Health-Related Quality-of-LifeReSPECTNCT07658937
Improving Sexual and Reproductive Health Communication for Adolescent and Young Adult Oncology Patients
A study testing ReSPECT in people with Health-Related Quality-of-Life and Cancer, run by Connecticut Children's Medical Center at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 15 to 25 years
- Conditions the study is for
- Health-Related Quality-of-Life, Cancer, Health Communication
- What is being tested?
- ReSPECT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2026to 30 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rachel Perry, BS contact
United States1 site
Children's Hospital Los Angeles
Los Angeles, California, 90027
David R Freyer, DO, MS, (323) 361-4624, DFreyer@chla.usc.edu
About this study
Official title: Improving Sexual and Reproductive Health Communication Between Adolescent and Young Adult Oncology Patients and Clinicians: ReSPECT Intervention Proof-of-Concept Testing
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:
Read more
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
Read the detailed description
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.
- Conditions
- Health-Related Quality-of-Life, Cancer, Health Communication
- Being tested
- ReSPECT
- Keywords
- Health-Related Quality-of-Life, Adolescent, Young Adult, Psychosocial Intervention, Health Communication, Cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReSPECTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| ReSPECT Intervention Arm | Experimental | AYA oncology patients and their primary oncology clinicians who will receive the ReSPECT intervention Receives: Behavioral: ReSPECT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: 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.
Measured: 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
Measured: From enrollment until T3 survey completion (8 weeks post-visit)
Secondary outcomes (6)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment until T3 survey completion (8 weeks post-visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start15 Nov 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (60)Papers the sponsor has linked to this study.
- Other trials for Health-Related Quality-of-LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Connecticut Children's Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Natasha N Frederick, MD, MPH, Principal investigator, Connecticut Children's Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07658937
- Sponsor's protocol ID
- 26-029
- Other IDs
- K08CA286736-01A1
- Acronym
- ReSPECT
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 25642841Teresi 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.
PubMed 34812790Weinfurt 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.
PubMed 26346418Flynn 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.
PubMed 25893421Bjelland 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.
PubMed 11832252Snaith RP. The Hospital Anxiety And Depression Scale. Health Qual Life Outcomes. 2003 Aug 1;1:29. doi: 10.1186/1477-7525-1-29.
PubMed 12914662Chew LD, Bradley KA, Boyko EJ. Brief questions to identify patients with inadequate health literacy. Fam Med. 2004 Sep;36(8):588-94.
PubMed 15343421Trevino 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.
PubMed 24888503Mack JW, Block SD, Nilsson M, Wright A, Trice E, Friedlander R, Paulk E, Prigerson HG. Measuring therapeutic alliance between oncologists and patients with advanced cancer: the Human Connection Scale. Cancer. 2009 Jul 15;115(14):3302-11. doi: 10.1002/cncr.24360.
PubMed 19484795Evangelia N, Kirana PS, Chiu G, Link C, Rosen R, Hatzichristou D. Level of bother and treatment-seeking predictors among male and female in-patients with sexual problems: a hospital-based study. J Sex Med. 2010 Feb;7(2 Pt 1):700-11. doi: 10.1111/j.1743-6109.2009.01605.x. Epub 2009 Nov 24.
PubMed 19968770Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
PubMed 28851459Lyon ME, Garvie PA, Briggs L, He J, McCarter R, D'Angelo LJ. Development, feasibility, and acceptability of the Family/Adolescent-Centered (FACE) Advance Care Planning intervention for adolescents with HIV. J Palliat Med. 2009 Apr;12(4):363-72. doi: 10.1089/jpm.2008.0261.
PubMed 19327074Doak LG, Doak CC, Meade CD. Strategies to improve cancer education materials. Oncol Nurs Forum. 1996 Sep;23(8):1305-12.
PubMed 8883075Chavarria EA, Christy SM, Simmons VN, Vadaparampil ST, Gwede CK, Meade CD. Learner Verification: A Methodology to Create Suitable Education Materials. Health Lit Res Pract. 2021 Jan 11;5(1):e49-e59. doi: 10.3928/24748307-20210201-02. Epub 2021 Feb 1.
PubMed 34251862Reese JB, Sorice KA, Pollard W, Handorf E, Beach MC, Daly MB, Porter LS, Tulsky JA, Lepore SJ. Efficacy of a multimedia intervention in facilitating breast cancer patients' clinical communication about sexual health: Results of a randomized controlled trial. Psychooncology. 2021 May;30(5):681-690. doi: 10.1002/pon.5613. Epub 2020 Dec 23.
PubMed 33305520
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Sexual and Reproductive Health Communication Between Adolescent and Young Adult Oncology Patients and Clinicians: ReSPECT Intervention Proof-of-Concept Testing
- ClinicalTrials.gov ID
- NCT07658937
- Acronym / sponsor ID
- ReSPECT / 26-029
- Conditions
- Health-Related Quality-of-Life, Cancer, Health Communication
- Keywords
- Health-Related Quality-of-Life, Adolescent, Young Adult, Psychosocial Intervention, Health Communication, Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Connecticut Children's Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ReSPECT Intervention Arm | Experimental | Behavioral: ReSPECTAYA oncology patients and their primary oncology clinicians who will receive the ReSPECT intervention |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReSPECTReSPECT 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. | Behavioural | ReSPECT Intervention Arm |
Primary outcome
Feasibility
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
6 secondary outcomes
Self-Efficacy
Time frame: From enrollment until T3 survey completion (8 weeks post-visit)
Outcome Expectancies
Time frame: From enrollment until T3 survey completion (8 weeks post-visit)
Decisional Confidence (Decision Making)
Time frame: From enrollment until T3 survey completion (8 weeks post-visit)
Distress/Bother
Time frame: From enrollment until T3 survey completion (8 weeks post-visit)
Risk Behaviors (Decision Making)
Time frame: From enrollment until T3 survey completion (8 weeks post-visit)
Therapeutic Alliance
Time frame: From enrollment until T3 survey completion (8 weeks post-visit)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Background: PubMed 25642841Czajkowski 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.
- Background: PubMed 34812790Teresi 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.
- Background: PubMed 26346418Weinfurt 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.
- Background: PubMed 25893421Flynn 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.
- Background: PubMed 11832252Bjelland 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.
- Background: PubMed 12914662Snaith RP. The Hospital Anxiety And Depression Scale. Health Qual Life Outcomes. 2003 Aug 1;1:29. doi: 10.1186/1477-7525-1-29.
- Background: PubMed 15343421Chew LD, Bradley KA, Boyko EJ. Brief questions to identify patients with inadequate health literacy. Fam Med. 2004 Sep;36(8):588-94.
- Background: PubMed 24888503Trevino 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.
- Background: PubMed 19484795Mack JW, Block SD, Nilsson M, Wright A, Trice E, Friedlander R, Paulk E, Prigerson HG. Measuring therapeutic alliance between oncologists and patients with advanced cancer: the Human Connection Scale. Cancer. 2009 Jul 15;115(14):3302-11. doi: 10.1002/cncr.24360.
- Background: PubMed 19968770Evangelia N, Kirana PS, Chiu G, Link C, Rosen R, Hatzichristou D. Level of bother and treatment-seeking predictors among male and female in-patients with sexual problems: a hospital-based study. J Sex Med. 2010 Feb;7(2 Pt 1):700-11. doi: 10.1111/j.1743-6109.2009.01605.x. Epub 2009 Nov 24.
- Background: PubMed 28851459Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
- Background: PubMed 19327074Lyon ME, Garvie PA, Briggs L, He J, McCarter R, D'Angelo LJ. Development, feasibility, and acceptability of the Family/Adolescent-Centered (FACE) Advance Care Planning intervention for adolescents with HIV. J Palliat Med. 2009 Apr;12(4):363-72. doi: 10.1089/jpm.2008.0261.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rachel Perry, BS contact
Natasha N Frederick, MD, MPH principal investigator
Connecticut Children's Medical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ReSPECT in people with Health-Related Quality-of-Life and Cancer, run by Connecticut Children's Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natasha N Frederick, MD, MPH (8605459630, nfrederick@connecticutchildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: From enrollment until T3 survey completion (8 weeks post-visit)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07658937, which also lists 60 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.