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出境医 / 临床实验 / Multimodal Mobile Intervention Application (App) to Address Sexual Dysfunction in Hematopoietic Stem Cell Transplant Survivors

Multimodal Mobile Intervention Application (App) to Address Sexual Dysfunction in Hematopoietic Stem Cell Transplant Survivors

Study Description
Brief Summary:
This research study is being done to evaluate whether the use of a mobile app can help transplant survivors experiencing sexual health problems.

Condition or disease Intervention/treatment Phase
Other Cancer Behavioral: Mobile App + enhanced standard care Other: Enhanced Standard Care 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 study doctors want to know if the use of a mobile app intervention focused on improving sexual function may improve participants overall care.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Multimodal Mobile Intervention Application (App) to Address Sexual Dysfunction in Hematopoietic Stem Cell Transplant Survivors
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : July 1, 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: Mobile app plus enhanced standard care
  • Patients will received enhanced standard care in addition to access to the sexual health mobile app.
  • The app will also prompt patients to engage their partners with specific exercises.
 Behavioral: Mobile App + enhanced standard care
An intervention to help address sexual dysfunction among HCT survivors

Other: Enhanced Standard Care
Standard of care administered by the institution
Enhanced Standard Care
  • Patients will receive Enhanced Standard Care
  • Patients will meet with a transplant clinician for a brief medical examination to assess the need for medications for erectile dysfunction, vaginal atrophy, or vulvovaginal GVHD
  • Patients will not have access to the sexual health mobile app
 Other: Enhanced Standard Care
Standard of care administered by the institution
Outcome Measures
Primary Outcome Measures :
  1. To assess the feasibility of the intervention [ Time Frame: 2 years ]
    feasibility will be defined if at least 60% of eligible patients enroll and engage with at least 70% of the intervention modules


Secondary Outcome Measures :
  1. Compare patient-reported global satisfaction with sex (PROMIS Sexual Function and Satisfaction Measure) between the study groups [ Time Frame: 8 and 12 weeks ]
    patient-reported global satisfaction using the PROMIS Sexual Function and Satisfaction Measure. Higher scores indicate better global satisfaction with sex (there is a raw and T score. T score range 0-100)

  2. Compare patient-reported interest in sexual activity (PROMIS Sexual Function and Satisfaction Measure - Interest in sexual activity domain) between the study groups [ Time Frame: 8 and 12 weeks ]
    compare patient-reported interest in sexual activity using the PROMIS Sexual Function and Satisfaction Measure - Interest in Sexual Activity Domain). higher score indicate better interest in sex (there is a raw and T score, T score range 0-100)

  3. Compare patient-reported orgasm (PROMIS Sexual Function and Satisfaction Measure - Orgasm domain) between the study groups [ Time Frame: 8 and 12 weeks ]
    compare patient-reported orgasm using the PROMIS Sexual Function and Satisfaction Measure - Orgasm Domain). higher score indicate better orgasm (there is a raw and t-score, t-score range 0-100)

  4. For males: compare patient-reported erectile function (PROMIS Sexual Function and Satisfaction Measure - Erectile function domain) between the study groups [ Time Frame: 8 and 12 weeks ]
    for males: compare patient-reported erectile function using the PROMIS Sexual Function and Satisfaction Measure - Erectile Function Domain). higher score indicate better erectile function (there is a raw and t-score, T-score range 0-100)

  5. For females: compare patient-reported lubrication and vaginal comfort (PROMIS Sexual Function and Satisfaction Measure - lubrication and vaginal comfort domains) between the study groups [ Time Frame: 8 and 12 weeks ]
    For females: compare patient-reported vaginal comfort and lubrication using the PROMIS Sexual Function and Satisfaction Measure- Lubrication and Vaginal Comfort Domain). higher score indicate better lubrication and vagina comfort (there is a raw and T-score, T-score range 0-100)

  6. Compare patient reported quality of life (FACT-BMT) between the study groups [ Time Frame: 8 and 12 weeks ]
    compare patient-reported quality of life using the Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT). higher score indicate better quality of life (range 0-196)

  7. Compare patient reported depression symptoms (HADS-depression) between the two study groups [ Time Frame: 8 and 12 weeks ]
    compare patient-reported depression symptoms using Hospital Anxiety and Depression Scale (HADS-Depression). higher subscale score indicate worse depression symptoms (range 0-21)

  8. Compare patient reported anxiety symptoms (HADS-anxiety) between the two study groups [ Time Frame: 8 and 12 weeks ]
    compare patient-reported depression symptoms using Hospital Anxiety and Depression Scale (HADS-Anxiety). higher subscale score indicate worse anxiety symptoms (range 0-21)


Eligibility Criteria
Layout table for eligibility information
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) who underwent an autologous or allogeneic HCT at least 3 months prior to study enrollment.
  • Ability to speak English or able to complete questionnaires with assistance required from an interpreter or family member.
  • Positive screen for sexual dysfunction that is causing distress based on the NCCN survivorship guidelines

Exclusion Criteria:

  • Recurrent disease requiring treatment
  • Significant uncontrolled psychiatric disorder (psychotic disorder, bipolar disorder, major depression) or other co-morbid disease (dementia, cognitive impairment), which the treating clinician believes prohibits the ability to participate in study procedures.
Contacts and Locations

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

Locations
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United States, Massachusetts
Massachusetts General Hospital Cancer Center Recruiting
Boston, Massachusetts, United States, 02114
Contact: Areej El-Jawahri, MD    617-643-4003    ael-jawahri@partners.org   
Principal Investigator: Areej El-Jawahri, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Layout table for investigator information
Principal Investigator: Areej El-Jawahri, MD Massachusetts General Hospital
Tracking Information
First Submitted Date  ICMJE May 27, 2019
First Posted Date  ICMJE May 30, 2019
Last Update Posted Date October 1, 2019
Actual Study Start Date  ICMJE February 1, 2019
Estimated Primary Completion Date July 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2019) 		To assess the feasibility of the intervention [ Time Frame: 2 years ]
feasibility will be defined if at least 60% of eligible patients enroll and engage with at least 70% of the intervention modules
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2019)
  • Compare patient-reported global satisfaction with sex (PROMIS Sexual Function and Satisfaction Measure) between the study groups [ Time Frame: 8 and 12 weeks ]
    patient-reported global satisfaction using the PROMIS Sexual Function and Satisfaction Measure. Higher scores indicate better global satisfaction with sex (there is a raw and T score. T score range 0-100)
  • Compare patient-reported interest in sexual activity (PROMIS Sexual Function and Satisfaction Measure - Interest in sexual activity domain) between the study groups [ Time Frame: 8 and 12 weeks ]
    compare patient-reported interest in sexual activity using the PROMIS Sexual Function and Satisfaction Measure - Interest in Sexual Activity Domain). higher score indicate better interest in sex (there is a raw and T score, T score range 0-100)
  • Compare patient-reported orgasm (PROMIS Sexual Function and Satisfaction Measure - Orgasm domain) between the study groups [ Time Frame: 8 and 12 weeks ]
    compare patient-reported orgasm using the PROMIS Sexual Function and Satisfaction Measure - Orgasm Domain). higher score indicate better orgasm (there is a raw and t-score, t-score range 0-100)
  • For males: compare patient-reported erectile function (PROMIS Sexual Function and Satisfaction Measure - Erectile function domain) between the study groups [ Time Frame: 8 and 12 weeks ]
    for males: compare patient-reported erectile function using the PROMIS Sexual Function and Satisfaction Measure - Erectile Function Domain). higher score indicate better erectile function (there is a raw and t-score, T-score range 0-100)
  • For females: compare patient-reported lubrication and vaginal comfort (PROMIS Sexual Function and Satisfaction Measure - lubrication and vaginal comfort domains) between the study groups [ Time Frame: 8 and 12 weeks ]
    For females: compare patient-reported vaginal comfort and lubrication using the PROMIS Sexual Function and Satisfaction Measure- Lubrication and Vaginal Comfort Domain). higher score indicate better lubrication and vagina comfort (there is a raw and T-score, T-score range 0-100)
  • Compare patient reported quality of life (FACT-BMT) between the study groups [ Time Frame: 8 and 12 weeks ]
    compare patient-reported quality of life using the Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT). higher score indicate better quality of life (range 0-196)
  • Compare patient reported depression symptoms (HADS-depression) between the two study groups [ Time Frame: 8 and 12 weeks ]
    compare patient-reported depression symptoms using Hospital Anxiety and Depression Scale (HADS-Depression). higher subscale score indicate worse depression symptoms (range 0-21)
  • Compare patient reported anxiety symptoms (HADS-anxiety) between the two study groups [ Time Frame: 8 and 12 weeks ]
    compare patient-reported depression symptoms using Hospital Anxiety and Depression Scale (HADS-Anxiety). higher subscale score indicate worse anxiety symptoms (range 0-21)
Original Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2019)
  • Compare patient-reported global satisfaction with sex (PROMIS Sexual Function and Satisfaction Measure) between the study groups [ Time Frame: 8 and 12 weeks ]
    patient-reported global satisfaction using the PROMIS Sexual Function and Satisfaction Measure
  • Compare patient-reported interest in sexual activity (PROMIS Sexual Function and Satisfaction Measure - Interest in sexual activity domain) between the study groups [ Time Frame: 8 and 12 weeks ]
    compare patient-reported interest in sexual activity using the PROMIS Sexual Function and Satisfaction Measure - Interest in Sexual Activity Domain)
  • Compare patient-reported orgasm (PROMIS Sexual Function and Satisfaction Measure - Orgasm domain) between the study groups [ Time Frame: 8 and 12 weeks ]
    compare patient-reported orgasm using the PROMIS Sexual Function and Satisfaction Measure - Orgasm Domain)
  • For males: compare patient-reported erectile function (PROMIS Sexual Function and Satisfaction Measure - Erectile function domain) between the study groups [ Time Frame: 8 and 12 weeks ]
    for males: compare patient-reported erectile function using the PROMIS Sexual Function and Satisfaction Measure - Erectile Function Domain)
  • For females: compare patient-reported lubrication and vaginal comfort (PROMIS Sexual Function and Satisfaction Measure - lubrication and vaginal comfort domains) between the study groups [ Time Frame: 8 and 12 weeks ]
    For females: compare patient-reported vaginal comfort and lubrication using the PROMIS Sexual Function and Satisfaction Measure- Lubrication and Vaginal Comfort Domain)
  • Compare patient reported quality of life (FACT-BMT) between the study groups [ Time Frame: 8 and 12 weeks ]
    compare patient-reported quality of life using the Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT)
  • Compare patient reported depression symptoms (HADS-depression) between the two study groups [ Time Frame: 8 and 12 weeks ]
    compare patient-reported depression symptoms using Hospital Anxiety and Depression Scale (HADS-Depression)
  • Compare patient reported anxiety symptoms (HADS-anxiety) between the two study groups [ Time Frame: 8 and 12 weeks ]
    compare patient-reported depression symptoms using Hospital Anxiety and Depression Scale (HADS-Anxiety)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multimodal Mobile Intervention Application (App) to Address Sexual Dysfunction in Hematopoietic Stem Cell Transplant Survivors
Official Title  ICMJE Multimodal Mobile Intervention Application (App) to Address Sexual Dysfunction in Hematopoietic Stem Cell Transplant Survivors
Brief Summary This research study is being done to evaluate whether the use of a mobile app can help transplant survivors experiencing sexual health problems.
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 study doctors want to know if the use of a mobile app intervention focused on improving sexual function may improve participants overall care.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Other Cancer
Intervention  ICMJE
  • Behavioral: Mobile App + enhanced standard care
    An intervention to help address sexual dysfunction among HCT survivors
  • Other: Enhanced Standard Care
    Standard of care administered by the institution
Study Arms  ICMJE
  • Experimental: Mobile app plus enhanced standard care
    • Patients will received enhanced standard care in addition to access to the sexual health mobile app.
    • The app will also prompt patients to engage their partners with specific exercises.
    Interventions:
    • Behavioral: Mobile App + enhanced standard care
    • Other: Enhanced Standard Care
  • Enhanced Standard Care
    • Patients will receive Enhanced Standard Care
    • Patients will meet with a transplant clinician for a brief medical examination to assess the need for medications for erectile dysfunction, vaginal atrophy, or vulvovaginal GVHD
    • Patients will not have access to the sexual health mobile app
    Intervention: Other: Enhanced Standard Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 27, 2019) 		60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2022
Estimated Primary Completion Date July 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult patients (≥18 years) who underwent an autologous or allogeneic HCT at least 3 months prior to study enrollment.
  • Ability to speak English or able to complete questionnaires with assistance required from an interpreter or family member.
  • Positive screen for sexual dysfunction that is causing distress based on the NCCN survivorship guidelines

Exclusion Criteria:

  • Recurrent disease requiring treatment
  • Significant uncontrolled psychiatric disorder (psychotic disorder, bipolar disorder, major depression) or other co-morbid disease (dementia, cognitive impairment), which the treating clinician believes prohibits the ability to participate in study procedures.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Areej El-Jawahri, MD 617-643-4003 ael-jawahri@partners.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03967379
Other Study ID Numbers  ICMJE 19-104
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Time Frame: Data can be shared no earlier than 1 year following the date of publication
Access Criteria: BCH - Contact the Technology & Innovation Development Office at www.childrensinnovations.org or email TIDO@childrens.harvard.edu BIDMC - Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu BWH - Contact the Partners Innovations team at http://www.partners.org/innovation DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu MGH - Contact the Partners Innovations team at http://www.partners.org/innovation
Responsible Party El-Jawahri, Areej,M.D., Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Areej El-Jawahri, MD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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