Clinical trial · Interventional
A Pragmatic Trial of Ambulatory Toxicity Management in Patients Receiving Adjuvant or Neo-adjuvant Chemotherapy for Early Stage Breast Cancer
A Pragmatic Cluster-Randomized Trial of Ambulatory Toxicity Management in Patients Receiving Adjuvant or Neo-adjuvant Chemotherapy for Early Stage Breast Cancer (AToM)
NCT02485678CI-TRIAL-00046957AToMcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Comparison of the number of ER plus hospital visits that occurred during chemotherapy between the telephone intervention and control arms.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early Stage Breast Cancer | Early Stage Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control Arm | Other | — | UNRESOLVED |
| Proactive Telephone Toxicity Management | Other | — | UNRESOLVED |
| PRO Sub-Study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Proactive Telephone Toxicity Management
- description
- Proactive Telephone Toxicity Management
- interventionNames
- Other: Proactive Telephone Toxicity Management
- Other: PRO Sub-Study
- type
- ACTIVE_COMPARATOR
- label
- Control Arm
- description
- Control
- interventionNames
- Other: Control Arm
- Other: PRO Sub-Study
Primary outcomes (1)
- measure
- Number of Emergency and Hospital (ED+H) visits during chemotherapy
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Currently participating in a clinical trial involving an investigational agent Inclusion Criteria for PRO Sub-Study * 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
References
Publications (2)
- DERIVEDKrzyzanowska 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. PMID 34880055
- DERIVEDKrzyzanowska 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. PMID 31488084