Improving Sexual and Reproductive Health Communication for Adolescent and Young Adult Oncology Patients (ReSPECT)
3 agosto 2026 aggiornato da: 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
Panoramica dello studio
Stato
Non ancora reclutamento
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Stimato)
30
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Natasha N Frederick, MD, MPH
- Numero di telefono: 8605459630
- Email: nfrederick@connecticutchildrens.org
Backup dei contatti dello studio
- Nome: Rachel Perry, BS
- Email: rperry01@connecticutchildrens.org
Luoghi di studio
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California
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Los Angeles, California, Stati Uniti, 90027
- Children's Hospital Los Angeles
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Contatto:
- David R Freyer, DO, MS
- Numero di telefono: (323) 361-4624
- Email: DFreyer@chla.usc.edu
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
Accetta volontari sani
No
Descrizione
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)
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Feasibility
Lasso di tempo: From enrollment until T3 survey completion (8 weeks post-visit)
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Feasibility will be evaluated based on intervention enrollment (% of participants that complete consent/assent that complete all enrollment procedures, including the T1 survey), completion (% of enrolled AYAs completing the PVQ and the T2 survey) and retention (% of enrolled AYAs and clinicians completing all steps through the T3 survey).
ReSPECT will be deemed feasible if intervention enrollment, completion and retention rates are ≥80%, ≥80%, and ≥70%, respectively
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From enrollment until T3 survey completion (8 weeks post-visit)
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Acceptability
Lasso di tempo: From enrollment until T2 survey completion (within 48 hours post-visit)
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Acceptability will include usability.
Acceptability measures will be modeled on the Theoretical Framework of Acceptability, and include the rating of seven statements on a 5-point Likert scale (Strongly Disagree to Strongly Agree).
Acceptability will be defined as ≥70% of AYA and clinician participants rating the intervention acceptable (average score 4 or higher).
Usability will be assessed by the Intervention Usability Scale (IUS), a 10-item survey that measures responses to statements on a 5-point Likert scale ("strongly disagree" to "strongly agree".
Scores are converted and averaged to produce a total score from 0 to 100, with a score of 70 or higher set as the threshold for satisfactory usability.
ReSPECT will be deemed usable if ≥70% of AYA and clinician participants rate the intervention usable (average score 70 or higher).
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From enrollment until T2 survey completion (within 48 hours post-visit)
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Perceived Usefulness
Lasso di tempo: Timepoint 2
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Perceived usefulness will be evaluated in post-encounter semi-structured qualitative interviews with AYAs and clinicians.
Sample questions include, "Was the SRH conversation helpful?
Why or why not?" and, "What is the most useful part of ReSPECT?
What is the least useful?".
Additional questions will also cover perceived potential impact of ReSPECT improving SRH, barriers encountered using ReSPECT, and opportunities for improvement.
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Timepoint 2
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SRH Communication
Lasso di tempo: From enrollment until T3 survey completion (8 weeks post-visit)
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Participants will be asked if the sexual health topic(s) selected on the PVQ were discussed during the clinic visit (yes/no) and about who initiated the conversation (AYA patient/clinician).
They will also complete a brief survey listing each of the 7 sexual health subtopics and indicate whether or not the topic was discussed, who initiated the topic conversation, and (for patients) whether they asked their clinician any questions about the specific topic.
AYA patient participants will also be asked if there were topics/information not addressed or inadequately addressed during the visit along with whether or not additional people were in the room during the conversation.
Data to be collected were adapted from an instrument used for similar sexual health communication research in adult cancer populations
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From enrollment until T3 survey completion (8 weeks post-visit)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Self-Efficacy
Lasso di tempo: 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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Decisional Confidence (Decision Making)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: From enrollment until T3 survey completion (8 weeks post-visit)
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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)
Lasso di tempo: 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.
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From enrollment until T3 survey completion (8 weeks post-visit)
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Therapeutic Alliance
Lasso di tempo: 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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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Health Literacy
Lasso di tempo: Timepoint 1
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The Chew Health Literacy Screen is a validated 3-item questionnaire designed to identify individuals with inadequate health literacy.
Items are scored on a 5-point Likert scale, with higher scores indicating greater health literacy
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Timepoint 1
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Depression and Anxiety
Lasso di tempo: From enrollment until T3 survey completion (8 weeks post-visit)
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The Hospital Anxiety and Depression Scale (HADS) is a 14-item scale with subscales for anxiety and depression (7 items each).
Items were validated in the outpatient medical clinic setting and do not assess somatic complaints.
Each item is rated on a 4-point scale ranging from 0 (absence) to 3 (extreme presence), with higher scores indicating greater levels of anxiety and depression
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From enrollment until T3 survey completion (8 weeks post-visit)
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Sexual Health
Lasso di tempo: From enrollment until T3 survey completion (8 weeks post-visit)
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The COG Sexual Health Task Force Sexual Health Assessment is an 8-item survey designed to assess SH outcomes among AYAs with cancer and includes sexual history, sexual function, body image, and romantic relationships.
Question types include Likert scales, yes/no questions, and multiple-response checklists.
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From enrollment until T3 survey completion (8 weeks post-visit)
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Collaboratori
Investigatori
- Investigatore principale: Natasha N Frederick, MD, MPH, Connecticut Children's Medical
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002 Feb;52(2):69-77. doi: 10.1016/s0022-3999(01)00296-3.
- Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
- Mack JW, Block SD, Nilsson M, Wright A, Trice E, Friedlander R, Paulk E, Prigerson HG. Measuring therapeutic alliance between oncologists and patients with advanced cancer: the Human Connection Scale. Cancer. 2009 Jul 15;115(14):3302-11. doi: 10.1002/cncr.24360.
- Czajkowski SM, Powell LH, Adler N, Naar-King S, Reynolds KD, Hunter CM, Laraia B, Olster DH, Perna FM, Peterson JC, Epel E, Boyington JE, Charlson ME. From ideas to efficacy: The ORBIT model for developing behavioral treatments for chronic diseases. Health Psychol. 2015 Oct;34(10):971-82. doi: 10.1037/hea0000161. Epub 2015 Feb 2.
- Snaith RP. The Hospital Anxiety And Depression Scale. Health Qual Life Outcomes. 2003 Aug 1;1:29. doi: 10.1186/1477-7525-1-29.
- Griffin SJ, Kinmonth AL, Veltman MW, Gillard S, Grant J, Stewart M. Effect on health-related outcomes of interventions to alter the interaction between patients and practitioners: a systematic review of trials. Ann Fam Med. 2004 Nov-Dec;2(6):595-608. doi: 10.1370/afm.142.
- Chew LD, Bradley KA, Boyko EJ. Brief questions to identify patients with inadequate health literacy. Fam Med. 2004 Sep;36(8):588-94.
- Lyon ME, Garvie PA, Briggs L, He J, McCarter R, D'Angelo LJ. Development, feasibility, and acceptability of the Family/Adolescent-Centered (FACE) Advance Care Planning intervention for adolescents with HIV. J Palliat Med. 2009 Apr;12(4):363-72. doi: 10.1089/jpm.2008.0261.
- Weinfurt KP, Lin L, Bruner DW, Cyranowski JM, Dombeck CB, Hahn EA, Jeffery DD, Luecht RM, Magasi S, Porter LS, Reese JB, Reeve BB, Shelby RA, Smith AW, Willse JT, Flynn KE. Development and Initial Validation of the PROMIS((R)) Sexual Function and Satisfaction Measures Version 2.0. J Sex Med. 2015 Sep;12(9):1961-74. doi: 10.1111/jsm.12966. Epub 2015 Sep 7.
- Frederick NN, Campbell K, Kenney LB, Moss K, Speckhart A, Bober SL. Barriers and facilitators to sexual and reproductive health communication between pediatric oncology clinicians and adolescent and young adult patients: The clinician perspective. Pediatr Blood Cancer. 2018 Aug;65(8):e27087. doi: 10.1002/pbc.27087. Epub 2018 Apr 26.
- Reese JB, Lepore SJ, Daly MB, Handorf E, Sorice KA, Porter LS, Tulsky JA, Beach MC. A brief intervention to enhance breast cancer clinicians' communication about sexual health: Feasibility, acceptability, and preliminary outcomes. Psychooncology. 2019 Apr;28(4):872-879. doi: 10.1002/pon.5036. Epub 2019 Mar 13.
- Greydanus DE, Pratt HD, Patel DR. Concepts of contraception for adolescent and young adult women with chronic illness and disability. Dis Mon. 2012 May;58(5):258-320. doi: 10.1016/j.disamonth.2012.02.001.
- Barnett M, McDonnell G, DeRosa A, Schuler T, Philip E, Peterson L, Touza K, Jhanwar S, Atkinson TM, Ford JS. Psychosocial outcomes and interventions among cancer survivors diagnosed during adolescence and young adulthood (AYA): a systematic review. J Cancer Surviv. 2016 Oct;10(5):814-31. doi: 10.1007/s11764-016-0527-6. Epub 2016 Feb 26.
- Doak LG, Doak CC, Meade CD. Strategies to improve cancer education materials. Oncol Nurs Forum. 1996 Sep;23(8):1305-12.
- Carter J, Lacchetti C, Andersen BL, Barton DL, Bolte S, Damast S, Diefenbach MA, DuHamel K, Florendo J, Ganz PA, Goldfarb S, Hallmeyer S, Kushner DM, Rowland JH. Interventions to Address Sexual Problems in People With Cancer: American Society of Clinical Oncology Clinical Practice Guideline Adaptation of Cancer Care Ontario Guideline. J Clin Oncol. 2018 Feb 10;36(5):492-511. doi: 10.1200/JCO.2017.75.8995. Epub 2017 Dec 11.
- Teresi JA, Yu X, Stewart AL, Hays RD. Guidelines for Designing and Evaluating Feasibility Pilot Studies. Med Care. 2022 Jan 1;60(1):95-103. doi: 10.1097/MLR.0000000000001664.
- Knight JR, Sherritt L, Gibson EB, Levinson JA, Grubb LK, Samuels RC, Silva T, Vernacchio L, Wornham W, Harris SK. Effect of Computer-Based Substance Use Screening and Brief Behavioral Counseling vs Usual Care for Youths in Pediatric Primary Care: A Pilot Randomized Clinical Trial. JAMA Netw Open. 2019 Jun 5;2(6):e196258. doi: 10.1001/jamanetworkopen.2019.6258.
- Wettergren L, Kent EE, Mitchell SA, Zebrack B, Lynch CF, Rubenstein MB, Keegan THM, Wu XC, Parsons HM, Smith AW; AYA HOPE Study Collaborative Group. Cancer negatively impacts on sexual function in adolescents and young adults: The AYA HOPE study. Psychooncology. 2017 Oct;26(10):1632-1639. doi: 10.1002/pon.4181. Epub 2016 Jun 20.
- Flynn KE, Lindau ST, Lin L, Reese JB, Jeffery DD, Carter J, Baron SR, Abramsohn E, Weinfurt KP. Development and Validation of a Single-Item Screener for Self-Reporting Sexual Problems in U.S. Adults. J Gen Intern Med. 2015 Oct;30(10):1468-75. doi: 10.1007/s11606-015-3333-3. Epub 2015 Apr 18.
- Trevino KM, Abbott CH, Fisch MJ, Friedlander RJ, Duberstein PR, Prigerson HG. Patient-oncologist alliance as protection against suicidal ideation in young adults with advanced cancer. Cancer. 2014 Aug 1;120(15):2272-81. doi: 10.1002/cncr.28740. Epub 2014 May 28.
- Evangelia N, Kirana PS, Chiu G, Link C, Rosen R, Hatzichristou D. Level of bother and treatment-seeking predictors among male and female in-patients with sexual problems: a hospital-based study. J Sex Med. 2010 Feb;7(2 Pt 1):700-11. doi: 10.1111/j.1743-6109.2009.01605.x. Epub 2009 Nov 24.
- Chavarria EA, Christy SM, Simmons VN, Vadaparampil ST, Gwede CK, Meade CD. Learner Verification: A Methodology to Create Suitable Education Materials. Health Lit Res Pract. 2021 Jan 11;5(1):e49-e59. doi: 10.3928/24748307-20210201-02. Epub 2021 Feb 1.
- Reese JB, Sorice KA, Pollard W, Handorf E, Beach MC, Daly MB, Porter LS, Tulsky JA, Lepore SJ. Efficacy of a multimedia intervention in facilitating breast cancer patients' clinical communication about sexual health: Results of a randomized controlled trial. Psychooncology. 2021 May;30(5):681-690. doi: 10.1002/pon.5613. Epub 2020 Dec 23.
- Epstein RM, Duberstein PR, Fenton JJ, Fiscella K, Hoerger M, Tancredi DJ, Xing G, Gramling R, Mohile S, Franks P, Kaesberg P, Plumb S, Cipri CS, Street RL Jr, Shields CG, Back AL, Butow P, Walczak A, Tattersall M, Venuti A, Sullivan P, Robinson M, Hoh B, Lewis L, Kravitz RL. Effect of a Patient-Centered Communication Intervention on Oncologist-Patient Communication, Quality of Life, and Health Care Utilization in Advanced Cancer: The VOICE Randomized Clinical Trial. JAMA Oncol. 2017 Jan 1;3(1):92-100. doi: 10.1001/jamaoncol.2016.4373.
- Chisolm DJ, Gardner W, Julian T, Kelleher KJ. Adolescent Satisfaction with Computer-Assisted Behavioural Risk Screening in Primary Care. Child Adolesc Ment Health. 2008 Nov 1;13(4):163-168. doi: 10.1111/j.1475-3588.2007.00474.x.
- Gadomski AM, Fothergill KE, Larson S, Wissow LS, Winegrad H, Nagykaldi ZJ, Olson AL, Roter DL. Integrating mental health into adolescent annual visits: impact of previsit comprehensive screening on within-visit processes. J Adolesc Health. 2015 Mar;56(3):267-73. doi: 10.1016/j.jadohealth.2014.11.011. Epub 2015 Jan 10.
- Krouwel EM, Albers LF, Nicolai MPJ, Putter H, Osanto S, Pelger RCM, Elzevier HW. Discussing Sexual Health in the Medical Oncologist's Practice: Exploring Current Practice and Challenges. J Cancer Educ. 2020 Dec;35(6):1072-1088. doi: 10.1007/s13187-019-01559-6.
- Coccia PF, Pappo AS, Beaupin L, Borges VF, Borinstein SC, Chugh R, Dinner S, Folbrecht J, Frazier AL, Goldsby R, Gubin A, Hayashi R, Huang MS, Link MP, Livingston JA, Matloub Y, Millard F, Oeffinger KC, Puccetti D, Reed D, Robinson S, Rosenberg AR, Sanft T, Spraker-Perlman HL, von Mehren M, Wechsler DS, Whelan KF, Yeager N, Gurski LA, Shead DA. Adolescent and Young Adult Oncology, Version 2.2018, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2018 Jan;16(1):66-97. doi: 10.6004/jnccn.2018.0001.
- Landier W, Chen Y, Namdar G, Francisco L, Wilson K, Herrera C, Armenian S, Wolfson JA, Sun CL, Wong FL, Bhatia S. Impact of Tailored Education on Awareness of Personal Risk for Therapy-Related Complications Among Childhood Cancer Survivors. J Clin Oncol. 2015 Nov 20;33(33):3887-93. doi: 10.1200/JCO.2015.62.7562. Epub 2015 Aug 31.
- Lehmann V, Flynn JS, Foster RH, Russell KM, Klosky JL. Accurate understanding of infertility risk among families of adolescent males newly diagnosed with cancer. Psychooncology. 2018 Apr;27(4):1193-1199. doi: 10.1002/pon.4646. Epub 2018 Feb 20.
- Oosterhuis BE, Goodwin T, Kiernan M, Hudson MM, Dahl GV. Concerns about infertility risks among pediatric oncology patients and their parents. Pediatr Blood Cancer. 2008 Jan;50(1):85-9. doi: 10.1002/pbc.21261.
- Stein DM, Victorson DE, Choy JT, Waimey KE, Pearman TP, Smith K, Dreyfuss J, Kinahan KE, Sadhwani D, Woodruff TK, Brannigan RE. Fertility Preservation Preferences and Perspectives Among Adult Male Survivors of Pediatric Cancer and Their Parents. J Adolesc Young Adult Oncol. 2014 Jun 1;3(2):75-82. doi: 10.1089/jayao.2014.0007.
- Thompson AL, Long KA, Marsland AL. Impact of childhood cancer on emerging adult survivors' romantic relationships: a qualitative account. J Sex Med. 2013 Feb;10 Suppl 1:65-73. doi: 10.1111/j.1743-6109.2012.02950.x. Epub 2012 Oct 11.
- Stinson JN, Jibb LA, Greenberg M, Barrera M, Luca S, White ME, Gupta A. A Qualitative Study of the Impact of Cancer on Romantic Relationships, Sexual Relationships, and Fertility: Perspectives of Canadian Adolescents and Parents During and After Treatment. J Adolesc Young Adult Oncol. 2015 Jun;4(2):84-90. doi: 10.1089/jayao.2014.0036.
- Ford JS, Kawashima T, Whitton J, Leisenring W, Laverdiere C, Stovall M, Zeltzer L, Robison LL, Sklar CA. Psychosexual functioning among adult female survivors of childhood cancer: a report from the childhood cancer survivor study. J Clin Oncol. 2014 Oct 1;32(28):3126-36. doi: 10.1200/JCO.2013.54.1086. Epub 2014 Aug 11.
- Acquati C, Zebrack BJ, Faul AC, Embry L, Aguilar C, Block R, Hayes-Lattin B, Freyer DR, Cole S. Sexual functioning among young adult cancer patients: A 2-year longitudinal study. Cancer. 2018 Jan 15;124(2):398-405. doi: 10.1002/cncr.31030. Epub 2017 Nov 17.
- Lehmann V, Gerhardt CA, Baust K, Kaatsch P, Hagedoorn M, Tuinman MA. Psychosexual Development and Sexual Functioning in Young Adult Survivors of Childhood Cancer. J Sex Med. 2022 Nov;19(11):1644-1654. doi: 10.1016/j.jsxm.2022.07.014. Epub 2022 Sep 8.
- Zebrack BJ, Foley S, Wittmann D, Leonard M. Sexual functioning in young adult survivors of childhood cancer. Psychooncology. 2010 Aug;19(8):814-22. doi: 10.1002/pon.1641.
- Bober SL, Zhou ES, Chen B, Manley PE, Kenney LB, Recklitis CJ. Sexual function in childhood cancer survivors: a report from Project REACH. J Sex Med. 2013 Aug;10(8):2084-93. doi: 10.1111/jsm.12193. Epub 2013 May 16.
- Grunloh DS, Casner T, Secura GM, Peipert JF, Madden T. Characteristics associated with discontinuation of long-acting reversible contraception within the first 6 months of use. Obstet Gynecol. 2013 Dec;122(6):1214-21. doi: 10.1097/01.AOG.0000435452.86108.59.
- Cherven B, Klosky JL, Chen Y, York JM, Heaton K, Childs G, Flynn JS, Connelly JA, Wasilewski-Masker K, Robison LL, Hudson MM, Wong FL, Bhatia S, Landier W. Sexual behaviors and human papillomavirus vaccine non-initiation among young adult cancer survivors. J Cancer Surviv. 2021 Dec;15(6):942-950. doi: 10.1007/s11764-021-01000-2. Epub 2021 Feb 6.
- Bahamondes MV, Monteiro I, Castro S, Espejo-Arce X, Bahamondes L. Prospective study of the forearm bone mineral density of long-term users of the levonorgestrel-releasing intrauterine system. Hum Reprod. 2010 May;25(5):1158-64. doi: 10.1093/humrep/deq043. Epub 2010 Feb 25.
- Maslow BS, Morse CB, Schanne A, Loren A, Domchek SM, Gracia CR. Contraceptive use and the role of contraceptive counseling in reproductive-aged women with cancer. Contraception. 2014 Jul;90(1):79-85. doi: 10.1016/j.contraception.2014.03.002. Epub 2014 Mar 11.
- Murphy D, Klosky JL, Termuhlen A, Sawczyn KK, Quinn GP. The need for reproductive and sexual health discussions with adolescent and young adult cancer patients. Contraception. 2013 Aug;88(2):215-20. doi: 10.1016/j.contraception.2012.08.041. Epub 2012 Oct 4.
- Rosenberg AR, Bona K, Ketterl T, Wharton CM, Wolfe J, Baker KS. Intimacy, Substance Use, and Communication Needs During Cancer Therapy: A Report From the "Resilience in Adolescents and Young Adults" Study. J Adolesc Health. 2017 Jan;60(1):93-99. doi: 10.1016/j.jadohealth.2016.08.017. Epub 2016 Oct 18.
- Aubin S, Perez S. The Clinician's Toolbox: Assessing the Sexual Impacts of Cancer on Adolescents and Young Adults with Cancer (AYAC). Sex Med. 2015 Sep;3(3):198-212. doi: 10.1002/sm2.75. Epub 2015 Jul 30.
- Murphy D, Klosky JL, Reed DR, Termuhlen AM, Shannon SV, Quinn GP. The importance of assessing priorities of reproductive health concerns among adolescent and young adult patients with cancer. Cancer. 2015 Aug 1;121(15):2529-36. doi: 10.1002/cncr.29466. Epub 2015 Jun 5.
- Gorman JR, Bailey S, Pierce JP, Su HI. How do you feel about fertility and parenthood? The voices of young female cancer survivors. J Cancer Surviv. 2012 Jun;6(2):200-9. doi: 10.1007/s11764-011-0211-9. Epub 2011 Dec 17.
- Klosky JL, Simmons JL, Russell KM, Foster RH, Sabbatini GM, Canavera KE, Hodges JR, Schover LR, McDermott MJ. Fertility as a priority among at-risk adolescent males newly diagnosed with cancer and their parents. Support Care Cancer. 2015 Feb;23(2):333-41. doi: 10.1007/s00520-014-2366-1. Epub 2014 Aug 2.
- Vrancken Peeters NJMC, Vlooswijk C, Bijlsma RM, Kaal SEJ, Kerst JM, Tromp JM, Bos MEMM, van der Hulle T, Lalisang RI, Nuver J, Kouwenhoven MCM, van der Ploeg IMC, van der Graaf WTA, Husson O. Sexual quality of life of adolescents and young adult breast cancer survivors. ESMO Open. 2024 Feb;9(2):102234. doi: 10.1016/j.esmoop.2024.102234. Epub 2024 Jan 27.
- Andreu Y, Martinez P, Soto-Rubio A, Perez-Marin M, Cervantes A, Arribas L. Quality of life in cancer survivorship: Sociodemographic and disease-related moderators. Eur J Cancer Care (Engl). 2022 Nov;31(6):e13692. doi: 10.1111/ecc.13692. Epub 2022 Sep 7.
- Frederick NN, Recklitis CJ, Blackmon JE, Bober S. Sexual Dysfunction in Young Adult Survivors of Childhood Cancer. Pediatr Blood Cancer. 2016 Sep;63(9):1622-8. doi: 10.1002/pbc.26041. Epub 2016 May 10.
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
15 novembre 2026
Completamento primario (Stimato)
30 giugno 2028
Completamento dello studio (Stimato)
30 giugno 2029
Date di iscrizione allo studio
Primo inviato
2 giugno 2026
Primo inviato che soddisfa i criteri di controllo qualità
15 giugno 2026
Primo Inserito (Effettivo)
22 giugno 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
5 agosto 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
3 agosto 2026
Ultimo verificato
1 giugno 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 26-029 (The Cleveland Clinic Foundation Institutional Review Board)
- K08CA286736-01A1 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Descrizione del piano IPD
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.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .