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| ID | Type | Description | Link |
|---|---|---|---|
| 1R03CA235238-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iShare | Experimental | Participants will be asked to listen to a podcast intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer B Reese, PhD | Fox Chase Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 33 participants were analyzed because 33 eligible study candidates were approached for enrollment. Of these, 32 participants enrolled. | Posted | Number | percent of eligible study candidates | Baseline |
|
1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jennifer Reese, Associate Professor | Fox Chase Cancer Center | 215-214-3223 | Jennifer.Reese@fccc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 4, 2020 | Oct 12, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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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 |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Clinical role | Count of Participants | Participants |
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| Years of Practice in Oncology | Count of Participants | Participants |
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| Primary | Feasibility of the Intervention Trial - Retention | Study retention will defined as percentage of enrolled participants who complete all study surveys. | Posted | Number | percentage of participants | Baseline up to 1 month |
|
|
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| Primary | Feasibility of the Intervention Trial - Intervention Completion | Intervention completion will defined as percentage of enrolled participants who complete participation in the podcast intervention. | Posted | Number | percentage of participants | 1 month |
|
|
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| Primary | 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). | Posted | Number | percentage of participants | 1 week up to 1 month |
|
|
|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline up to 1 month |
|
|
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| Primary | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline up to 1 month |
|
|
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| Primary | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline up to 1 month |
|
|
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| Primary | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline up to 1 month |
|
|
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| Primary | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline up to 1 month |
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| 0 |
| 32 |
| 0 |
| 32 |
| 0 |
| 32 |
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| D017437 |
| Skin and Connective Tissue Diseases |