Sexual Function Screening in Childhood Cancer Survivors

June 29, 2022 updated by: University of Colorado, Denver

Assessing Patient Preferences and a Clinical Tool for Evaluating for Sexual Function in Adolescent and Young Adult Survivors of Childhood Cancer

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Children's Hospital Colorado
      • Aurora, Colorado, United States, 80045
        • Colorado School of Public Health, University of Colorado Denver

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years to 24 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
age 15-19
The investigators plan to complete 24 interviews with 12 in the age 15-19 cohort.The investigators will also ensure that at least 8 people from each sex are included in this study.
Other: Interviews
  • Participation will serve as verbal consent.
  • Qualitative PRA will call participant to schedule either phone or in person interview. If via phone, the study PRA performing the interview, will remind them to find a private space to speak.
  • REDCap link will be sent for PROMIS SexFS Brief.
  • PRA will perform semistructured interview and guide Think-Aloud to complete the PROMIS SexFS Brief.
  • Participants will not submit responses to PROMIS SexFS Brief responses after completing the tool.
age 20-24
The investigators plan to complete 24 interviews with 12 in the age 20-24 cohort. The investigators will also ensure that at least 8 people from each sex are included in this study.
Other: Interviews
  • Participation will serve as verbal consent.
  • Qualitative PRA will call participant to schedule either phone or in person interview. If via phone, the study PRA performing the interview, will remind them to find a private space to speak.
  • REDCap link will be sent for PROMIS SexFS Brief.
  • PRA will perform semistructured interview and guide Think-Aloud to complete the PROMIS SexFS Brief.
  • Participants will not submit responses to PROMIS SexFS Brief responses after completing the tool.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Describe AYA CCS perspectives on implementation of screening for sexual dysfunction, including preferred modality, setting and timing for evaluating sexual dysfunction.
Time Frame: 1 year
Qualitative interviews will be conducted by phone by a trained qualitative research interviewer. Interviews will be in-depth and semistructured, utilizing a combination of broad, open-ended questions and more specific probes. The interview guide was developed with the help of Dr. Michael Fisher, PhD, who has expertise in qualitative research methodology. The interviewer will take detailed field notes. This portion of the interview will last approximately 25-35 minutes and will be digitally recorded and professionally transcribed. After each interview, the interviewer will complete an Interview Summary Form, which will serve as a memoing tool and summarize initial themes or impressions that may be relevant to the research question.
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assess AYA CCS perceptions of the PROMIS SexFS Brief, an existing adult clinical screening tool for sexual dysfunction, in a qualitative pilot study.
Time Frame: 1 year
Participants will be asked to evaluate the PROMIS SexFS Brief, which will be emailed to them at the time of the interview via a unique/secure REDCap link. Participants will be given a choice of which version of the tool they complete (male or female). Participants will be asked to complete the PROMIS SexFS Brief via REDCap while completing Think-Aloud methodology. Via Think-Aloud, participants will be asked to verbalize their thoughts as they proceed through the task, which asks participants to verbalize their thoughts, without probing or additional explanations, as they undertake a task such as completing a clinical screening questionnaire. In accordance with recommendations for conducting Think-Aloud, participants will participate in a warm-up exercise unrelated to sexual dysfunction prior to completing Think-Aloud.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Colorado, Denver

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 16, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 7, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 26, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 30, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19-1111.cc
  • P30CA046934 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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