Clinical trial NCT04066218: Sexual Function Screening in Childhood Cancer Survivors
Official title: Assessing Patient Preferences and a Clinical Tool for Evaluating for Sexual Function in Adolescent and Young Adult Survivors of Childhood Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Childhood Cancer
Survivorship
Sexual Dysfunction
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-08-26
Enrollment: 24
Sex: ALL
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * Sample size

  * Max number of participants that can be enrolled is 30
  * Max number of participants that can be interviewed is 24
* Gender Male and Female
* Age Range 15-24
* Demographic group English-speaking
* General health status Pediatric cancer survivors (diagnosed at \<18 years of age and now at least 2 years off therapy)
* Geographic location Children's Hospital Colorado and University of Colorado Hospital

Brief summary: This is a qualitative research study involving semistructured interviews and Think-Aloud methodology during completion of a clinical screening tool. All participants will undergo the same semistructured interviews.

Detailed description: The proposed research will explore patient-centered approaches to evaluating younger Adolescent/young adult Childhood cancer survivors for sexual dysfunction, including strategies for implementation and usability of thePatient-Reported Outcomes Measurement Information® v2.0 Brief Profile for Sexual Function and Satisfaction Brief, an existing adult screening tool. This study will include interviews with 24 patients age 15-24 who were diagnosed with cancer prior to age 18, and treated with chemotherapy, radiation and/or surgery and are now at least two years off therapy.

Eligibility criteria: Inclusion Criteria:

1. Ability to read and understand the postcard consent.
2. Stated willingness to comply with all study procedures and be available for the duration of the study.
3. Age 15-24 at time of enrollment
4. History of cancer diagnosis, diagnosed at \<18 years old
5. Off therapy (chemotherapy, surgery, radiation) for a minimum of 2 years
6. Sufficient cognitive functioning such that participants are able to complete study measures, as determined by their physician and research personnel.

Exclusion Criteria:

1. Developmental or intellectual disability, as determined by the patient's physician
2. Received neither chemotherapy nor radiation therapy
3. Non-English speaking
4. Non-English reading

Primary outcomes:
measure: Describe AYA CCS perspectives on implementation of screening for sexual dysfunction, including preferred modality, setting and timing for evaluating sexual dysfunction.
timeFrame: 1 year
Secondary outcomes:
measure: Assess AYA CCS perceptions of the PROMIS SexFS Brief, an existing adult clinical screening tool for sexual dysfunction, in a qualitative pilot study.
timeFrame: 1 year
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Aurora
country: United States
facility: Colorado School of Public Health, University of Colorado Denver
state: Colorado
Study officials:
References: