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

NCT ID: NCT02287519

Last Updated: 2020-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2019-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Ovarian Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Group Session

Intervention Type BEHAVIORAL

Telephone Coaching Session

Intervention Type BEHAVIORAL

Webinar

Intervention Type BEHAVIORAL

Interventions

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Group Session

Intervention Type BEHAVIORAL

Telephone Coaching Session

Intervention Type BEHAVIORAL

Webinar

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Patty Brisben Foundation For Women's Sexual Health

OTHER

Sponsor Role collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Sharon Bober, Ph.D

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sharon Bober, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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14-368

Identifier Type: -

Identifier Source: org_study_id

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