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

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ClinicalTrials.gov Identifier: NCT02287519
Recruitment Status : Recruiting
First Posted : November 10, 2014
Last Update Posted : December 3, 2018
Sponsor:
Collaborator:
Patty Brisben Foundation For Women's Sexual Health
Information provided by (Responsible Party):
Sharon Bober, Ph.D, Dana-Farber Cancer Institute

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

Condition or disease Intervention/treatment Phase
Ovarian Cancer Behavioral: Group Session Behavioral: Telephone Coaching Session Behavioral: Webinar Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Sexual Therapy and Rehabilitation After Treatment for Ovarian Cancer (START-OC): A Pilot Intervention
Study Start Date : November 2014
Actual Primary Completion Date : February 2018
Estimated Study Completion Date : October 2019


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



Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02287519


Contacts
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Contact: Sharon Bober, Ph.D 617-632-6547 sharon_bober@dfci.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Carolyn Krasner, MD    617-726-1941    pdicicco@partners.org   
Principal Investigator: Carolyn Krasner, MD         
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Sharon Bober, Ph.D    617-632-6547    sharon_bober@dfci.harvard.edu   
Principal Investigator: Sharon Bober, Ph.D         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Patty Brisben Foundation For Women's Sexual Health
Investigators
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Principal Investigator: Sharon Bober, Ph.D Dana-Farber Cancer Institute

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Responsible Party: Sharon Bober, Ph.D, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT02287519     History of Changes
Other Study ID Numbers: 14-368
First Posted: November 10, 2014    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: November 2018
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Carcinoma