Breast Cancer
Conditions
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.
Detailed description
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.
Interventions
BEHAVIORALiShare
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.
Sponsors
National Cancer Institute (NCI)
Fox Chase Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the Intervention Trial - Enrollment | Baseline | Enrollment will be measured through measures of participant enrollment defined as the percent of eligible candidates approached who enroll in the pilot trial. |
| Feasibility of the Intervention Trial - Retention | Baseline up to 1 month | Study retention will defined as percentage of enrolled participants who complete all study surveys. |
| Feasibility of the Intervention Trial - Intervention Completion | 1 month | Intervention completion will defined as percentage of enrolled participants who complete participation in the podcast intervention. |
| Acceptability | 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). |
| Change in Clinician Knowledge About Sexual Health and Related Communication | 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. |
| Change in Clinician Self-Efficacy About Sexual Health Communication | 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. |
| Change in Clinician Outcome Expectancies for Sexual Health Communication | 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. |
| Change in Clinician Comfort With Communicating About Sexual Health | 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. |
| Change in Clinician Communication About Sexual Health | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 32 |
| Total | 32 |
Baseline characteristics
| Characteristic | iShare |
|---|---|
| Age, Continuous | 42.28 years STANDARD_DEVIATION 9.69 |
| Clinical role Nurse Practitioner | 7 Participants |
| Clinical role Oncologist | 22 Participants |
| Clinical role Physician Assistant | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 23 Participants |
| Region of Enrollment United States | 32 participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 9 Participants |
| Years of Practice in Oncology 0-5 Years | 11 Participants |
| Years of Practice in Oncology 11-15 Years | 6 Participants |
| Years of Practice in Oncology 6-10 Years | 7 Participants |
| Years of Practice in Oncology More than 15 Years | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 32 |
| other Total, other adverse events | 0 / 32 |
| serious Total, serious adverse events | 0 / 32 |
Outcome results
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).
Time frame: 1 week up to 1 month
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| iShare | Acceptability | 80 percentage of participants |
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.
Time frame: Baseline up to 1 month
| Arm | Measure | Value (MEAN) |
|---|---|---|
| iShare | Change in Clinician Comfort With Communicating About Sexual Health | 0.80 units on a scale |
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.
Time frame: Baseline up to 1 month
| Arm | Measure | Value (MEAN) |
|---|---|---|
| iShare | Change in Clinician Communication About Sexual Health | 0.16 units on a scale |
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.
Time frame: Baseline up to 1 month
| Arm | Measure | Value (MEAN) |
|---|---|---|
| iShare | Change in Clinician Knowledge About Sexual Health and Related Communication | 1.6 score on a scale |
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.
Time frame: Baseline up to 1 month
| Arm | Measure | Value (MEAN) |
|---|---|---|
| iShare | Change in Clinician Outcome Expectancies for Sexual Health Communication | 0.52 units on a scale |
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.
Time frame: Baseline up to 1 month
| Arm | Measure | Value (MEAN) |
|---|---|---|
| iShare | Change in Clinician Self-Efficacy About Sexual Health Communication | 0.76 units on a scale |
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.
Time frame: Baseline
Population: 33 participants were analyzed because 33 eligible study candidates were approached for enrollment. Of these, 32 participants enrolled.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| iShare | Feasibility of the Intervention Trial - Enrollment | 96.97 percent of eligible study candidates |
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| iShare | Feasibility of the Intervention Trial - Intervention Completion | 93.75 percentage of participants |
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| iShare | Feasibility of the Intervention Trial - Retention | 93.75 percentage of participants |