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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve sexual function, quality of life, and mood for individuals who have undergone a stem cell transplant and are experiencing distressing sexual dysfunction. It will compare two approaches: enhanced standard care, which includes educational materials, and a more involved multimodal intervention addressing sexual dysfunction through regular visits and potential specialist referrals. Suitable participants have had a stem cell transplant at least three months ago and are experiencing sexual difficulties affecting their well-being. As an unphased trial, this study provides a unique opportunity to explore innovative solutions for enhancing post-transplant sexual health and overall well-being.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the combined approach to treating sexual problems in individuals who have undergone a stem cell transplant is safe and generally well-received. Earlier studies found that this treatment improved sexual satisfaction without causing major side effects. For example, one study reported that 94% of participants with sexual issues due to their treatment experienced positive results after using this approach.

Although a few participants might experience mild discomfort or distress, such cases are rare. Overall, this treatment seems to be a promising and safe option for those seeking to enhance their sexual health after a transplant. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these interventions for addressing sexual dysfunction in bone marrow transplant survivors because they offer a more comprehensive approach than current standard care. Unlike typical treatments that primarily provide educational material, the multimodal intervention involves personalized care with monthly visits from trained nurse practitioners. This approach allows for referrals to specialists for psychological issues, relationship discord, or concerns about malignancy, providing a tailored treatment plan. This holistic strategy aims to address the root causes of sexual dysfunction, potentially leading to more effective and sustainable results.

What evidence suggests that this trial's treatments could be effective for improving sexual function in stem cell transplant survivors?

This trial will compare two approaches for addressing sexual dysfunction in bone marrow transplant survivors. The Enhanced Standard Care arm includes baseline data collection, informing the primary transplant clinician of sexual dysfunction, and providing American Cancer Society sexual educational material. The Multimodal Intervention arm involves monthly visits with trained study nurse practitioners and referrals to specialists if needed. Research has shown that a combined treatment approach, like the Multimodal Intervention, can improve sexual satisfaction for people who have had a stem cell transplant. Studies have found that this method, guided by trained healthcare professionals, leads to better sexual health and quality of life. Participants in these studies also felt less anxious or depressed. These findings suggest that the treatment could help with sexual problems in this group. ^{1 2 6 7 8}

Who Is on the Research Team?

Areej El-Jawhri, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40769685/

A multimodal sexual dysfunction intervention versus ... Interpretation: A multimodal intervention delivered by trained HSCT clinicians resulted in improvements in global satisfaction with sex. These findings ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2352302625001607

A multimodal sexual dysfunction intervention versus ... A multimodal intervention delivered by trained HSCT clinicians resulted in improvements in global satisfaction with sex. These findings underscore the potential ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02492100

A Multimodal Intervention to Address Sexual Dysfunction in ... This research study is evaluating the feasibility and impact of an intervention to improve sexual function in stem cell transplant survivors on participants' ...

4. thelancet.com thelancet.com/journals/lanhae/article/PIIS2352-3026(25)00160-7/abstract

A multimodal sexual dysfunction intervention versus ... A multimodal intervention delivered by trained HSCT clinicians resulted in improvements in global satisfaction with sex. These findings underscore the potential ...

5. astctjournal.org astctjournal.org/article/S2666-6367(23)02211-X/fulltext

Randomized Trial of a Multimodal Intervention to Enhance ... A multimodal intervention delivered by trained HSCT clinicians is effective for improving sexual health outcomes, QOL, and psychological distress in HSCT ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03803696

Multimodal Sexual Dysfunction Intervention In HCT | ... This research study is evaluating the impact of an intervention to improve sexual function in stem cell transplant survivors on participants' sexual ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006497123117435

Multimodal Mobile Application to Address Sexual ... A multimodal mobile app to address sexual dysfunction is feasible to use for HCT survivors and has promising preliminary efficacy for improving sexual health ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29537491/

Pilot study of a multimodal intervention to enhance sexual ... Results: Approximately 33.1% of patients (50 of 151 patients) screened positive for sexual dysfunction causing distress and 94.0% (47 of 50 ...