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Completed

NCT Number: NCT02485678

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

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

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Key information

Conditions

Early Stage Breast Cancer

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Royal Victoria Hospital, Barrie, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Proactive Telephone Toxicity Management

Other

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 Arm

Other

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-Study

Other

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    Severity of treatment side effects will be measured using the NCI PRO CTCAE self-report tool (assessment on a 5 point scale).

  2. 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

    Measured using the Self-Care during Chemotherapy (L-PaSC), Stanford Self-Management Self-Efficacy Scale, FACT-B, GAD-7, PHQ-9, EQ-5D-3L

  3. 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

    Measured using the adapted Picker survey.

  4. Health Economics

    Time frame: Initiation of chemotherapy to the end of chemotherapy plus 30 days

    Health system resources utilized by women receiving adjuvant or neo-adjuvant chemotherapy will be analyzed

Sponsors and collaborators

Lead sponsor

Ontario Clinical Oncology Group (OCOG)

Other

Collaborators

  • Princess Margaret Hospital, Canada
  • University Health Network, Toronto

Registry information

Official study title

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

Acronym: AToM

Important dates

Study start
2016
Primary completion
2018
Study completion
2020
First posted
Jun 30, 2015
Registry last updated
Sep 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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