Gynecologic CancersNCT06904339
Communication About Sexual Health in Gynecologic Cancer
A study testing Starting the Conversation and Sexual Health Resources in people with Gynecologic Cancers, run by Fox Chase Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if an educational video and workbook can help gynecologic cancer patients talk to their cancer providers about sexual health concerns. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Cancers
- What is being tested?
- Starting the Conversation and Sexual Health Resources
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2025to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- At least 18 years old
- Diagnosed with any stage (I-IV) gynecologic cancer
- Receiving treatment for gynecologic cancer or completed active treatment less than 10 years ago
- Attending visits in follow-up care at Fox Chase Cancer Center
- Score of at least 3 on a sexual concerns screener question
Who cannot join
- Not able to speak English
- Not willing to have clinic visit audio recorded
- Eastern Cooperative Oncology Group (ECOG) score > 2
- Overt cognitive dysfunction or psychiatric disturbance
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Kristen A Sorice, 215-214-1433, kristen.sorice@fccc.edu
About this study
Official title: Promoting Effective Clinical Communication About Sexual Health After Gynecologic Cancer: A Randomized Controlled Trial of a Patient-Focused Intervention
The goal of this clinical trial is to learn if an educational video and workbook can help gynecologic cancer patients talk to their cancer providers about sexual health concerns.
The main questions it aims to answer are:
Read more
- Do gynecologic cancer patients who take part in the educational program and get a resource booklet talk to their cancer clinicians more about sexual health concerns than patients who get a resource booklet alone?
- Do gynecologic cancer patients who take part in the educational program and get a resource booklet have better sexual function and less anxiety and depression than patients who get a resource booklet alone?
Researchers will compare those who get the educational program and the resource booklet to those who get the resource booklet alone along with their usual care.
Participants will:
- Fill out a consent form and survey
- Have their next clinic visit audio recorded
- Fill out another survey right after their clinic visit
- Fill out a final survey 6 months after their clinic visit
- Conditions
- Gynecologic Cancers
- Being tested
- Starting the Conversation, Sexual Health Resources
- Keywords
- sexual health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Starting the ConversationBehavioural
Starting the Conversation includes a 25-minute video with information about sexual health and gynecologic cancer and tips about how to talk to their cancer care team about sexual health concerns. Participants will also fill out a workbook with activities to help them practice communication skills.
Sexual Health ResourcesBehavioural
The sexual health resource guide includes institutional resources for patients with sexual concerns (for example, the Women's Survivorship Clinic) and links to reputable websites with information about sexual health after gynecologic cancer.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Care-as-Usual (Sexual Health Resources Alone) | Active comparator | Participants will receive their usual care and a resource guide with information on sexual health and gynecologic cancer. The guide will include organizational resources and links to websites with information about sexual health and gynecologic cancer. Receives: Behavioral: Sexual Health Resources |
| Sexual Health Resources + Starting the Conversation Video/Workbook | Experimental | Participants will receive a resource guide on sexual health and gynecologic cancer and will be asked to watch a 25-minute video with information about sexual health and gynecologic cancer and learn ways to talk to their cancer care provider effectively about sexual health concerns. Participants will also fill out a workbook with activities to help them practice communication skills and plan their discussion. Receives: Behavioral: Starting the Conversation; Behavioral: Sexual Health Resources |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Communication - Raise Topic of Sexual Health
Number of patients who raise the topic of sexual health concerns in a clinic visit.
Measured: 2 weeks
Clinical Communication - Ask a Question about Sexual Health
Number of patients who ask a question about sexual health concerns in a clinic visit.
Measured: 2 weeks
Clinical Communication - Express a Concern about Sexual Health
Number of patients who express a sexual health concern in a clinic visit.
Measured: 2 weeks
Secondary outcomes (4)
Self-Reported Sexual Function
Patients' self-reported sexual function will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) SexFS Brief Profile Version 2.0. Four domains (lubrication, vaginal discomfort, satisfaction, and interest) will be scored. Domains are scored using T-scores, with higher scores signifying better sexual function for the lubrication, satisfaction, and interest domains. Lower scores in the vaginal discomfort range signify better sexual function.
Measured: Baseline, 2 weeks, 3 months, 6 months
Self-Reported Sexual Activity
Patients' self-reported sexual activity will be measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Sexual Activity screener. Number of participants reporting any sexual activity will be reported.
Measured: Baseline, 2 weeks, 3 months, 6 months
Self-Reported Anxiety Symptoms
Patients' self-reported anxiety symptoms will be measured using the Hospital Anxiety and 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.
Measured: Baseline, 2 weeks, 3 months, 6 months
Self-Reported Depressive Symptoms
Patients' self-reported depressive symptoms will be measured using the Hospital Anxiety and 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 depressive symptoms.
Measured: Baseline, 2 weeks, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start20 Feb 2025
- Primary completion31 Mar 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancersStudies 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
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06904339
- Sponsor's protocol ID
- 24-1010
- Other IDs
- R01CA285674
- Status last verified
- Apr 2026
- First submitted
- 31 Mar 2025
- Last updated
- 2 Jun 2026
- Results posted
- No
- 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 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Effective Clinical Communication About Sexual Health After Gynecologic Cancer: A Randomized Controlled Trial of a Patient-Focused Intervention
- ClinicalTrials.gov ID
- NCT06904339
- Acronym / sponsor ID
- 24-1010
- Conditions
- Gynecologic Cancers
- Keywords
- sexual health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 1 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if an educational video and workbook can help gynecologic cancer patients talk to their cancer providers about sexual health concerns.
The main questions it aims to answer are:
- Do gynecologic cancer patients who take part in the educational program and get a resource booklet talk to their cancer clinicians more about sexual health concerns than patients who get a resource booklet alone?
- Do gynecologic cancer patients who take part in the educational program and get a resource booklet have better sexual function and less anxiety and depression than patients who get a resource booklet alone?
Researchers will compare those who get the educational program and the resource booklet to those who get the resource booklet alone along with their usual care.
Participants will:
- Fill out a consent form and survey
- Have their next clinic visit audio recorded
- Fill out another survey right after their clinic visit
- Fill out a final survey 6 months after their clinic visit
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Care-as-Usual (Sexual Health Resources Alone) | Active comparator | Behavioral: Sexual Health ResourcesParticipants will receive their usual care and a resource guide with information on sexual health and gynecologic cancer. The guide will include organizational resources and links to websites with information about sexual health and gynecologic cancer. |
| Sexual Health Resources + Starting the Conversation Video/Workbook | Experimental | Behavioral: Starting the Conversation, Behavioral: Sexual Health ResourcesParticipants will receive a resource guide on sexual health and gynecologic cancer and will be asked to watch a 25-minute video with information about sexual health and gynecologic cancer and learn ways to talk to their cancer care provider effectively about sexual health concerns. Participants will also fill out a workbook with activities to help them practice communication skills and plan their discussion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 18 years old
- Diagnosed with any stage (I-IV) gynecologic cancer
- Receiving treatment for gynecologic cancer or completed active treatment less than 10 years ago
- Attending visits in follow-up care at Fox Chase Cancer Center
- Score of at least 3 on a sexual concerns screener question
Key exclusion criteria (4 listed)
- Not able to speak English
- Not willing to have clinic visit audio recorded
- Eastern Cooperative Oncology Group (ECOG) score > 2
- Overt cognitive dysfunction or psychiatric disturbance
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 ConversationStarting the Conversation includes a 25-minute video with information about sexual health and gynecologic cancer and tips about how to talk to their cancer care team about sexual health concerns. Participants will also fill out a workbook with activities to help them practice communication skills. | Behavioural | Sexual Health Resources + Starting the Conversation Video/Workbook |
| Sexual Health ResourcesThe sexual health resource guide includes institutional resources for patients with sexual concerns (for example, the Women's Survivorship Clinic) and links to reputable websites with information about sexual health after gynecologic cancer. | Behavioural | Enhanced Care-as-Usual (Sexual Health Resources Alone), Sexual Health Resources + Starting the Conversation Video/Workbook |
Primary outcome
Clinical Communication - Raise Topic of Sexual Health
Time frame: 2 weeks
Number of patients who raise the topic of sexual health concerns in a clinic visit.
Clinical Communication - Ask a Question about Sexual Health
Time frame: 2 weeks
Number of patients who ask a question about sexual health concerns in a clinic visit.
Clinical Communication - Express a Concern about Sexual Health
Time frame: 2 weeks
Number of patients who express a sexual health concern in a clinic visit.
4 secondary outcomes
Self-Reported Sexual Function
Time frame: Baseline, 2 weeks, 3 months, 6 months
Self-Reported Sexual Activity
Time frame: Baseline, 2 weeks, 3 months, 6 months
Self-Reported Anxiety Symptoms
Time frame: Baseline, 2 weeks, 3 months, 6 months
Self-Reported Depressive Symptoms
Time frame: Baseline, 2 weeks, 3 months, 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- 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.
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 Health Resources in people with Gynecologic Cancers, 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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 2 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer B Reese, PhD (215-214-3223, jennifer.reese@fccc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Communication - Raise Topic of Sexual Health (time frame: 2 weeks). The study lists 3 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 2 Jun 2026.