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Clinical Trials/NCT03967379
NCT03967379CompletedNot Applicable

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

Massachusetts General Hospital1 site in 1 country60 target enrollmentStarted: February 1, 2019Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
1
Primary Endpoint
Feasibility Based on Proportion of Subjects Enrolled
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Mobile app plus enhanced standard care

Experimental
  • 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.

Intervention: Mobile App + enhanced standard care (Behavioral)

Mobile app plus enhanced standard care

Experimental
  • 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.

Intervention: Enhanced Standard Care (Other)

Enhanced Standard Care

Other
  • 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

Intervention: Enhanced Standard Care (Other)

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 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)
  • Compare Patient-reported Orgasm (PROMIS Sexual Function and Satisfaction Measure - Orgasm 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

El-Jawahri, Areej,M.D.

Principal Investigator

Massachusetts General Hospital

Study Sites (1)

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