Recruiting

SHIFT

Sponsor:

Massachusetts General Hospital

Code:

NCT06541002

Conditions

Sexual Dysfunction

Stem Cell Transplant Complications

Bone Marrow Transplant Complications

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

SHIFT Intervention Group

Enhanced Usual Care Group

Study Details

Brief summary:

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.

Conditions

Sexual Dysfunction

Stem Cell Transplant Complications

Bone Marrow Transplant Complications

Study ID

NCT06541002

Start date

Jan 27, 2025

Status verified date

Mar, 2026

Completion date

Apr 30, 2030

Anticipated

Primary completion date

Apr 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adult patients (> 18 years) who underwent autologous or allogeneic HCT > three months prior to study enrollment
  • Screen positive for sexual health concerns causing distress based on the National Comprehensive Network (NCCN) survivorship guidelines screening questions

Exclusion Criteria:

  • Patients who do not comprehend English or Spanish since SHIFT will only be available in these two languages for this efficacy trial.
  • Patients with any major uncontrolled psychiatric disorder or other comorbid cognitive conditions, which the treating HCT clinician believes would prohibit the patients' capacity to provide informed consent and participate in study procedures.
  • Patients with relapsed disease requiring treatment.

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

SHIFT Intervention Group

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

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.

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 and Locations

Central contacts

Areej El-Jawahri, MD

617-724-4000ael-jawahri@mgb.org

Sajeewani Samarakoon, PhD

ssamarakoon@mgh.harvard.edu

Locations

Massachusetts General Hospital (MGH)

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Areej El-Jawahri, MD

617-724-4000ael-jawahri@mgb.org

Sajeewani Samarakoon, PhD

ssamarakoon@mgh.harvard.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Mar 19, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-03-19.