Improving Sexual and Reproductive Health Communication for Adolescent and Young Adult Oncology Patients

Официальное название

Improving Sexual and Reproductive Health Communication Between Adolescent and Young Adult Oncology Patients and Clinicians: ReSPECT Intervention Proof-of-Concept Testing

Обзор

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

Подробное описание

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.

Вмешательства

• Поведенческое ReSPECT
  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.

Первичные конечные точки

• Feasibility [Срок оценки: From enrollment until T3 survey completion (8 weeks post-visit)]
• Acceptability [Срок оценки: From enrollment until T2 survey completion (within 48 hours post-visit)]
• Perceived Usefulness [Срок оценки: Timepoint 2]
• SRH Communication [Срок оценки: From enrollment until T3 survey completion (8 weeks post-visit)]

Вторичные конечные точки (6)

• Self-Efficacy [Срок оценки: From enrollment until T3 survey completion (8 weeks post-visit)]
• Outcome Expectancies [Срок оценки: From enrollment until T3 survey completion (8 weeks post-visit)]
• Decisional Confidence (Decision Making) [Срок оценки: From enrollment until T3 survey completion (8 weeks post-visit)]
• Distress/Bother [Срок оценки: From enrollment until T3 survey completion (8 weeks post-visit)]
• Risk Behaviors (Decision Making) [Срок оценки: From enrollment until T3 survey completion (8 weeks post-visit)]
• Therapeutic Alliance [Срок оценки: From enrollment until T3 survey completion (8 weeks post-visit)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Children's Hospital Los Angeles — Los Angeles

Публикации

• 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. PMID 25642841
• 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. PMID 34812790
• 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. PMID 26346418
• 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. PMID 25893421
• 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. PMID 11832252
• Snaith RP. The Hospital Anxiety And Depression Scale. Health Qual Life Outcomes. 2003 Aug 1;1:29. doi: 10.1186/1477-7525-1-29. PMID 12914662
• Chew LD, Bradley KA, Boyko EJ. Brief questions to identify patients with inadequate health literacy. Fam Med. 2004 Sep;36(8):588-94. PMID 15343421
• 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. PMID 24888503

Идентификаторы

NCT: NCT07658937 · 26-029 · K08CA286736-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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