A Novel Digital Application (SHIFT) to Improve Outcomes for Hematopoietic Stem Cell Transplant Survivors

Part of paid clinical trials in Coral Gables, Florida.

Sponsor
Massachusetts General Hospital
Study ID
NCT06541002
Status
Recruiting
Apply to this trial

Conditions

  • Bone Marrow Transplant Complications
  • Sexual Dysfunction
  • Stem Cell Transplant Complications

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SHIFT Intervention Group — BEHAVIORAL
    Participants assigned to SHIFT will meet with their HCT clinician for a brief medical examination to assess the need for medications for erectile dysfunction, vaginal atrophy, or genital graft-versus-host disease; and start using SHIFT at their desired pace over 8 weeks to complete five modules.
  • Enhanced Usual Care Group — BEHAVIORAL
    Participants assigned to the enhanced usual care group will meet with their HCT clinician for a brief medical examination to assess the need for medications for erectile dysfunction, vaginal atrophy, or genital graft-versus-host disease; and maybe referred to a psychologist, urologist, or gynecologist at the participants' request or at the discretion of the HCT clinician.

Study Details

This research study is evaluating the efficacy of a novel self-administered digital application for improving sexual health outcomes, quality of life, and psychological distress in hematopoietic stem cell transplant survivors.

Key Dates

Start date
Jan 27, 2025
Status verified
Mar 2026
Primary completion
Apr 30, 2029
Completion
Apr 30, 2030

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: SHIFT Intervention Group
    SHIFT is a self-administered, multi-component digital application for HCT survivors, incorporating several features to promote engagement and health behavior change, and includes gamification strategies, videos of HCT survivors, intimacy exercises, and optional content.
  • Active Comparator: Enhanced Usual Care Group
    Patients assigned to enhanced usual care group will not receive access to the SHIFT application. They will meet with their HCT clinician and maybe referred to specialist care at the patients' request or at the discretion of the HCT clinician.

Primary Outcome Measure

Global satisfaction with sex at week 8 as measured by the global satisfaction with sex domain from the Patient-Reported Outcomes Measurement Information System (PROMIS) Satisfaction with Sex Life scale. [ Time Frame: Week 8 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of MiamiCoral GablesFlorida33124
Lara Traeger, PhD
[email protected]
305-284-3012
Massachusetts General Hospital (MGH)BostonMassachusetts02114
Areej El-Jawahri, MD
[email protected]
617-724-4000
Sajeewani Samarakoon, PhD
[email protected]
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111
Jennifer Reese
[email protected]
215-214-3223

Find similar trials in Coral Gables, FL

By research site
University of Miami· Coral Gables, FLMassachusetts General Hospital (MGH)· Boston, MAFox Chase Cancer Center· Philadelphia, PA

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