Clinical trial NCT03803696: Multimodal Sexual Dysfunction Intervention In HCT
Official title: Randomized Trial of a Multimodal Sexual Dysfunction Intervention for Hematopoietic Stem Cell Transplant Survivors
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hematopoietic Stem Cell Transplantation
Hematologic Diseases
Sexual Dysfunction
Keywords: Hematopoietic Stem Cell Transplantation
Hematologic Diseases
Sexual Dysfunction
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
name: The Leukemia and Lymphoma Society
First posted: 2019-01-15
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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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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.

Primary outcomes:
measure: Compare Patient Global Satisfaction with Sex
timeFrame: 3 Months
Secondary outcomes:
measure: Compare Patient reported interest in sexual activity
timeFrame: 3 Months
measure: Compare Patient global satisfaction with sex longitudinally
timeFrame: up to 6 months
measure: Compare Patient reported interest in sexual activity longitudinally
timeFrame: up to 6 months
measure: Compare patient-reported orgasm
timeFrame: 3 Months
measure: Compare patient-reported orgasm longitudinally
timeFrame: up to 6 months
measure: For males: compare patient-reported erectile function
timeFrame: 3 Months
measure: For males: compare patient-reported erectile function longitudinally
timeFrame: up to 6 months
measure: For females: compare patient-reported vaginal lubrication
timeFrame: 3 Months
measure: For females: compare patient-reported vaginal lubrication longitudinally
timeFrame: up to 6 months
measure: For females: compare patient-reported vaginal comfort
timeFrame: 3 months
measure: For females: compare patient-reported vaginal comfort longitudinally
timeFrame: up to 6 months
measure: Compare Patient Reported Quality of Life
timeFrame: 3 Months
measure: Compare Patient Reported Quality of Life longitudinally
timeFrame: up to 6 months
measure: Compare Patient Reported Anxiety Symptoms
timeFrame: 3 Months
measure: Compare Patient Reported Anxiety Symptoms Longitudinally
timeFrame: up to 6 months
measure: Compare Patient Reported Depression Symptoms
timeFrame: 3 Months
measure: Compare Patient Reported Depression Symptoms Longitudinally
timeFrame: up to 6 Months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Areej El-Jawhri, MD
role: PRINCIPAL_INVESTIGATOR
References: