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eSMART Trial to Evaluate ASyMS

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ClinicalTrials.gov Identifier: NCT02356081
Recruitment Status : Unknown
Verified November 2017 by Louise McKean, University of Strathclyde.
Recruitment status was:  Recruiting
First Posted : February 5, 2015
Last Update Posted : November 13, 2017
Sponsor:
Collaborators:
University College Dublin
King's College London
University of California, San Francisco
University of Athens
Medical University of Vienna
University of Dundee
European Cancer Patient Coalition (ECPC)
Docobo Ltd.
University of Surrey
Sykehuset Innlandet HF
Information provided by (Responsible Party):
Louise McKean, University of Strathclyde

Tracking Information
First Submitted Date  ICMJE January 26, 2015
First Posted Date  ICMJE February 5, 2015
Last Update Posted Date November 13, 2017
Study Start Date  ICMJE February 2015
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2017)
  • Memorial Symptom Assessment Scale (MSAS) [ Time Frame: baseline (within 1 week before 1st chemotherapy cycle) ]
    The MSAS is a multidimensional selfreport questionnaire that evaluates 32 physical and psychological symptoms according to their frequency, severity and distress/bother to the person in the past week.
  • Memorial Symptom Assessment Scale (MSAS) [ Time Frame: On the day scheduled for each subsequent chemotherapy cycle (up to 3 days before to 3 days after the 1st day of each cycle) ]
    The MSAS is a multidimensional selfreport questionnaire that evaluates 32 physical and psychological symptoms according to their frequency, severity and distress/bother to the person in the past week.
  • Memorial Symptom Assessment Scale (MSAS) [ Time Frame: Mid-way each chemotherapy cycle, (Day 6-8, 9-11, or 13-15 - dependent on number of days in the chemotherapy cycle) ]
    The MSAS is a multidimensional selfreport questionnaire that evaluates 32 physical and psychological symptoms according to their frequency, severity and distress/bother to the person in the past week.
  • Memorial Symptom Assessment Scale (MSAS) [ Time Frame: 1-5 days after the end of the final or 6th chemotherapy cycle ]
    The MSAS is a multidimensional selfreport questionnaire that evaluates 32 physical and psychological symptoms according to their frequency, severity and distress/bother to the person in the past week.
  • Memorial Symptom Assessment Scale (MSAS) [ Time Frame: 3 months post chemotherapy completion ]
    The MSAS is a multidimensional selfreport questionnaire that evaluates 32 physical and psychological symptoms according to their frequency, severity and distress/bother to the person in the past week.
  • Memorial Symptom Assessment Scale (MSAS) [ Time Frame: 6 months post chemotherapy completion ]
    The MSAS is a multidimensional selfreport questionnaire that evaluates 32 physical and psychological symptoms according to their frequency, severity and distress/bother to the person in the past week.
  • Memorial Symptom Assessment Scale (MSAS) [ Time Frame: 9 months post chemotherapy completion ]
    The MSAS is a multidimensional selfreport questionnaire that evaluates 32 physical and psychological symptoms according to their frequency, severity and distress/bother to the person in the past week.
  • Memorial Symptom Assessment Scale (MSAS) [ Time Frame: 12 months post chemotherapy completion ]
    The MSAS is a multidimensional selfreport questionnaire that evaluates 32 physical and psychological symptoms according to their frequency, severity and distress/bother to the person in the past week.
Original Primary Outcome Measures  ICMJE
 (submitted: February 4, 2015)
  • Memorial Symptom Assessment Scale (MSAS) [ Time Frame: baseline (within 1 week before 1st chemotherapy cycle) ]
    The MSAS is a multidimensional selfreport questionnaire that evaluates 32 physical and psychological symptoms according to their frequency, severity and distress/bother to the person in the past week.
  • Memorial Symptom Assessment Scale (MSAS) [ Time Frame: On the day scheduled for each subsequent chemotherapy cycle (up to 3 days before to 3 days after the 1st day of each cycle) ]
    The MSAS is a multidimensional selfreport questionnaire that evaluates 32 physical and psychological symptoms according to their frequency, severity and distress/bother to the person in the past week.
  • Memorial Symptom Assessment Scale (MSAS) [ Time Frame: Mid-way each chemotherapy cycle, (Day 6-8, 9-11, or 13-15 - dependent on number of days in the chemotherapy cycle) ]
    The MSAS is a multidimensional selfreport questionnaire that evaluates 32 physical and psychological symptoms according to their frequency, severity and distress/bother to the person in the past week.
  • Memorial Symptom Assessment Scale (MSAS) [ Time Frame: 1-5 days after the end of the final chemotherapy cycle ]
    The MSAS is a multidimensional selfreport questionnaire that evaluates 32 physical and psychological symptoms according to their frequency, severity and distress/bother to the person in the past week.
  • Memorial Symptom Assessment Scale (MSAS) [ Time Frame: 3 months post chemotherapy completion ]
    The MSAS is a multidimensional selfreport questionnaire that evaluates 32 physical and psychological symptoms according to their frequency, severity and distress/bother to the person in the past week.
  • Memorial Symptom Assessment Scale (MSAS) [ Time Frame: 6 months post chemotherapy completion ]
    The MSAS is a multidimensional selfreport questionnaire that evaluates 32 physical and psychological symptoms according to their frequency, severity and distress/bother to the person in the past week.
  • Memorial Symptom Assessment Scale (MSAS) [ Time Frame: 9 months post chemotherapy completion ]
    The MSAS is a multidimensional selfreport questionnaire that evaluates 32 physical and psychological symptoms according to their frequency, severity and distress/bother to the person in the past week.
  • Memorial Symptom Assessment Scale (MSAS) [ Time Frame: 12 months post chemotherapy completion ]
    The MSAS is a multidimensional selfreport questionnaire that evaluates 32 physical and psychological symptoms according to their frequency, severity and distress/bother to the person in the past week.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE eSMART Trial to Evaluate ASyMS
Official Title  ICMJE eSMART: Randomised Controlled Trial to Evaluate Electronic Symptom Management Using the Advanced Symptom Management System (ASyMS) Remote Technology for Patients With Cancers
Brief Summary Chemotherapy may cause distressing symptoms which can impact on patients' quality of life. Chemotherapy is frequently given on an outpatient basis therefore patients are often required to manage the symptoms they experience at home without direct supervision from healthcare professionals. This study aims to evaluate the impact of a mobile phone based, remote monitoring, symptom management system (ASyMS) on the delivery of care to people with nonmetastatic breast, colorectal or haematological cancer during chemotherapy and for one year following treatment. The study aims to compare a number of outcomes of patients using the ASyMS intervention with outcomes of patients who receive normal care at their hospital. For up to 6 cycles of chemotherapy treatment, once a day and any other time they feel unwell, patients allocated to the mobile phone group will enter information on the phone regarding any symptoms they are experiencing, take their temperature and enter this on the phone. The information is sent via secure connection to a computer, which assesses the information and sends an alert to their health care professional in the hospital, who will call the patient at home if the patient has reported problematic symptoms. Patients in the normal care group will receive care as normal at their hospital. Both groups of patients will be asked to complete a series of questionnaires before they start treatment, after each chemotherapy cycle (for a maximum of 6 cycles) and at 3 monthly intervals for up to one year thereafter (a subset of patients will also be asked to complete midcycle symptom assessments). The study will also evaluate the cost benefit of ASyMS, assess changes in clinical practice as a result of ASyMS and develop a predictive risk model (statistical model) for use in future care of patients receiving chemotherapy for these cancers. This multicentre study is taking place across a number of European countries.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Cancer
Intervention  ICMJE Other: ASyMS intervention Group
ASyMS is a mobile phone-based remote-monitoring system that enables the 'real-time' monitoring of patients' symptoms through use of a patient-reported outcome measure (PROM)
Study Arms  ICMJE
  • Experimental: ASyMS intervention Group
    Patients in the intervention group will be instructed to use the ASyMS intervention once daily (and whenever they feel unwell) for up to 6 cycles of chemotherapy treatment.
    Intervention: Other: ASyMS intervention Group
  • No Intervention: Control Group
    Patients in the control group will receive standard care as is currently available at their clinical site.
Publications * Maguire R, Fox PA, McCann L, Miaskowski C, Kotronoulas G, Miller M, Furlong E, Ream E, Armes J, Patiraki E, Gaiger A, Berg GV, Flowerday A, Donnan P, McCrone P, Apostolidis K, Harris J, Katsaragakis S, Buick AR, Kearney N. The eSMART study protocol: a randomised controlled trial to evaluate electronic symptom management using the advanced symptom management system (ASyMS) remote technology for patients with cancer. BMJ Open. 2017 Jun 6;7(5):e015016. doi: 10.1136/bmjopen-2016-015016.

*   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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 4, 2015)
1108
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2019
Estimated Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosed with breast cancer, colorectal cancer, or haematological malignancies (i.e. HD or NHL).
  • Scheduled to receive first-line cytotoxic chemotherapy.
  • Scheduled to receive 2-, 3- or 4-weekly chemotherapy protocols (i.e. chemotherapy administered at repeated cycles of 14, 21 or 28 days, respectively).
  • Planned to receive a minimum of 3 chemotherapy cycles.
  • Deemed physically/psychologically fit to participate in the study by a member of the multidisciplinary team.
  • Able to understand and communicate in the respective language.

Exclusion Criteria:

  • Patients with breast cancer or colorectal cancer with a distant metastasis, i.e. stage IV disease as defined by the TNM/UICC, (at the start of their chemotherapy treatment).
  • Patients with a haematological malignancy (HD or NHL), who have B symptoms, (at the start of their chemotherapy treatment).
  • Scheduled to receive concurrent radiotherapy during chemotherapy treatment.
  • Scheduled to receive weekly chemotherapy protocols. Also, patients who shift from a 2-, 3- or 4-weekly protocol to a weekly protocol during chemotherapy will be excluded from further participation in the study.
  • Diagnosed with the same type of cancer (i.e. where relapse has occurred) AND/OR another type of cancer (the only exception non-melanoma skin cancer) within the 5 years prior to recruitment to the study.
  • Received chemotherapy treatment for any medical reason within the last 5 years, unless this is chemoradiation for colorectal cancer.
  • Unable to provide written informed consent.
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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Greece,   Ireland,   Norway,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02356081
Other Study ID Numbers  ICMJE CRC331
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Louise McKean, University of Strathclyde
Study Sponsor  ICMJE Louise McKean
Collaborators  ICMJE
  • University College Dublin
  • King's College London
  • University of California, San Francisco
  • University of Athens
  • Medical University of Vienna
  • University of Dundee
  • European Cancer Patient Coalition (ECPC)
  • Docobo Ltd.
  • University of Surrey
  • Sykehuset Innlandet HF
Investigators  ICMJE
Principal Investigator: Roma Maguire University of Strathclyde
PRS Account University of Strathclyde
Verification Date November 2017

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