Multimodal Sexual Dysfunction Intervention In HCT



Status:Recruiting
Conditions:Blood Cancer, Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:3/8/2019
Start Date:February 1, 2019
End Date:December 31, 2024
Contact:Areej El-Jawhri, MD
Email:ael-jawahri@partners.org
Phone:617-643-4003

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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 230 people who have undergone a stem cell transplant will take part
in this research study.

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.

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.
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Areej El-Jawahri, MD
Phone: 617-643-4003
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from
Boston, MA
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