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eSMART Trial to Evaluate ASyMS

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ClinicalTrials.gov Identifier: NCT02356081
Recruitment Status : Completed
First Posted : February 5, 2015
Last Update Posted : May 26, 2021
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

Study Description
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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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 829 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
Actual Primary Completion Date : March 31, 2019
Actual Study Completion Date : March 31, 2019
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Memorial Symptom Assessment Scale (MSAS) [ Time Frame: At the end of each cycle of chemotherapy (each cycle can be either 14, 21 or 28 days long) for up to a maximum of 6 cycles of chemotherapy. ]
    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.


Secondary Outcome Measures :
  1. Memorial Symptom Assessment Scale (MSAS) [ Time Frame: At the halfway point during each cycle of chemotherapy (each cycle can be wither 14, 21 or 28 days long) for up to a maximum of 6 cycles of chemotherapy and/or at 3 monthly intervals for up to one year following a maximum of 6 cycles of chemotherapy. ]
    The MSAS is a multidimensional self-report questionnaire that evaluates 32 physical and psychological symptoms according to their frequency, severity and distress/bother to the person in the past week.

  2. Functional Assessment of Cancer Therapy General (FACT-G) [ Time Frame: At the end of each cycle of chemotherapy (each cycle can be either 14, 21 or 28 days long) for up to a maximum of 6 cycles of chemotherapy and/or at 3 monthly intervals for up to one year following a maximum of 6 cycles of chemotherapy. ]
    during active chemotherapy and/or at the 1 year follow-up

  3. Supportive Care Needs Survey Short Form [ Time Frame: At the end of each cycle of chemotherapy (each cycle can be either 14, 21 or 28 days long) for up to a maximum of 6 cycles of chemotherapy and/or at 3 monthly intervals for up to one year following a maximum of 6 cycles of chemotherapy. ]
    The 34-item instrument measures supportive care needs in five domains: health system and information, psychological needs, physical and daily living, patient care and support, and sexual-related.

  4. State-Trait Anxiety Inventory-Revised [ Time Frame: At the end of each cycle of chemotherapy (each cycle can be either 14, 21 or 28 days long) for up to a maximum of 6 cycles of chemotherapy and/or at 3 monthly intervals for up to one year following a maximum of 6 cycles of chemotherapy. ]
    The STAI-R is a 40-item measure of two types of anxiety - state anxiety (anxiety about an event), and trait anxiety (anxiety level as a personal characteristic). The State Anxiety scale assesses intensity of current feelings "at this moment". The Trait Anxiety scale assesses frequency of feelings 'in general'.

  5. Communication and Attitudinal Self-Efficacy scale for cancer [ Time Frame: At the end of each cycle of chemotherapy (each cycle can be either 14, 21 or 28 days long) for up to a maximum of 6 cycles of chemotherapy and/or at 3 monthly intervals for up to one year following a maximum of 6 cycles of chemotherapy. ]
    A 12-item measure of cancer patients' confidence and ability to engage in their self-care (i.e. self-efficacy) contributing to 3 dimensions (maintaining a positive attitude, understanding and participating in care, seeking and obtaining information).

  6. Work Limitations Questionnaire [ Time Frame: At the end of each cycle of chemotherapy (each cycle can be either 14, 21 or 28 days long) for up to a maximum of 6 cycles of chemotherapy and/or at 3 monthly intervals for up to one year following a maximum of 6 cycles of chemotherapy. ]
    A 25-item measure corresponding to 4 dimensions: time management; physical; mental/interpersonal; output demands). This was only completed by those individuals who were working.


Other Outcome Measures:
  1. EuroQol 5-Dimensions combined with the Client Services Receipt Inventory [ Time Frame: At the end of each cycle of chemotherapy (each cycle can be either 14, 21 or 28 days long) for up to a maximum of 6 cycles of chemotherapy and/or at 3 monthly intervals for up to one year following a maximum of 6 cycles of chemotherapy. ]
    To evaluate the cost-effectiveness of the intervention for the management of chemotherapy-related symptoms

  2. Changes in clinical practice as a result of the intervention [ Time Frame: Baseline and immediately after the intervention ]
    Exploring experiences of an anticipatory and preventative model of care

  3. Predictive Risk Models (PRMs) to predict patients' chemotherapy-related symptoms by combining demographic, clinical, social and health service data collected from previous studies, as well as the current study, to inform the predictions made. [ Time Frame: Daily throughout each cycle of chemotherapy (each cycle can be either 14, 21 or 28 days long) for up to a maximum of 6 cycles of chemotherapy. ]
    To move beyond traditional approaches to manage symptoms in oncology patients receiving chemotherapy to more tailored and anticipatory approaches.


Eligibility Criteria
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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.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Locations
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Austria
Medical University Vienna Comprehensive Cancer Center
Vienna, Austria
Greece
Agioi Anargiri Cancer Hospital
Athens, Greece
Air Force General Hospital
Athens, Greece
Metropolitan Hospital
Athens, Greece
Ireland
St James's Hospital
Dublin, Ireland
St Vincent's Healthcare Group
Dublin, Ireland
Norway
Innlandet Hospital Trust
Lillehammer, Norway
United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom
St George's Healthcare Trust
London, United Kingdom
University College London
London, United Kingdom
Mount Vernon Cancer Centre
Northwood, United Kingdom
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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Louise McKean, Solicitor, University of Strathclyde
ClinicalTrials.gov Identifier: NCT02356081    
Other Study ID Numbers: CRC331
First Posted: February 5, 2015    Key Record Dates
Last Update Posted: May 26, 2021
Last Verified: May 2021