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Behavioral Intervention

SHIFT Intervention Group for Sexual Dysfunction (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
* 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week-24
Awards & highlights

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 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

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

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

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.

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,979 Previous Clinical Trials
13,220,000 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,789 Previous Clinical Trials
40,985,995 Total Patients Enrolled
~200 spots leftby Apr 2029
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