Trial Outcomes & Findings for Clinician Communication About Sexual Health (NCT NCT04262219)

Last Updated: 2022-12-23

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

32 participants

Primary outcome timeframe

Baseline

Results posted on

2022-12-23

Participant Flow

Participant milestones

Participant milestones
Measure	iShare Participants will be asked to listen to a podcast intervention. 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.
Overall Study STARTED	32
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinician Communication About Sexual Health

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	iShare n=32 Participants Participants will be asked to listen to a podcast intervention. 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.
Age, Continuous	42.28 years STANDARD_DEVIATION 9.69 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	32 participants n=5 Participants
Clinical role Oncologist	22 Participants n=5 Participants
Clinical role Physician Assistant	3 Participants n=5 Participants
Clinical role Nurse Practitioner	7 Participants n=5 Participants
Years of Practice in Oncology 0-5 Years	11 Participants n=5 Participants
Years of Practice in Oncology 6-10 Years	7 Participants n=5 Participants
Years of Practice in Oncology 11-15 Years	6 Participants n=5 Participants
Years of Practice in Oncology More than 15 Years	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Population: 33 participants were analyzed because 33 eligible study candidates were approached for enrollment. Of these, 32 participants enrolled.

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

Outcome measures

Outcome measures
Measure	iShare n=33 Participants Participants will be asked to listen to a podcast intervention. 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.
Feasibility of the Intervention Trial - Enrollment	96.97 percent of eligible study candidates

PRIMARY outcome

Timeframe: Baseline up to 1 month

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

Outcome measures

Outcome measures
Measure	iShare n=32 Participants Participants will be asked to listen to a podcast intervention. 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.
Feasibility of the Intervention Trial - Retention	93.75 percentage of participants

PRIMARY outcome

Timeframe: 1 month

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

Outcome measures

Outcome measures
Measure	iShare n=32 Participants Participants will be asked to listen to a podcast intervention. 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.
Feasibility of the Intervention Trial - Intervention Completion	93.75 percentage of participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	iShare n=30 Participants Participants will be asked to listen to a podcast intervention. 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.
Acceptability	80 percentage of participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	iShare n=30 Participants Participants will be asked to listen to a podcast intervention. 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.
Change in Clinician Knowledge About Sexual Health and Related Communication	1.6 score on a scale Interval 0.82 to 2.3

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	iShare n=30 Participants Participants will be asked to listen to a podcast intervention. 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.
Change in Clinician Self-Efficacy About Sexual Health Communication	0.76 units on a scale Interval 0.29 to 1.2

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	iShare n=30 Participants Participants will be asked to listen to a podcast intervention. 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.
Change in Clinician Outcome Expectancies for Sexual Health Communication	0.52 units on a scale Interval 0.17 to 0.86

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	iShare n=30 Participants Participants will be asked to listen to a podcast intervention. 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.
Change in Clinician Comfort With Communicating About Sexual Health	0.80 units on a scale Interval 0.46 to 1.14

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	iShare n=30 Participants Participants will be asked to listen to a podcast intervention. 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.
Change in Clinician Communication About Sexual Health	0.16 units on a scale Interval -0.15 to 0.46

Adverse Events

iShare

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jennifer Reese, Associate Professor

Fox Chase Cancer Center

Phone: 215-214-3223

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place