Improving Sexual and Reproductive Health Communication Between Adolescent and Young Adult Oncology Patients and Clinicians: ReSPECT Intervention Proof-of-Concept Testing
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Feasibility (as assessed by intervention completion and retention rates)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
ReSPECT Intervention Arm
AYA oncology patients and their primary oncology clinicians who will receive the ReSPECT intervention
干预措施: ReSPECT (Behavioral)
结局指标
主要结局
Feasibility (as assessed by intervention completion and retention rates)
时间窗: From enrollment until T3 survey completion (8 weeks post-visit)
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.
Acceptability (as assessed by Lyon Satisfaction Questionnaire)
时间窗: From enrollment until T2 survey completion (within 48 hours post-visit)
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).
Perceived Usefulness (as assessed by Intervention Usability/Sustainability Scale, qualitative interviews)
时间窗: From enrollment until T3 survey completion (8 weeks post-visit)
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.
Feasibility
时间窗: From enrollment until T3 survey completion (8 weeks post-visit)
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
Acceptability
时间窗: From enrollment until T2 survey completion (within 48 hours post-visit)
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).
Perceived Usefulness
时间窗: Timepoint 2
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.
SRH Communication
时间窗: From enrollment until T3 survey completion (8 weeks post-visit)
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
次要结局
- Exchange of Information(From enrollment until T3 survey completion (8 weeks post-visit))
- Self-Efficacy(From enrollment until T3 survey completion (8 weeks post-visit))
- Fostering Healing Relationships (Therapeutic Alliance)(From enrollment until T3 survey completion (8 weeks post-visit))
- Decisional Confidence (Decision Making)(From enrollment until T3 survey completion (8 weeks post-visit))
- Distress/Bother(From enrollment until T3 survey completion (8 weeks post-visit))
- Outcome Expectancies(From enrollment until T3 survey completion (8 weeks post-visit))
- Risk Behaviors (Decision Making)(From enrollment until T3 survey completion (8 weeks post-visit))
- Therapeutic Alliance(From enrollment until T3 survey completion (8 weeks post-visit))