Multimodal Mobile Intervention Application (App) to Address Sexual Dysfunction in Hematopoietic Stem Cell Transplant Survivors
NCT ID: NCT03967379
Last Updated: 2025-02-04
Study Results
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View full resultsBasic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2019-02-01
2024-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Mobile app plus enhanced standard care
* Patients will received enhanced standard care in addition to access to the sexual health mobile app.
* The app will also prompt patients to engage their partners with specific exercises.
Mobile App + enhanced standard care
An intervention to help address sexual dysfunction among HCT survivors
Enhanced Standard Care
Standard of care administered by the institution
Enhanced Standard Care
* Patients will receive Enhanced Standard Care
* Patients will meet with a transplant clinician for a brief medical examination to assess the need for medications for erectile dysfunction, vaginal atrophy, or vulvovaginal GVHD
* Patients will not have access to the sexual health mobile app
Enhanced Standard Care
Standard of care administered by the institution
Interventions
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Mobile App + enhanced standard care
An intervention to help address sexual dysfunction among HCT survivors
Enhanced Standard Care
Standard of care administered by the institution
Eligibility Criteria
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Inclusion Criteria
* Ability to speak English or able to complete questionnaires with assistance required from an interpreter or family member.
* Positive screen for sexual dysfunction that is causing distress based on the NCCN survivorship guidelines
Exclusion Criteria
* Significant uncontrolled psychiatric disorder (psychotic disorder, bipolar disorder, major depression) or other co-morbid disease (dementia, cognitive impairment), which the treating clinician believes prohibits the ability to participate in study procedures.
18 Years
ALL
No
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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El-Jawahri, Areej,M.D.
Principal Investigator
Principal Investigators
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Areej El-Jawahri, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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19-104
Identifier Type: -
Identifier Source: org_study_id
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