eSMART Trial to Evaluate ASyMS
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ClinicalTrials.gov Identifier: NCT02356081 |
Recruitment Status : Unknown
Verified November 2017 by Louise McKean, University of Strathclyde.
Recruitment status was: Recruiting
First Posted : February 5, 2015
Last Update Posted : November 13, 2017
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Condition or disease | Intervention/treatment | Phase |
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Cancer | Other: ASyMS intervention Group | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1108 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
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 Start Date : | February 2015 |
Estimated Primary Completion Date : | January 2019 |
Estimated Study Completion Date : | January 2019 |
Arm | Intervention/treatment |
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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.
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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) |
No Intervention: Control Group
Patients in the control group will receive standard care as is currently available at their clinical site.
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- 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 or 6th 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02356081
Contact: Roma Maguire | +44 (0)141 249 0921 | roma.maguire@strath.ac.uk | |
Contact: Lisa McCann | +44 (0)141 249 0921 | lisa.mccann@strath.ac.uk |
Austria | |
Medical University Vienna Comprehensive Cancer Center | Recruiting |
Vienna, Austria | |
Contact: Alexander Gaiger Alexander.gaiger@meduniwien.ac.at | |
Principal Investigator: Alexander Gaiger | |
Greece | |
Agioi Anargiri Cancer Hospital | Recruiting |
Athens, Greece | |
Contact: Anna Papadouri annapapadouri@windowslive.com | |
Principal Investigator: Anna Papadouri | |
Air Force General Hospital | Recruiting |
Athens, Greece | |
Contact: Chrysoula Karlou xk1965@freemail.gr | |
Principal Investigator: Chrysoula Karlou | |
Metropolitan Hospital | Recruiting |
Athens, Greece | |
Contact: Vasileios Barmpounis | |
Contact vasbarb@gmail.com | |
Principal Investigator: Vasileios Barmpounis | |
Ireland | |
St James's Hospital | Recruiting |
Dublin, Ireland | |
Contact: John Kennedy jkennedy@stjames.ie | |
Principal Investigator: John Kennedy | |
St Vincent's Healthcare Group | Recruiting |
Dublin, Ireland | |
Contact: Giuseppe Gullo g.gullo@st-vincents.ie | |
Principal Investigator: Giuseppe Gullo | |
University Hospital Waterford | Completed |
Waterford, Ireland | |
Norway | |
Innlandet Hospital Trust | Recruiting |
Lillehammer, Norway | |
Contact: Geir Berg geir.berg@sykehuset-innlandet.no | |
Principal Investigator: Geir Berg | |
United Kingdom | |
Royal Surrey County Hospital | Completed |
Guildford, United Kingdom | |
Guy's and St Thomas' NHS Foundation Trust | Recruiting |
London, United Kingdom | |
Contact: Michael Flynn Michael.Flynn@gstt.nhs.uk | |
Principal Investigator: Michael Flynn | |
St George's Healthcare Trust | Recruiting |
London, United Kingdom | |
Contact: Ruth Petteng rpetteng@sgul.ac.uk | |
Principal Investigator: Ruth Petteng | |
University College London | Recruiting |
London, United Kingdom | |
Contact: Tom Marler-Hausen Tom.Marler-Hausen@uclh.nhs.uk | |
Principal Investigator: Tom Marler-Hausen | |
Mount Vernon Cancer Centre | Recruiting |
Northwood, United Kingdom | |
Contact: Teresa Young teresa.young2@nhs.net | |
Principal Investigator: Teresa Young |
Principal Investigator: | Roma Maguire | University of Strathclyde |
Responsible Party: | Louise McKean, Solicitor, University of Strathclyde |
ClinicalTrials.gov Identifier: | NCT02356081 |
Other Study ID Numbers: |
CRC331 |
First Posted: | February 5, 2015 Key Record Dates |
Last Update Posted: | November 13, 2017 |
Last Verified: | November 2017 |