A Pragmatic Trial of Ambulatory Toxicity Management in Patients Receiving Adjuvant or Neo-adjuvant Chemotherapy for Early Stage Breast Cancer (AToM)

Ontario Clinical Oncology Group (OCOG)

Status: Completed

Conditions: Early Stage Breast Cancer

Treatments: Other: PRO Sub-Study; Other: Control Arm; Other: Proactive Telephone Toxicity Management

Study type: Interventional

Funder types: Other

Identifiers

NCT02485678

OCOG-2015-ATOM

Details and patient eligibility

About

Comparison of the number of ER plus hospital visits that occurred during chemotherapy between the telephone intervention and control arms.

Full 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.

Enrollment: 1,460 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,460 participants in 2 patient groups

Proactive Telephone Toxicity Management

Experimental group

Description:

Proactive Telephone Toxicity Management

Treatment:

Other: Proactive Telephone Toxicity Management

Other: PRO Sub-Study

Control Arm

Active Comparator group

Description:

Control

Treatment:

Other: Control Arm

Other: PRO Sub-Study