Clinical trial NCT02356081: eSMART Trial to Evaluate ASyMS
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Lead sponsor: University of Strathclyde
Sponsor class: OTHER
Collaborators: name: University College Dublin
name: King's College London
name: University of California, San Francisco
name: University of Athens
name: Medical University of Vienna
name: University of Dundee
name: European Cancer Patient Coalition (ECPC)
name: Docobo Ltd.
name: University of Surrey
name: Sykehuset Innlandet HF
First posted: 2015-02-05
Enrollment: 829
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Memorial Symptom Assessment Scale (MSAS)
timeFrame: 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:
measure: Memorial Symptom Assessment Scale (MSAS)
timeFrame: 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.
measure: Functional Assessment of Cancer Therapy General (FACT-G)
timeFrame: 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.
measure: Supportive Care Needs Survey Short Form
timeFrame: 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.
measure: State-Trait Anxiety Inventory-Revised
timeFrame: 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.
measure: Communication and Attitudinal Self-Efficacy scale for cancer
timeFrame: 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.
measure: Work Limitations Questionnaire
timeFrame: 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:
measure: EuroQol 5-Dimensions combined with the Client Services Receipt Inventory
timeFrame: 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.
measure: Changes in clinical practice as a result of the intervention
timeFrame: Baseline and immediately after the intervention
measure: 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.
timeFrame: 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.
Locations:
city: Vienna
country: Austria
facility: Medical University Vienna Comprehensive Cancer Center
city: Athens
country: Greece
facility: Agioi Anargiri Cancer Hospital
city: Athens
country: Greece
facility: Air Force General Hospital
city: Athens
country: Greece
facility: Metropolitan Hospital
city: Dublin
country: Ireland
facility: St James's Hospital
city: Dublin
country: Ireland
facility: St Vincent's Healthcare Group
city: Lillehammer
country: Norway
facility: Innlandet Hospital Trust
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
city: London
country: United Kingdom
facility: St George's Healthcare Trust
city: London
country: United Kingdom
facility: University College London
city: Northwood
country: United Kingdom
facility: Mount Vernon Cancer Centre
Study officials:
affiliation: University of Strathclyde
name: Roma Maguire
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.