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Completed

NCT Number: NCT02356081

eSMART Trial to Evaluate ASyMS

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University Vienna Comprehensive Cancer Center, Vienna, Austria

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Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

ASyMS intervention Group

Other

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)

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Louise McKean

Other

Collaborators

  • Docobo Ltd.
  • European Cancer Patient Coalition (ECPC)
  • King's College London
  • Medical University of Vienna
  • Sykehuset Innlandet HF
  • University College Dublin
  • University of Athens
  • University of California, San Francisco
  • University of Dundee
  • University of Surrey

Registry information

Official study title

eSMART: Randomised Controlled Trial to Evaluate Electronic Symptom Management Using the Advanced Symptom Management System (ASyMS) Remote Technology for Patients With Cancers

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Feb 5, 2015
Registry last updated
May 26, 2021

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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