eSMART Trial to Evaluate ASyMS

NCT ID: NCT02356081

Last Updated: 2021-05-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 829 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2019-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

ASyMS intervention Group

Intervention Type: 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)

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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)

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University College Dublin

OTHER

Sponsor Role: collaborator

King's College London

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: collaborator

University of Athens

OTHER

Sponsor Role: collaborator

Medical University of Vienna

OTHER

Sponsor Role: collaborator

University of Dundee

OTHER

Sponsor Role: collaborator

European Cancer Patient Coalition (ECPC)

UNKNOWN

Sponsor Role: collaborator

Docobo Ltd.

INDUSTRY

Sponsor Role: collaborator

University of Surrey

OTHER

Sponsor Role: collaborator

Sykehuset Innlandet HF

OTHER

Sponsor Role: collaborator

Louise McKean

OTHER

Sponsor Role: lead

Responsible Party

Louise McKean

Solicitor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Roma Maguire

Role: PRINCIPAL_INVESTIGATOR

University of Strathclyde

Locations

Medical University Vienna Comprehensive Cancer Center

Vienna, , Austria

Agioi Anargiri Cancer Hospital

Athens, , Greece

Air Force General Hospital

Athens, , Greece

Metropolitan Hospital

Athens, , Greece

St James's Hospital

Dublin, , Ireland

St Vincent's Healthcare Group

Dublin, , Ireland

Innlandet Hospital Trust

Lillehammer, , Norway

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

Countries

Austria; Greece; Ireland; Norway; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 39626227 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 38901021 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34289996 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28592577 (View on PubMed)

Other Identifiers

CRC331

Identifier Type: -

Identifier Source: org_study_id