Sexual Therapy and Rehabilitation After Treatment for Ovarian Cancer (START-OC): A Pilot Intervention (START-OC)

February 27, 2020 updated by: Sharon Bober, Ph.D, Dana-Farber Cancer Institute
This research study is evaluating an educational intervention for women who have experienced changes in sexual function after treatment for ovarian cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this research is to study the effectiveness of an educational intervention for women who have experienced changes in sexual function after treatment for ovarian cancer. The aim is to develop an effective intervention to help women manage these changes and restore sexual health and functioning. This study consists of attending a group educational session followed by a one-on-one telephone counseling session.

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02115
        • Dana Farber Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women diagnosed with Stage1-IV ovarian cancer
  • Prognosis of at least one year to live (as assessed by provider)
  • Endorsement of at least one sexual symptom (see Appendix A for eligibility screening)
  • English speaking
  • Signed informed consent

Exclusion Criteria:

  • History of pelvic radiation
  • Cognitive impairment which would interfere with the ability to participate in the study (as assessed by provider)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Support Group
  • One group educational session will include information on resources, self-help strategies, and relaxation techniques.
  • One telephone coaching session after the group session Or
  • Pilot webinar format of the educational session
Behavioral: Group Session
Behavioral: Telephone Coaching Session
Behavioral: Webinar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in sexual dysfunction will be assessed by change on the Female Sexual Function Index (FSFI).
Time Frame: Baseline, 2 month Post Intervention, 6 Month Post Intervention
Baseline, 2 month Post Intervention, 6 Month Post Intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in sexual self-efficacy will be assessed by change on the Sexual Self-Efficacy Scale
Time Frame: Baseline, 2 Month Post Intervention, 6 Month Post Intervention
Baseline, 2 Month Post Intervention, 6 Month Post Intervention
Improvement in sexual knowledge will be assessed by change on the Sexual Knowledge after Ovarian Cancer questionnaire
Time Frame: Baseline, 2 Month Post Intervention, 6 Month Post Intervention
Baseline, 2 Month Post Intervention, 6 Month Post Intervention
Change in psychological distress will be assessed by change on the BSI-18 (Brief Symptom Inventory)
Time Frame: Baseline, 2 Month Post Intervention, 6 Month Post Intervention
Baseline, 2 Month Post Intervention, 6 Month Post Intervention
Feasibility of conducting a group sexual health intervention via webinar format will be assessed with descriptive data and qualitative feedback from participants
Time Frame: Baseline, 2 Month Post Intervention, 6 Month Post Intervention
To explore and describe women's experience of webinar platform.
Baseline, 2 Month Post Intervention, 6 Month Post Intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

Patty Brisben Foundation For Women's Sexual Health

Investigators

  • Principal Investigator: Sharon Bober, Ph.D, Dana-Farber Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

November 4, 2014

First Submitted That Met QC Criteria

November 7, 2014

First Posted (Estimate)

November 10, 2014

Study Record Updates

Last Update Posted (Actual)

February 28, 2020

Last Update Submitted That Met QC Criteria

February 27, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-368

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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