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Multimodal Sexual Dysfunction Intervention In HCT

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ClinicalTrials.gov Identifier: NCT03803696
Recruitment Status : Recruiting
First Posted : January 15, 2019
Last Update Posted : April 29, 2021
Sponsor:
Collaborators:
American Cancer Society, Inc.
The Leukemia and Lymphoma Society
Information provided by (Responsible Party):
El-Jawahri, Areej,M.D., Massachusetts General Hospital

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


Condition or disease Intervention/treatment Phase
Hematopoietic Stem Cell Transplantation Hematologic Diseases Sexual Dysfunction Behavioral: Enhanced Standard Care Behavioral: Multimodal Intervention to Address Sexual Dysfunction Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Randomized Trial of a Multimodal Sexual Dysfunction Intervention for Hematopoietic Stem Cell Transplant Survivors
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : December 31, 2024
Arms and Interventions
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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 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

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


Outcome Measures
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Primary Outcome Measures :
  1. Compare Patient Global Satisfaction with Sex [ Time Frame: 3 Months ]
    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


Secondary Outcome Measures :
  1. Compare Patient reported interest in sexual activity [ Time Frame: 3 Months ]
    PROMIS Sexual Function and Satisfaction Measure Interest in sexual activity domain)

  2. Compare Patient global satisfaction with sex longitudinally [ Time Frame: up to 9 months ]
    compare PROMIS Sexual function and Satisfaction Measure - global satisfaction with sex domain) longitudinally between study groups

  3. Compare Patient reported interest in sexual activity longitudinally [ Time Frame: up to 9 months ]
    compare PROMIS Sexual Function and Satisfaction Measure Interest in sexual activity domain) longitudinally between study groups

  4. Compare patient-reported orgasm [ Time Frame: 3 Months ]
    Compare PROMIS Sexual Function and Satisfaction Measure - Orgasm domain

  5. Compare patient-reported orgasm longitudinally [ Time Frame: up to 9 months ]
    Compare PROMIS Sexual Function and Satisfaction Measure - Orgasm domain) longitudinally between the study groups

  6. For males: compare patient-reported erectile function [ Time Frame: 3 Months ]
    PROMIS Sexual Function and Satisfaction Measure - Erectile function domain

  7. For males: compare patient-reported erectile function longitudinally [ Time Frame: up to 9 months ]
    Compare PROMIS Sexual Function and Satisfaction Measure - Erectile function domain longitudinally between the two groups

  8. For females: compare patient-reported vaginal lubrication [ Time Frame: 3 Months ]
    compare (PROMIS Sexual Function and Satisfaction Measure - lubrication domain)

  9. For females: compare patient-reported vaginal lubrication longitudinally [ Time Frame: up to 9 months ]
    compare (PROMIS Sexual Function and Satisfaction Measure - lubrication domain) longitudinally between the two study groups

  10. For females: compare patient-reported vaginal comfort [ Time Frame: 3 months ]
    compare (PROMIS Sexual Function and Satisfaction Measure - vaginal comfort domain

  11. For females: compare patient-reported vaginal comfort longitudinally [ Time Frame: up to 9 months ]
    compare (PROMIS Sexual Function and Satisfaction Measure - vaginal comfort domain) longitudinally between the two study groups

  12. Compare Patient Reported Quality of Life [ Time Frame: 3 Months ]
    Compare patient-reported QOL using the Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT)

  13. Compare Patient Reported Quality of Life longitudinally [ Time Frame: up to 9 months ]
    Compare patient-reported QOL using the Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT) longitudinally between the two groups

  14. Compare Patient Reported Anxiety Symptoms [ Time Frame: 3 Months ]
    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

  15. Compare Patient Reported Anxiety Symptoms Longitudinally [ Time Frame: up to 9 months ]
    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

  16. Compare Patient Reported Depression Symptoms [ Time Frame: 3 Months ]
    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

  17. Compare Patient Reported Depression Symptoms Longitudinally [ Time Frame: up to 9 Months ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03803696


Contacts
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Contact: Areej El-Jawhri, MD 617-643-4003 ael-jawahri@partners.org

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Areej El-Jawahri, MD    617-643-4003      
Principal Investigator: Areej El-Jawahri, MD         
Sponsors and Collaborators
Massachusetts General Hospital
American Cancer Society, Inc.
The Leukemia and Lymphoma Society
Investigators
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Principal Investigator: Areej El-Jawhri, MD Massachusetts General Hospital
More Information
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Responsible Party: El-Jawahri, Areej,M.D., Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03803696    
Other Study ID Numbers: 18-543
First Posted: January 15, 2019    Key Record Dates
Last Update Posted: April 29, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by El-Jawahri, Areej,M.D., Massachusetts General Hospital:
Hematopoietic Stem Cell Transplantation
Hematologic Diseases
Sexual Dysfunction
Additional relevant MeSH terms:
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Hematologic Diseases