Multimodal Sexual Dysfunction Intervention In HCT

NCT ID: NCT03803696

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 230 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2025-12-31

Brief Summary

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.

Detailed Description

Frequently survivors of stem cell transplantation report significant problems with their sexual function that impacts their quality of life, mood, and their intimacy and relationship with their partners. These issues can be very distressing to patients and their loved ones. The Investigators want to know if the introduction of an intervention focused on improving sexual function may improve a participant's overall care and quality of life.

The main purpose of this study is to compare two types of care - the study intervention versus enhanced standard care which includes receiving an educational handout about sexual dysfunction. The main goal is to assess if the intervention will improve participant's sexual function, quality of life, and mood.

The intervention includes a comprehensive assessment by a transplant clinician (a transplant physician or nurse practitioner) who is trained in sexual dysfunction assessment to explore the reasons for sexual dysfunction and focus on ways to improve symptoms.

-- If the transplant clinician feels additional help is needed by a sexual health expert, the participant will be referred to the sexual health clinic. In the sexual health clinic, the participant will be evaluated by an expert physician who will also focus on strategies to improve sexual function.

The study will use a series of questionnaires to measure sexual function, quality of life, physical symptoms, and mood. Study questionnaires will be completed in the clinic or remotely with assistance provided as needed.

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Conditions

Hematopoietic Stem Cell Transplantation; Hematologic Diseases; Sexual Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Enhanced Standard Care

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

Group Type: ACTIVE_COMPARATOR

Enhanced Standard Care

Intervention Type: BEHAVIORAL

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

Multimodal Intervention to Address Sexual Dysfunction

• 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

Group Type: ACTIVE_COMPARATOR

Multimodal Intervention to Address Sexual Dysfunction

Intervention Type: BEHAVIORAL

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

Interventions

Enhanced Standard Care

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

Intervention Type: BEHAVIORAL

Multimodal Intervention to Address Sexual Dysfunction

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Adult patients (≥ 18 years) with hematologic malignancy who underwent autologous or allogeneic HCT ≥ three months prior to study enrollment.
• Positive screen for sexual dysfunction that is causing distress based on the National Comprehensive Cancer Network (NCCN) survivorship guidelines
• Ability to read and respond to questions in English or to complete questionnaires with assistance from an interpreter.

Exclusion Criteria

• Patients with relapsed disease requiring treatment
• Patients with a planned second transplant
• Patients > 5 years from their HCT
• Patients with psychiatric or cognitive conditions which the treating clinicians believes prohibits compliance with study procedures.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Cancer Society, Inc.

OTHER

Sponsor Role: collaborator

The Leukemia and Lymphoma Society

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

El-Jawahri, Areej,M.D.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Areej El-Jawhri, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

El-Jawahri A, Traeger L, Reese JB, Dizon D, Bober SL, Greer JA, Vanderklish J, Horick N, Ufere N, Reynolds MJ, Rice J, Clay M, Newcomb R, DeFilipp Z, Chen YB, Temel JS. A multimodal sexual dysfunction intervention versus enhanced usual care for survivors of haematopoietic stem-cell transplantation: a single-centre, open-label, randomised clinical trial. Lancet Haematol. 2025 Aug;12(8):e611-e620. doi: 10.1016/S2352-3026(25)00160-7.

Reference Type: DERIVED

PMID: 40769685 (View on PubMed)

Other Identifiers

18-543

Identifier Type: -

Identifier Source: org_study_id