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Behavioral Intervention

Digital App for Stem Cell Transplant Survivors (SHIFT Trial)

N/A

Waitlist Available

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Patients who do not comprehend English or Spanish since SHIFT will only be available in these two languages for this efficacy trial

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week-24

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new digital app that people can use on their own to help improve sexual health, quality of life, and mental well-being in survivors of stem cell transplants.

Who is the study for?

This trial is for individuals who have undergone a hematopoietic stem cell transplant and are experiencing sexual dysfunction or complications from the procedure. Participants should be interested in using a digital application to improve their sexual health, quality of life, and psychological well-being.

What is being tested?

The study is testing a new self-help digital app called SHIFT designed to help stem cell transplant survivors with their sexual health. It compares outcomes between those using SHIFT and those receiving enhanced usual care without the app.

What are the potential side effects?

Since this intervention involves a digital application, there are no direct medical side effects. However, users may experience emotional or psychological discomfort when addressing sensitive topics like sexual health.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I understand either English or Spanish.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week-24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week-24

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week-24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

Secondary study objectives

Anxiety symptoms as measured by the Hospital Anxiety and Depression Scale

Depression symptoms as measured by the Hospital Anxiety and Depression Scale

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

+5 more

Other study objectives

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

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

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: SHIFT Intervention GroupExperimental Treatment1 Intervention

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.

Group II: Enhanced Usual Care GroupActive Control1 Intervention

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.

0 / 1Eligibility criteria met