Gynecologic Cancer
Conditions
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.
Interventions
BEHAVIORALStarting 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.
BEHAVIORALSexual and Menopausal Health Resources Only
A list of resources on sexual/menopausal health both within and outside the institution, including websites.
Sponsors
Fox Chase Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility - Enrollment | Baseline | Study enrollment, defined as the number of participants randomized out of the number of eligible patients approached for participation |
| Feasibility - Retention | 2 months | Number of enrolled participants that complete the final study survey. |
| Feasibility - Intervention Completion | 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. |
| Acceptability | 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
| Measure | Time frame | Description |
|---|---|---|
| Clinical Communication - Asking a Question About Sexual Health | 2 weeks | Number of patients who ask a question about sexual health concerns in a clinic visit. |
| Change in Sexual Function | 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. |
| Self-Efficacy - Post-Intervention | 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. |
| Psychological Distress - Depression | 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. |
| Psychological Distress - Anxiety | 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. |
| Sexual Activity | 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. |
| Self-Efficacy - 2-Month Follow Up | 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. |
| Clinical Communication - Discussion of Sexual Health | 2 weeks | Number of patients who discuss sexual health concerns in a clinic visit. |
| Clinical Communication - Raising Topic of Sexual Health | 2 weeks | Number of patients who raise the topic of sexual health concerns in a clinic visit. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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.
Sexual and Menopausal Health Resources Only: A list of resources on sexual/menopausal health both within and outside the institution, including websites. | 21 |
| Sexual and Menopausal Health Resources Only Participants are given the list of resources about sexual and menopausal health only.
Sexual and Menopausal Health Resources Only: A list of resources on sexual/menopausal health both within and outside the institution, including websites. | 11 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Sexual and Menopausal Health Resources Only | Total | Starting the Conversation |
|---|---|---|---|
| Age, Continuous | 65.4 years STANDARD_DEVIATION 10.2 | 62.2 years STANDARD_DEVIATION 9.9 | 60.6 years STANDARD_DEVIATION 9.5 |
| Chemotherapy Received Chemotherapy received | 6 Participants | 21 Participants | 15 Participants |
| Chemotherapy Received No chemotherapy received | 5 Participants | 11 Participants | 6 Participants |
| Disease Site Cervical | 2 Participants | 2 Participants | 0 Participants |
| Disease Site Endometrial | 6 Participants | 17 Participants | 11 Participants |
| Disease Site Other | 0 Participants | 2 Participants | 2 Participants |
| Disease Site Ovarian | 3 Participants | 11 Participants | 8 Participants |
| Disease Stage Stage III | 2 Participants | 11 Participants | 9 Participants |
| Disease Stage Stage I-II | 8 Participants | 18 Participants | 10 Participants |
| Disease Stage Stage IV | 1 Participants | 3 Participants | 2 Participants |
| Education Completed college/graduate school | 5 Participants | 19 Participants | 14 Participants |
| Education High school or less | 2 Participants | 5 Participants | 3 Participants |
| Education Some college | 4 Participants | 8 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants | 31 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Hormonal Therapy Received Hormonal therapy received | 3 Participants | 4 Participants | 1 Participants |
| Hormonal Therapy Received No hormonal therapy received | 8 Participants | 28 Participants | 20 Participants |
| Immunotherapy Received Immunotherapy received | 4 Participants | 13 Participants | 9 Participants |
| Immunotherapy Received No immunotherapy received | 7 Participants | 19 Participants | 12 Participants |
| Partnered Status Married or partnered | 5 Participants | 23 Participants | 18 Participants |
| Partnered Status Not partnered | 6 Participants | 9 Participants | 3 Participants |
| Primary Surgery Hysterectomy/oophorectomy | 10 Participants | 30 Participants | 20 Participants |
| Primary Surgery None | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 8 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 24 Participants | 17 Participants |
| Radiation Therapy Received No radiation therapy received | 6 Participants | 21 Participants | 15 Participants |
| Radiation Therapy Received Radiation therapy received | 5 Participants | 11 Participants | 6 Participants |
| Region of Enrollment United States | 11 participants | 32 participants | 21 participants |
| Sex: Female, Male Female | 11 Participants | 32 Participants | 21 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Sexual Orientation Don't know | 0 Participants | 1 Participants | 1 Participants |
| Sexual Orientation Heterosexual/straight | 11 Participants | 31 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 11 |
| other Total, other adverse events | 0 / 21 | 0 / 11 |
| serious Total, serious adverse events | 0 / 21 | 0 / 11 |
Outcome results
Primary
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).
Time frame: 2 weeks
Population: Acceptability only measured in Starting the Conversation participants. One Starting the Conversation participant did not return the 2 week follow-up survey which measured acceptability.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Candidates | Acceptability | 20 Participants |
Primary
Feasibility - Enrollment
Study enrollment, defined as the number of participants randomized out of the number of eligible patients approached for participation
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Candidates | Feasibility - Enrollment | 32 Participants |
Primary
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.
Time frame: 2 weeks
Population: Only Starting the Conversation participants were asked about engagement with materials.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Candidates | Feasibility - Intervention Completion | Engaged with workbook and/or video | 21 Participants |
| Study Candidates | Feasibility - Intervention Completion | Did not engage with workbook or video | 0 Participants |
Primary
Feasibility - Retention
Number of enrolled participants that complete the final study survey.
Time frame: 2 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Candidates | Feasibility - Retention | 20 Participants |
| Sexual and Menopausal Health Resources Only | Feasibility - Retention | 11 Participants |
Secondary
Change in 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. Positive mean change scores indicate increase in sexual functioning over time while negative mean change scores indicate decrease in sexual functioning over time.
Time frame: baseline to 2 months
Population: One Starting the Conversation participant did not complete the 2-month follow-up assessment, and 6 Starting the Conversation participants did not have sufficient data on the scale to calculate a change score. Four Resources Only participants did not have sufficient data on the scale to calculate a change score.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Candidates | Change in Sexual Function | 1.3 score on a scale | Standard Deviation 3.9 |
| Sexual and Menopausal Health Resources Only | Change in Sexual Function | 4.5 score on a scale | Standard Deviation 9 |
Secondary
Clinical Communication - Asking a Question About Sexual Health
Number of patients who ask a question about sexual health concerns in a clinic visit.
Time frame: 2 weeks
Population: One Starting the Conversation participant did not complete the 2-week follow-up assessment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Candidates | Clinical Communication - Asking a Question About Sexual Health | 9 Participants |
| Sexual and Menopausal Health Resources Only | Clinical Communication - Asking a Question About Sexual Health | 3 Participants |
Secondary
Clinical Communication - Discussion of Sexual Health
Number of patients who discuss sexual health concerns in a clinic visit.
Time frame: 2 weeks
Population: One Starting the Conversation participant did not complete the 2-week follow-up assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Candidates | Clinical Communication - Discussion of Sexual Health | 9 Participants |
| Sexual and Menopausal Health Resources Only | Clinical Communication - Discussion of Sexual Health | 5 Participants |
Secondary
Clinical Communication - Raising Topic of Sexual Health
Number of patients who raise the topic of sexual health concerns in a clinic visit.
Time frame: 2 weeks
Population: One Starting the Conversation participant did not complete the 2-week follow-up assessment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Candidates | Clinical Communication - Raising Topic of Sexual Health | 7 Participants |
| Sexual and Menopausal Health Resources Only | Clinical Communication - Raising Topic of Sexual Health | 0 Participants |
Secondary
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.
Time frame: 2 months
Population: One Starting the Conversation participant did not complete the 2-month follow-up assessment.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Study Candidates | Psychological Distress - Anxiety | 8.20 score on a scale |
| Sexual and Menopausal Health Resources Only | Psychological Distress - Anxiety | 5.55 score on a scale |
Secondary
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.
Time frame: 2 months
Population: One Starting the Conversation participant did not complete the 2-month follow-up assessment.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Study Candidates | Psychological Distress - Depression | 5.4 score on a scale |
| Sexual and Menopausal Health Resources Only | Psychological Distress - Depression | 4.55 score on a scale |
Secondary
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.
Time frame: 2 months
Population: One Starting the Conversation participant did not complete the 2-month follow-up assessment.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Study Candidates | Self-Efficacy - 2-Month Follow Up | 8.00 units on a scale |
| Sexual and Menopausal Health Resources Only | Self-Efficacy - 2-Month Follow Up | 8.68 units on a scale |
Secondary
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.
Time frame: 2 weeks
Population: One Starting the Conversation participant did not complete the 2-week follow-up assessment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Study Candidates | Self-Efficacy - Post-Intervention | 8.18 units on a scale |
| Sexual and Menopausal Health Resources Only | Self-Efficacy - Post-Intervention | 9.18 units on a scale |
Secondary
Sexual Activity
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.
Time frame: 2 months
Population: One Starting the Conversation participant did not complete the 2-month follow-up assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Candidates | Sexual Activity | 10 Participants |
| Sexual and Menopausal Health Resources Only | Sexual Activity | 4 Participants |