Sexual Health and Rehabilitation Online (SHAREonline)

NCT ID: NCT06458049

Last Updated: 2025-02-21

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

RECRUITING

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-19

Study Completion Date

2027-05-31

Brief Summary

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SHAREonline is a study for young female cancer survivors that are experiencing changes in sexual health and function.

The purpose of this research is to compare two brief interventions delivered by videoconference to learn if they help women effectively manage these changes and restore sexual health and functioning.

Detailed Description

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The purpose of this research is to compare two brief interventions delivered by videoconference to learn if they help women effectively manage these changes and restore sexual health and functioning.

Participants in this study would first complete health questionnaires and then be randomized to take part in one of two types of education sessions delivered by an instructor over videoconference: 1) Group education session or 2) Individual self-management session.

About 56 women will receive the group education session and about 28 will receive the individual self-management session.

It is expected that about 84 women will take part in this study.

Conditions

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Cancer Survivorship Sexual Function Disturbances

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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SHAREonline

Participants will receive:

* One online group session structured around three 60-minute modules and creation of a personal action plan
* Single Coaching phone call at one month
* Questionnaires to complete at baseline, 2 and 4 Months

Group Type EXPERIMENTAL

Group Session

Intervention Type BEHAVIORAL

On-line educational session-3 modules-1 hour each for a total of 3 hours

Coaching Call

Intervention Type BEHAVIORAL

Single Coaching phone call at one month

Individual Self Management

Brief individualized session with online and written materials and guidance.

All Participants will complete study questionnaires at baseline, 2 months and 4 months post intervention

Group Type ACTIVE_COMPARATOR

Educational Materials

Intervention Type BEHAVIORAL

Individual videoconference session in which participants will receive a pdf of the American Cancer Society booklet, 'Sex and the Adult Female with Cancer

Interventions

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Group Session

On-line educational session-3 modules-1 hour each for a total of 3 hours

Intervention Type BEHAVIORAL

Coaching Call

Single Coaching phone call at one month

Intervention Type BEHAVIORAL

Educational Materials

Individual videoconference session in which participants will receive a pdf of the American Cancer Society booklet, 'Sex and the Adult Female with Cancer

Intervention Type BEHAVIORAL

Eligibility Criteria

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Exclusion Criteria

* Has never been sexually active
* Any impairment (e.g., hearing, visual, cognitive) that interferes with the ability to complete all study procedures independently
Minimum Eligible Age

19 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

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, PhD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

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Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sharon Bober, PhD

Role: CONTACT

617-632-6547

Facility Contacts

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Sharon Bober, Ph.D

Role: primary

617-632-6547

Other Identifiers

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R21CA279278

Identifier Type: NIH

Identifier Source: secondary_id

View Link

21-697

Identifier Type: -

Identifier Source: org_study_id

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