Women's Health Communication Study

NCT05359952 | Completed Results

• 1 other identifier: 21-1066
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Gynecologic Cancer

Outcome Measures

Primary Outcomes (4)

• Feasibility - Enrollment

  Study enrollment, defined as the number of participants randomized out of the number of eligible patients approached for participation

  Baseline

• Feasibility - Retention

  Number of enrolled participants that complete the final study survey.

  2 months

• Feasibility - Intervention Completion

  Number 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 number 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 Outcomes (9)

• Self-Efficacy - Post-Intervention

  2 weeks

• Self-Efficacy - 2-Month Follow Up

  2 months

• Clinical Communication - Discussion of Sexual Health

  2 weeks

• Clinical Communication - Raising Topic of Sexual Health

  2 weeks

• Clinical Communication - Asking a Question About Sexual Health

  2 weeks

Study Arms (2)

Starting the Conversation

EXPERIMENTAL

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; Behavioral: Sexual and Menopausal Health Resources Only

Sexual and Menopausal Health Resources Only

ACTIVE COMPARATOR

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

Behavioral: Sexual and Menopausal Health Resources Only

Interventions

Starting the Conversation BEHAVIORAL

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.

Starting the Conversation

Sexual and Menopausal Health Resources Only BEHAVIORAL

A list of resources on sexual/menopausal health both within and outside the institution, including websites.

Sexual and Menopausal Health Resources Only; Starting the Conversation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fox Chase Cancer Center: lead

Study Sites (1)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

MeSH Terms

Interventions

Sex

Intervention Hierarchy (Ancestors)

Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Results Point of Contact

• Title: Dr. Jennifer Reese, Associate Professor
• Organization: Fox Chase Cancer Center

Jennifer.Reese@fccc.edu

215-214-3223

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2022
• First Posted: May 4, 2022
• Study Start: February 9, 2022
• Primary Completion: August 22, 2022
• Study Completion: August 22, 2022
• Last Updated: September 25, 2024
• Results First Posted: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)