Early Stage Breast CancerAToMNCT02485678
A Pragmatic Trial of Ambulatory Toxicity Management in Patients Receiving Adjuvant or Neo-adjuvant Chemotherapy for Early Stage Breast Cancer
A study testing Proactive Telephone Toxicity Management and PRO Sub-Study in people with Early Stage Breast Cancer, run by Ontario Clinical Oncology Group (OCOG) at 20 sites in Canada.
Trial summary
Comparison of the number of ER plus hospital visits that occurred during chemotherapy between the telephone intervention and control arms. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Early Stage Breast Cancer
- What is being tested?
- Proactive Telephone Toxicity Management and PRO Sub-Study
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,460 participants
- Where
- 20 sitesCanada
- Study dates
- Feb 2016to 30 Jun 2020
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women 18 years of age or older
- Diagnosis of early stage (I-III) breast cancer
- Starting adjuvant or neo-adjuvant chemotherapy within the intervention period at a participating centre
- Willingness to participate in the study and complete PRO questionnaires as required
- Ability to understand and provide written informed consent
- Language and literacy skills consistent with completing study questionnaires
Who cannot join
- Currently participating in a clinical trial involving an investigational agent
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Canada20 sites
Royal Victoria Hospital
Barrie, Ontario, L4M 6M2
William Osler Health Centre
Brampton, Ontario, L6R 3J7
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
Cancer Centre of Southeastern Ontario at Kingston
Kingston, Ontario, K7L 5P9
Grand River Regional Cancer Centre
Kitchener, Ontario, N2G 1G3
London Regional Cancer Program
London, Ontario, N6A 4L6
Markham Stouffville
Markham, Ontario, L3P 7P3
Trillium Health Partners - The Credit Valley Hospital
Mississauga, Ontario, L5M 2N1
Southlake Regional Cancer Centre
Newmarket, Ontario, L3Y 2P9
R.S. McLaughlin Durham Regional Cancer Centre, Lakeridge Health
Oshawa, Ontario, L1G 2B9
The Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, K1H 8L6
Sault Area Hospital
Sault Ste. Marie, Ontario, P6B 0A8
Thunder Bay Regional Health Science Centre
Thunder Bay, Ontario, P7B 6V4
Rouge Valley Health System
Toronto, Ontario, M1E 4B9
Sunnybrook Health Sciences Centre, Odette Cancer Centre
Toronto, Ontario, M4N 3M5
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Mt. Sinai Hospital
Toronto, Ontario, M5G 1X5
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Trillium Health Partners - Queensway Health Centre
Toronto, Ontario, M9C 1A5
Windsor Regional Cancer Centre
Windsor, Ontario, N8W 2X3
About this study
Official title: A Pragmatic Cluster-Randomized Trial of Ambulatory Toxicity Management in Patients Receiving Adjuvant or Neo-adjuvant Chemotherapy for Early Stage Breast Cancer (AToM)
Comparison of the number of ER plus hospital visits that occurred during chemotherapy between the telephone intervention and control arms.
Read the detailed description
Using a pragmatic cluster-randomized trial design, 20 Ontario cancer centres that provide care to patients with breast cancer will be randomly allocated to one of two arms: pro-active telephone toxicity management (intervention), or control (routine care). All patients with early stage (I-III) breast cancer who commence adjuvant or neo-adjuvant chemotherapy at participating institutions during the 6 to 12-month intervention period (will vary between centres depending on the number of incident cases) will be evaluated using Ontario healthcare administrative data. A sub-set of at least 25 patients at each participating institution will participate in a PRO sub-study involving the completion of standardized questionnaires to measure: a) severity of chemotherapy treatment toxicities; b) self-care for management of chemotherapy toxicities; c) self-efficacy (confidence) for managing symptoms; d) quality of life; and e) coordination of care. Patients participating in the PRO sub-study will be asked to provide consent to link their PRO data to Ontario healthcare administrative data so that correlations between the symptom self-assessments and Quality of Life (QoL) measures can be made with the administrative data on ED+H visits and use of supportive care medications. the investigators will compare the use of supportive care medications (i.e. anti-emetics, growth factors) by patients in the intervention and control arms to assess their influence on severity of chemotherapy-related toxicities as part of an exploratory sub-group analysis in patients >65 years of age as administrative data on supportive care medication use is only available for this age group.
- Conditions
- Early Stage Breast Cancer
- Being tested
- Proactive Telephone Toxicity Management, Control Arm, PRO Sub-Study
- Keywords
- ambulatory toxicity management, adjuvant or neoadjuvant chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proactive Telephone Toxicity ManagementOther
Centres randomized to this arm will implement a pro-active telephone toxicity management program, for all eligible early stage breast cancer patients beginning neo-adjuvant or adjuvant chemotherapy within the intervention period until the end of their systemic treatment. Patients will receive a phone call from a local nurse who has been trained on the toxicity management toolkit at 24-72 hours and at 8 to 10 days following each chemotherapy administration. The provider conducting the call will be provided with a script and will complete the Telephone Follow-Up Questionnaire which includes questions from the abbreviated NCI PRO-CTCAE tool. The nurse conducting the call will also be provided with the provider version of the symptom management booklet and provide toxicity management counseling. If any toxicity-related problems are identified during the call, a second call will take place 24 hours after the initial call to ensure the problem is resolving or to provide additional support.
Control ArmOther
Centres randomized to the control arm will continue to provide routine care for chemotherapy-related toxicities as is the current standard in the centre.
PRO Sub-StudyOther
A sub-set of approximately 25 patients enrolled at each participating centre will participate in a Patient Reported Outcomes (PRO) sub-study to assess the effect of the intervention on secondary outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Proactive Telephone Toxicity Management | Experimental | Proactive Telephone Toxicity Management Receives: Other: Proactive Telephone Toxicity Management; Other: PRO Sub-Study |
| Control Arm | Active comparator | Control Receives: Other: Control Arm; Other: PRO Sub-Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Emergency and Hospital (ED+H) visits during chemotherapy
Collect the number of ED+H visits that occurred during chemotherapy for all patients
Measured: During chemotherapy and the 30 days post-chemotherapy
Secondary outcomes (4)
Severity of Chemotherapy
Severity of treatment side effects will be measured using the NCI PRO CTCAE self-report tool (assessment on a 5 point scale).
Measured: Assessed at baseline, at day 1 of cycle 2 prior to start of chemotherapy and again within 60 days of the completion of chemotherapy treatment
Quality of Life (QOL)
Measured using the Self-Care during Chemotherapy (L-PaSC), Stanford Self-Management Self-Efficacy Scale, FACT-B, GAD-7, PHQ-9, EQ-5D-3L
Measured: Assessed at baseline, at day 1 of cycle 2 prior to start of chemotherapy and again within 60 days of the completion of chemotherapy treatment
Coordination of Care
Measured using the adapted Picker survey.
Measured: Assessed at baseline, at day 1 of cycle 2 prior to start of chemotherapy and again within 60 days of the completion of chemotherapy treatment
Health Economics
Health system resources utilized by women receiving adjuvant or neo-adjuvant chemotherapy will be analyzed
Measured: Initiation of chemotherapy to the end of chemotherapy plus 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2015 (estimated)
- Study startFeb 2016
- Primary completion29 Mar 2018
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Early Stage Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,460 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)
- Sponsor type
- University, hospital or other
- Collaborators
- University Health Network, Toronto, Princess Margaret Hospital, Canada
- Responsible party
- Sponsor
- Investigators
- Monika Krzyzanowska, MD, Principal investigator, University Health Network - Princess Margaret Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02485678
- Sponsor's protocol ID
- OCOG-2015-ATOM
- Acronym
- AToM
- Status last verified
- Sep 2020
- First submitted
- 10 Jun 2015
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Krzyzanowska MK, Julian JA, Gu CS, Powis M, Li Q, Enright K, Howell D, Earle CC, Gandhi S, Rask S, Brezden-Masley C, Dent S, Hajra L, Freeman O, Spadafora S, Hamm C, Califaretti N, Trudeau M, Levine MN, Amir E, Bordeleau L, Chiarotto JA, Elser C, Husain J, Laferriere N, Rahim Y, Robinson AG, Vandenberg T, Grunfeld E. Remote, proactive, telephone based management of toxicity in outpatients during adjuvant or neoadjuvant chemotherapy for early stage breast cancer: pragmatic, cluster randomised trial. BMJ. 2021 Dec 8;375:e066588. doi: 10.1136/bmj-2021-066588.
PubMed 34880055Krzyzanowska MK, Julian JA, Powis M, Howell D, Earle CC, Enright KA, Mittmann N, Trudeau ME, Grunfeld E. Ambulatory Toxicity Management (AToM) in patients receiving adjuvant or neo-adjuvant chemotherapy for early stage breast cancer - a pragmatic cluster randomized trial protocol. BMC Cancer. 2019 Sep 5;19(1):884. doi: 10.1186/s12885-019-6099-x.
PubMed 31488084
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Cluster-Randomized Trial of Ambulatory Toxicity Management in Patients Receiving Adjuvant or Neo-adjuvant Chemotherapy for Early Stage Breast Cancer (AToM)
- ClinicalTrials.gov ID
- NCT02485678
- Acronym / sponsor ID
- AToM / OCOG-2015-ATOM
- Conditions
- Early Stage Breast Cancer
- Keywords
- ambulatory toxicity management, adjuvant or neoadjuvant chemotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,460 participants (actual)
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)University, hospital or other
- Collaborators
- University Health Network, Toronto, Princess Margaret Hospital, Canada
- Study start
- Feb 2016
- Primary completion
- 29 Mar 2018 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 30 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison of the number of ER plus hospital visits that occurred during chemotherapy between the telephone intervention and control arms.
Detailed description
Using a pragmatic cluster-randomized trial design, 20 Ontario cancer centres that provide care to patients with breast cancer will be randomly allocated to one of two arms: pro-active telephone toxicity management (intervention), or control (routine care). All patients with early stage (I-III) breast cancer who commence adjuvant or neo-adjuvant chemotherapy at participating institutions during the 6 to 12-month intervention period (will vary between centres depending on the number of incident cases) will be evaluated using Ontario healthcare administrative data. A sub-set of at least 25 patients at each participating institution will participate in a PRO sub-study involving the completion of standardized questionnaires to measure: a) severity of chemotherapy treatment toxicities; b) self-care for management of chemotherapy toxicities; c) self-efficacy (confidence) for managing symptoms; d) quality of life; and e) coordination of care. Patients participating in the PRO sub-study will be asked to provide consent to link their PRO data to Ontario healthcare administrative data so that correlations between the symptom self-assessments and Quality of Life (QoL) measures can be made with the administrative data on ED+H visits and use of supportive care medications. the investigators will compare the use of supportive care medications (i.e. anti-emetics, growth factors) by patients in the intervention and control arms to assess their influence on severity of chemotherapy-related toxicities as part of an exploratory sub-group analysis in patients >65 years of age as administrative data on supportive care medication use is only available for this age group.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proactive Telephone Toxicity Management | Experimental | Other: Proactive Telephone Toxicity Management, Other: PRO Sub-StudyProactive Telephone Toxicity Management |
| Control Arm | Active comparator | Other: Control Arm, Other: PRO Sub-StudyControl |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Women 18 years of age or older
- Diagnosis of early stage (I-III) breast cancer
- Starting adjuvant or neo-adjuvant chemotherapy within the intervention period at a participating centre
- Willingness to participate in the study and complete PRO questionnaires as required
- Ability to understand and provide written informed consent
Key exclusion criteria (1 listed)
- Currently participating in a clinical trial involving an investigational agent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proactive Telephone Toxicity ManagementCentres randomized to this arm will implement a pro-active telephone toxicity management program, for all eligible early stage breast cancer patients beginning neo-adjuvant or adjuvant chemotherapy within the intervention period until the end of their systemic treatment. Patients will receive a phone call from a local nurse who has been trained on the toxicity management toolkit at 24-72 hours and at 8 to 10 days following each chemotherapy administration. The provider conducting the call will be provided with a script and will complete the Telephone Follow-Up Questionnaire which includes questions from the abbreviated NCI PRO-CTCAE tool. The nurse conducting the call will also be provided with the provider version of the symptom management booklet and provide toxicity management counseling. If any toxicity-related problems are identified during the call, a second call will take place 24 hours after the initial call to ensure the problem is resolving or to provide additional support. | Other | Proactive Telephone Toxicity Management |
| Control ArmCentres randomized to the control arm will continue to provide routine care for chemotherapy-related toxicities as is the current standard in the centre. | Other | Control Arm |
| PRO Sub-StudyA sub-set of approximately 25 patients enrolled at each participating centre will participate in a Patient Reported Outcomes (PRO) sub-study to assess the effect of the intervention on secondary outcomes. | Other | Control Arm, Proactive Telephone Toxicity Management |
Primary outcome
Number of Emergency and Hospital (ED+H) visits during chemotherapy
Time frame: During chemotherapy and the 30 days post-chemotherapy
Collect the number of ED+H visits that occurred during chemotherapy for all patients
4 secondary outcomes
Severity of Chemotherapy
Time frame: Assessed at baseline, at day 1 of cycle 2 prior to start of chemotherapy and again within 60 days of the completion of chemotherapy treatment
Quality of Life (QOL)
Time frame: Assessed at baseline, at day 1 of cycle 2 prior to start of chemotherapy and again within 60 days of the completion of chemotherapy treatment
Coordination of Care
Time frame: Assessed at baseline, at day 1 of cycle 2 prior to start of chemotherapy and again within 60 days of the completion of chemotherapy treatment
Health Economics
Time frame: Initiation of chemotherapy to the end of chemotherapy plus 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
- Derived from this study: PubMed 34880055Krzyzanowska MK, Julian JA, Gu CS, Powis M, Li Q, Enright K, Howell D, Earle CC, Gandhi S, Rask S, Brezden-Masley C, Dent S, Hajra L, Freeman O, Spadafora S, Hamm C, Califaretti N, Trudeau M, Levine MN, Amir E, Bordeleau L, Chiarotto JA, Elser C, Husain J, Laferriere N, Rahim Y, Robinson AG, Vandenberg T, Grunfeld E. Remote, proactive, telephone based management of toxicity in outpatients during adjuvant or neoadjuvant chemotherapy for early stage breast cancer: pragmatic, cluster randomised trial. BMJ. 2021 Dec 8;375:e066588. doi: 10.1136/bmj-2021-066588.
- Derived from this study: PubMed 31488084Krzyzanowska MK, Julian JA, Powis M, Howell D, Earle CC, Enright KA, Mittmann N, Trudeau ME, Grunfeld E. Ambulatory Toxicity Management (AToM) in patients receiving adjuvant or neo-adjuvant chemotherapy for early stage breast cancer - a pragmatic cluster randomized trial protocol. BMC Cancer. 2019 Sep 5;19(1):884. doi: 10.1186/s12885-019-6099-x.
Related trials for Early Stage Breast Cancer
RecruitingObservational study
A Study to Assess Treatment Patterns and Treatment Adherence in Early HER2-positive Breast Cancer Participants After Treatment Decentralization
Early-stage HER2+ Breast Cancer
RecruitingPhase 2
Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)
Breast Neoplasms, Breast Cancer
RecruitingPhase 2
BRE-04: Window of Opportunity Trial of Preoperative Low Dose Azacitidine in High-Risk Early Stage Breast Cancer
Breast Cancer Invasive, Early-stage Breast Cancer
Active, not recruitingObservational study
Longitudinal ctDNA Surveillance for Older Women With ER+ Breast Cancer Who Omit Surgery
Breast Cancer
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monika Krzyzanowska, MD principal investigator
University Health Network - Princess Margaret Hospital
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proactive Telephone Toxicity Management and PRO Sub-Study in people with Early Stage Breast Cancer, run by Ontario Clinical Oncology Group (OCOG) at 20 sites 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 1 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 3 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites 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?
Number of Emergency and Hospital (ED+H) visits during chemotherapy (time frame: During chemotherapy and the 30 days post-chemotherapy). 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 NCT02485678, which also lists 2 linked publications.
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 3 Sep 2020; AzTrials last refreshed its copy on 8 Nov 2026.