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Hematopoietic Stem Cell TransplantationNCT03803696

Multimodal Sexual Dysfunction Intervention In HCT

A study testing Multimodal Intervention to Address Sexual Dysfunction in people with Hematopoietic Stem Cell Transplantation and Hematologic Diseases, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Multimodal Intervention to Address Sexual Dysfunction
Could I receive a placebo?
No, everyone receives an active treatment
How many people
230 participants
Where
1 siteUnited States
Study dates
1 Feb 2019to 31 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Massachusetts General Hospital

    Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: 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.

Read the 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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Being tested
Enhanced Standard Care, Multimodal Intervention to Address Sexual Dysfunction
Keywords
Hematopoietic Stem Cell Transplantation, Hematologic Diseases, Sexual Dysfunction
Medical subject headings
Hematologic Diseases, Sexual Dysfunction, Physiological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Enhanced Standard CareBehavioural

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

  • Multimodal Intervention to Address Sexual DysfunctionBehavioural

    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
Study groups in NCT03803696
Study groupRoleWhat they receive
Enhanced Standard CareActive comparator* Baseline data collection, registration and randomization * Inform primary transplant clinician of sexual dysfunction causing distress * Receive American Cancer Society sexual educational material
Receives: Behavioral: Enhanced Standard Care
Multimodal Intervention to Address Sexual DysfunctionActive 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
Receives: Behavioral: Multimodal Intervention to Address Sexual Dysfunction

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 3 Months

Secondary outcomes (17)

  1. Compare Patient reported interest in sexual activity

    PROMIS Sexual Function and Satisfaction Measure Interest in sexual activity domain)

    Measured: 3 Months

  2. Compare Patient global satisfaction with sex longitudinally

    compare PROMIS Sexual function and Satisfaction Measure - global satisfaction with sex domain) longitudinally between study groups

    Measured: up to 6 months

  3. Compare Patient reported interest in sexual activity longitudinally

    compare PROMIS Sexual Function and Satisfaction Measure Interest in sexual activity domain) longitudinally between study groups

    Measured: up to 6 months

  4. Compare patient-reported orgasm

    Compare PROMIS Sexual Function and Satisfaction Measure - Orgasm domain

    Measured: 3 Months

  5. Compare patient-reported orgasm longitudinally

    Compare PROMIS Sexual Function and Satisfaction Measure - Orgasm domain) longitudinally between the study groups

    Measured: up to 6 months

  6. For males: compare patient-reported erectile function

    PROMIS Sexual Function and Satisfaction Measure - Erectile function domain

    Measured: 3 Months

  7. For males: compare patient-reported erectile function longitudinally

    Compare PROMIS Sexual Function and Satisfaction Measure - Erectile function domain longitudinally between the two groups

    Measured: up to 6 months

  8. For females: compare patient-reported vaginal lubrication

    compare (PROMIS Sexual Function and Satisfaction Measure - lubrication domain)

    Measured: 3 Months

  9. For females: compare patient-reported vaginal lubrication longitudinally

    compare (PROMIS Sexual Function and Satisfaction Measure - lubrication domain) longitudinally between the two study groups

    Measured: up to 6 months

  10. For females: compare patient-reported vaginal comfort

    compare (PROMIS Sexual Function and Satisfaction Measure - vaginal comfort domain

    Measured: 3 months

  11. For females: compare patient-reported vaginal comfort longitudinally

    compare (PROMIS Sexual Function and Satisfaction Measure - vaginal comfort domain) longitudinally between the two study groups

    Measured: up to 6 months

  12. Compare Patient Reported Quality of Life

    Compare patient-reported QOL using the Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT)

    Measured: 3 Months

  13. 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

    Measured: up to 6 months

  14. 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

    Measured: 3 Months

  15. 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

    Measured: up to 6 months

  16. 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

    Measured: 3 Months

  17. 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

    Measured: up to 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2019
  2. Study start1 Feb 2019
  3. Primary completion1 Jan 2023
  4. Study completion31 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
230 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03803696
Sponsor's protocol ID
18-543
Status last verified
Mar 2026
First submitted
9 Jan 2019
Last updated
6 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 40769685

  • Markovitz NH, Traeger L, Vanderklish J, Horick N, Newcomb R, Larizza IS, Boardman AC, DeFilipp Z, Chen YB, Dizon DS, Reese JB, Temel J, Amonoo HL, El-Jawahri A. Sexual Health in Hematopoietic Stem Cell Transplantation Survivors. J Natl Compr Canc Netw. 2025 Jun 9;23(7):e257019. doi: 10.6004/jnccn.2025.7019.

    PubMed 40490014

Questions about this trial

What is this clinical trial studying?

A study testing Multimodal Intervention to Address Sexual Dysfunction in people with Hematopoietic Stem Cell Transplantation and Hematologic Diseases, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compare Patient Global Satisfaction with Sex (time frame: 3 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03803696, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.

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