This clinical trial tests how well the Starting the Conversation educational intervention works to promote effective clinical communication about sexual health for patients with gynecologic cancer. Common sexual problems after undergoing treatment for gynecologic cancer include vaginal dryness/pain, arousal difficulties, loss of sexual desire and activity, and body image concerns. Symptoms may often persist years after treatment ends, leading to substantial psychological distress. Many patients feel unprepared for how to raise sexual health concerns to their providers and therefore uncomfortable holding such discussions. The Starting the Conversation intervention may facilitate effective patient-clinician communication about sexual health concerns patients with gynecologic cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06904339.
Locations matching your search criteria
United States
Pennsylvania
Philadelphia
Fox Chase Cancer CenterStatus: Active
Contact: Jennifer B. Reese
Phone: 215-214-3223
PRIMARY OBJECTIVES:
I. To evaluate the efficacy of Starting the Conversation – Gynecologic Cancer (STC-GC) for facilitating patient clinical communication about sexual health (primary) and in improving patients’ sexual and psychological health outcomes (secondary).
II. To examine mediators of the STC-GC intervention on patient communication and health outcomes.
III. To qualitatively examine:
IIIa. Patients’ perspectives on ways STC-GC influenced their clinical communication about sexual health as well as their sexual and psychological health outcomes;
IIIb. Clinicians’ perspectives on barriers and facilitators to sexual health communication.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients watch a 25-minute video and complete a workbook that includes skills training and education for communicating with providers about sexual concerns. Patients also receive a resource guide with information about institutional and external resources on sexual and menopausal health related to gynecologic cancer and its treatment. Patients are instructed to view the materials and complete the workbook prior to their scheduled visit. Patients receive a reminder call before their visit and may review/complete the materials at the clinic immediately prior to their visit.
ARM II: Patients receive usual care and a resource guide with information about institutional and external resources on sexual and menopausal health related to gynecologic cancer and its treatment. Patients are instructed to view the materials prior to their scheduled visit. Patients receive a reminder call before their visit and may review the materials at the clinic immediately prior to their visit.
After completion of study intervention, patients are followed up at 2 and 6 months.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationFox Chase Cancer Center
Principal InvestigatorJennifer B. Reese
