Back to resultsClinician Communication About Sexual Health
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iShare
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Clinician is a medical oncologist or medical oncology advanced practice clinician (Nurse Practitioner, Physician Assistant) who treats breast cancer patients
Exclusion Criteria:
- Clinician has participated in previous pilot study of the intervention
Sites / Locations
- Fox Chase Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
iShare
Arm Description
Participants will be asked to listen to a podcast intervention.
Outcomes
Primary Outcome Measures
Feasibility of the Intervention Trial - Enrollment
Enrollment will be measured through measures of participant enrollment defined as the percent of eligible candidates approached who enroll in the pilot trial.
Feasibility of the Intervention Trial - Retention
Study retention will defined as percentage of enrolled participants who complete all study surveys.
Feasibility of the Intervention Trial - Intervention Completion
Intervention completion will defined as percentage of enrolled participants who complete participation in the podcast intervention.
Acceptability
Acceptability will be measured through the percentage of the sample endorsing 6 primary acceptability items favorably at two time points (1 week and 1 month; satisfaction, informativeness, relevance, ease of listening, likelihood to recommend, likelihood to impact practice).
Change in Clinician Knowledge About Sexual Health and Related Communication
Clinician knowledge about sexual health and communication will be measured using a 10-item scale asking about common sexual problems experienced by breast cancer patients and the most effective ways to communicate with patients about these issues. Knowledge scores range from 0 to 10, with higher scores indicating more knowledge.
Knowledge will be reported as the mean of items answered correctly. Positive mean change scores indicate an increase in knowledge over time.
Change in Clinician Self-Efficacy About Sexual Health Communication
Clinician self-efficacy about sexual health communication will be measured using a 3-item scale asking about confidence in discussing sexual concerns with patients. Mean scores range from 0-10, with higher scores indicating higher self-efficacy. Positive mean change scores indicate an increase in self-efficacy over time.
Change in Clinician Outcome Expectancies for Sexual Health Communication
Clinician outcome expectancies for sexual health communication will be measured using a 7-item scale asking about expected positive results in discussing sexual concerns with patients. Mean scores range from 0-10, with higher scores indicating better expected outcomes. Positive mean change scores indicate an increase in outcome expectancies over time.
Change in Clinician Comfort With Communicating About Sexual Health
Clinician comfort with sexual health communication will be measured using a 7-item scale asking about comfort level in discussing sexual concerns with patients. Mean scores range from 0-10, with higher scores indicating a higher level of comfort. Positive mean change scores indicate an increase in comfort level over time.
Change in Clinician Communication About Sexual Health
Clinician communication about sexual health will be measured using a 3-item scale asking about recent communication practices around sexual health (initiating conversations, offering information, giving referrals). Mean scores range from 1-5, with higher scores indicating higher amounts of communication. Positive mean change scores indicate an increase in communication behaviors over time.
Secondary Outcome Measures
Full Information
NCT ID
NCT04262219
First Posted
February 7, 2020
Last Updated
December 1, 2022
Sponsor
Fox Chase Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT04262219
Brief Title
Clinician Communication About Sexual Health
Official Title
Enhancing Clinician Communication About Sexual Health in Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
February 7, 2020 (Actual)
Primary Completion Date
October 12, 2020 (Actual)
Study Completion Date
October 12, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fox Chase Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to adapt a previously tested brief intervention aimed at enhancing clinicians communication about sexual health (iSHARE) to a mobile web-based platform showcasing a two-part podcast and to assess the feasibility, acceptability, and preliminary effects of the intervention in breast cancer clinicians.
Detailed Description
Specific aims are: 1) To assess the feasibility and acceptability of iSHARE in a mobile learning (mLearning) format and 2) To assess the preliminary effects of iSHARE in a mLearning format.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
iShare
Arm Type
Experimental
Arm Description
Participants will be asked to listen to a podcast intervention.
Intervention Type
Behavioral
Intervention Name(s)
iShare
Intervention Description
The iShare intervention consists of a two-episode educational podcast series containing information about breast cancer patients' sexual problems, approaches for addressing sexual concerns, and information about discussing sexual concerns with patients, such as initiating a conversation about sexual health and asking questions to assess sexual concern. Both episodes feature expert guests and relevant discussions or case studies.
Primary Outcome Measure Information:
Title
Feasibility of the Intervention Trial - Enrollment
Description
Enrollment will be measured through measures of participant enrollment defined as the percent of eligible candidates approached who enroll in the pilot trial.
Time Frame
Baseline
Title
Feasibility of the Intervention Trial - Retention
Description
Study retention will defined as percentage of enrolled participants who complete all study surveys.
Time Frame
Baseline up to 1 month
Title
Feasibility of the Intervention Trial - Intervention Completion
Description
Intervention completion will defined as percentage of enrolled participants who complete participation in the podcast intervention.
Time Frame
1 month
Title
Acceptability
Description
Acceptability will be measured through the percentage of the sample endorsing 6 primary acceptability items favorably at two time points (1 week and 1 month; satisfaction, informativeness, relevance, ease of listening, likelihood to recommend, likelihood to impact practice).
Time Frame
1 week up to 1 month
Title
Change in Clinician Knowledge About Sexual Health and Related Communication
Description
Clinician knowledge about sexual health and communication will be measured using a 10-item scale asking about common sexual problems experienced by breast cancer patients and the most effective ways to communicate with patients about these issues. Knowledge scores range from 0 to 10, with higher scores indicating more knowledge.
Knowledge will be reported as the mean of items answered correctly. Positive mean change scores indicate an increase in knowledge over time.
Time Frame
Baseline up to 1 month
Title
Change in Clinician Self-Efficacy About Sexual Health Communication
Description
Clinician self-efficacy about sexual health communication will be measured using a 3-item scale asking about confidence in discussing sexual concerns with patients. Mean scores range from 0-10, with higher scores indicating higher self-efficacy. Positive mean change scores indicate an increase in self-efficacy over time.
Time Frame
Baseline up to 1 month
Title
Change in Clinician Outcome Expectancies for Sexual Health Communication
Description
Clinician outcome expectancies for sexual health communication will be measured using a 7-item scale asking about expected positive results in discussing sexual concerns with patients. Mean scores range from 0-10, with higher scores indicating better expected outcomes. Positive mean change scores indicate an increase in outcome expectancies over time.
Time Frame
Baseline up to 1 month
Title
Change in Clinician Comfort With Communicating About Sexual Health
Description
Clinician comfort with sexual health communication will be measured using a 7-item scale asking about comfort level in discussing sexual concerns with patients. Mean scores range from 0-10, with higher scores indicating a higher level of comfort. Positive mean change scores indicate an increase in comfort level over time.
Time Frame
Baseline up to 1 month
Title
Change in Clinician Communication About Sexual Health
Description
Clinician communication about sexual health will be measured using a 3-item scale asking about recent communication practices around sexual health (initiating conversations, offering information, giving referrals). Mean scores range from 1-5, with higher scores indicating higher amounts of communication. Positive mean change scores indicate an increase in communication behaviors over time.
Time Frame
Baseline up to 1 month
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Clinician is a medical oncologist or medical oncology advanced practice clinician (Nurse Practitioner, Physician Assistant) who treats breast cancer patients
Exclusion Criteria:
Clinician has participated in previous pilot study of the intervention
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer B Reese, PhD
Organizational Affiliation
Fox Chase Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Clinician Communication About Sexual Health
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