Scripted Sexual Health Informational Intervention in Improving Sexual Function in Patients With Gynecologic Cancer

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by University of Wisconsin, Madison
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT02096783
First received: March 21, 2014
Last updated: NA
Last verified: March 2014
History: No changes posted
  Purpose

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.


Condition Intervention
Anxiety Disorder
Cervical Cancer
Endometrial Cancer
Female Reproductive Cancer
Gestational Trophoblastic Tumor
Ovarian Epithelial Cancer
Ovarian Germ Cell Tumor
Sexual Dysfunction
Uterine Sarcoma
Vaginal Cancer
Vulvar Cancer
Other: informational intervention
Other: counseling intervention
Other: questionnaire administration

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Randomized-Controlled, Pilot Study of the Effects of a Brief, Scripted Sexual Health Intervention on Sexual Function for Women With Gynecologic Cancer

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Feasibility of patient recruitment [ Time Frame: Up to 9 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Resumption of sexual activity after cancer surgery [ Time Frame: Up to 9 months ] [ Designated as safety issue: No ]
    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.

  • Retention [ Time Frame: Up to 9 months ] [ Designated as safety issue: No ]
    The percentage of subjects completing the final assessment from the total number of subjects enrolled will be calculated.

  • 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 ] [ Designated as safety issue: No ]
    Descriptive statistics will be used to summarize survey responses overall and separately for both the experimental and control arms.

  • PROMIS Sexual Function Profile [ Time Frame: Up to 9 months ] [ Designated as safety issue: No ]
    Descriptive statistics will be used to summarize survey responses overall and separately for both the experimental and control arms.

  • Recall of intervention [ Time Frame: Up to 9 months ] [ Designated as safety issue: No ]
    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.

  • Patient-reported anxiety measured by PROMIS Anxiety 4a short form [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    Descriptive statistics will be used to summarize survey responses overall and separately for both the experimental and control arms.

  • Rate of referral acceptance [ Time Frame: Up to 9 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 30
Study Start Date: March 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I (standard counseling)
Patients receive standard counseling at both the pre-operative and 2-4 week post-operative visit.
Other: counseling intervention
Given standard counseling
Other Name: counseling and communications studies
Other: questionnaire administration
Ancillary studies
Experimental: Arm II (standard counseling, scripted intervention)
Patients receive standard counseling at the pre-operative visit and the scripted sexual health intervention at the 2-4 week post-operative visit.
Other: informational intervention
Given scripted intervention
Other: counseling intervention
Given standard counseling
Other Name: counseling and communications studies
Other: questionnaire administration
Ancillary studies
Experimental: Arm III (standard counseling, scripted intervention)
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.
Other: informational intervention
Given scripted intervention
Other: counseling intervention
Given standard counseling
Other Name: counseling and communications studies
Other: questionnaire administration
Ancillary studies
Experimental: Arm IV (standard counseling, scripted intervention)
Patients receive standard counseling and the scripted sexual health intervention at both the pre-operative and 2-4 week post-operative visit.
Other: informational intervention
Given scripted intervention
Other: counseling intervention
Given standard counseling
Other Name: counseling and communications studies
Other: questionnaire administration
Ancillary studies

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Previous treatment of any cancer excluding skin cancer
  • Patients with a suspected benign gynecologic process
  • Patients who are prisoners or incarcerated
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02096783

Locations
United States, Illinois
University of Chicago Not yet recruiting
Chicago, Illinois, United States, 60637
Contact: Seiko D. Yamada    773-834-7424    sdyamada@babies.bsd.uchicago.edu   
Principal Investigator: Seiko D. Yamada         
United States, Wisconsin
University of Wisconsin, Madison Not yet recruiting
Madison, Wisconsin, United States, 53792
Contact: David M. Kushner    800-622-8922    cancerconnect@uwcarbone.wisc.edu   
Principal Investigator: David M. Kushner         
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: David Kushner University of Wisconsin, Madison
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT02096783     History of Changes
Other Study ID Numbers: UW13080, NCI-2014-00471, UW13080, P30CA014520
Study First Received: March 21, 2014
Last Updated: March 21, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Gestational Trophoblastic Neoplasms
Anxiety Disorders
Endometrial Neoplasms
Uterine Cervical Neoplasms
Sexual Dysfunctions, Psychological
Trophoblastic Neoplasms
Vaginal Neoplasms
Vulvar Neoplasms
Neoplasms, Germ Cell and Embryonal
Germinoma
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Sarcoma
Mental Disorders
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female
Uterine Cervical Diseases
Sexual and Gender Disorders
Neoplasms by Histologic Type
Pregnancy Complications, Neoplastic
Pregnancy Complications
Vaginal Diseases
Vulvar Diseases
Endocrine Gland Neoplasms
Ovarian Diseases

ClinicalTrials.gov processed this record on July 29, 2014