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Completed

NCT Number: NCT05359952

Women's Health Communication Study

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.

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Key information

Conditions

Gynecologic Cancer

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Sexual and Menopausal Health Resources Only

Behavioral

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

Primary outcomes

  1. Feasibility - Enrollment

    Time frame: Baseline

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

  2. Feasibility - Retention

    Time frame: 2 months

    Number of enrolled participants that complete the final study survey.

  3. Feasibility - Intervention Completion

    Time frame: 2 weeks

    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.

  4. Acceptability

    Time frame: 2 weeks

    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).

Secondary outcomes

  1. Self-Efficacy - Post-Intervention

    Time frame: 2 weeks

    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. Self-Efficacy - 2-Month Follow Up

    Time frame: 2 months

    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.

  3. Clinical Communication - Discussion of Sexual Health

    Time frame: 2 weeks

    Number of patients who discuss sexual health concerns in a clinic visit.

  4. Clinical Communication - Raising Topic of Sexual Health

    Time frame: 2 weeks

    Number of patients who raise the topic of sexual health concerns in a clinic visit.

  5. Clinical Communication - Asking a Question About Sexual Health

    Time frame: 2 weeks

    Number of patients who ask a question about sexual health concerns in a clinic visit.

  6. Change in Sexual Function

    Time frame: baseline to 2 months

    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. Positive mean change scores indicate increase in sexual functioning over time while negative mean change scores indicate decrease in sexual functioning over time.

  7. Sexual Activity

    Time frame: 2 months

    A single item asking (yes/no) whether the participant had any kind of sexual activity in the past 30 days. Percent reporting sexual activity is reported.

  8. Psychological Distress - Depression

    Time frame: 2 months

    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.

  9. Psychological Distress - Anxiety

    Time frame: 2 months

    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.

Sponsors and collaborators

Lead sponsor

Fox Chase Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 4, 2022
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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