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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized-Controlled, Pilot Study of the Effects of a Brief, Scripted Sexual Health Intervention on Sexual Function for Women With Gynecologic Cancer

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.

Detailed Summary:

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.


Sponsor: University of Wisconsin, Madison

Current 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Resumption of sexual activity after cancer surgery [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.


Original Secondary Outcome: Same as current

Information By: University of Wisconsin, Madison

Dates:
Date Received: March 21, 2014
Date Started: September 2014
Date Completion:
Last Updated: November 2, 2016
Last Verified: November 2016