Pediatric CancerNCT06982066
Improving Communication Between AYA Oncology Patients and Clinicians: A Patient-Centered Intervention
A study testing ReSPECT in people with Pediatric Cancer and Adolescent and Young Adult Cancer, run by Connecticut Children's Medical Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 15 to 25 years
- Conditions the study is for
- Pediatric Cancer, Adolescent and Young Adult Cancer
- What is being tested?
- ReSPECT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2025to 29 Jun 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescent and Young Adult Oncology Patients
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Be aged 15-25 years old at time of enrollment.
- Have a cancer diagnosis and currently be on cancer-directed therapy with at least one of the following:
- Chemotherapy: any anticancer drug to treat the cancer diagnosis, including immunotherapy.
- Radiotherapy: any radiotherapy to treat the cancer diagnosis.
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- Surgery: any surgery to remove cancer including partial of total resections. Biopsies are not considered surgery.
- Be greater than or equal to 2 months from diagnosis/initiation of therapy, whichever occurred later.
- Be able to speak and read English
- Have permission to participate from a member of the patient's primary oncology team.
- 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
Who cannot join
- An individual who meets and of the following criteria will be excluded from participation in this study:
- 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)
- Pediatric Oncology Clinicians
- 1. Be a pediatric oncology physician, clinical fellow, or advanced practice provider (including nurse practitioners and physician assistants) that provides clinical care for AYA patients with cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Natasha Frederick, MD, MPH, 860-545-9618, nfrederick@connecticutchildrens.org
About this study
Official title: Improving Health-Related Quality of Life Communication Between AYA Oncology Patients and Clinicians: A Patient-Centered Intervention
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.
Read the detailed description
To improve sexual and reproductive health communication between adolescent and young adult oncology patients and their clinicians, the Investigator will be developing and testing proof-of-concept of a novel web-based intervention called ReSPECT (Reproductive and Sexual health Patient Education and Communication Tool). The overarching goal of this proposal is to develop and pilot test a patient-centered approach to improve sexual and reproductive health communication during cancer care.
Prior to the clinical trial, Aim 1 of this study will develop and refine ReSPECT by integrating feedback from AYAs and pediatric oncology clinicians on individual intervention components followed by additional feedback collected through cognitive debriefing. Once Aim 1 is completed, the intervention will be ready for proof-of-concept testing.
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.
- Being tested
- ReSPECT
- Keywords
- adolescent young adult, sexual health communication, cancer, patient provider communication, sexual and reproductive health
- Medical subject headings
- Neoplasms, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReSPECTBehavioural
ReSPECT 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).
| Study group | Role | What they receive |
|---|---|---|
| ReSPECT | Experimental | 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. Receives: Behavioral: ReSPECT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months
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.
Measured: 2 months
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.
Measured: 2 months
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.
Measured: 2 months
Secondary outcomes (9)
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.
Measured: 2 months
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.
Measured: 2 months
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.
Measured: 2 months
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.
Measured: 2 months
Comparison of patient- reported outcome expectancies related to discussing SRH topics with their oncology clinician before and after intervention implementation.
Comparison of pre- and post- intervention patient report of perceived benefit of discussing SRH with their clinician. Patients will complete a 6-item questionnaire adapted for this study on perceived benefit where 0 is "not at all" and 10 is "very much." Subjects will report via survey at baseline and after the healthcare visit.
Measured: 2 months
Intervention impact on decision-making.
The proportion of patients that report the intervention helped them get the information that they needed to make informed decisions about SRH. Subjects will report (yes/no) via survey after their healthcare visit.
Measured: 2 months
Comparison of patient-reported distress/bother by SRH-related questions or concerns before and after the intervention.
Comparison of pre- and post- intervention rating of distress/bother by SRH-related questions or concerns. Patients will complete a single item scale on the degree of bother on the Distress/Bother Scale where 1 is "Not at all bothersome" and 4 is "Bothers me a lot". Subjects will report via survey at baseline and after the healthcare visit.
Measured: 2 months
Comparison of patient-reported engagement in sexual health risk behaviors before and after the intervention.
Comparison of patient-reported engagement in sexual health risk behaviors pre- and post- intervention implementation. Patients will complete a study-specific survey consisting of several questions about engagement in sexual health risk behaviors (yes/no and nominal). Subjects will report via survey at baseline and after the healthcare visit.
Measured: 2 months
Comparison of patient-reported therapeutic alliance before and after the intervention.
Comparison of patient-reported therapeutic alliance with primary oncology clinician pre- and post- intervention implementation. Patients will complete 16 items on The Human Connection Scale (4-point scale). Subjects will report via survey at baseline and after the healthcare visit.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start10 Feb 2025
- Primary completion15 Mar 2029 (estimated)
- Study completion29 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Connecticut Children's Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Natasha Frederick, MD, MPH, Principal investigator, nfrederick@connecticutchildrens.org
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06982066
- Sponsor's protocol ID
- 24-081
- Other IDs
- K08CA286736
- Status last verified
- Oct 2026
- First submitted
- 13 May 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No