Women's Health Communication Study

Temple University Health System (TUHS)

Status: Completed

Conditions: Gynecologic Cancer

Treatments: Behavioral: Starting the Conversation; Behavioral: Sexual and Menopausal Health Resources Only

Study type: Interventional

Funder types: Other

Identifiers

NCT05359952

21-1066

Details and patient eligibility

About

The central goal of this randomized, controlled pilot study is to examine the feasibility, acceptability, and preliminary effects of an educational intervention (called "Starting the Conversation"; STC) on patient communication about sexual health in gynecologic cancer and other patient health outcomes. Approximately 30 women with a diagnosis of gynecologic cancer will be randomized to either participate in either the Starting the Conversation (STC) condition, consisting of an educational video, workbook, and list of resources on sexual and menopausal health, or to a control condition offering the resource guide only. Patients will be asked to review intervention materials prior to their next clinic visit with their gynecologic cancer provider. The investigators will examine effects of the interventions on patients' beliefs about communication about sexual health and on patients' communication about sexual health during clinic visits with their providers. Secondarily, the investigators will examine effects of the interventions on sexual outcomes and other health outcomes, including psychological well-being.

Enrollment: 32 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of any stage (I-IV) gynecologic cancer (uterine, ovarian, cervical, vaginal/vulvar, fallopian tube, peritoneal)
• Receiving any treatment for gynecologic cancer or have completed acute treatment < 10 years ago
• Attending clinic visits in the course of follow-up care (i.e., not an initial consult visit)

Exclusion criteria

• Not able to speak English
• Eastern Cooperative Oncology Group (ECOG) Performance status score > 2
• Overt cognitive dysfunction or psychiatric disturbance or severe mental illness (e.g., dementia, suicidal behavior, or psychosis), as observed or judged by the researcher or referring source.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Starting the Conversation

Experimental group

Description:

Participants are asked to watch an educational video along with an accompanying workbook (called "Starting the Conversation"). Participants are also asked to review a list of resources about sexual and menopausal health relevant to gynecologic cancer.

Treatment:

Behavioral: Sexual and Menopausal Health Resources Only

Behavioral: Starting the Conversation

Sexual and Menopausal Health Resources Only

Active Comparator group

Description:

Participants are given the list of resources about sexual and menopausal health only.

Treatment:

Behavioral: Sexual and Menopausal Health Resources Only