eSMART Trial to Evaluate ASyMS

NCT02356081 | Completed DMC

• 1 other identifier: CRC331
• Study Type: interventional
• Target: 829
• Locations: 5 countries
• Sites: 11

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• Memorial Symptom Assessment Scale (MSAS)

  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.

  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.

Secondary Outcomes (6)

• Memorial Symptom Assessment Scale (MSAS)

  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.

• Functional Assessment of Cancer Therapy General (FACT-G)

  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.

• Supportive Care Needs Survey Short Form

  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.

• State-Trait Anxiety Inventory-Revised

  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.

• Communication and Attitudinal Self-Efficacy scale for cancer

  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.

Other Outcomes (3)

• EuroQol 5-Dimensions combined with the Client Services Receipt Inventory

  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.

• Changes in clinical practice as a result of the intervention

  Baseline and immediately after the intervention

• 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.

  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.

Study Arms (2)

ASyMS intervention Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

Patients in the control group will receive standard care as is currently available at their clinical site.

Interventions

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)

ASyMS intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (11)

Medical University Vienna Comprehensive Cancer Center

Vienna, Austria

Location

Agioi Anargiri Cancer Hospital

Athens, Greece

Location

Air Force General Hospital

Athens, Greece

Location

Metropolitan Hospital

Athens, Greece

Location

St James's Hospital

Dublin, Ireland

Location

St Vincent's Healthcare Group

Dublin, Ireland

Location

Innlandet Hospital Trust

Lillehammer, Norway

Location

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom

Location

St George's Healthcare Trust

London, United Kingdom

Location

University College London

London, United Kingdom

Location

Mount Vernon Cancer Centre

Northwood, United Kingdom

Location

Related Publications (4)

• McCann L, Lewis L, Oduntan O, Harris J, Darley A, Berg GV, Lubowitzki S, Cheevers K, Miller M, Armes J, Ream E, Fox P, Furlong EP, Gaiger A, Kotronoulas G, Patiraki E, Katsaragakis S, McCrone P, Miaskowski C, Cardone A, Orr D, Flowerday A, Skene S, Moore M, De Souza N, Donnan P, Maguire R. Patients' and Clinicians' Experiences Using a Real-Time Remote Monitoring System for Chemotherapy Symptom Management (ASyMS): Qualitative Study. J Med Internet Res. 2024 Dec 3;26:e53834. doi: 10.2196/53834.

  PMID: 39626227 DERIVED

• Miller M, McCann L, Lewis L, Miaskowski C, Ream E, Darley A, Harris J, Kotronoulas G, V Berg G, Lubowitzki S, Armes J, Patiraki E, Furlong E, Fox P, Gaiger A, Cardone A, Orr D, Flowerday A, Katsaragakis S, Skene S, Moore M, McCrone P, De Souza N, Donnan PT, Maguire R. Patients' and Clinicians' Perceptions of the Clinical Utility of Predictive Risk Models for Chemotherapy-Related Symptom Management: Qualitative Exploration Using Focus Groups and Interviews. J Med Internet Res. 2024 Jun 20;26:e49309. doi: 10.2196/49309.

  PMID: 38901021 DERIVED

• Maguire R, McCann L, Kotronoulas G, Kearney N, Ream E, Armes J, Patiraki E, Furlong E, Fox P, Gaiger A, McCrone P, Berg G, Miaskowski C, Cardone A, Orr D, Flowerday A, Katsaragakis S, Darley A, Lubowitzki S, Harris J, Skene S, Miller M, Moore M, Lewis L, DeSouza N, Donnan PT. Real time remote symptom monitoring during chemotherapy for cancer: European multicentre randomised controlled trial (eSMART). BMJ. 2021 Jul 21;374:n1647. doi: 10.1136/bmj.n1647.

  PMID: 34289996 DERIVED

• 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.

  PMID: 28592577 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Roma Maguire

  University of Strathclyde

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Solicitor

Study Record Dates

• First Submitted: January 26, 2015
• First Posted: February 5, 2015
• Study Start: February 1, 2015
• Primary Completion: March 31, 2019
• Study Completion: March 31, 2019
• Last Updated: May 26, 2021

Record last verified: 2021-05

Locations

GB (4); GR (3); AU (1); NO (1); IE (2)