Multimodal Sexual Dysfunction Intervention In HCT

Randomized Trial of a Multimodal Sexual Dysfunction Intervention for Hematopoietic Stem Cell Transplant Survivors

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hematologic Diseases; Sexual Dysfunction; Hematopoietic Stem Cell Transplantation
• Intervention / Treatment: Behavioral: Enhanced Standard Care; Behavioral: Multimodal Intervention to Address Sexual Dysfunction

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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• Study Type: Interventional
• Enrollment (Estimated): 230
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Areej El-Jawhri, MD; Phone Number: 617-643-4003; Email: ael-jawahri@partners.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Behavioral: 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
Active Comparator: Multimodal Intervention to Address Sexual Dysfunction; Baseline data collection, registration and randomization; 3 Monthly visits with trained study nurse practitionersReferral to specialist ifPsychological etiologySexual TraumaRelationship DiscordConcern for Malignancy or anatomic scarring requiring surgery	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare Patient reported interest in sexual activity	PROMIS Sexual Function and Satisfaction Measure Interest in sexual activity domain)	3 Months
Compare patient-reported orgasm	Compare PROMIS Sexual Function and Satisfaction Measure - Orgasm domain	3 Months
For males: compare patient-reported erectile function	PROMIS Sexual Function and Satisfaction Measure - Erectile function domain	3 Months
For females: compare patient-reported vaginal lubrication	compare (PROMIS Sexual Function and Satisfaction Measure - lubrication domain)	3 Months
For females: compare patient-reported vaginal comfort	compare (PROMIS Sexual Function and Satisfaction Measure - vaginal comfort domain	3 months
Compare Patient Reported Quality of Life	Compare patient-reported QOL using the Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT)	3 Months
Compare Patient Reported Anxiety Symptoms	Compare patient reported anxiety symptoms using the Hospital Anxiety and Depression Scale (HADS- anxiety subscale). Subscale ranges from 0-21 with higher score indicating higher anxiety symptoms	3 Months
Compare Patient Reported Depression Symptoms	Compare Patient Reported Depression Symptoms using the Hospital Anxiety and Depression Scale (HADS - depression subscale). Subscale ranges from 0-21 with higher score indicating higher depression symptoms	3 Months
Compare Patient global satisfaction with sex longitudinally	compare PROMIS Sexual function and Satisfaction Measure - global satisfaction with sex domain) longitudinally between study groups	up to 6 months
Compare Patient reported interest in sexual activity longitudinally	compare PROMIS Sexual Function and Satisfaction Measure Interest in sexual activity domain) longitudinally between study groups	up to 6 months
Compare patient-reported orgasm longitudinally	Compare PROMIS Sexual Function and Satisfaction Measure - Orgasm domain) longitudinally between the study groups	up to 6 months
For males: compare patient-reported erectile function longitudinally	Compare PROMIS Sexual Function and Satisfaction Measure - Erectile function domain longitudinally between the two groups	up to 6 months
For females: compare patient-reported vaginal lubrication longitudinally	compare (PROMIS Sexual Function and Satisfaction Measure - lubrication domain) longitudinally between the two study groups	up to 6 months
For females: compare patient-reported vaginal comfort longitudinally	compare (PROMIS Sexual Function and Satisfaction Measure - vaginal comfort domain) longitudinally between the two study groups	up to 6 months
Compare Patient Reported Quality of Life longitudinally	Compare patient-reported QOL using the Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT) longitudinally between the two groups	up to 6 months
Compare Patient Reported Anxiety Symptoms Longitudinally	Compare patient reported anxiety symptoms using the Hospital Anxiety and Depression Scale (HADS- anxiety subscale) longitudinally between the two study groups. Subscale ranges from 0-21 with higher score indicating higher anxiety symptoms	up to 6 months
Compare Patient Reported Depression Symptoms Longitudinally	Compare Patient Reported Depression Symptoms using the Hospital Anxiety and Depression Scale (HADS - depression subscale) longitudinally between the two study groups. Subscale ranges from 0-21 with higher score indicating higher depression symptoms	up to 6 Months

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: American Cancer Society, Inc.; The Leukemia and Lymphoma Society
• Investigators: Principal Investigator: Areej El-Jawhri, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): January 1, 2023
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: January 9, 2019
• First Submitted That Met QC Criteria: January 9, 2019
• First Posted (Actual): January 15, 2019

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Hematologic Diseases; Hematopoietic Stem Cell Transplantation; Sexual Dysfunction
• Additional Relevant MeSH Terms: Hematologic Diseases
• Other Study ID Numbers: 18-543

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication.
• IPD Sharing Access Criteria: Requests may be directed to:MGH - Contact the Partners Innovations team at http://www.partners.org/innovation
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No