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Behavioral Intervention

Mobile App Intervention for Sexual Dysfunction in Cancer Survivors

N/A

Waitlist Available

Led By Areej El-Jawahri, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial will test whether a mobile app can help transplant survivors with sexual health problems.

Who is the study for?

This trial is for adult hematopoietic stem cell transplant survivors, at least 18 years old, who have been through the procedure at least 3 months ago and are experiencing distressing sexual dysfunction. Participants must speak English or be able to complete surveys with help.Check my eligibility

What is being tested?

The study is testing if a mobile app combined with enhanced standard care can improve sexual health in transplant survivors. It compares outcomes between those using the app plus enhanced care versus those receiving only enhanced care.See study design

What are the potential side effects?

Since this trial involves a mobile application and not medication, traditional side effects are not expected. However, users may experience emotional or psychological responses to the content.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To assess the feasibility of the intervention

Secondary outcome measures

Compare patient reported anxiety symptoms (HADS-anxiety) between the two study groups

Compare patient reported depression symptoms (HADS-depression) between the two study groups

Compare patient reported quality of life (FACT-BMT) between the study groups

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Mobile app plus enhanced standard careExperimental Treatment2 Interventions

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.

Group II: Enhanced Standard CareExperimental Treatment1 Intervention

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,928 Previous Clinical Trials

13,198,295 Total Patients Enrolled

4 Trials studying Other Cancers

30,291 Patients Enrolled for Other Cancers

Areej El-Jawahri, MDPrincipal InvestigatorMassachusetts General Hospital

18 Previous Clinical Trials

4,452 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research project currently open to participants?

"According to the clinicaltrials.gov website, this research project is currently enrolling patients. The trial was initially launched on February 1st 2019 and its most recent revision took place on August 23rd 2022."

Answered by AI

How many participants have been accepted into this trial?

"Affirmative. According to clinicaltrials.gov, this research endeavour is actively recruiting participants who responded to the original invitation on February 1st 2019 and subsequent update of August 23rd 2022. A total of 60 individuals must be enrolled from a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Multimodal Mobile Intervention Application (App) to Address Sexual Dysfunction in Hematopoietic Stem Cell Transplant Survivors

El-Jawahri, Areej,M.D. 2019. "Multimodal Mobile Intervention Application (App) to Address Sexual Dysfunction in Hematopoietic Stem Cell Transplant Survivors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03967379.