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OpenTrials
Completed

NCT Number: NCT04262219

Clinician Communication About Sexual Health

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Feasibility of the Intervention Trial - Enrollment

    Time frame: Baseline

    Enrollment will be measured through measures of participant enrollment defined as the percent of eligible candidates approached who enroll in the pilot trial.

  2. Feasibility of the Intervention Trial - Retention

    Time frame: Baseline up to 1 month

    Study retention will defined as percentage of enrolled participants who complete all study surveys.

  3. Feasibility of the Intervention Trial - Intervention Completion

    Time frame: 1 month

    Intervention completion will defined as percentage of enrolled participants who complete participation in the podcast intervention.

  4. Acceptability

    Time frame: 1 week up to 1 month

    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).

  5. Change in Clinician Knowledge About Sexual Health and Related Communication

    Time frame: Baseline up to 1 month

    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.

  6. Change in Clinician Self-Efficacy About Sexual Health Communication

    Time frame: Baseline up to 1 month

    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.

  7. Change in Clinician Outcome Expectancies for Sexual Health Communication

    Time frame: Baseline up to 1 month

    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.

  8. Change in Clinician Comfort With Communicating About Sexual Health

    Time frame: Baseline up to 1 month

    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.

  9. Change in Clinician Communication About Sexual Health

    Time frame: Baseline up to 1 month

    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.

Sponsors and collaborators

Lead sponsor

Fox Chase Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Enhancing Clinician Communication About Sexual Health in Breast Cancer

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 10, 2020
Registry last updated
Dec 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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