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Trial Title:
Development and Evaluation of a Screening Approach for Sexual Dysfunction in AYA Patients With and Surviving Childhood Cancer
NCT ID:
NCT05524610
Condition:
Pediatric Cancer
Survivorship
Conditions: Keywords:
Cancer Survivor
Cancer Patient
Young Adult
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Sexual Function Screening Approach
Description:
The 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.
Arm group label:
Post-Implementation of Routine Sexual Function Screening
Other name:
National Institute of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS®) Sexual Function and Satisfaction (SexFS) Brief v2.0 tool
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. 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. After effectiveness data collection is complete, implementation
outcomes will also be assessed via surveys and interviews with consenting provider
stakeholders.
Criteria for eligibility:
Criteria:
Inclusion Criteria
In order to be eligible to participate in this study, an individual must meet all of the
following criteria:
1. Provision to sign and date the consent form.
2. Stated willingness to comply with all study procedures and be available for the
duration of the study.
3. Be aged 15-24 years old at the time of enrollment
4. 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)
5. Must have received cancer-directed therapy with at least one of the following:
- 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.
6. Cancer must have been diagnosed before the age of 18 years
7. 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
Exclusion Criteria
An individual who meets any of the following criteria will be excluded from participation
in this study:
1. Unable to read and speak English
2. Patients who did not receive cancer-directed therapy
3. Insufficient cognitive functioning to complete study measures, as determined by
patient's
4. Participation in intervention development
5. Patient is at end of life or on hospice, as determined by primary oncologist
6. Patients who did not undergo sexual function screening within 1 month of being due
will be excluded from implementation outcomes measurement
7. Patient is at end of life or on hospice, as determined by primary oncologist
Gender:
All
Minimum age:
15 Years
Maximum age:
24 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Childrens Hospital Colorado
Address:
City:
Aurora
Zip:
80045
Country:
United States
Status:
Recruiting
Contact:
Last name:
Barbara Shepperd
Phone:
720-777-6819
Email:
barbara.shepperd@childrenscolorado.otg
Facility:
Name:
University of Colorado Hospital
Address:
City:
Aurora
Zip:
80045
Country:
United States
Status:
Recruiting
Contact:
Last name:
Barbara Shepperd
Phone:
720-777-0188
Email:
barbara.shepperd@childrenscolorado.org
Investigator:
Last name:
Jenna Demedis
Email:
Principal Investigator
Start date:
February 14, 2023
Completion date:
June 30, 2027
Lead sponsor:
Agency:
University of Colorado, Denver
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
University of Colorado, Denver
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05524610
