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

Sponsor

University of Wisconsin, Madison (Other)

Overall Status

Completed

CT.gov ID

NCT02096783

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arms

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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. Discussing sexual outcomes and counseling options with patients may help improve sexual outcomes and/or anxiety after primary gynecologic cancer treatment.

Condition or Disease	Intervention/Treatment	Phase
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	N/A

Detailed Description

PRIMARY OBJECTIVES:

To evaluate the feasibility of patient recruitment, including time required to consent, enroll and retain the necessary number of participants.
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.
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

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

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

Study Start Date :

Sep 1, 2014

Actual Primary Completion Date :

Jun 1, 2015

Actual Study Completion Date :

Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: 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 Names: 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 Names: counseling and communications studies Other: questionnaire administration Ancillary studies

Outcome Measures

Primary Outcome Measures

Feasibility of patient recruitment [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.

Secondary Outcome Measures

Resumption of sexual activity after cancer surgery [Up to 9 months]
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 [Up to 9 months]
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 [Up to 9 months]
Descriptive statistics will be used to summarize survey responses overall and separately for both the experimental and control arms.
PROMIS Sexual Function Profile [Up to 9 months]
Descriptive statistics will be used to summarize survey responses overall and separately for both the experimental and control arms.
Recall of intervention [Up to 9 months]
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 [Up to 6 months]
Descriptive statistics will be used to summarize survey responses overall and separately for both the experimental and control arms.
Rate of referral acceptance [Up to 9 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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