RecruitingNot Applicable

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

United States300 participantsStarted 2025-01-27

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

Timeframe: Week 8

Trial details

NCT IDNCT06541002

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-04-30

Contact for this trial

Areej El-Jawahri, MD

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

View on ClinicalTrials.gov More Sexual Dysfunction trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.