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Supportive CareASyMS-CanNCT03335189

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

A study testing ASyMS-Can in people with Supportive Care and Cancer, run by University Health Network, Toronto at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Supportive Care, Cancer
What is being tested?
ASyMS-Can
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteCanada
Study dates
15 Nov 2017to 28 May 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Princess Margaret Cancer Centre

    Toronto, Ontario

Other trials in Canada

About this study

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

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).

Read the 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

Being tested
ASyMS-Can
Keywords
E-Health, Smartphone technology, Real-time symptom assessment, Self-care, Symptom management
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ASyMS-CanDevice

    Also called ASyMS

    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.

Study groups in NCT03335189
Study groupRoleWhat they receive
ASyMS-CanExperimentalTParticipants 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).
Receives: Device: ASyMS-Can
ControlNo interventionControl 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of recruitment

    Recruitment Rate (RRa)

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

Secondary outcomes (9)

  1. Symptom Severity

    Symptom severity will be measured using the Memorial Symptom Assessment Scale (MSAS). 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.

    Measured: 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).

  2. Chemotherapy Self-Management Behaviours

    Chemotherapy Self-Management Behaviours will be measured using the Leuven questionnaire for self-care behaviours during chemotherapy (L-PaSC). The L-PaSC is a 22-item instrument with 7 themes that capture the most relevant aspects of patient self-care during chemotherapy.

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

  3. Self-Efficacy for Coping

    Self-efficacy will be measured using the Cancer Behavior Inventory (CBI-B) which is a 12-item unidimensional instrument designed to assess coping self-efficacy of cancer patients.

    Measured: 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).

  4. Psychological Distress

    Using the Depression, Anxiety and Stress Scale (DASS21) which contains 21 items for self-reporting for measuring a range of symptoms common to both depression and anxiety. Each item is scored from 0 (did not apply to me at all over the last week) to 3 (applied to me very much for most of the time over the past week).

    Measured: 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).

  5. Information and Support Needs

    Using the Cancer Treatment Scale (CaTS) that is a two factor, 25-item measure that assesses sensory/psychological concerns and procedural concerns relating to cancer treatment.

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

  6. Health Related Quality of Life

    EuroQual-5D-5L (EQ-5D-5L). The questionnaire offers 5 levels of response for 5 dimensions including Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression.

    Measured: 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).

  7. Health Service Utilization

    Including days in hospital, ED visits, urgent care use, unscheduled clinic visits) self-reported by patients at end of each treatment cycle and calculated as group proportions over the entire course of treatment.

    Measured: End of each chemotherapy cycle (Week 2-3, or 4-5 - dependent on chemotherapy regimen being given).

  8. Acceptance, Patient User/Satisfaction, System Usefulness, Information Quality and Interface Quality of User Interface

    Using the Post-Study System Usability Questionnaire (PSSUQ) that consists of 16 items which produce four scores-one overall and three sub-scales. The questionnaire designed to assess users' perceived satisfaction with computer systems or applications. The self-administered questionnaire are composed of multiple separate items organized into scales, with each scale assumed to measure an attribute or attitude dimension is a common approach to usability evaluation.

    Measured: End of study (Week 16)

  9. Clinicians' acceptance

    using the Treatment Evaluation Inventory Short-Form (TEI-SF)

    Measured: End of study (Week 16)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2017
  2. Study start15 Nov 2017
  3. Primary completion28 Feb 2019
  4. Study completion28 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03335189
Sponsor's protocol ID
CAPCR ID: 17-5367.0
Acronym
ASyMS-Can
Status last verified
Jun 2019
First submitted
17 Oct 2017
Last updated
7 Jun 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 32554724

Questions about this trial

What is this clinical trial studying?

A study testing ASyMS-Can in people with Supportive Care and Cancer, run by University Health Network, Toronto at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of recruitment (time frame: Recruitment rate aim is 7-8 patients/month, for 1 year.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03335189, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2019.

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