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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Other Cancer
• Intervention / Treatment: Behavioral: Mobile App + enhanced standard care; Other: Enhanced Standard Care

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Areej El-Jawahri, MD; Phone Number: 617-643-4003; Email: AEL-JAWAHRI@PARTNERS.ORG

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Mobile App + enhanced standard care; An intervention to help address sexual dysfunction among HCT survivors; Other: Enhanced Standard Care; Standard of care administered by the institution
Other: 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	Other: Enhanced Standard Care; Standard of care administered by the institution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the feasibility of the intervention	feasibility will be defined if at least 60% of eligible patients enroll and engage with at least 70% of the intervention modules	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare patient-reported global satisfaction with sex (PROMIS Sexual Function and Satisfaction Measure) between the study groups	patient-reported global satisfaction using the PROMIS Sexual Function and Satisfaction Measure. Higher scores indicate better global satisfaction with sex (there is a raw and T score. T score range 0-100)	8 and 12 weeks
Compare patient-reported interest in sexual activity (PROMIS Sexual Function and Satisfaction Measure - Interest in sexual activity domain) between the study groups	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 (there is a raw and T score, T score range 0-100)	8 and 12 weeks
Compare patient-reported orgasm (PROMIS Sexual Function and Satisfaction Measure - Orgasm domain) between the study groups	compare patient-reported orgasm using the PROMIS Sexual Function and Satisfaction Measure - Orgasm Domain). higher score indicate better orgasm (there is a raw and t-score, t-score range 0-100)	8 and 12 weeks
For males: compare patient-reported erectile function (PROMIS Sexual Function and Satisfaction Measure - Erectile function domain) between the study groups	for males: compare patient-reported erectile function using the PROMIS Sexual Function and Satisfaction Measure - Erectile Function Domain). higher score indicate better erectile function (there is a raw and t-score, T-score range 0-100)	8 and 12 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	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 and vagina comfort (there is a raw and T-score, T-score range 0-100)	8 and 12 weeks
Compare patient reported quality of life (FACT-BMT) between the study groups	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)	8 and 12 weeks
Compare patient reported depression symptoms (HADS-depression) between the two study groups	compare patient-reported depression symptoms using Hospital Anxiety and Depression Scale (HADS-Depression). higher subscale score indicate worse depression symptoms (range 0-21)	8 and 12 weeks
Compare patient reported anxiety symptoms (HADS-anxiety) between the two study groups	compare patient-reported depression symptoms using Hospital Anxiety and Depression Scale (HADS-Anxiety). higher subscale score indicate worse anxiety symptoms (range 0-21)	8 and 12 weeks

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Areej El-Jawahri, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): January 1, 2023
• Study Completion (Estimated): January 1, 2024

Study Registration Dates

• First Submitted: May 27, 2019
• First Submitted That Met QC Criteria: May 27, 2019
• First Posted (Actual): May 30, 2019

Study Record Updates

• Last Update Posted (Actual): November 27, 2023
• Last Update Submitted That Met QC Criteria: November 23, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Other Cancer
• Other Study ID Numbers: 19-104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: BCH - Contact the Technology & Innovation Development Office at www.childrensinnovations.org or email TIDO@childrens.harvard.edu BIDMC - Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu BWH - Contact the Partners Innovations team at http://www.partners.org/innovation DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu MGH - Contact the Partners Innovations team at http://www.partners.org/innovation
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No