Clinical trial NCT05359952: Women's Health Communication Study
Official title: Enhancing Clinical Communication About Sexual Health for Women With Gynecologic Cancer: Adaptation of a Multimedia Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecologic Cancer
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
First posted: 2022-05-04
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility - Enrollment
timeFrame: Baseline
measure: Feasibility - Retention
timeFrame: 2 months
measure: Feasibility - Intervention Completion
timeFrame: 2 weeks
measure: Acceptability
timeFrame: 2 weeks
Secondary outcomes:
measure: Self-Efficacy - Post-Intervention
timeFrame: 2 weeks
measure: Self-Efficacy - 2-Month Follow Up
timeFrame: 2 months
measure: Clinical Communication - Discussion of Sexual Health
timeFrame: 2 weeks
measure: Clinical Communication - Raising Topic of Sexual Health
timeFrame: 2 weeks
measure: Clinical Communication - Asking a Question About Sexual Health
timeFrame: 2 weeks
measure: Change in Sexual Function
timeFrame: baseline to 2 months
measure: Sexual Activity
timeFrame: 2 months
measure: Psychological Distress - Depression
timeFrame: 2 months
measure: Psychological Distress - Anxiety
timeFrame: 2 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
References: