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NCT04262219

Clinician Communication About Sexual Health

Completed NA Results posted Last updated 23 December 2022
What this trial tests

NA trial testing iShare in Breast Cancer in 32 participants. Completed in 12 October 2020.

Timeline
7 February 2020
Primary endpoint
12 October 2020
12 October 2020

Quick facts

Lead sponsorFox Chase Cancer Center
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposesupportive care
Enrollment32
Start date7 February 2020
Primary completion12 October 2020
Estimated completion12 October 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Fox Chase Cancer Center — full company profile →

Who can join

Eligibility, any sex, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Feasibility of the Intervention Trial - Enrollment Primary · Baseline

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

GroupValue95% CI
iShare96.97
Feasibility of the Intervention Trial - Retention Primary · Baseline up to 1 month

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

GroupValue95% CI
iShare93.75
Feasibility of the Intervention Trial - Intervention Completion Primary · 1 month

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

GroupValue95% CI
iShare93.75
Acceptability Primary · 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).

GroupValue95% CI
iShare80
Change in Clinician Knowledge About Sexual Health and Related Communication Primary · 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.

GroupValue95% CI
iShare1.60.82 – 2.3
Change in Clinician Self-Efficacy About Sexual Health Communication Primary · 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.

GroupValue95% CI
iShare0.760.29 – 1.2
Change in Clinician Outcome Expectancies for Sexual Health Communication Primary · 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.

GroupValue95% CI
iShare0.520.17 – 0.86
Change in Clinician Comfort With Communicating About Sexual Health Primary · 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.

GroupValue95% CI
iShare0.800.46 – 1.14
Change in Clinician Communication About Sexual Health Primary · 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.

GroupValue95% CI
iShare0.16-0.15 – 0.46

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Mobile Technology-Based (mLearning) Intervention to Enhance Breast Cancer Clinicians' Communication About Sexual Health: A Pilot Trial.
    Reese JB, Zimmaro LA, Bober SL, Sorice K, et al · · 2021 · cited 18× · PMID 34388731 · DOI 10.6004/jnccn.2021.7032
  2. Investigating the impact of the COVID-19 pandemic on breast cancer clinicians' communication about sexual health.
    Reese JB, El-Jawahri A, Sorice K, Cruz C, et al · · 2022 · cited 4× · PMID 35352140 · DOI 10.1007/s00520-022-07003-8

Verify or expand the search:

Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

Other Fox Chase Cancer Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04262219.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing