N/A
N=32
Women's Health Communication Study
Gynecologic Cancer
Bottom Line
View on ClinicalTrials.gov: NCT05359952 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Feasibility - Enrollment — 32 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Starting the Conversation (Behavioral); Sexual and Menopausal Health Resources Only (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Fox Chase Cancer Center
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility - Enrollment |
32 | — |
| PRIMARY Feasibility - Retention |
20; 11 | — |
| PRIMARY Feasibility - Intervention Completion |
21; 0 | — |
| PRIMARY Acceptability |
20 | — |
| SECONDARY Self-Efficacy - Post-Intervention |
8.18; 9.18 | — |
| SECONDARY Self-Efficacy - 2-Month Follow Up |
8.00; 8.68 | — |
| SECONDARY Clinical Communication - Discussion of Sexual Health |
9; 5 | — |
| SECONDARY Clinical Communication - Raising Topic of Sexual Health |
7; 0 | — |
| SECONDARY Clinical Communication - Asking a Question About Sexual Health |
9; 3 | — |
| SECONDARY Change in Sexual Function |
1.3; 4.5 | — |
| SECONDARY Sexual Activity |
10; 4 | — |
| SECONDARY Psychological Distress - Depression |
5.4; 4.55 | — |
| SECONDARY Psychological Distress - Anxiety |
8.20; 5.55 | — |
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 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.
Data sourced from ClinicalTrials.gov (NCT05359952). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.