Improving Sexual and Reproductive Health Communication for Adolescent and Young Adult Oncology Patients (ReSPECT)
15. juni 2026 opdateret af: Connecticut Children's Medical Center
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
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
30
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Natasha N Frederick, MD, MPH
- Telefonnummer: 8605459630
- E-mail: nfrederick@connecticutchildrens.org
Undersøgelse Kontakt Backup
- Navn: Rachel Perry, BS
- E-mail: rperry01@connecticutchildrens.org
Studiesteder
-
-
California
-
Los Angeles, California, Forenede Stater, 90027
- Children's Hospital Los Angeles
-
Kontakt:
- David R Freyer, DO, MS
- Telefonnummer: (323) 361-4624
- E-mail: DFreyer@chla.usc.edu
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Age 15-25 years old
- Has a cancer diagnosis
- ≥2 months from diagnosis/initiation of therapy, whichever occurred later
- Currently on cancer-directed therapy
- Speaks and reads English
- Approval from primary oncology team
- Study participation by primary oncology clinician
Exclusion Criteria:
- Not able to provide informed consent/assent
- Insufficient cognitive functioning to complete study measures, as determined by a member of the patient's primary oncology team
- Exceeds primary oncologist's participant limit (3 patients/clinician)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: ReSPECT Intervention Arm
AYA oncology patients and their primary oncology clinicians who will receive the ReSPECT intervention
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ReSPECT is a multi-modal digital intervention that integrates a pre-visit questionnaire and targeted patient and clinician education to support SRH communication in the outpatient oncology clinic setting.
For the purposes of this study it will be used in conjunction with a single regularly scheduled clinic visit.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Feasibility (as assessed by intervention completion and retention rates)
Tidsramme: From enrollment until T3 survey completion (8 weeks post-visit)
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Feasibility will be evaluated based on intervention completion (% of AYAs completing all steps through T2) and retention (% of enrolled AYAs and clinicians completing all steps through T3).
ReSPECT will be deemed feasible if intervention completion and retention rates are ≥80% and ≥70%, respectively.
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From enrollment until T3 survey completion (8 weeks post-visit)
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Acceptability (as assessed by Lyon Satisfaction Questionnaire)
Tidsramme: From enrollment until T2 survey completion (within 48 hours post-visit)
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Acceptability will be measured using the 11-item Lyon Satisfaction Questionnaire, included in the T2 survey, with a threshold of ≥70% of AYA and clinician participants rating the intervention acceptable (average score 4 or higher).
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From enrollment until T2 survey completion (within 48 hours post-visit)
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Perceived Usefulness (as assessed by Intervention Usability/Sustainability Scale, qualitative interviews)
Tidsramme: From enrollment until T3 survey completion (8 weeks post-visit)
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Perceived Usefulness will encompass usability and utility.
Usability will be assessed by the 4-item Intervention Usability/Sustainability Scale, included in the T2 and T3 surveys, with a threshold of ≥70% of AYA and clinician participants rating the intervention usable (average score 4 or higher).
Utility will be evaluated in post-encounter qualitative interviews with AYAs and clinicians.
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From enrollment until T3 survey completion (8 weeks post-visit)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Exchange of Information
Tidsramme: From enrollment until T3 survey completion (8 weeks post-visit)
|
Initiation and content of AYA-clinician SRH conversations will be evaluated with a three-item instrument adapted for this study from similar health communication research
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From enrollment until T3 survey completion (8 weeks post-visit)
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Self-Efficacy
Tidsramme: From enrollment until T3 survey completion (8 weeks post-visit)
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Self-efficacy will be measured by a two-item scale assessing AYA and clinician confidence (1) initiating and (2) participating in discussions about SRH topics.
Responses range from 0 (not at all confident) to 10 (extremely confident) for each topic.
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From enrollment until T3 survey completion (8 weeks post-visit)
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Fostering Healing Relationships (Therapeutic Alliance)
Tidsramme: From enrollment until T3 survey completion (8 weeks post-visit)
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The Human Connection (THC) scale is a 16-item scale measuring therapeutic alliance (TA) between AYAs and clinicians.
Items are scored on a 4-point Likert scale, with response categories based on question content, and higher scores indicating greater TA.
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From enrollment until T3 survey completion (8 weeks post-visit)
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Decisional Confidence (Decision Making)
Tidsramme: From enrollment until T3 survey completion (8 weeks post-visit)
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Decisional confidence will be assessed by a single-item survey measure to assess whether ReSPECT helped AYAs make an informed decision about a SRH question/concern.
Participants will be asked to respond with yes/no, then to describe why/why not.
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From enrollment until T3 survey completion (8 weeks post-visit)
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Distress/Bother
Tidsramme: From enrollment until T3 survey completion (8 weeks post-visit)
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The Level of Bother Scale is a single-item scale assessing the extent to which participants have been bothered by specific SRH concerns in the last month.
Responses are scored on a 4-point Likert scale, with higher scores indicating greater levels of bother.
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From enrollment until T3 survey completion (8 weeks post-visit)
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Outcome Expectancies
Tidsramme: From enrollment until T3 survey completion (8 weeks post-visit)
|
The Outcome Expectancy Scale is a 6-item scale assessing AYA's perception of the extent to which outcomes may result from discussing SRH topics with their oncology clinician.
Potential outcomes include answering question(s), finding a solution to a problem, giving peace of mind, helping play an active role in one's health care, improving SRH, and helping make decisions.
For each item, responses range from 0 (not at all) to 10 (very much).
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From enrollment until T3 survey completion (8 weeks post-visit)
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Risk Behaviors (Decision Making)
Tidsramme: From enrollment until T3 survey completion (8 weeks post-visit)
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A 9-item questionnaire adapted from the National Youth Risk Behavior Survey will be used to characterize quality and frequency of health risk behaviors among AYA participants.
|
From enrollment until T3 survey completion (8 weeks post-visit)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Natasha N Frederick, MD, MPH, Connecticut Children's Medical
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
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- Frederick NN, Revette A, Michaud A, Bober SL. A qualitative study of sexual and reproductive health communication with adolescent and young adult oncology patients. Pediatr Blood Cancer. 2019 Jun;66(6):e27673. doi: 10.1002/pbc.27673. Epub 2019 Feb 15.
- Close AG, Ghuman A, Friehling E, Hamm M, Frederick NN, Miller E, Kazmerski TM. Experiences with Menses and Menstrual Suppression of Young Women with a History of Cancer. J Adolesc Young Adult Oncol. 2020 Feb;9(1):23-29. doi: 10.1089/jayao.2019.0077. Epub 2019 Oct 8.
- Frederick NN, Fine E, Michaud A, Recklitis CJ, Bober SL. Pediatric hematology and oncology fellow education in sexual and reproductive health: A survey of fellowship program directors in the United States. Pediatr Blood Cancer. 2020 May;67(5):e28245. doi: 10.1002/pbc.28245. Epub 2020 Mar 8.
- Frederick NN, Bingen K, Bober SL, Cherven B, Xu X, Quinn GP, Ji L, Freyer DR. Pediatric oncology clinician communication about sexual health with adolescents and young adults: A report from the children's oncology group. Cancer Med. 2021 Aug;10(15):5110-5119. doi: 10.1002/cam4.4077. Epub 2021 Jun 15.
- Sopfe J, Marsh R, Frederick NN, Klosky JL, Chow EJ, Dorsey Holliman B, Peterson PN. Adolescent and young adult childhood cancer survivors' preferences for screening and education of sexual function. Pediatr Blood Cancer. 2021 Dec;68(12):e29229. doi: 10.1002/pbc.29229. Epub 2021 Jul 10.
- Frederick NN, Klosky JL, Meacham L, Quinn GP, Kelvin JF, Cherven B, Freyer DR, Dvorak CC, Brackett J, Ahmed-Winston S, Bryson E, Su HI, Chow EJ, Levine J. Fertility Preservation Practices at Pediatric Oncology Institutions in the United States: A Report From the Children's Oncology Group. JCO Oncol Pract. 2023 Apr;19(4):e550-e558. doi: 10.1200/OP.22.00349. Epub 2023 Feb 10.
- Frederick NN, Lehmann V, Ahler A, Carpenter K, Cherven B, Klosky JL, Nahata L, Quinn GP. Psychosexual functioning in cancer survivorship: What the pediatric oncologist needs to know. Pediatr Blood Cancer. 2023 Sep;70 Suppl 5:e30611. doi: 10.1002/pbc.30611. Epub 2023 Aug 7.
- Cherven BO, Demedis J, Frederick NN. Sexual Health in Adolescents and Young Adults With Cancer. J Clin Oncol. 2024 Feb 20;42(6):717-724. doi: 10.1200/JCO.23.01390. Epub 2023 Oct 19.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
15. november 2026
Primær færdiggørelse (Anslået)
30. juni 2028
Studieafslutning (Anslået)
30. juni 2029
Datoer for studieregistrering
Først indsendt
2. juni 2026
Først indsendt, der opfyldte QC-kriterier
15. juni 2026
Først opslået (Faktiske)
22. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 26-029 (The Cleveland Clinic Foundation Institutional Review Board)
- K08CA286736-01A1 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
Given the relatively small sample size and the rarity of pediatric cancer, even after removal of identifiers we believe a risk remains of deductive identification of participants.
Consequently, we are not planning to share IPD.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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