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eSMART Trial to Evaluate ASyMS

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ClinicalTrials.gov Identifier: NCT02356081
Recruitment Status : 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

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.

Condition or disease Intervention/treatment Phase
Cancer Other: ASyMS intervention Group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: eSMART: Randomised Controlled Trial to Evaluate Electronic Symptom Management Using the Advanced Symptom Management System (ASyMS) Remote Technology for Patients With Cancers
Study Start Date : February 2015
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Arm Intervention/treatment
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.
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)

No Intervention: Control Group
Patients in the control group will receive standard care as is currently available at their clinical site.



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.



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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:

  • 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.

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): NCT02356081


Contacts
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Contact: Roma Maguire +44 (0)141 249 0921 roma.maguire@strath.ac.uk
Contact: Lisa McCann +44 (0)141 249 0921 lisa.mccann@strath.ac.uk

Locations
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Austria
Medical University Vienna Comprehensive Cancer Center Recruiting
Vienna, Austria
Contact: Alexander Gaiger       Alexander.gaiger@meduniwien.ac.at   
Principal Investigator: Alexander Gaiger         
Greece
Agioi Anargiri Cancer Hospital Recruiting
Athens, Greece
Contact: Anna Papadouri       annapapadouri@windowslive.com   
Principal Investigator: Anna Papadouri         
Air Force General Hospital Recruiting
Athens, Greece
Contact: Chrysoula Karlou       xk1965@freemail.gr   
Principal Investigator: Chrysoula Karlou         
Metropolitan Hospital Recruiting
Athens, Greece
Contact: Vasileios Barmpounis         
Contact       vasbarb@gmail.com   
Principal Investigator: Vasileios Barmpounis         
Ireland
St James's Hospital Recruiting
Dublin, Ireland
Contact: John Kennedy       jkennedy@stjames.ie   
Principal Investigator: John Kennedy         
St Vincent's Healthcare Group Recruiting
Dublin, Ireland
Contact: Giuseppe Gullo       g.gullo@st-vincents.ie   
Principal Investigator: Giuseppe Gullo         
University Hospital Waterford Completed
Waterford, Ireland
Norway
Innlandet Hospital Trust Recruiting
Lillehammer, Norway
Contact: Geir Berg       geir.berg@sykehuset-innlandet.no   
Principal Investigator: Geir Berg         
United Kingdom
Royal Surrey County Hospital Completed
Guildford, United Kingdom
Guy's and St Thomas' NHS Foundation Trust Recruiting
London, United Kingdom
Contact: Michael Flynn       Michael.Flynn@gstt.nhs.uk   
Principal Investigator: Michael Flynn         
St George's Healthcare Trust Recruiting
London, United Kingdom
Contact: Ruth Petteng       rpetteng@sgul.ac.uk   
Principal Investigator: Ruth Petteng         
University College London Recruiting
London, United Kingdom
Contact: Tom Marler-Hausen       Tom.Marler-Hausen@uclh.nhs.uk   
Principal Investigator: Tom Marler-Hausen         
Mount Vernon Cancer Centre Recruiting
Northwood, United Kingdom
Contact: Teresa Young       teresa.young2@nhs.net   
Principal Investigator: Teresa Young         
Sponsors and Collaborators
Louise McKean
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
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Principal Investigator: Roma Maguire University of Strathclyde