Multimodal Sexual Dysfunction Intervention for Bone Marrow Transplant Survivors

Overseen By Areej El-Jawhri, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Relapsed disease, Planned second transplant, Psychiatric conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 3 months

230 Participants Needed

Trial Summary

What is the purpose of this trial?

This research study is evaluating the impact of an intervention to improve sexual function in stem cell transplant survivors on participants' sexual function, quality of life, and mood. It is expected that about 120 people who have undergone a stem cell transplant will take part in this research study.

Research Team

Areej El-Jawhri, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

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.

Inclusion Criteria

Ability to read and respond to questions in English or to complete questionnaires with assistance from an interpreter.

I am experiencing sexual dysfunction that is distressing to me.

I am an adult who had a stem cell transplant for blood cancer more than 3 months ago.

Exclusion Criteria

You have a mental or cognitive condition that may make it difficult for you to follow the study procedures.

It has been over 5 years since my hematopoietic cell transplantation.

I am scheduled for a second transplant.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline and Randomization

Baseline data collection, registration, and randomization of participants into study groups

1 week

1 visit (in-person)

Treatment

Participants receive either the multimodal intervention or enhanced standard care, including monthly visits and potential referrals to specialists

3 months

3 visits (in-person)

Follow-up

Participants are monitored for sexual function, quality of life, and mood using questionnaires

up to 6 months

Treatment Details

Interventions

• Enhanced Standard Care
• Multimodal Intervention to Address Sexual Dysfunction

Trial Overview 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.

Participant Groups

Group I: Enhanced Standard Care Active Control 1 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 Dysfunction Active Control 1 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

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

The Leukemia and Lymphoma Society

Collaborator

Trials

87

Recruited

26,200+

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+