Trial Outcomes & Findings for Women's Health Communication Study (NCT NCT05359952)
NCT ID: NCT05359952
Last Updated: 2024-09-25
Results Overview
Study enrollment, defined as the number of participants randomized out of the number of eligible patients approached for participation
COMPLETED
NA
32 participants
Baseline
2024-09-25
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
11
|
|
Overall Study
COMPLETED
|
20
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Women's Health Communication Study
Baseline characteristics by cohort
| Measure |
Starting the Conversation
n=21 Participants
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.
|
Sexual and Menopausal Health Resources Only
n=11 Participants
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.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.6 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
65.4 years
STANDARD_DEVIATION 10.2 • n=7 Participants
|
62.2 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
11 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Education
High school or less
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Education
Some college
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Education
Completed college/graduate school
|
14 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sexual Orientation
Heterosexual/straight
|
20 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sexual Orientation
Don't know
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Partnered Status
Married or partnered
|
18 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Partnered Status
Not partnered
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Disease Site
Endometrial
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Disease Site
Ovarian
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Disease Site
Cervical
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Disease Site
Other
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Disease Stage
Stage I-II
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Disease Stage
Stage III
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Disease Stage
Stage IV
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Primary Surgery
Hysterectomy/oophorectomy
|
20 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Primary Surgery
None
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Chemotherapy Received
Chemotherapy received
|
15 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Chemotherapy Received
No chemotherapy received
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Radiation Therapy Received
Radiation therapy received
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Radiation Therapy Received
No radiation therapy received
|
15 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Immunotherapy Received
Immunotherapy received
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Immunotherapy Received
No immunotherapy received
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Hormonal Therapy Received
Hormonal therapy received
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Hormonal Therapy Received
No hormonal therapy received
|
20 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselineStudy enrollment, defined as the number of participants randomized out of the number of eligible patients approached for participation
Outcome measures
| Measure |
Study Candidates
n=131 Participants
All potentially eligible study candidates approached for participation.
|
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.
|
|---|---|---|
|
Feasibility - Enrollment
|
32 Participants
|
—
|
PRIMARY outcome
Timeframe: 2 monthsNumber of enrolled participants that complete the final study survey.
Outcome measures
| Measure |
Study Candidates
n=21 Participants
All potentially eligible study candidates approached for participation.
|
Sexual and Menopausal Health Resources Only
n=11 Participants
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.
|
|---|---|---|
|
Feasibility - Retention
|
20 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: Only Starting the Conversation participants were asked about engagement with materials.
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.
Outcome measures
| Measure |
Study Candidates
n=21 Participants
All potentially eligible study candidates approached for participation.
|
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.
|
|---|---|---|
|
Feasibility - Intervention Completion
Engaged with workbook and/or video
|
21 Participants
|
—
|
|
Feasibility - Intervention Completion
Did not engage with workbook or video
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: 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.
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).
Outcome measures
| Measure |
Study Candidates
n=20 Participants
All potentially eligible study candidates approached for participation.
|
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.
|
|---|---|---|
|
Acceptability
|
20 Participants
|
—
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: One Starting the Conversation participant did not complete the 2-week follow-up assessment
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.
Outcome measures
| Measure |
Study Candidates
n=20 Participants
All potentially eligible study candidates approached for participation.
|
Sexual and Menopausal Health Resources Only
n=11 Participants
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.
|
|---|---|---|
|
Self-Efficacy - Post-Intervention
|
8.18 units on a scale
Interval 6.99 to 9.35
|
9.18 units on a scale
Interval 8.15 to 10.22
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: One Starting the Conversation participant did not complete the 2-month follow-up assessment.
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.
Outcome measures
| Measure |
Study Candidates
n=20 Participants
All potentially eligible study candidates approached for participation.
|
Sexual and Menopausal Health Resources Only
n=11 Participants
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.
|
|---|---|---|
|
Self-Efficacy - 2-Month Follow Up
|
8.00 units on a scale
Interval 6.59 to 9.41
|
8.68 units on a scale
Interval 7.21 to 10.16
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: One Starting the Conversation participant did not complete the 2-week follow-up assessment.
Number of patients who discuss sexual health concerns in a clinic visit.
Outcome measures
| Measure |
Study Candidates
n=20 Participants
All potentially eligible study candidates approached for participation.
|
Sexual and Menopausal Health Resources Only
n=11 Participants
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.
|
|---|---|---|
|
Clinical Communication - Discussion of Sexual Health
|
9 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: One Starting the Conversation participant did not complete the 2-week follow-up assessment
Number of patients who raise the topic of sexual health concerns in a clinic visit.
Outcome measures
| Measure |
Study Candidates
n=20 Participants
All potentially eligible study candidates approached for participation.
|
Sexual and Menopausal Health Resources Only
n=11 Participants
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.
|
|---|---|---|
|
Clinical Communication - Raising Topic of Sexual Health
|
7 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: One Starting the Conversation participant did not complete the 2-week follow-up assessment
Number of patients who ask a question about sexual health concerns in a clinic visit.
Outcome measures
| Measure |
Study Candidates
n=20 Participants
All potentially eligible study candidates approached for participation.
|
Sexual and Menopausal Health Resources Only
n=11 Participants
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.
|
|---|---|---|
|
Clinical Communication - Asking a Question About Sexual Health
|
9 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: baseline to 2 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Study Candidates
n=14 Participants
All potentially eligible study candidates approached for participation.
|
Sexual and Menopausal Health Resources Only
n=7 Participants
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.
|
|---|---|---|
|
Change in Sexual Function
|
1.3 score on a scale
Standard Deviation 3.9
|
4.5 score on a scale
Standard Deviation 9.0
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: One Starting the Conversation participant did not complete the 2-month follow-up assessment.
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.
Outcome measures
| Measure |
Study Candidates
n=20 Participants
All potentially eligible study candidates approached for participation.
|
Sexual and Menopausal Health Resources Only
n=11 Participants
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.
|
|---|---|---|
|
Sexual Activity
|
10 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: One Starting the Conversation participant did not complete the 2-month follow-up assessment.
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.
Outcome measures
| Measure |
Study Candidates
n=20 Participants
All potentially eligible study candidates approached for participation.
|
Sexual and Menopausal Health Resources Only
n=11 Participants
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.
|
|---|---|---|
|
Psychological Distress - Depression
|
5.4 score on a scale
Interval 3.45 to 7.35
|
4.55 score on a scale
Interval 2.15 to 6.94
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: One Starting the Conversation participant did not complete the 2-month follow-up assessment.
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.
Outcome measures
| Measure |
Study Candidates
n=20 Participants
All potentially eligible study candidates approached for participation.
|
Sexual and Menopausal Health Resources Only
n=11 Participants
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.
|
|---|---|---|
|
Psychological Distress - Anxiety
|
8.20 score on a scale
Interval 5.76 to 10.64
|
5.55 score on a scale
Interval 2.87 to 8.22
|
Adverse Events
Starting the Conversation
Sexual and Menopausal Health Resources Only
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jennifer Reese, Associate Professor
Fox Chase Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place