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

Sponsor
Dana-Farber Cancer Institute (Other)
Overall Status
Completed
CT.gov ID
NCT02287519
Collaborator
Patty Brisben Foundation For Women's Sexual Health (Other)
53
Enrollment
2
Locations
1
Arm
61
Duration (Months)
26.5
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Behavioral: Group Session
  • Behavioral: Telephone Coaching Session
  • Behavioral: Webinar
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
53 participants
Allocation:
N/A
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 :
Nov 1, 2014
Actual Primary Completion Date :
Feb 1, 2018
Actual Study Completion Date :
Dec 1, 2019

Arms and Interventions

ArmIntervention/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

Outcome Measures

Primary Outcome Measures

  1. Change in sexual dysfunction will be assessed by change on the Female Sexual Function Index (FSFI). [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 [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 [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) [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 [Baseline, 2 Month Post Intervention, 6 Month Post Intervention]

    To explore and describe women's experience of webinar platform.

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Massachusetts General HospitalBostonMassachusettsUnited States02114
2Dana Farber Cancer InstituteBostonMassachusettsUnited States02115

Sponsors and Collaborators

  • Dana-Farber Cancer Institute
  • Patty Brisben Foundation For Women's Sexual Health

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sharon Bober, Ph.D, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT02287519
Other Study ID Numbers:
  • 14-368
First Posted:
Nov 10, 2014
Last Update Posted:
Feb 28, 2020
Last Verified:
Feb 1, 2020
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 28, 2020