Women's Health Communication Study

Study Overview
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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.

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

Conditions
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Gynecologic Cancer

Intervention / Treatment
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* Behavioral: Starting the Conversation
* Behavioral: Sexual and Menopausal Health Resources Only


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Starting the Conversation<br>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<br>* 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.<br>Behavioral: Sexual and Menopausal Health Resources Only<br>* A list of resources on sexual/menopausal health both within and outside the institution, including websites.<br>|
| Active Comparator: Sexual and Menopausal Health Resources Only<br>Participants are given the list of resources about sexual and menopausal health only. | Behavioral: Sexual and Menopausal Health Resources Only<br>* A list of resources on sexual/menopausal health both within and outside the institution, including websites.<br>|

What is the study measuring?
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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 |