Gynecologic CancerNCT05359952
Women's Health Communication Study
A study testing Starting the Conversation and Sexual and Menopausal Health Resources Only in people with Gynecologic Cancer, run by Fox Chase Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Cancer
- What is being tested?
- Starting the Conversation and Sexual and Menopausal Health Resources Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2022to 22 Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
Official title: Enhancing Clinical Communication About Sexual Health for Women With Gynecologic Cancer: Adaptation of a Multimedia Intervention
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.
- Conditions
- Gynecologic Cancer
- Being tested
- Starting the Conversation, Sexual and Menopausal Health Resources Only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Starting the ConversationBehavioural
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 OnlyBehavioural
A list of resources on sexual/menopausal health both within and outside the institution, including websites.
| Study group | Role | What they receive |
|---|---|---|
| Starting the Conversation | Experimental | 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. Receives: Behavioral: Starting the Conversation; Behavioral: Sexual and Menopausal Health Resources Only |
| Sexual and Menopausal Health Resources Only | Active comparator | Participants are given the list of resources about sexual and menopausal health only. Receives: Behavioral: Sexual and Menopausal Health Resources Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - Enrollment
Study enrollment, defined as the number of participants randomized out of the number of eligible patients approached for participation
Measured: Baseline
Feasibility - Retention
Number of enrolled participants that complete the final study survey.
Measured: 2 months
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.
Measured: 2 weeks
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).
Measured: 2 weeks
Secondary outcomes (9)
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.
Measured: 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.
Measured: 2 months
Clinical Communication - Discussion of Sexual Health
Number of patients who discuss sexual health concerns in a clinic visit.
Measured: 2 weeks
Clinical Communication - Raising Topic of Sexual Health
Number of patients who raise the topic of sexual health concerns in a clinic visit.
Measured: 2 weeks
Clinical Communication - Asking a Question About Sexual Health
Number of patients who ask a question about sexual health concerns in a clinic visit.
Measured: 2 weeks
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.
Measured: baseline to 2 months
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.
Measured: 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.
Measured: 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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start9 Feb 2022
- Primary completion22 Aug 2022
- Study completion22 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- More trials run by Fox Chase Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05359952
- Sponsor's protocol ID
- 21-1066
- Status last verified
- Sep 2024
- First submitted
- 29 Apr 2022
- Last updated
- 25 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Clinical Communication About Sexual Health for Women With Gynecologic Cancer: Adaptation of a Multimedia Intervention
- ClinicalTrials.gov ID
- NCT05359952
- Acronym / sponsor ID
- 21-1066
- Conditions
- Gynecologic Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Study start
- 9 Feb 2022 (actual)
- Primary completion
- 22 Aug 2022 (actual)
- Study completion
- 22 Aug 2022 (actual)
- First posted
- 4 May 2022 (actual)
- Results
- Posted 25 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Starting the Conversation | Experimental | Behavioral: Starting the Conversation, Behavioral: Sexual and Menopausal Health Resources OnlyParticipants 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. |
| Sexual and Menopausal Health Resources Only | Active comparator | Behavioral: Sexual and Menopausal Health Resources OnlyParticipants are given the list of resources about sexual and menopausal health only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Starting the ConversationThe 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. | Behavioural | Starting the Conversation |
| Sexual and Menopausal Health Resources OnlyA list of resources on sexual/menopausal health both within and outside the institution, including websites. | Behavioural | Sexual and Menopausal Health Resources Only, Starting the Conversation |
Primary outcome
Feasibility - Enrollment
Time frame: Baseline
Study enrollment, defined as the number of participants randomized out of the number of eligible patients approached for participation
Feasibility - Retention
Time frame: 2 months
Number of enrolled participants that complete the final study survey.
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.
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).
9 secondary outcomes
Self-Efficacy - Post-Intervention
Time frame: 2 weeks
Self-Efficacy - 2-Month Follow Up
Time frame: 2 months
Clinical Communication - Discussion of Sexual Health
Time frame: 2 weeks
Clinical Communication - Raising Topic of Sexual Health
Time frame: 2 weeks
Clinical Communication - Asking a Question About Sexual Health
Time frame: 2 weeks
Change in Sexual Function
Time frame: baseline to 2 months
Sexual Activity
Time frame: 2 months
Psychological Distress - Depression
Time frame: 2 months
Psychological Distress - Anxiety
Time frame: 2 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Starting the Conversation and Sexual and Menopausal Health Resources Only in people with Gynecologic Cancer, run by Fox Chase Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility - Enrollment (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.