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Multimodal Sexual Dysfunction Intervention for Bone Marrow Transplant Survivors

N/A

Waitlist Available

Led By Areej El-Jawhri, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

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

Must have

Positive screen for sexual dysfunction that is causing distress based on the National Comprehensive Cancer Network (NCCN) survivorship guidelines.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Awards & highlights

Study Summary

This trial is studying an intervention to improve sexual function in stem cell transplant survivors. The trial will look at sexual function, quality of life, and mood.

Who is the study for?

This trial is for adults who've had a stem cell transplant at least three months ago, are experiencing distressing sexual dysfunction, and can understand English or have an interpreter. It's not for those over five years post-transplant, with relapsed disease needing treatment, planning another transplant, or with certain psychiatric conditions.Check my eligibility

What is being tested?

The study compares two approaches: a multimodal intervention designed to address sexual dysfunction versus enhanced standard care. The goal is to see which method better improves sexual function, quality of life, and mood in stem cell transplant survivors.See study design

What are the potential side effects?

Since this trial focuses on interventions like counseling rather than medication, side effects may be minimal but could include emotional discomfort or increased anxiety when discussing personal issues related to sexual function.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am experiencing sexual dysfunction that is distressing to me.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Compare Patient Global Satisfaction with Sex

Secondary outcome measures

Compare Patient Reported Anxiety Symptoms

Compare Patient Reported Anxiety Symptoms Longitudinally

Compare Patient Reported Depression Symptoms

+14 more

Trial Design

2Treatment groups

Active Control

Group I: Enhanced Standard CareActive Control1 Intervention

Baseline data collection, registration and randomization Inform primary transplant clinician of sexual dysfunction causing distress Receive American Cancer Society sexual educational material

Group II: Multimodal Intervention to Address Sexual DysfunctionActive Control1 Intervention

Baseline data collection, registration and randomization 3 Monthly visits with trained study nurse practitioners Referral to specialist if Psychological etiology Sexual Trauma Relationship Discord Concern for Malignancy or anatomic scarring requiring surgery

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Leukemia and Lymphoma SocietyOTHER

81 Previous Clinical Trials

16,861 Total Patients Enrolled

Massachusetts General HospitalLead Sponsor

2,925 Previous Clinical Trials

13,197,893 Total Patients Enrolled

American Cancer Society, Inc.OTHER

224 Previous Clinical Trials

110,227 Total Patients Enrolled

Media Library

Enhanced Standard Care Clinical Trial Eligibility Overview. Trial Name: NCT03803696 — N/A

Blood Diseases Research Study Groups: Enhanced Standard Care, Multimodal Intervention to Address Sexual Dysfunction

Blood Diseases Clinical Trial 2023: Enhanced Standard Care Highlights & Side Effects. Trial Name: NCT03803696 — N/A

Enhanced Standard Care 2023 Treatment Timeline for Medical Study. Trial Name: NCT03803696 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the population size of this experiment?

"Yes, the clinicaltrials.gov listing confirms that this investigation is actively recruiting participants. It was first published on February 1st 2019 and has recently been updated on August 23rd 2022. The trial requires 230 patients enrolled at a single location."

Answered by AI

Are any enrollment opportunities available at the present time for this clinical trial?

"Clinicialtrials.gov confirms that this clinical trial is actively recruiting participants, having first been listed on February 1, 2019 and receiving its most recent update August 23rd 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Multimodal Sexual Dysfunction Intervention In HCT

El-Jawahri, Areej,M.D. 2019. "Multimodal Sexual Dysfunction Intervention In HCT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03803696.