Breast CancerNCT04262219
Clinician Communication About Sexual Health
A study testing iShare in people with Breast Cancer, run by Fox Chase Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- iShare
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2020to 12 Oct 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Clinician is a medical oncologist or medical oncology advanced practice clinician (Nurse Practitioner, Physician Assistant) who treats breast cancer patients
Who cannot join
- Clinician has participated in previous pilot study of the intervention
Trial locations and contacts
1 site in 1 country.
United States1 site
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
Official title: Enhancing Clinician Communication About Sexual Health in Breast Cancer
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- iShare
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iShareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| iShare | Experimental | Participants will be asked to listen to a podcast intervention. Receives: Behavioral: iShare |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Feasibility of the Intervention Trial - Retention
Study retention will defined as percentage of enrolled participants who complete all study surveys.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start7 Feb 2020
- Primary completion12 Oct 2020
- Study completion12 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Fox Chase Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jennifer B Reese, PhD, Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04262219
- Sponsor's protocol ID
- 18-1068
- Other IDs
- 1R03CA235238-01
- Status last verified
- Dec 2022
- First submitted
- 7 Feb 2020
- Last updated
- 23 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Clinician Communication About Sexual Health in Breast Cancer
- ClinicalTrials.gov ID
- NCT04262219
- Acronym / sponsor ID
- 18-1068
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 7 Feb 2020 (actual)
- Primary completion
- 12 Oct 2020 (actual)
- Study completion
- 12 Oct 2020 (actual)
- First posted
- 10 Feb 2020 (actual)
- Results
- Posted 23 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iShare | Experimental | Behavioral: iShareParticipants will be asked to listen to a podcast intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Clinician is a medical oncologist or medical oncology advanced practice clinician (Nurse Practitioner, Physician Assistant) who treats breast cancer patients
Key exclusion criteria (1 listed)
- Clinician has participated in previous pilot study of the intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iShareThe 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. | Behavioural | iShare |
Primary outcome
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.
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.
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.
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).
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.
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.
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer B Reese, PhD principal investigator
Fox Chase Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iShare in people with Breast Cancer, run by Fox Chase Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the Intervention Trial - Enrollment (time frame: Baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2022.