Anxiety DisorderNCT02096783
Scripted Sexual Health Informational Intervention in Improving Sexual Function in Patients With Gynecologic Cancer
A study testing informational intervention, counseling intervention and questionnaire administration in people with Anxiety Disorder and Cervical Cancer, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This randomized pilot clinical trial studies the feasibility of a pre-operative and/or post-operative scripted sexual health informational intervention and how well it works in improving sexual function in patients with gynecologic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anxiety Disorder, Cervical Cancer, Endometrial Cancer
- What is being tested?
- informational intervention, counseling intervention and questionnaire administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patients with a new suspected or confirmed gynecologic malignancies
- Patients plan to have primary surgery at either the University of Chicago Hospital or the University of Wisconsin Hospital
- Patients must be English speaking
Who cannot join
- Previous treatment of any cancer excluding skin cancer
- Patients with a suspected benign gynecologic process
- Patients who are prisoners or incarcerated
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin, Madison
Madison, Wisconsin, 53792
About this study
Official title: Randomized-Controlled, Pilot Study of the Effects of a Brief, Scripted Sexual Health Intervention on Sexual Function for Women With Gynecologic Cancer
This randomized pilot clinical trial studies the feasibility of a pre-operative and/or post-operative scripted sexual health informational intervention and how well it works in improving sexual function in patients with gynecologic cancer. Discussing sexual outcomes and counseling options with patients may help improve sexual outcomes and/or anxiety after primary gynecologic cancer treatment.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the feasibility of patient recruitment, including time required to consent, enroll and retain the necessary number of participants.
II. To determine the distribution of candidate primary patient-reported outcome measures, including time to resumption of sexual activity, global satisfaction with sex life, sexual function and anxiety in this particular population.
III. To establish the prevalence of patient recall of the intervention to determine the most effective time at which to deliver the intervention.
OUTLINE: Patients are randomized to 1 of 4 treatment arms.
ARM I: Patients receive standard counseling at both the pre-operative and 2-4 week post-operative visit.
ARM II: Patients receive standard counseling at the pre-operative visit and the scripted sexual health intervention at the 2-4 week post-operative visit.
ARM III: Patients receive standard counseling and the scripted sexual health intervention at the pre-operative visit and standard counseling at the 2-4 week post-operative visit.
ARM IV: Patients receive standard counseling and the scripted sexual health intervention at both the pre-operative and 2-4 week post-operative visit.
- Conditions
- Anxiety Disorder, Cervical Cancer, Endometrial Cancer, Female Reproductive Cancer, Gestational Trophoblastic Tumor, Ovarian Epithelial Cancer
- Being tested
- informational intervention, counseling intervention, questionnaire administration
- Medical subject headings
- Anxiety Disorders, Uterine Cervical Neoplasms, Endometrial Neoplasms, Gestational Trophoblastic Disease, Carcinoma, Ovarian Epithelial, Sexual Dysfunction, Physiological, Vaginal Neoplasms, Vulvar Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
informational interventionOther
Given scripted intervention
counseling interventionOther
Also called counseling and communications studies
Given standard counseling
questionnaire administrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (standard counseling) | Active comparator | Patients receive standard counseling at both the pre-operative and 2-4 week post-operative visit. Receives: Other: counseling intervention; Other: questionnaire administration |
| Arm II (standard counseling, scripted intervention) | Experimental | Patients receive standard counseling at the pre-operative visit and the scripted sexual health intervention at the 2-4 week post-operative visit. Receives: Other: informational intervention; Other: counseling intervention; Other: questionnaire administration |
| Arm III (standard counseling, scripted intervention) | Experimental | Patients receive standard counseling and the scripted sexual health intervention at the pre-operative visit and standard counseling at the 2-4 week post-operative visit. Receives: Other: informational intervention; Other: counseling intervention; Other: questionnaire administration |
| Arm IV (standard counseling, scripted intervention) | Experimental | Patients receive standard counseling and the scripted sexual health intervention at both the pre-operative and 2-4 week post-operative visit. Receives: Other: informational intervention; Other: counseling intervention; Other: questionnaire administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of patient recruitment
To inform possible issues in recruitment for a large-scale randomized controlled trial, the ratio of enrolled subjects to total eligible potential subjects as well as the time necessary to recruit those subjects will be tracked.
Measured: Up to 9 months
Secondary outcomes (7)
Resumption of sexual activity after cancer surgery
Resumption of sexual activity after cancer surgery will be measured using items adapted from a previous national, multi-site study of sexual outcomes following an acute myocardial infarction.
Measured: Up to 9 months
Retention
The percentage of subjects completing the final assessment from the total number of subjects enrolled will be calculated.
Measured: Up to 9 months
Satisfaction with sex life independent of specific sexual function measured by Patient Reported Outcomes Measurement Information System (PROMIS) Global Satisfaction with Sex Life questionnaire
Descriptive statistics will be used to summarize survey responses overall and separately for both the experimental and control arms.
Measured: Up to 9 months
PROMIS Sexual Function Profile
Descriptive statistics will be used to summarize survey responses overall and separately for both the experimental and control arms.
Measured: Up to 9 months
Recall of intervention
Subjects will be queried to learn whether they recall receiving physician counseling about sexual health outcomes after surgery with follow up questions regarding whether or not the patient has spoken with other healthcare providers about sexual concerns.
Measured: Up to 9 months
Patient-reported anxiety measured by PROMIS Anxiety 4a short form
Descriptive statistics will be used to summarize survey responses overall and separately for both the experimental and control arms.
Measured: Up to 6 months
Rate of referral acceptance
The rate of acceptance of sexual health clinic referrals as well as rates of utilization of these referrals will be tracked using medical record abstraction.
Measured: Up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startSep 2014
- Primary completionJun 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisorderStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- David Kushner, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02096783
- Sponsor's protocol ID
- UW13080
- Other IDs
- NCI-2014-00471, UW13080, P30CA014520, 2014-0122, A532820, SMPH/OBSTET & GYNECOL/OBSTET
- Status last verified
- Nov 2016
- First submitted
- 21 Mar 2014
- Last updated
- 18 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized-Controlled, Pilot Study of the Effects of a Brief, Scripted Sexual Health Intervention on Sexual Function for Women With Gynecologic Cancer
- ClinicalTrials.gov ID
- NCT02096783
- Acronym / sponsor ID
- UW13080
- Conditions
- Anxiety Disorder, Cervical Cancer, Endometrial Cancer, Female Reproductive Cancer, Gestational Trophoblastic Tumor, Ovarian Epithelial Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 26 Mar 2014 (estimated)
- 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.
This randomized pilot clinical trial studies the feasibility of a pre-operative and/or post-operative scripted sexual health informational intervention and how well it works in improving sexual function in patients with gynecologic cancer. Discussing sexual outcomes and counseling options with patients may help improve sexual outcomes and/or anxiety after primary gynecologic cancer treatment.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the feasibility of patient recruitment, including time required to consent, enroll and retain the necessary number of participants.
II. To determine the distribution of candidate primary patient-reported outcome measures, including time to resumption of sexual activity, global satisfaction with sex life, sexual function and anxiety in this particular population.
III. To establish the prevalence of patient recall of the intervention to determine the most effective time at which to deliver the intervention.
OUTLINE: Patients are randomized to 1 of 4 treatment arms.
ARM I: Patients receive standard counseling at both the pre-operative and 2-4 week post-operative visit.
ARM II: Patients receive standard counseling at the pre-operative visit and the scripted sexual health intervention at the 2-4 week post-operative visit.
ARM III: Patients receive standard counseling and the scripted sexual health intervention at the pre-operative visit and standard counseling at the 2-4 week post-operative visit.
ARM IV: Patients receive standard counseling and the scripted sexual health intervention at both the pre-operative and 2-4 week post-operative visit.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm I (standard counseling) | Active comparator | Other: counseling intervention, Other: questionnaire administrationPatients receive standard counseling at both the pre-operative and 2-4 week post-operative visit. |
| Arm II (standard counseling, scripted intervention) | Experimental | Other: informational intervention, Other: counseling intervention, Other: questionnaire administrationPatients receive standard counseling at the pre-operative visit and the scripted sexual health intervention at the 2-4 week post-operative visit. |
| Arm III (standard counseling, scripted intervention) | Experimental | Other: informational intervention, Other: counseling intervention, Other: questionnaire administrationPatients receive standard counseling and the scripted sexual health intervention at the pre-operative visit and standard counseling at the 2-4 week post-operative visit. |
| Arm IV (standard counseling, scripted intervention) | Experimental | Other: informational intervention, Other: counseling intervention, Other: questionnaire administrationPatients receive standard counseling and the scripted sexual health intervention at both the pre-operative and 2-4 week post-operative visit. |
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)
- Patients with a new suspected or confirmed gynecologic malignancies
- Patients plan to have primary surgery at either the University of Chicago Hospital or the University of Wisconsin Hospital
- Patients must be English speaking
Key exclusion criteria (3 listed)
- Previous treatment of any cancer excluding skin cancer
- Patients with a suspected benign gynecologic process
- Patients who are prisoners or incarcerated
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 |
|---|---|---|
| informational interventionGiven scripted intervention | Other | Arm II (standard counseling, scripted intervention), Arm III (standard counseling, scripted intervention), Arm IV (standard counseling, scripted intervention) |
| counseling interventionAlso: counseling and communications studiesGiven standard counseling | Other | Arm I (standard counseling), Arm II (standard counseling, scripted intervention), Arm III (standard counseling, scripted intervention), Arm IV (standard counseling, scripted intervention) |
| questionnaire administrationAncillary studies | Other | Arm I (standard counseling), Arm II (standard counseling, scripted intervention), Arm III (standard counseling, scripted intervention), Arm IV (standard counseling, scripted intervention) |
Primary outcome
Feasibility of patient recruitment
Time frame: Up to 9 months
To inform possible issues in recruitment for a large-scale randomized controlled trial, the ratio of enrolled subjects to total eligible potential subjects as well as the time necessary to recruit those subjects will be tracked.
7 secondary outcomes
Resumption of sexual activity after cancer surgery
Time frame: Up to 9 months
Retention
Time frame: Up to 9 months
Satisfaction with sex life independent of specific sexual function measured by Patient Reported Outcomes Measurement Information System (PROMIS) Global Satisfaction with Sex Life questionnaire
Time frame: Up to 9 months
PROMIS Sexual Function Profile
Time frame: Up to 9 months
Recall of intervention
Time frame: Up to 9 months
Patient-reported anxiety measured by PROMIS Anxiety 4a short form
Time frame: Up to 6 months
Rate of referral acceptance
Time frame: Up to 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
- University of Wisconsin Carbone Cancer CenterLink provided by the sponsor.
Related trials for Anxiety Disorder
Recruiting
Electroacupuncture for Generalized Anxiety Disorder: Clinical Efficacy and Neuroimaging Mechanisms
Generalized Anxiety Disorder
Recruiting
Effects of Connective Tissue Massage Plus Biofeedback for Dyssynergic Defecation
Dyssynergic Defecation
RecruitingObservational study
Development of Magnetic Resonance Imaging Techniques for Studying Mood and Anxiety Disorders
Mood Disorders, Anxiety Disorders
RecruitingPhase 2
Study of Neuro-Cognitive Correlates of Pediatric Anxiety Disorders
Anxiety Disorders, Major Depressive Disorder
Recruiting
Virtual Reality Intervention to Improve Psychological Symptom Burden for Cancer Patients Undergoing Treatment
Adjustment Disorder, Anxiety Disorder
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.
David Kushner principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing informational intervention, counseling intervention and questionnaire administration in people with Anxiety Disorder and Cervical Cancer, run by University of Wisconsin, Madison 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 18 Nov 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 of patient recruitment (time frame: Up to 9 months). 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 18 Nov 2019.