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

NCT02287519 | Completed DMC

• 1 other identifier: 14-368
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (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 Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (1)

Support Group

EXPERIMENTAL

* 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

Interventions

Group Session BEHAVIORAL

Support Group

Telephone Coaching Session BEHAVIORAL

Support Group

Webinar BEHAVIORAL

Support Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Sharon Bober, Ph.D

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 4, 2014
• First Posted: November 10, 2014
• Study Start: November 1, 2014
• Primary Completion: February 1, 2018
• Study Completion: December 1, 2019
• Last Updated: February 28, 2020

Record last verified: 2020-02

Locations

US (2)