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Women's Health Communication Study
NA trial testing Starting the Conversation in Gynecologic Cancer in 32 participants. Completed in 22 August 2022.
| Lead sponsor | Fox Chase Cancer Center |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 32 |
| Start date | 9 February 2022 |
| Primary completion | 22 August 2022 |
| Estimated completion | 22 August 2022 |
| Sites | 1 location across United States |
Fox Chase Cancer Center — full company profile →
18 and older, female only, with Gynecologic Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Study enrollment, defined as the number of participants randomized out of the number of eligible patients approached for participation
| Group | Value | 95% CI |
|---|---|---|
| Study Candidates | 32 |
Number of enrolled participants that complete the final study survey.
| Group | Value | 95% CI |
|---|---|---|
| Starting the Conversation | 20 | |
| Sexual and Menopausal Health Resources Only | 11 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Starting the Conversation | 21 | |
| Starting the Conversation | 0 |
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).
| Group | Value | 95% CI |
|---|---|---|
| Starting the Conversation | 20 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Starting the Conversation | 8.18 | 6.99 – 9.35 |
| Sexual and Menopausal Health Resources Only | 9.18 | 8.15 – 10.22 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Starting the Conversation | 8.00 | 6.59 – 9.41 |
| Sexual and Menopausal Health Resources Only | 8.68 | 7.21 – 10.16 |
Number of patients who discuss sexual health concerns in a clinic visit.
| Group | Value | 95% CI |
|---|---|---|
| Starting the Conversation | 9 | |
| Sexual and Menopausal Health Resources Only | 5 |
Number of patients who raise the topic of sexual health concerns in a clinic visit.
| Group | Value | 95% CI |
|---|---|---|
| Starting the Conversation | 7 | |
| Sexual and Menopausal Health Resources Only | 0 |
Number of patients who ask a question about sexual health concerns in a clinic visit.
| Group | Value | 95% CI |
|---|---|---|
| Starting the Conversation | 9 | |
| Sexual and Menopausal Health Resources Only | 3 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Starting the Conversation | 1.3 | ± 3.9 |
| Sexual and Menopausal Health Resources Only | 4.5 | ± 9.0 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Starting the Conversation | 10 | |
| Sexual and Menopausal Health Resources Only | 4 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Starting the Conversation | 5.4 | 3.45 – 7.35 |
| Sexual and Menopausal Health Resources Only | 4.55 | 2.15 – 6.94 |
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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