 0 is "not at all confident" and 10 is "extremely confident." Subjects will report via survey at baseline and after the healthcare visit.
Time frame
2 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Connecticut Children's Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov