Multimodal Sexual Dysfunction Intervention In HCT

NCT03803696 | Active Not Recruiting

• 1 other identifier: 18-543
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematopoietic Stem Cell Transplantation; Hematologic Diseases; Sexual Dysfunction

Keywords

Hematopoietic Stem Cell Transplantation; Hematologic Diseases; Sexual Dysfunction

Outcome Measures

Primary Outcomes (1)

• Compare Patient Global Satisfaction with Sex

  compare patients' global satisfaction with sex using PROMIS Sexual Function and Satisfaction Measure (global satisfaction domain) at three months between the study groups using linear regression controlling for baseline values (as necessary for any imbalances in baseline variables

  3 Months

Secondary Outcomes (17)

• Compare Patient reported interest in sexual activity

  3 Months

• Compare Patient global satisfaction with sex longitudinally

  up to 6 months

• Compare Patient reported interest in sexual activity longitudinally

  up to 6 months

• Compare patient-reported orgasm

  3 Months

• Compare patient-reported orgasm longitudinally

  up to 6 months

Study Arms (2)

Enhanced Standard Care

ACTIVE COMPARATOR

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

Behavioral: Enhanced Standard Care

Multimodal Intervention to Address Sexual Dysfunction

ACTIVE COMPARATOR

* 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

Behavioral: Multimodal Intervention to Address Sexual Dysfunction

Interventions

Enhanced Standard Care BEHAVIORAL

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

Enhanced Standard Care

Multimodal Intervention to Address Sexual Dysfunction 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

Multimodal Intervention to Address Sexual Dysfunction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• American Cancer Society, Inc.: collaborator
• The Leukemia and Lymphoma Society: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• 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.

  PMID: 40769685 DERIVED

MeSH Terms

Conditions

Hematologic Diseases; Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases; Genital Diseases; Urogenital Diseases

Study Officials

• Areej El-Jawhri, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: January 15, 2019
• Study Start: February 1, 2019
• Primary Completion: January 1, 2023
• Study Completion: December 31, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication.
• Access Criteria: Requests may be directed to:MGH - Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US (1)