Women's Health Communication Study

NCT ID: NCT05359952

Last Updated: 2024-09-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-09

Study Completion Date

2022-08-22

Brief Summary

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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.

Detailed Description

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Conditions

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Gynecologic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Starting the Conversation

Intervention Type 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.

Sexual and Menopausal Health Resources Only

Intervention Type BEHAVIORAL

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

Sexual and Menopausal Health Resources Only

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

Group Type ACTIVE_COMPARATOR

Sexual and Menopausal Health Resources Only

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

Sexual and Menopausal Health Resources Only

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fox Chase Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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21-1066

Identifier Type: -

Identifier Source: org_study_id

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