An interventional study of ReSPECT in Health-Related Quality-of-Life, Cancer and Health Communication, sponsored by Connecticut Children's Medical Center. Not yet recruiting at 1 site in United States. Open to participants aged 15 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by Connecticut Children's Medical Center · Not applicable, Interventional, and Supportive care
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
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.
Exclusion Criteria:
AYA oncology patients and their primary oncology clinicians who will receive the ReSPECT intervention
Behavioral: 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.
Feasibility
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
Time frame: From enrollment until T3 survey completion (8 weeks post-visit)
Acceptability
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).
Time frame: From enrollment until T2 survey completion (within 48 hours post-visit)
Perceived Usefulness
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.
Time frame: Timepoint 2
SRH Communication
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
Time frame: From enrollment until T3 survey completion (8 weeks post-visit)
Self-Efficacy
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.
Time frame: From enrollment until T3 survey completion (8 weeks post-visit)
Outcome Expectancies
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).
Time frame: From enrollment until T3 survey completion (8 weeks post-visit)
Decisional Confidence (Decision Making)
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.
Time frame: From enrollment until T3 survey completion (8 weeks post-visit)
Distress/Bother
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.
Time frame: From enrollment until T3 survey completion (8 weeks post-visit)
Risk Behaviors (Decision Making)
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.
Time frame: From enrollment until T3 survey completion (8 weeks post-visit)
Therapeutic Alliance
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.
Time frame: From enrollment until T3 survey completion (8 weeks post-visit)
Health Literacy
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
Time frame: Timepoint 1
Depression and Anxiety
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
Time frame: From enrollment until T3 survey completion (8 weeks post-visit)
Sexual Health
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.
Time frame: From enrollment until T3 survey completion (8 weeks post-visit)
Plan to share: No — 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.
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Connecticut Children's Medical Center