eSMART Trial to Evaluate ASyMS

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

Tracking Information

• First Submitted Date: January 26, 2015
• First Posted Date: February 5, 2015
• Last Update Posted Date: May 26, 2021
• Study Start Date: February 2015
• Actual Primary Completion Date: March 31, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 24, 2021)

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.

Original Primary Outcome Measures (submitted: February 4, 2015)

• Memorial Symptom Assessment Scale (MSAS) [ Time Frame: baseline (within 1 week before 1st chemotherapy cycle) ]
  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.
• Memorial Symptom Assessment Scale (MSAS) [ Time Frame: On the day scheduled for each subsequent chemotherapy cycle (up to 3 days before to 3 days after the 1st day of each cycle) ]
  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.
• Memorial Symptom Assessment Scale (MSAS) [ Time Frame: Mid-way each chemotherapy cycle, (Day 6-8, 9-11, or 13-15 - dependent on number of days in the chemotherapy cycle) ]
  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.
• Memorial Symptom Assessment Scale (MSAS) [ Time Frame: 1-5 days after the end of the final chemotherapy cycle ]
  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.
• Memorial Symptom Assessment Scale (MSAS) [ Time Frame: 3 months post chemotherapy completion ]
  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.
• Memorial Symptom Assessment Scale (MSAS) [ Time Frame: 6 months post chemotherapy completion ]
  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.
• Memorial Symptom Assessment Scale (MSAS) [ Time Frame: 9 months post chemotherapy completion ]
  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.
• Memorial Symptom Assessment Scale (MSAS) [ Time Frame: 12 months post chemotherapy completion ]
  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.

Current Secondary Outcome Measures (submitted: May 24, 2021)

• 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.
• 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
• 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.
• 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'.
• 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).
• 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.

• Original Secondary Outcome Measures: Not Provided

Current Other Pre-specified Outcome Measures (submitted: May 24, 2021)

• 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
• 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
• 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.

• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Other
• Condition: Cancer

Intervention

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)

Study Arms

• 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.
  Intervention: Other: ASyMS intervention Group
• No Intervention: Control Group
  Patients in the control group will receive standard care as is currently available at their clinical site.

Publications *

• 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. Erratum In: BMJ. 2021 Aug 26;374:n2116.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 24, 2021): 829
• Original Estimated Enrollment (submitted: February 4, 2015): 1108
• Actual Study Completion Date: March 31, 2019
• Actual Primary Completion Date: March 31, 2019 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Austria, Greece, Ireland, Norway, United Kingdom

Administrative Information

• NCT Number: NCT02356081
• Other Study ID Numbers: CRC331
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Louise McKean, University of Strathclyde
• Original Responsible Party: University of Surrey
• Current Study Sponsor: Louise McKean
• Original Study Sponsor: University of Surrey

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

Investigators

• Principal Investigator: Roma Maguire; University of Strathclyde

• PRS Account: University of Strathclyde
• Verification Date: May 2021