Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Improving Sexual Health in Gynecologic Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03827993
Recruitment Status : Recruiting
First Posted : February 4, 2019
Last Update Posted : February 28, 2020
Sponsor:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Tracking Information
First Submitted Date  ICMJE January 31, 2019
First Posted Date  ICMJE February 4, 2019
Last Update Posted Date February 28, 2020
Actual Study Start Date  ICMJE March 26, 2019
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 19, 2019)
Change in sexual dysfunction as measured by FSFI [ Time Frame: At 3, 6, 9, and 12 months from start of treatment ]
Change in sexual function as measured by FSFI, a 19-question, standardized scale of female sexual function, validated in cancer survivors as compared to start of study.
Original Primary Outcome Measures  ICMJE
 (submitted: January 31, 2019)
  • Change in sexual dysfunction as measured by FSFI [ Time Frame: 3 months from start of treatment ]
    Change in sexual function as measured by FSFI, a 19-question, standardized scale of female sexual function, validated in cancer survivors as compared to start of study.
  • Change in sexual dysfunction as measured by FSFI [ Time Frame: 6 months from start of treatment ]
    Change in sexual function as measured by FSFI, a 19-question, standardized scale of female sexual function, validated in cancer survivors as compared to start of study.
  • Change in sexual dysfunction as measured by FSFI [ Time Frame: 9 months from start of treatment ]
    Change in sexual function as measured by FSFI, a 19-question, standardized scale of female sexual function, validated in cancer survivors as compared to start of study.
  • Change in sexual dysfunction as measured by FSFI [ Time Frame: 12 months from start of treatment ]
    Change in sexual function as measured by FSFI, a 19-question, standardized scale of female sexual function, validated in cancer survivors as compared to start of study.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2019)
  • Change in sexual distress as measured by FSDS [ Time Frame: At 3, 6, 9, and 12 months from start of treatment ]
    Change in sexual distress score as measured by FSDS, a 13-question, validated questionnaire assessing sexually related personal distress in women with female sexual dysfunction. This questionnaire will be used for follow up visits to help assess the level of distress participants are enduring related to their sexual dysfunction.
  • Change in psychologic distress as measured by Kessler K10 Scale [ Time Frame: At 3, 6, 9, and 12 months from start of treatment ]
    Change in psychologic distress as measured by Kessler K10 Scale, a 10-question, validated questionnaire assessing psychological distress. This survey will be used at follow up visits to help determine baseline psychological distress unrelated to sexual distress for a more global picture of the participants' coping throughout their illness. Scores range from 10 to 50 with higher scores indicating worse distress symptoms.
  • Change in clinical assessment of vaginal symptoms as measured by VAS [ Time Frame: At 3, 6, 9, and 12 months from start of treatment ]
    Change in vaginal symptoms as measured by VAS, a 4-item validated clinical measure of vaginal health, with scores ranging from 0-12 and higher scores indicating worse symptoms.
  • Change in clinical assessment of vulvar symptoms as measured by VuAS [ Time Frame: At 3, 6, 9, and 12 months from start of treatment ]
    Change in vulvar symptoms as measured by VAS, a 4-item validated clinical measure of vulvar health with scores ranging from 0-12 and higher scores indicating worse symptoms.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2019)
  • Change in sexual distress as measured by FSDS [ Time Frame: 3 months from start of treatment ]
    Change in sexual distress score as measured by FSDS, a 13-question, validated questionnaire assessing sexually related personal distress in women with female sexual dysfunction. This questionnaire will be used for follow up visits to help assess the level of distress patients are enduring related to their sexual dysfunction.
  • Change in sexual distress as measured by FSDS [ Time Frame: 6 months from start of treatment ]
    Change in sexual distress score as measured by FSDS, a 13-question, validated questionnaire assessing sexually related personal distress in women with female sexual dysfunction. This questionnaire will be used for follow up visits to help assess the level of distress patients are enduring related to their sexual dysfunction.
  • Change in sexual distress as measured by FSDS [ Time Frame: 9 months from start of treatment ]
    Change in sexual distress score as measured by FSDS, a 13-question, validated questionnaire assessing sexually related personal distress in women with female sexual dysfunction. This questionnaire will be used for follow up visits to help assess the level of distress patients are enduring related to their sexual dysfunction.
  • Change in sexual distress as measured by FSDS [ Time Frame: 12 months from start of treatment ]
    Change in sexual distress score as measured by FSDS, a 13-question, validated questionnaire assessing sexually related personal distress in women with female sexual dysfunction. This questionnaire will be used for follow up visits to help assess the level of distress patients are enduring related to their sexual dysfunction.
  • Change in psychologic distress as measured by Kessler K10 Scale [ Time Frame: 3 months from start of treatment ]
    Change in psychologic distress as measured by Kessler K10 Scale, a 10-question, validated questionnaire assessing psychological distress. This survey will be used at follow up visits to help determine baseline psychological distress unrelated to sexual distress for a more global picture of the patient's coping throughout their illness.
  • Change in psychologic distress as measured by Kessler K10 Scale [ Time Frame: 6 months from start of treatment ]
    Change in psychologic distress as measured by Kessler K10 Scale, a 10-question, validated questionnaire assessing psychological distress. This survey will be used at follow up visits to help determine baseline psychological distress unrelated to sexual distress for a more global picture of the patient's coping throughout their illness.
  • Change in psychologic distress as measured by Kessler K10 Scale [ Time Frame: 9 months from start of treatment ]
    Change in psychologic distress as measured by Kessler K10 Scale, a 10-question, validated questionnaire assessing psychological distress. This survey will be used at follow up visits to help determine baseline psychological distress unrelated to sexual distress for a more global picture of the patient's coping throughout their illness.
  • Change in psychologic distress as measured by Kessler K10 Scale [ Time Frame: 12 months from start of treatment ]
    Change in psychologic distress as measured by Kessler K10 Scale, a 10-question, validated questionnaire assessing psychological distress. This survey will be used at follow up visits to help determine baseline psychological distress unrelated to sexual distress for a more global picture of the patient's coping throughout their illness.
  • Change in clinical assessment of vaginal symptoms as measured by VAS [ Time Frame: 3 months from start of treatment ]
    Change in vaginal symptoms as measured by VAS, a 4-item validated clinical measure of vaginal health.
  • Change in clinical assessment of vaginal symptoms as measured by VAS [ Time Frame: 6 months from start of treatment ]
    Change in vaginal symptoms as measured by VAS, a 4-item validated clinical measure of vaginal health.
  • Change in clinical assessment of vaginal symptoms as measured by VAS [ Time Frame: 9 months from start of treatment ]
    Change in vaginal symptoms as measured by VAS, a 4-item validated clinical measure of vaginal health.
  • Change in clinical assessment of vaginal symptoms as measured by VAS [ Time Frame: 12 months from start of treatment ]
    Change in vaginal symptoms as measured by VAS, a 4-item validated clinical measure of vaginal health.
  • Change in clinical assessment of vulvar symptoms as measured by VuAS [ Time Frame: 3 months from start of treatment ]
    Change in vulvar symptoms as measured by VAS, a 4-item validated clinical measure of vulvar health.
  • Change in clinical assessment of vulvar symptoms as measured by VuAS [ Time Frame: 6 months from start of treatment ]
    Change in vulvar symptoms as measured by VAS, a 4-item validated clinical measure of vulvar health.
  • Change in clinical assessment of vulvar symptoms as measured by VuAS [ Time Frame: 9 months from start of treatment ]
    Change in vulvar symptoms as measured by VAS, a 4-item validated clinical measure of vulvar health.
  • Change in clinical assessment of vulvar symptoms as measured by VuAS [ Time Frame: 12 months from start of treatment ]
    Change in vulvar symptoms as measured by VAS, a 4-item validated clinical measure of vulvar health.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Improving Sexual Health in Gynecologic Cancer Patients
Official Title  ICMJE Improving Sexual Health in Gynecologic Cancer Patients
Brief Summary This study seeks to find out if an early intervention of providing directed sexual health education and treatment for gynecologic cancer patients will improve patient outcomes as compared to routine clinic visits.
Detailed Description

Participants will be randomly placed to one of two groups. This random placement allows our research study to be more significant when the study team checks the results. In one group, the "control" group, participants will attend their usual clinic visits with their provider every 3 months for a year. At each clinic visit participants will be asked to fill out 3 short surveys (each takes less than 3 minutes). Participants will have a gynecologic exam like they routinely would for cancer surveillance, and confidential notes will be made regarding their exam to assess for improvement or worsening over time.

In the other group, the "intervention" group, participants will attend one focused Sexual Health Clinic visit, where a provider specialized in sexual health for cancer patients will review a focused history and physical, and will provide education, as well as recommend any helpful treatments.

This provider may or may not recommend follow up with her again after this initial visit. Participants will otherwise continue the usual every 3 month clinic visits with their Gynecologic Oncologist for a year. At each clinic visit participants will be asked to fill out 3 short surveys (each takes less than 3 minutes). Participants will have a gynecologic exam like they routinely would for cancer surveillance, and confidential notes will be made regarding their exam to assess for improvement or worsening over time. Participants will not need any additional blood draws or procedures. During their gynecologic exam, a swab will be collected to test participants vaginal pH - a test to see the health of their vaginal flora.

In brief, participants will have their usual 4 clinic visits: one at 3 months, 6 months, 9 months, and 12 months. At each visit, participants will fill out 3 surveys and have a gynecologic exam performed as they usually would, but with a vaginal swab for vaginal pH. This swab will be assessed in the clinic by their provider as the swab will change colors to show pH at the time of exam. This result will be noted in the participants' chart and the swab will be discarded.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Gynecologic Cancer
Intervention  ICMJE Behavioral: dedicated sexual health clinic appointment
Intervention will consist of a dedicated sexual health clinic appointment with a physician provider focused on sexual health in this population. This provider will perform a focused history and physical, and will then determine need for appropriate treatment and management, which may consist of recommendations for medications, psychosocial counseling, physical therapy, and/or dilator use, but are not required.
Study Arms  ICMJE
  • No Intervention: Routine surveillance

    Routine surveillance consists of attending gynecologic oncology office visits and being provided with an educational pamphlet discussing common sexual health concerns in gynecologic cancer patients, describing vaginal dilators, moisturizers, and lubrication. Resources for psychosocial counseling, physical therapy, and the sexual health clinic will be provided as well.

    Participants will have follow up at baseline, 3, 6, 9, and 12 months. Baseline visit consists of the initial visit where the Female Sexual Function Index (FSFI) screen was performed. Subsequent follow up visits will consist of FSFI, Female Sexual Distress Scale (FSDS), Kessler 10 surveys, and clinical assessment with Vaginal Assessment Scale and Vulvar Assessment Scale (VAS and VuAS).

  • Experimental: Dedicated sexual health clinic appointment

    Dedicated sexual health clinic appointment with a physician provider focused on sexual health in this population. This will consist of the provider performing a focused history and physical, who will then determine need for appropriate treatment and management, which may consist of recommendations for medications, psychosocial counseling, physical therapy, and/or dilator use, but are not required.

    The participants will follow up at 3, 6, 9, and 12 months after initial visit, either with the sexual health focused provider or their primary gynecologic oncologist, as determined by the needs of the participant per the provider.

    Intervention: Behavioral: dedicated sexual health clinic appointment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 31, 2019)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2020
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Able to consent
  • Screening positive for sexual health dysfunction as per baseline FSFI
  • Diagnosed with any gynecologic malignancy

It is acceptable to have received treatment prior to or during enrollment, including prior surgery, chemotherapy, radiation, hormonal therapy, or clinical trial.

Exclusion Criteria:

  • Unable to speak English
  • Patients unable to consent
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Stephanie Ricci, MD 886-223-8100 CancerCenterResearch@ccf.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03827993
Other Study ID Numbers  ICMJE CASE14818
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Sensitive personal information collected regarding sexual health, concern for recruitment of patients with data sharing
Responsible Party Case Comprehensive Cancer Center
Study Sponsor  ICMJE Case Comprehensive Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stephanie Ricci, MD The Cleveland Clinic
PRS Account Case Comprehensive Cancer Center
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP