Pediatric CancerNCT05524610
Development and Evaluation of a Screening Approach for Sexual Dysfunction in AYA Patients With and Surviving Childhood Cancer
A study testing Sexual Function Screening Approach in people with Pediatric Cancer and Survivorship, run by University of Colorado, Denver at 2 sites in United States.
Trial summary
Prior research determined adolescent and young adult-aged childhood cancer survivor (AYA-CCS) and medical provider acceptability of the SexFS Brief in a controlled research setting. Read more about this study
- Who is it for?
- Ages 15 to 24 years
- Conditions the study is for
- Pediatric Cancer, Survivorship
- What is being tested?
- Sexual Function Screening Approach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Feb 2023to 30 Jun 2027
- 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 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision to sign and date the consent form.
- Stated willingness to comply with all study procedures and be available for the duration of the study.
- Be aged 15-24 years old at the time of enrollment
- Patients with or surviving of cancer (must be found in the International Classification of Diseases for Oncology (ICD-O) and have a behavior code ≥2)
- Must have received cancer-directed therapy with at least one of the following:
Show all 11Show fewer
- Chemotherapy: any anticancer drug to treat the cancer diagnosis including immunotherapy
- Radiotherapy: any radiotherapy to treat the cancer diagnosis
- Surgery: any surgery to remove cancer including partial or total resections. Biopsies are not considered surgery.
- Cancer must have been diagnosed before the age of 18 years
- Patient must have an appointment at one of four clinical sites: CHCO HOPE Survivorship Program, CHCO Oncology Clinic, CHCO Neuro-Oncology Clinic, Seattle Children's Hospital Survivorship Program
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Unable to read and speak English
- Patients who did not receive cancer-directed therapy
- Insufficient cognitive functioning to complete study measures, as determined by patient's
- Participation in intervention development
- Patient is at end of life or on hospice, as determined by primary oncologist
- Patients who did not undergo sexual function screening within 1 month of being due will be excluded from implementation outcomes measurement
- Patient is at end of life or on hospice, as determined by primary oncologist
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Childrens Hospital Colorado
Aurora, Colorado, 80045
Barbara Shepperd, 7207776819, barbara.shepperd@childrenscolorado.otg
- Recruiting
University of Colorado Hospital
Aurora, Colorado, 80045
Barbara Shepperd, 7207770188, barbara.shepperd@childrenscolorado.org
Jenna Demedis
About this study
Official title: Stakeholder-Engaged Development and Evaluation of a Screening Approach for Sexual Dysfunction in Adolescent and Young Adult Patients With and Surviving Childhood Cancer
Prior research determined adolescent and young adult-aged childhood cancer survivor (AYA-CCS) and medical provider acceptability of the SexFS Brief in a controlled research setting. Development of an acceptable, effective, and feasible screening approach will result in improved recognition of SD in AYA patients with and surviving childhood cancer.
Read the detailed description
Detailed Description:
To adhere to National Comprehensive Cancer Network (NCCN) Adolescent and young adult (AYA) and Survivorship Guidelines, the Investigator will be developing and implementing a standardized screening approach for sexual function using the Patient Reported Outcome Measurement Information System (PROMIS) for Sexual Function and Satisfaction (SexFS) Brief. The overarching goal of this proposal is to develop and pilot test a patient-centered approach to assessing AYA patients with and surviving childhood cancer (age 15-24) for SD.
Prior to the clinical trial, Aim 1 of this study will integrate patient and provider feedback to refine an approach to standardized sexual function screening. Once Aim 1 has been completed, the study protocol will be amended to update intervention details prior to proceeding with implementation across all clinics as routine clinical care.
Aims 2 and 3 involve a pilot type 1 hybrid effectiveness-implementation trial using a pre-post design. Prior to implementation of the intervention, data on sexual function screening and patient satisfaction will be collected through surveys and medical record review. Subsequently, the sexual function screening intervention will be implemented clinic-wide as standard of care for patients age 15-24 years with or surviving childhood cancer. Following implementation of the screening approach, post-implementation data (effectiveness and implementation outcomes) will be collecting via survey and EHR review in consenting patients. A subset of patients will also undergo qualitative interviews after consent to this additional study procedure. After effectiveness data collection is complete, implementation outcomes will also be assessed via surveys and interviews with consenting provider stakeholders.
- Conditions
- Pediatric Cancer, Survivorship
- Being tested
- Sexual Function Screening Approach
- Keywords
- Cancer Survivor, Cancer Patient, Young Adult
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sexual Function Screening ApproachBehavioural
Also called National Institute of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS®) Sexual Function and Satisfaction (SexFS) Brief v2.0 tool
The screening approach will consist of:
- Standardized use of the PROMIS SexFS Brief in a clinic setting. This tool assesses sexual interest/desire, arousal, discomfort/pain, climax, and satisfaction, among other SD concerns and has comparable sex-specific versions. It has been validated in adult cancer populations.
- An implementation package to aid in successful implementation. The implementation package will be finalized in the non-trial portion of this study, which will include iterative intervention adaptation. The protocol will be amended as needed to include any relevant updates to the screening approach. Some components may vary per site.
| Study group | Role | What they receive |
|---|---|---|
| Pre-Implementation of Routine Sexual Function Screening (Baseline) | No intervention | This arm will include patients with and surviving cancer who are seen during the Pre-Implementation study period. It will include patients diagnosed prior to age 18 years and 15-24 years old at the time of study. Patients will be approached by research personnel at the end of each visit for participation in a survey. The pre-implementation survey will assess sexual function communication and patient satisfaction. In addition, medical record data abstraction of clinical care related to sexual health and function will be collected. |
| Post-Implementation of Routine Sexual Function Screening | Experimental | This arm will include patients with and surviving cancer who are seen during the Post-Implementation study period, once the routine sexual function screening intervention has been implemented. It will include patients diagnosed prior to age 18 years and 15-24 years old at the time of study. Patients will be approached by research personnel at the end of each visit for participation in a survey. The post-implementation survey will assess sexual function communication and patient satisfaction, as well as measures of acceptability, feasibility, and appropriateness of the intervention. In addition, medical record data abstraction of clinical care related to sexual health and function will be collected. Receives: Behavioral: Sexual Function Screening Approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of sexual function communication before and after intervention implementation
Comparison of pre- and post- intervention percentage of patients reporting that his/her provider has communicated with them about sexual function Subjects will report (yes or no) via survey after their healthcare visit.
Measured: 5 years
Secondary outcomes (15)
Comparison of patient satisfaction before and after intervention implementation
Comparison of pre- and post-intervention rating of patient satisfaction with sexual function communication. Subjects will report via survey after their healthcare visit. This will be rated on a 10-point scale with 10 being very satisfied and 0 being not at all satisfied.
Measured: 5 years
Comparison of healthcare needs being met before and after intervention implementation
Comparison of pre- and post-intervention percentage of patients with self-identified sexual function needs reporting that this need was met. Subjects will report (yes or no) via survey after their healthcare visit. .
Measured: 5 years
Reach - proportion of eligible patients who completed sexual function screening
Record abstraction evaluating the proportion of eligible patients who completed sexual function screening
Measured: 5 years
Representativeness - sociodemographic characteristics of patients who received and did not receive screening
Comparison of sociodemographic characteristics between eligible patients who did versus did not receive sexual function screening.
Measured: 5 years
Adoption of the screening tool by medical stakeholders (self-reported results review)
Medical stakeholder survey score of a 5-point scale (1=never, 5=every time) on a survey at the conclusion of the study, asking how often they reviewed sexual function screening results with relevant patients
Measured: 5 years
Adoption of the screening tool by medical stakeholders (self-reported results discussion)
Medical stakeholder survey score of a 5-point scale (1=never, 5=every time) on a survey at the conclusion of the study, asking how often they discussed results with patients
Measured: 5 years
Patient-reported acceptability of the sexual function screening approach
Patients will complete a study-specific acceptability survey consisting of several questions on a 5-point scale (0=low acceptability, 5=high acceptability). A subset of patients will also undergo qualitative interviews to further explore this outcome.
Measured: 5 years
Provider-reported acceptability of the sexual function screening approach
Providers will complete the Acceptability of Intervention Measure (AIM), adapted for this study, which consists of several questions on a 5-point scale (0=low acceptability, 5=high acceptability)
Measured: 5 years
Patient-reported appropriateness of the sexual function screening approach
Patients will complete a study-specific appropriateness survey consisting of several questions on a 5-point scale (0=low acceptability, 5=high acceptability). A subset of patients will also undergo qualitative interviews to further explore this outcome.
Measured: 5 years
Provider-reported appropriateness of the sexual function screening approach
Providers will complete the Intervention Appropriateness Measure (IAM), adapted for this study, which consists of several questions on a 5-point scale (0=low appropriateness, 5=high appropriateness)
Measured: 5 years
Patient-reported feasibility of the sexual function screening approach
Patients will complete a study-specific feasibility survey consisting of several questions on a 5-point scale (0=low feasibility, 5=high feasibility). A subset of patients will also undergo qualitative interviews to further explore this outcome.
Measured: 5 years
Provider-reported feasibility of the sexual function screening approach
Providers will complete the Feasibility of Intervention Measure (FIM), adapted for this study, which consists of several questions on a 5-point scale (0=low feasibility, 5=high feasibility)
Measured: 5 years
Evaluate implementation of the standardized screening approach by fidelity (patient-reported)
Patients will respond regarding whether or not they experienced key components (Fidelity Checklist) of the intervention.
Measured: 5 years
Evaluate implementation of the standardized screening approach by fidelity (direct observation)
The study team will evaluate whether key components of the intervention (Fidelity Checklist) are completed via direct observation in 10% of patients across sites.
Measured: 5 years
Contextual factors influencing implementation success
Qualitative description of themes, barriers and facilitators to implementation will be determined via interviews with medical providers after completion of patient enrollment.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start14 Feb 2023
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 205 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jenna Demedis, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05524610
- Sponsor's protocol ID
- 22-0709.ccc
- Other IDs
- K08CA263192
- Status last verified
- May 2026
- First submitted
- 25 Aug 2022
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Demedis J, Reedy J, Miller K, Hu J, Klosky JL, Dorsey Holliman B, Peterson PN, Chow EJ, Studts C. Testing effectiveness and implementation of a standardized approach to sexual dysfunction screening among adolescent and young adult-aged survivors of childhood cancer: A type I hybrid, mixed methods trial protocol. PLoS One. 2024 Jul 22;19(7):e0305677. doi: 10.1371/journal.pone.0305677. eCollection 2024.
PubMed 39038011
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stakeholder-Engaged Development and Evaluation of a Screening Approach for Sexual Dysfunction in Adolescent and Young Adult Patients With and Surviving Childhood Cancer
- ClinicalTrials.gov ID
- NCT05524610
- Acronym / sponsor ID
- 22-0709.ccc
- Conditions
- Pediatric Cancer, Survivorship
- Keywords
- Cancer Survivor, Cancer Patient, Young Adult
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 205 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 14 Feb 2023 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 1 Sep 2022 (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.
Prior research determined adolescent and young adult-aged childhood cancer survivor (AYA-CCS) and medical provider acceptability of the SexFS Brief in a controlled research setting. Development of an acceptable, effective, and feasible screening approach will result in improved recognition of SD in AYA patients with and surviving childhood cancer.
Detailed description
Detailed Description:
To adhere to National Comprehensive Cancer Network (NCCN) Adolescent and young adult (AYA) and Survivorship Guidelines, the Investigator will be developing and implementing a standardized screening approach for sexual function using the Patient Reported Outcome Measurement Information System (PROMIS) for Sexual Function and Satisfaction (SexFS) Brief. The overarching goal of this proposal is to develop and pilot test a patient-centered approach to assessing AYA patients with and surviving childhood cancer (age 15-24) for SD.
Prior to the clinical trial, Aim 1 of this study will integrate patient and provider feedback to refine an approach to standardized sexual function screening. Once Aim 1 has been completed, the study protocol will be amended to update intervention details prior to proceeding with implementation across all clinics as routine clinical care.
Aims 2 and 3 involve a pilot type 1 hybrid effectiveness-implementation trial using a pre-post design. Prior to implementation of the intervention, data on sexual function screening and patient satisfaction will be collected through surveys and medical record review. Subsequently, the sexual function screening intervention will be implemented clinic-wide as standard of care for patients age 15-24 years with or surviving childhood cancer. Following implementation of the screening approach, post-implementation data (effectiveness and implementation outcomes) will be collecting via survey and EHR review in consenting patients. A subset of patients will also undergo qualitative interviews after consent to this additional study procedure. After effectiveness data collection is complete, implementation outcomes will also be assessed via surveys and interviews with consenting provider stakeholders.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-Implementation of Routine Sexual Function Screening (Baseline) | No intervention | –This arm will include patients with and surviving cancer who are seen during the Pre-Implementation study period. It will include patients diagnosed prior to age 18 years and 15-24 years old at the time of study. Patients will be approached by research personnel at the end of each visit for participation in a survey. The pre-implementation survey will assess sexual function communication and patient satisfaction. In addition, medical record data abstraction of clinical care related to sexual health and function will be collected. |
| Post-Implementation of Routine Sexual Function Screening | Experimental | Behavioral: Sexual Function Screening ApproachThis arm will include patients with and surviving cancer who are seen during the Post-Implementation study period, once the routine sexual function screening intervention has been implemented. It will include patients diagnosed prior to age 18 years and 15-24 years old at the time of study. Patients will be approached by research personnel at the end of each visit for participation in a survey. The post-implementation survey will assess sexual function communication and patient satisfaction, as well as measures of acceptability, feasibility, and appropriateness of the intervention. In addition, medical record data abstraction of clinical care related to sexual health and function will be collected. |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision to sign and date the consent form.
- Stated willingness to comply with all study procedures and be available for the duration of the study.
- Be aged 15-24 years old at the time of enrollment
- Patients with or surviving of cancer (must be found in the International Classification of Diseases for Oncology (ICD-O) and have a behavior code ≥2)
Key exclusion criteria (8 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Unable to read and speak English
- Patients who did not receive cancer-directed therapy
- Insufficient cognitive functioning to complete study measures, as determined by patient's
- Participation in intervention development
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 |
|---|---|---|
| Sexual Function Screening ApproachAlso: National Institute of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS®) Sexual Function and Satisfaction (SexFS) Brief v2.0 toolThe screening approach will consist of: 1. Standardized use of the PROMIS SexFS Brief in a clinic setting. This tool assesses sexual interest/desire, arousal, discomfort/pain, climax, and satisfaction, among other SD concerns and has comparable sex-specific versions. It has been validated in adult cancer populations. 2. An implementation package to aid in successful implementation. The implementation package will be finalized in the non-trial portion of this study, which will include iterative intervention adaptation. The protocol will be amended as needed to include any relevant updates to the screening approach. Some components may vary per site. | Behavioural | Post-Implementation of Routine Sexual Function Screening |
Primary outcome
Comparison of sexual function communication before and after intervention implementation
Time frame: 5 years
Comparison of pre- and post- intervention percentage of patients reporting that his/her provider has communicated with them about sexual function Subjects will report (yes or no) via survey after their healthcare visit.
15 secondary outcomes
Comparison of patient satisfaction before and after intervention implementation
Time frame: 5 years
Comparison of healthcare needs being met before and after intervention implementation
Time frame: 5 years
Reach - proportion of eligible patients who completed sexual function screening
Time frame: 5 years
Representativeness - sociodemographic characteristics of patients who received and did not receive screening
Time frame: 5 years
Adoption of the screening tool by medical stakeholders (self-reported results review)
Time frame: 5 years
Adoption of the screening tool by medical stakeholders (self-reported results discussion)
Time frame: 5 years
Patient-reported acceptability of the sexual function screening approach
Time frame: 5 years
Provider-reported acceptability of the sexual function screening approach
Time frame: 5 years
Patient-reported appropriateness of the sexual function screening approach
Time frame: 5 years
Provider-reported appropriateness of the sexual function screening approach
Time frame: 5 years
Patient-reported feasibility of the sexual function screening approach
Time frame: 5 years
Provider-reported feasibility of the sexual function screening approach
Time frame: 5 years
Evaluate implementation of the standardized screening approach by fidelity (patient-reported)
Time frame: 5 years
Evaluate implementation of the standardized screening approach by fidelity (direct observation)
Time frame: 5 years
Contextual factors influencing implementation success
Time frame: 5 years
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 6 May 2026.
- Derived from this study: PubMed 39038011Demedis J, Reedy J, Miller K, Hu J, Klosky JL, Dorsey Holliman B, Peterson PN, Chow EJ, Studts C. Testing effectiveness and implementation of a standardized approach to sexual dysfunction screening among adolescent and young adult-aged survivors of childhood cancer: A type I hybrid, mixed methods trial protocol. PLoS One. 2024 Jul 22;19(7):e0305677. doi: 10.1371/journal.pone.0305677. eCollection 2024.
- Individual participant dataSharing planned: No
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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.
Jenna Demedis principal investigator
University of Colorado, Denver
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sexual Function Screening Approach in people with Pediatric Cancer and Survivorship, run by University of Colorado, Denver at 2 sites 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 11 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Barbara Shepperd (7207776819, barbara.shepperd@childrenscolorado.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of sexual function communication before and after intervention implementation (time frame: 5 years). 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 NCT05524610, which also lists 1 linked publication.
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 6 May 2026.