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Trial Title:
Sexual Health and Rehabilitation Online (SHAREonline)
NCT ID:
NCT06458049
Condition:
Cancer Survivorship
Sexual Function Disturbances
Conditions: Official terms:
Sexual Dysfunctions, Psychological
Conditions: Keywords:
Cancer Survivorship
Sexual Function Disturbances
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Group Session
Description:
On-line educational session-3 modules-1 hour each for a total of 3 hours
Arm group label:
SHAREonline
Intervention type:
Behavioral
Intervention name:
Coaching Call
Description:
Single Coaching phone call at one month
Arm group label:
SHAREonline
Intervention type:
Behavioral
Intervention name:
Educational Materials
Description:
Individual videoconference session in which participants will receive a pdf of the
American Cancer Society booklet, 'Sex and the Adult Female with Cancer
Arm group label:
Individual Self Management
Summary:
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:
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.
Criteria for eligibility:
Criteria:
- Female cancer survivors age 19-49
- Cancer diagnosis (except non-melanoma skin cancer) ≥ 1 year prior
- Diagnosed with first cancer ≥ age 18
- No active cancer therapy (excluding chemoprevention) in the past four months, and no
further therapy planned
- Ability to read and write in English
- Bothered by significant sexual dysfunction as evidenced by a Female Sexual
Functioning Index (FSFI) score of ≤26.
- Regular access to the internet
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
Gender:
Female
Gender based:
Yes
Minimum age:
19 Years
Maximum age:
49 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Dana Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Start date:
December 28, 2024
Completion date:
May 31, 2027
Lead sponsor:
Agency:
Dana-Farber Cancer Institute
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Dana-Farber Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06458049
