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

Not Applicable

Completed

• Conditions: Other Cancer
• Interventions: Behavioral: Mobile App + enhanced standard care; Other: Enhanced Standard Care

• Registration Number: NCT03967379
• Lead Sponsor: Massachusetts General Hospital

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 Timeline

• Study Start: 2019-02-01
• Study First Submitted: 2019-05-27
• Study First Submitted QC: 2019-05-27
• Study First Posted: 2019-05-30
• Primary Completion: 2023-01-01
• Study Completion: 2024-01-01
• Results First Submitted: 2024-01-01
• Status Verified: 2025-02
• Results First Submitted QC: 2025-02-02
• Last Update Submitted: 2025-02-02
• Results First Posted: 2025-02-04
• Last Update Posted: 2025-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mobile app plus enhanced standard care	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 plus enhanced standard care	Mobile App + 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.
Enhanced Standard Care	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

Primary Outcome Measures

Name	Time	Method
Feasibility Based on Proportion of Subjects Enrolled	2 years	feasibility will be a priori defined as at least 60% o eligible patients enrolled in the study.

Secondary Outcome Measures

Name	Time	Method
Compare Patient-reported Global Satisfaction With Sex (PROMIS Sexual Function and Satisfaction Measure) Between the Study Groups	8 weeks	patient-reported global satisfaction using the PROMIS Sexual Function and Satisfaction Measure. Higher scores indicate better global satisfaction with sex (raw score range 4-25). We will use raw score for reporting in this study given the extent of illness in this population.
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 interest in sexual activity using the PROMIS Sexual Function and Satisfaction Measure - Interest in Sexual Activity Domain). higher score indicate better interest in sex (raw score range 2-10).
Compare Patient-reported Orgasm (PROMIS Sexual Function and Satisfaction Measure - Orgasm Domain) Between the Study Groups	8 weeks	compare patient-reported orgasm using the PROMIS Sexual Function and Satisfaction Measure - Orgasm Domain). higher score indicate better orgasm (raw score range 3-15).
For Males: Compare Patient-reported Erectile Function (PROMIS Sexual Function and Satisfaction Measure - Erectile Function Domain) Between the Study Groups	8 weeks	for males: compare patient-reported erectile function using the PROMIS Sexual Function and Satisfaction Measure - Erectile Function Domain). higher score indicate better erectile function (raw score range 0-55)
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	For females: compare patient-reported vaginal comfort and lubrication using the PROMIS Sexual Function and Satisfaction Measure- Lubrication and Vaginal Comfort Domain). higher score indicate better lubrication (raw score 0-25)
Compare Patient Reported Quality of Life (FACT-BMT) Between the Study Groups	8 weeks	compare patient-reported quality of life using the Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT). higher score indicate better quality of life (range 0-196)
Compare Patient Reported Depression Symptoms (HADS-depression) Between the Two Study Groups	8 weeks	compare patient-reported depression symptoms using Hospital Anxiety and Depression Scale (HADS-Depression). higher subscale score indicate worse depression symptoms (range 0-21)
Compare Patient Reported Anxiety Symptoms (HADS-anxiety) Between the Two Study Groups	8 weeks	compare patient-reported depression symptoms using Hospital Anxiety and Depression Scale (HADS-Anxiety). higher subscale score indicate worse anxiety symptoms (range 0-21)

Trial Locations

Locations (1)

Massachusetts General Hospital Cancer Center; 🇺🇸 Boston, Massachusetts, United States