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NCT Number: NCT03803696

Multimodal Sexual Dysfunction Intervention In HCT

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.

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Key information

Conditions

Hematopoietic Stem Cell Transplantation Genital Diseases Hematologic Diseases Hemic and Lymphatic Diseases Sexual Dysfunction Sexual Dysfunction, Physiological Urogenital Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

About this 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.

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Enhanced standard care

Behavioral
  • 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 Dysfunction

Behavioral

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

Primary outcomes

  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 outcomes

  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 6 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 6 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 6 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 6 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 6 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 6 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 6 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 6 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 6 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

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • American Cancer Society, Inc.
  • The Leukemia and Lymphoma Society

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2025
First posted
Jan 15, 2019
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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