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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02287519
Acronym
START-OC
Enrollment
53
Registered
2014-11-10
Start date
2014-11-30
Completion date
2019-12-31
Last updated
2020-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

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.

Interventions

BEHAVIORALGroup Session
BEHAVIORALTelephone Coaching Session
BEHAVIORALWebinar

Sponsors

Patty Brisben Foundation For Women's Sexual Health
CollaboratorOTHER
Dana-Farber Cancer Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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)

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frameDescription
Change in sexual self-efficacy will be assessed by change on the Sexual Self-Efficacy ScaleBaseline, 2 Month Post Intervention, 6 Month Post Intervention
Improvement in sexual knowledge will be assessed by change on the Sexual Knowledge after Ovarian Cancer questionnaireBaseline, 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 participantsBaseline, 2 Month Post Intervention, 6 Month Post InterventionTo explore and describe women's experience of webinar platform.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026