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Completed

NCT Number: NCT02287519

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

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dana Farber Cancer Institute, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Group Session

Behavioral

Telephone Coaching Session

Behavioral

Webinar

Behavioral

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • Patty Brisben Foundation For Women's Sexual Health

Registry information

Acronym: START-OC

Important dates

Study start
2014
Primary completion
2018
Study completion
2019
First posted
Nov 10, 2014
Registry last updated
Feb 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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