Digital application to improve sexual health for stem cell transplant survivors
Multi-Site Randomized Controlled Trial of a Novel Digital Application (SHIFT) to Improve Outcomes for Hematopoietic Stem Cell Transplant Survivors
This study is testing a new app to help survivors of stem cell transplants improve their sexual health and overall well-being.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 3 sites (Coral Gables, Florida and 2 other locations) |
| Trial ID | NCT06541002 on ClinicalTrials.gov |
What this trial studies
This research evaluates a novel self-administered digital application designed to enhance sexual health outcomes, quality of life, and reduce psychological distress in survivors of hematopoietic stem cell transplants. The study addresses the significant sexual dysfunction experienced by these patients, which is a common long-term complication following treatment. By utilizing a multimodal approach, the intervention aims to empower survivors to communicate their sexual health concerns with their clinicians, thereby improving their overall well-being. Participants will be divided into two groups: one receiving the SHIFT intervention and the other receiving enhanced usual care.
Who should consider this trial
Good fit: Ideal candidates are adult patients over 18 who have undergone autologous or allogeneic hematopoietic stem cell transplant more than three months prior and are experiencing distress related to sexual health concerns.
Not a fit: Patients who do not comprehend English or Spanish, or those with major uncontrolled psychiatric disorders that affect their capacity to participate, may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the sexual health and quality of life for hematopoietic stem cell transplant survivors.
How similar studies have performed: While there is a lack of tailored interventions for sexual health in HCT survivors, similar approaches in other populations have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Coral Gables, Florida and 2 other locations
- University of Miami — Coral Gables, Florida, United States (Not_yet_recruiting)
- Massachusetts General Hospital (MGH) — Boston, Massachusetts, United States (Recruiting)
- Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States (Not_yet_recruiting)
Study contacts
- Study coordinator: Areej El-Jawahri, MD
- Email: ael-jawahri@mgb.org
- Phone: 617-724-4000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.