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| ID | Type | Description | Link |
|---|---|---|---|
| K08CA286736-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ReSPECT Intervention Arm | Experimental | AYA oncology patients and their primary oncology clinicians who will receive the ReSPECT intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ReSPECT | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility (as assessed by intervention completion and retention rates) | 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. | From enrollment until T3 survey completion (8 weeks post-visit) |
| Acceptability (as assessed by Lyon Satisfaction Questionnaire) | 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). | From enrollment until T2 survey completion (within 48 hours post-visit) |
| Perceived Usefulness (as assessed by Intervention Usability/Sustainability Scale, qualitative interviews) | 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. | From enrollment until T3 survey completion (8 weeks post-visit) |
| Measure | Description | Time Frame |
|---|---|---|
| Exchange of Information | 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 | From enrollment until T3 survey completion (8 weeks post-visit) |
| Self-Efficacy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Natasha N Frederick, MD, MPH | Contact | 8605459630 | nfrederick@connecticutchildrens.org | |
| Rachel Perry, BS | Contact | rperry01@connecticutchildrens.org |
| Name | Affiliation | Role |
|---|---|---|
| Natasha N Frederick, MD, MPH | Connecticut Children's Medical | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25642841 | Background | 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. | |
| 34812790 | Background | 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. |
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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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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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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. |
| From enrollment until T3 survey completion (8 weeks post-visit) |
| Fostering Healing Relationships (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. | 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. | 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. | 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). | 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. | From enrollment until T3 survey completion (8 weeks post-visit) |
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| 37548483 | Background | 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. |
| 37856773 | Background | 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. |