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Spots Global Cancer Trial Database for Scripted Sexual Health Informational Intervention in Improving Sexual Function in Patients With Gynecologic Cancer

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Trial Identification

Brief Title: Scripted Sexual Health Informational Intervention in Improving Sexual Function in Patients With Gynecologic Cancer

Official Title: Randomized-Controlled, Pilot Study of the Effects of a Brief, Scripted Sexual Health Intervention on Sexual Function for Women With Gynecologic Cancer

Study ID: NCT02096783

Study Description

Brief Summary: This randomized pilot clinical trial studies the feasibility of a pre-operative and/or post-operative scripted sexual health informational intervention and how well it works in improving sexual function in patients with gynecologic cancer. Discussing sexual outcomes and counseling options with patients may help improve sexual outcomes and/or anxiety after primary gynecologic cancer treatment.

Detailed Description: PRIMARY OBJECTIVES: I. To evaluate the feasibility of patient recruitment, including time required to consent, enroll and retain the necessary number of participants. II. To determine the distribution of candidate primary patient-reported outcome measures, including time to resumption of sexual activity, global satisfaction with sex life, sexual function and anxiety in this particular population. III. To establish the prevalence of patient recall of the intervention to determine the most effective time at which to deliver the intervention. OUTLINE: Patients are randomized to 1 of 4 treatment arms. ARM I: Patients receive standard counseling at both the pre-operative and 2-4 week post-operative visit. ARM II: Patients receive standard counseling at the pre-operative visit and the scripted sexual health intervention at the 2-4 week post-operative visit. ARM III: Patients receive standard counseling and the scripted sexual health intervention at the pre-operative visit and standard counseling at the 2-4 week post-operative visit. ARM IV: Patients receive standard counseling and the scripted sexual health intervention at both the pre-operative and 2-4 week post-operative visit.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

University of Wisconsin, Madison, Madison, Wisconsin, United States

Contact Details

Name: David Kushner

Affiliation: University of Wisconsin, Madison

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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