Clinical trial · Interventional
Improving Sexual and Reproductive Health Communication for Adolescent and Young Adult Oncology Patients
Improving Sexual and Reproductive Health Communication Between Adolescent and Young Adult Oncology Patients and Clinicians: ReSPECT Intervention Proof-of-Concept Testing
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Health Communication | — | UNRESOLVED | — |
| Health-Related Quality-of-Life | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ReSPECT | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ReSPECT Intervention Arm
- description
- AYA oncology patients and their primary oncology clinicians who will receive the ReSPECT intervention
- interventionNames
- Behavioral: ReSPECT
Primary outcomes (4)
- measure
- Feasibility
- timeFrame
- From enrollment until T3 survey completion (8 weeks post-visit)
- description
- 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
- measure
- Acceptability
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 25 Years
Show eligibility criteria text
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)
References
Publications (60)
- BACKGROUNDCzajkowski 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
- BACKGROUNDTeresi 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
- BACKGROUNDWeinfurt 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
- BACKGROUNDFlynn 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
- BACKGROUNDBjelland 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
- BACKGROUNDSnaith 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
- BACKGROUNDChew LD, Bradley KA, Boyko EJ. Brief questions to identify patients with inadequate health literacy. Fam Med. 2004 Sep;36(8):588-94.