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

Massachusetts General Hospital1 site in 1 country60 target enrollmentFebruary 1, 2019

ConditionsOther Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Other Cancer
Sponsor: Massachusetts General Hospital
Enrollment: 60
Locations: 1
Primary Endpoint: Feasibility Based on Proportion of Subjects Enrolled
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This research study is being done to evaluate whether the use of a mobile app can help transplant survivors experiencing sexual health problems.

Detailed Description

Frequently survivors of stem cell transplantation report significant problems with their sexual function that impacts their quality of life, mood, and their intimacy and relationship with their partners. These issues can be very distressing to patients and their loved ones. The study doctors want to know if the use of a mobile app intervention focused on improving sexual function may improve participants overall care.

Registry

clinicaltrials.gov

Start Date

February 1, 2019

End Date

January 1, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Massachusetts General Hospital

Responsible Party

Principal Investigator

El-Jawahri, Areej,M.D.

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

Inclusion Criteria

•Adult patients (≥18 years) who underwent an autologous or allogeneic HCT at least 3 months prior to study enrollment.
•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

•Recurrent disease requiring treatment
•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.

Outcomes

Primary Outcomes

Feasibility Based on Proportion of Subjects Enrolled

Time Frame: 2 years

feasibility will be a priori defined as at least 60% o eligible patients enrolled in the study.

Secondary Outcomes

Compare Patient-reported Orgasm (PROMIS Sexual Function and Satisfaction Measure - Orgasm Domain) Between the Study Groups(8 weeks)
Compare Patient-reported Global Satisfaction With Sex (PROMIS Sexual Function and Satisfaction Measure) Between the Study Groups(8 weeks)
Compare Patient-reported Interest in Sexual Activity (PROMIS Sexual Function and Satisfaction Measure - Interest in Sexual Activity Domain) Between the Study Groups(8 weeks)
For Males: Compare Patient-reported Erectile Function (PROMIS Sexual Function and Satisfaction Measure - Erectile Function Domain) Between the Study Groups(8 weeks)
For Females: Compare Patient-reported Lubrication and Vaginal Comfort (PROMIS Sexual Function and Satisfaction Measure - Lubrication and Vaginal Comfort Domains) Between the Study Groups(8 weeks)
Compare Patient Reported Quality of Life (FACT-BMT) Between the Study Groups(8 weeks)
Compare Patient Reported Depression Symptoms (HADS-depression) Between the Two Study Groups(8 weeks)
Compare Patient Reported Anxiety Symptoms (HADS-anxiety) Between the Two Study Groups(8 weeks)