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

NCT06541002 | Recruiting DMC

• 2 other identifiers: 24-2561R01CA282182-01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• 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.

  To compare patient global satisfaction with sex scores at week 8 after enrollment between those receiving SHIFT versus enhanced usual care as measured by the PROMIS global satisfaction with sex domain from the PROMIS Scale v2.0 Satisfaction with Sex Life. Higher scores indicate higher satisfaction with sex life, and lower scores indicate less satisfaction with sex life.

  Week 8

Secondary Outcomes (8)

• Global satisfaction with sex (longitudinally) as measured by the global satisfaction with sex domain from the PROMIS Satisfaction with Sex Life scale

  Up to week-24

• Sexual interest as measured by the interest in sexual activity domain from the PROMIS Sexual Function and Satisfaction scale

  Up to week-24

• Sexual function (orgasm) as measured by the by the Orgasm - Pleasure domain from the PROMIS Sexual Function and Satisfaction scale

  Up to week-24

• Sexual function (vaginal discomfort, and vaginal lubrication) as measured by the Female Sexual Function Index scale

  Up to week-24

• Erectile function as measured by the International Index of Erectile Function scale

  Up to week-24

Other Outcomes (3)

• The proportion of participants who are sexually active using the PROMIS Sexual Activity Screener

  Up to week-24

• Emotional and sexual intimacy as measured by the emotional and sexual intimacy subscales in Personal Assessment of Intimacy in Relationship scale

  Up to week-24

• To compare participants' self-efficacy for discussing sexual health with their transplant clinicians using the Self-Efficacy Questionnaire

  Up to week-24

Study Arms (2)

SHIFT Intervention Group

EXPERIMENTAL

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.

Behavioral: SHIFT Intervention Group

Enhanced Usual Care Group

ACTIVE COMPARATOR

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.

Behavioral: Enhanced Usual Care Group

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.

SHIFT Intervention Group

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.

Enhanced Usual Care Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

University of Miami

Coral Gables, Florida, 33124, United States

NOT YET RECRUITING

Massachusetts General Hospital (MGH)

Boston, Massachusetts, 02114, United States

RECRUITING

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Central Study Contacts

Areej El-Jawahri, MD

CONTACT

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

Sajeewani Samarakoon, PhD

CONTACT

ssamarakoon@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: August 7, 2024
• Study Start: January 27, 2025
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): April 30, 2030
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Mass General Brigham Innovation team

Locations

US (3)