An interventional study of iShare in Breast Cancer, sponsored by Fox Chase Cancer Center. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2022-12-23.
Sponsored by Fox Chase Cancer Center · Not applicable, Interventional, and Supportive care
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.
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.
12,547 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 32 is below the median of 72 across 9,305 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Fox Chase Cancer Center is the lead sponsor of 211 studies on the registry; 30 are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 8 (53%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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.
Time frame: Baseline
Feasibility of the Intervention Trial - Retention
Study retention will defined as percentage of enrolled participants who complete all study surveys.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline up to 1 month
| Milestone | iShare |
|---|---|
| Started | 32 |
| Completed | 30 |
| Not completed | 2 |
Enrollment will be measured through measures of participant enrollment defined as the percent of eligible candidates approached who enroll in the pilot trial.
| percent of eligible study candidates | iShare |
|---|---|
| Feasibility of the Intervention Trial - Enrollment | 96.97 |
Study retention will defined as percentage of enrolled participants who complete all study surveys.
| percentage of participants | iShare |
|---|---|
| Feasibility of the Intervention Trial - Retention | 93.75 |
Intervention completion will defined as percentage of enrolled participants who complete participation in the podcast intervention.
| percentage of participants | iShare |
|---|---|
| Feasibility of the Intervention Trial - Intervention Completion | 93.75 |
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).
| percentage of participants | iShare |
|---|---|
| Acceptability | 80 |
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.
| score on a scale | iShare |
|---|---|
| Change in Clinician Knowledge About Sexual Health and Related Communication | 1.6 (0.82 to 2.3) |
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.
| units on a scale | iShare |
|---|---|
| Change in Clinician Self-Efficacy About Sexual Health Communication | 0.76 (0.29 to 1.2) |
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.
| units on a scale | iShare |
|---|---|
| Change in Clinician Outcome Expectancies for Sexual Health Communication | 0.52 (0.17 to 0.86) |
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.
| units on a scale | iShare |
|---|---|
| Change in Clinician Comfort With Communicating About Sexual Health | 0.80 (0.46 to 1.14) |
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.
| units on a scale | iShare |
|---|---|
| Change in Clinician Communication About Sexual Health | 0.16 (-0.15 to 0.46) |
Collected over 1 month. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| iShare | 0/32 (0%) | 0/32 (0%) | 0/32 (0%) |
| Age, Continuous(years) | iShare |
|---|---|
| Mean | 42.28 ± 9.69 |
| Sex: Female, Male(Participants) | iShare |
|---|---|
| Female | 23 |
| Male | 9 |
| Ethnicity (NIH/OMB)(Participants) | iShare |
|---|---|
| Hispanic or Latino | 3 |
| Not Hispanic or Latino | 28 |
| Unknown or Not Reported | 1 |
| Race (NIH/OMB)(Participants) | iShare |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 6 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 23 |
| More than one race | 1 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | iShare |
|---|---|
| United States | 32 |
| Clinical role(Participants) | iShare |
|---|---|
| Oncologist | 22 |
| Physician Assistant | 3 |
| Nurse Practitioner | 7 |
| Years of Practice in Oncology(Participants) | iShare |
|---|---|
| 0-5 Years | 11 |
| 6-10 Years | 7 |
| 11-15 Years | 6 |
| More than 15 Years | 8 |
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Plan to share: No
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Fox Chase Cancer Center