Clinician Communication About Sexual Health

NCT04262219 | Completed Results

• 2 other identifiers: 18-10681R03CA235238-01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (1)

iShare

EXPERIMENTAL

Participants will be asked to listen to a podcast intervention.

Behavioral: iShare

Interventions

iShare BEHAVIORAL

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.

iShare

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinician is a medical oncologist or medical oncology advanced practice clinician (Nurse Practitioner, Physician Assistant) who treats breast cancer patients

You may not qualify if:

• Clinician has participated in previous pilot study of the intervention

Sponsors & Collaborators

• Fox Chase Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr. Jennifer Reese, Associate Professor
• Organization: Fox Chase Cancer Center

Jennifer.Reese@fccc.edu

215-214-3223

Study Officials

• Jennifer B Reese, PhD

  Fox Chase Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2020
• First Posted: February 10, 2020
• Study Start: February 7, 2020
• Primary Completion: October 12, 2020
• Study Completion: October 12, 2020
• Last Updated: December 23, 2022
• Results First Posted: December 23, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)