Women's Health Communication Study

Enhancing Clinical Communication About Sexual Health for Women With Gynecologic Cancer: Adaptation of a Multimedia Intervention

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.

Study Overview

• Status: Completed
• Conditions: Gynecologic Cancer
• Intervention / Treatment: Behavioral: Starting the Conversation; Behavioral: Sexual and Menopausal Health Resources Only

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer B Reese, PhD; Phone Number: 215-214-3223; Email: jennifer.reese@fccc.edu
• Study Contact Backup: Name: Kristen A. Sorice, BA; Phone Number: 215-214-1433; Email: kristen.sorice@fccc.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Starting the Conversation; 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.	Behavioral: Starting the Conversation; The Starting the Conversation intervention consists of a brief educational video and accompanying workbook with activities to help prepare patients to discuss sexual and menopausal types of health concerns effectively with gynecologic cancer providers, including prioritizing concerns, tips for effective communication, communication practice, and self-feedback. In addition, participants receive a list of sexual and menopausal resources.; Behavioral: Sexual and Menopausal Health Resources Only; A list of resources on sexual/menopausal health both within and outside the institution, including websites.
ACTIVE_COMPARATOR: Sexual and Menopausal Health Resources Only; Participants are given the list of resources about sexual and menopausal health only.	Behavioral: Sexual and Menopausal Health Resources Only; A list of resources on sexual/menopausal health both within and outside the institution, including websites.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility - Enrollment	Study enrollment, defined as the proportion of participants randomized out of the number of eligible patients approached for participants.	Baseline
Feasibility - Retention	Proportion of enrolled participants that complete the final study survey.	2 months
Feasibility - Intervention Completion	Proportion of participants randomized to receive the Starting the Conversation intervention who report having engaged at least somewhat with the video and/or accompanying workbook.	2 weeks
Acceptability	The proportion of participants randomized to receive the Starting the Conversation intervention who endorse at least 6 of 8 core components of the Starting the Conversation Intervention (defined as satisfaction with the intervention, informativeness of the intervention, helpfulness of the intervention, relevance of the intervention, ease of participation, approval of the intervention format, likelihood of recommending the intervention to others, and perceived importance of the intervention for people with gynecologic cancer).	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-Efficacy - Post-Intervention	Patients' confidence that they can discuss sexual concerns with their provider and ask their provider about sexual concerns. Scale ranges from 0-10, with higher scores indicating higher self-efficacy. Means will be reported.	2 weeks
Self-Efficacy - 2-Month Follow Up	Patients' confidence that they can discuss sexual concerns with their provider and ask their provider about sexual concerns. Scale ranges from 0-10, with higher scores indicating higher self-efficacy. Means will be reported.	2 months
Clinical Communication - Discussion of Sexual Health	Proportion of patients who discuss sexual health concerns in a clinic visit.	2 weeks
Clinical Communication - Raising Topic of Sexual Health	Proportion of patients who raise the topic of sexual health concerns in a clinic visit.	2 weeks
Clinical Communication - Asking a Question About Sexual Health	Proportion of patients who ask a question about sexual health concerns in a clinic visit.	2 weeks
Sexual Function	Patients' self-reported sexual function will be measured using the 19-item Female Sexual Function Index (FSFI).Total scale scores range from 2 to 36, with higher scores indicating higher functioning. Mean change scores from baseline to 2 months will be reported: positive mean change scores indicate increase in sexual functioning over time while negative mean change scores indicate decrease in sexual functioning over time.	2 months
Sexual Activity	A single item asking (yes/no) whether the participant had any kind of sexual activity in the past 30 days.	2 months
Psychological Distress - Depression	Patients self-reported depression, as measured through depression subscale of the Hospital Anxiety & Depression Scale (HADS). The depression subscale consists of 7 items that are scored from 0 to 3. Summed scores range from 0 to 21, with higher scores indicating higher levels of depression. Means will be reported.	2 months
Psychological Distress - Anxiety	Patients self-reported anxiety, as measured through anxiety subscale of the Hospital Anxiety & Depression Scale (HADS). The anxiety subscale consists of 7 items that are scored from 0 to 3. Summed scores range from 0 to 21, with higher scores indicating higher levels of anxiety. Means will be reported.	2 months

Collaborators and Investigators

• Sponsor: Fox Chase Cancer Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 9, 2022
• Primary Completion (ACTUAL): August 22, 2022
• Study Completion (ACTUAL): August 22, 2022

Study Registration Dates

• First Submitted: April 29, 2022
• First Submitted That Met QC Criteria: April 29, 2022
• First Posted (ACTUAL): May 4, 2022

Study Record Updates

• Last Update Posted (ESTIMATE): February 14, 2023
• Last Update Submitted That Met QC Criteria: February 13, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 21-1066

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No