Clinician Communication About Sexual Health

Breast Cancer Clinical Trial

Official title:

Enhancing Clinician Communication About Sexual Health in Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04262219
• Other study ID #: 18-1068
• Secondary ID: 1R03CA235238-01
• Status: Completed
• Phase: N/A
• Start date: February 7, 2020
• Est. completion date: October 12, 2020

Study information

• Verified date: December 2022
• Source: Fox Chase Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 12, 2020
• Est. primary completion date: October 12, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• iShare
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.

Locations

Country	Name	City	State
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Fox Chase Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Primary	Feasibility of the Intervention Trial - Retention	Study retention will defined as percentage of enrolled participants who complete all study surveys.	Baseline up to 1 month
Primary	Feasibility of the Intervention Trial - Intervention Completion	Intervention completion will defined as percentage of enrolled participants who complete participation in the podcast intervention.	1 month
Primary	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).	1 week up to 1 month
Primary	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.	Baseline up to 1 month
Primary	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.	Baseline up to 1 month
Primary	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.	Baseline up to 1 month
Primary	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.	Baseline up to 1 month
Primary	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.	Baseline up to 1 month