Feasibility Study of the Advanced Symptom Management System (ASyMS) in Canadian Cancer Patients

NCT03335189 | Completed DMC

• 1 other identifier: CAPCR ID: 17-5367.0
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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).

Conditions

Supportive Care; Cancer

Keywords

E-Health; Smartphone technology; Real-time symptom assessment; Self-care; Symptom management

Outcome Measures

Primary Outcomes (1)

• Feasibility of recruitment

  Recruitment Rate (RRa)

  Recruitment rate aim is 7-8 patients/month, for 1 year.

Secondary Outcomes (9)

• Symptom Severity

  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).

• Chemotherapy Self-Management Behaviours

  Midpoint of treatment cycle (Week 3-4, or 7-8 - dependent on chemotherapy regimen being given).

• Self-Efficacy for Coping

  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).

• Psychological Distress

  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).

• Information and Support Needs

  Baseline(within 1 week before 1st chemotherapy cycle), midpoint of treatment cycle (Week 3-4, or 7-8 - dependent on chemotherapy regimen being given).

Study Arms (2)

ASyMS-Can

EXPERIMENTAL

TParticipants assigned to the experimental group will be provided with the encrypted, secure, pre-programmed ASyMS-Can android phone, and instructed of its use; how to report their symptomatology on a twice daily basis using the CTAQ for the first 14 days of each treatment cycle until end of the final cycle of treatment (or up to 16 weeks).

Device: ASyMS-Can

Control

NO INTERVENTION

Control group will be asked to complete the study questionnaires at your clinic visits. Also, research staff will contact participants at 1 to 14 days following each chemotherapy, mid and end of each chemotherapy appointment and again within week 8 and 16 of your participation to collect information about participants' symptoms.

Interventions

ASyMS-Can DEVICE

Data reported by the participants will be sent to a secure, encrypted clinical central server hosting the risk-alerting algorithms. The web interfaces will provide a clinical portal for the nurses to screen and follow any alerts being triggered, as well as review patient-specific information. Based on these back-end computations, participants will receive automated self-care notifications on their mobile phones. If incoming symptom reports indicate severe adverse effects a designated clinic nurse will receive an 'amber alert', or 'red alert', that will require response within 30 minutes. Nurses will handle alerts during business hours (9 am to 5 pm). After-hour alerts will be sent to the oncologist or nursing supervisor on call as per usual care. Patients will be instructed that clinicians will not receive alerts during the evening hours or night and instructed to follow usual practice of contacting their family physician, or oncologist on call, or call 911, as required.

Also known as: ASyMS

ASyMS-Can

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Location

Related Publications (1)

• 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.

  PMID: 32554724 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2017
• First Posted: November 7, 2017
• Study Start: November 15, 2017
• Primary Completion: February 28, 2019
• Study Completion: May 28, 2019
• Last Updated: June 7, 2019

Record last verified: 2019-06

Locations

CA (1)