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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-00471 | Registry Identifier | NCI Trial ID | |
| UW13080 | Other Identifier | University of Wisconsin Carbone Cancer Center | |
| P30CA014520 | U.S. NIH Grant/Contract | View source | |
| 2014-0122 | Other Identifier | Institutional Review Board | |
| A532820 | Other Identifier | UW Madison | |
| SMPH/OBSTET & GYNECOL/OBSTET | Other Identifier | UW Madison |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
PRIMARY OBJECTIVES:
I. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (standard counseling) | Active Comparator | Patients receive standard counseling at both the pre-operative and 2-4 week post-operative visit. |
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| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| informational intervention | Other | Given scripted intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 9 months |
| Retention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Kushner | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin, Madison | Madison | Wisconsin | 53792 | United States |
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| Label | URL |
|---|---|
| University of Wisconsin Carbone Cancer Center | View source |
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| counseling intervention | Other | Given standard counseling |
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| questionnaire administration | Other | Ancillary studies |
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The percentage of subjects completing the final assessment from the total number of subjects enrolled will be calculated. |
| 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. | 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. | 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. | 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. | 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. | Up to 9 months |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D002583 | Uterine Cervical Neoplasms |
| D016889 | Endometrial Neoplasms |
| D031901 | Gestational Trophoblastic Disease |
| D000077216 | Carcinoma, Ovarian Epithelial |
| D012735 | Sexual Dysfunction, Physiological |
| D014625 | Vaginal Neoplasms |
| D014846 | Vulvar Neoplasms |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D014328 | Trophoblastic Neoplasms |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D011252 | Pregnancy Complications, Neoplastic |
| D011248 | Pregnancy Complications |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D010051 | Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D014623 | Vaginal Diseases |
| D014845 | Vulvar Diseases |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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