Skip to main content
OpenTrials
Completed

NCT Number: NCT02096783

Scripted Sexual Health Informational Intervention in Improving Sexual Function in Patients 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anxiety Disorder Adnexal Diseases Anxiety Disorders Carcinoma Carcinoma, Ovarian Epithelial Cervical Cancer Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Cancer Endometrial Neoplasms Female Reproductive Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gestational Trophoblastic Disease Gestational Trophoblastic Tumor Gonadal Disorders Mental Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Ovarian Diseases Ovarian Epithelial Cancer Ovarian Germ Cell Tumor Ovarian Neoplasms Pregnancy Complications Pregnancy Complications, Neoplastic Sexual Dysfunction Sexual Dysfunction, Physiological Trophoblastic Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Uterine Sarcoma Vaginal Cancer Vaginal Diseases Vaginal Neoplasms Vulvar Cancer Vulvar Diseases Vulvar Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin, Madison

Madison, Wisconsin, 53792, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Informational intervention

Other

Given scripted intervention

counseling intervention

Other

Given standard counseling

Other names: counseling and communications studies

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Mar 26, 2014
Registry last updated
Nov 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.