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

Primary Purpose

Ovarian Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group Session
Telephone Coaching Session
Webinar
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Ovarian Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Massachusetts General Hospital
  • Dana Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Support Group

Arm Description

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

Outcomes

Primary Outcome Measures

Change in sexual dysfunction will be assessed by change on the Female Sexual Function Index (FSFI).

Secondary Outcome Measures

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

Full Information

First Posted
November 4, 2014
Last Updated
February 27, 2020
Sponsor
Dana-Farber Cancer Institute
Collaborators
Patty Brisben Foundation For Women's Sexual Health
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1. Study Identification

Unique Protocol Identification Number
NCT02287519
Brief Title
Sexual Therapy and Rehabilitation After Treatment for Ovarian Cancer (START-OC): A Pilot Intervention
Acronym
START-OC
Official Title
Sexual Therapy and Rehabilitation After Treatment for Ovarian Cancer (START-OC): A Pilot Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
December 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Patty Brisben Foundation For Women's Sexual Health

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This research study is evaluating an educational intervention for women who have experienced changes in sexual function after treatment for ovarian cancer.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Support Group
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Group Session
Intervention Type
Behavioral
Intervention Name(s)
Telephone Coaching Session
Intervention Type
Behavioral
Intervention Name(s)
Webinar
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
Feasibility of conducting a group sexual health intervention via webinar format will be assessed with descriptive data and qualitative feedback from participants
Description
To explore and describe women's experience of webinar platform.
Time Frame
Baseline, 2 Month Post Intervention, 6 Month Post Intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon Bober, Ph.D
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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