Clinical trial NCT03335189: Feasibility Study of the Advanced Symptom Management System (ASyMS) in Canadian Cancer Patients
Official title: Adaptation, Feasibility and Acceptability Study of the Advanced Symptom Management System (ASyMS) Mobile Health Intervention to Reduce Chemotherapy Toxicities in Canadian Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Supportive Care
Cancer
Keywords: E-Health
Smartphone technology
Real-time symptom assessment
Self-care
Symptom management
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2017-11-07
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The Advanced Symptom Monitoring and Management System - Canada (ASyMS-Can) is a remote phone-based symptom management system that prompts patient self-care and clinician telephone triage and intervention based on alerts for managing cancer treatment side effects such as nausea and vomiting, fatigue, etc. ASyMS-Can is an android phone-based application that is given to patients to self-report their symptoms using a patient reported outcome symptom questionnaire and level of severity daily, on a secure mobile android phone, from home or outside of clinics. Based on back-end computations, patients receive automated self-care notifications on their mobile phones with advice on self-care for mild to moderate severe symptoms. The system also in the case of severe symptoms will alert the designated clinic nurse to prompt electronic telephone triage and intervention (yellow alert response in 4 hours or within 30 minutes for severe symptoms-red alert).

Detailed description: In addition, patients can access a self-care library and symptom graphs (detailing trends in individual symptoms experienced) through the ASyMS-Can patient phones. If the incoming symptom reports are of clinical concern, the server software will generate two levels of alerts (amber\& red) that will be sent to the designated nurse, who will receive alerts on a dedicated ASyMS-Can nurse handset (mobile phone). The nurse will view the patient's symptom reports on a secure web page, and contact the patient directly at home by telephone, guided through a decision-support algorithm on the web-based platform to systematize the triage based on the COSTARS guideline, facilitating the initiation of "real-time" clinical interventions. An "amber alert", which requires response within 4 hours, indicates that the symptom(s) are not severe or life-threatening but early intervention might prevent further symptom progression. The second level of the triage alert, 'red alert', will be sent to the nurse for severe symptoms and will require response within 30 minutes of receipt of the alert

Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with early stage breast, colorectal, and lymphoma (Hodgkin's \[HD\], non- Hodgkin's \[NHL\].
2. Scheduled to receive 2-, 3- or 4-weekly chemotherapy protocols (i.e. chemotherapy administered at repeated cycles of 14, 21 or 28 days, respectively).
3. Scheduled to receive a minimum of 3 cycles of systemic chemotherapy (any regimen); adjuvant or neo-adjuvant on an out-patient basis;
4. Adults \>=18 years of age;
5. Able to provide written consent and willing to participate;
6. Adequate ability to use or be trained in use of a mobile phone for symptom reporting

Exclusion Criteria:

1. Enrolled/receiving an investigational treatment;
2. Scheduled to receive concurrent radiotherapy during chemotherapy treatment.
3. Scheduled to receive weekly chemotherapy protocols. In addition, 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.
4. Any distant metastasis based on Ann Arbor or TNM staging
5. Unable to speak/read/write English sufficiently to complete study measures.
6. Unable to complete study measures due to a pre-existing disability (e.g. visually impaired)
7. Cognitive impairment/severe pre-existing emotional issues as assessed by the treatment team which may impede completion of study measures.
8. Low performance status (ECOG \> or =3)

Primary outcomes:
measure: Feasibility of recruitment
timeFrame: Recruitment rate aim is 7-8 patients/month, for 1 year.
Secondary outcomes:
measure: Symptom Severity
timeFrame: Baseline (within 1 week before 1st chemotherapy cycle). Mid-way each chemotherapy cycle, (Day 6-8, 9-11, or 13-15 - dependent on number of days in the chemotherapy cycle).
measure: Chemotherapy Self-Management Behaviours
timeFrame: Midpoint of treatment cycle (Week 3-4, or 7-8 - dependent on chemotherapy regimen being given).
measure: Self-Efficacy for Coping
timeFrame: Baseline (within 1 week before 1st chemotherapy cycle), midpoint of treatment cycle (Week 3-4, or 7-8 - dependent on chemotherapy regimen being given), and end of treatment (Week 6-8 or 14-16-dependent on chemotherapy regimen being given).
measure: Psychological Distress
timeFrame: Baseline(within 1 week before 1st chemotherapy cycle), midpoint of treatment cycle (Week 3-4, or 7-8 - dependent on chemotherapy regimen being given), and end of treatment (Week 6-8 or 14-16-dependent on chemotherapy regimen being given).
measure: Information and Support Needs
timeFrame: Baseline(within 1 week before 1st chemotherapy cycle), midpoint of treatment cycle (Week 3-4, or 7-8 - dependent on chemotherapy regimen being given).
measure: Health Related Quality of Life
timeFrame: Baseline(within 1 week before 1st chemotherapy cycle), midpoint of treatment cycle (Week 3-4, or 7-8 - dependent on chemotherapy regimen being given), and end of treatment (Week 6-8 or 14-16-dependent on chemotherapy regimen being given).
measure: Health Service Utilization
timeFrame: End of each chemotherapy cycle (Week 2-3, or 4-5 - dependent on chemotherapy regimen being given).
measure: Acceptance, Patient User/Satisfaction, System Usefulness, Information Quality and Interface Quality of User Interface
timeFrame: End of study (Week 16)
measure: Clinicians' acceptance
timeFrame: End of study (Week 16)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
References:
citation: Moradian S, Krzyzanowska M, Maguire R, Kukreti V, Amir E, Morita PP, Liu G, Howell D. Feasibility randomised controlled trial of remote symptom chemotherapy toxicity monitoring using the Canadian adapted Advanced Symptom Management System (ASyMS-Can): a study protocol. BMJ Open. 2020 Jun 17;10(6):e035648. doi: 10.1136/bmjopen-2019-035648.