Clinician Communication About Sexual Health

Enhancing Clinician Communication About Sexual Health in Breast Cancer

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: iShare

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: iShare; Participants will be asked to listen to a podcast 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Fox Chase Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Jennifer B Reese, PhD, Fox Chase Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2020
• Primary Completion (Actual): October 12, 2020
• Study Completion (Actual): October 12, 2020

Study Registration Dates

• First Submitted: February 7, 2020
• First Submitted That Met QC Criteria: February 7, 2020
• First Posted (Actual): February 10, 2020

Study Record Updates

• Last Update Posted (Actual): December 23, 2022
• Last Update Submitted That Met QC Criteria: December 1, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 18-1068; 1R03CA235238-01 (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