A Multicentre, Non-Blinded Study Exploring Self-Administration of Chemotherapy in the Home Environment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bortezomib Injection.
- Who it may be relevant to
- Registry conditions: Myeloma, Myeloma Multiple. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This study is to see if the standard of care subcutaneous injection of bortezomib can safely be administered at home by the patient or caregiver. All tests and assessments are based on standard of care procedures.
Detailed description
Chemotherapy for malignancies is predominantly prescribed and delivered in a tertiary hospital and/or cancer centre setting. However, with modern chemotherapy, with a reduced side effect profile, this paradigm should be challenged. Indeed, the use of methotrexate and other biologics (a form of chemotherapy) in the Rheumatologic setting is commonly delivered effectively and safely in the community.
Taken together, a hospital-based model of chemotherapy delivery may not be warranted in all circumstances. Moreover, the use of this current model invariably discounts the time commitments, needs of patients and caregivers, as well as while not addressing the emerging concerns regarding system capacity, efficiency and effectiveness of safe chemotherapy delivery.
Interventions
- Drug Bortezomib Injection
Subcutaneous injection
Primary outcome measures
- Number of patients able to self-administer [Time frame: 2 years from study start]
- Myeloma response outcomes [Time frame: 2 years from study start]
- Adverse events great than grade 3 [Time frame: 2 years from study start]
- Number of patients with missed doses [Time frame: 2 years from study start]
- Patient Satisfaction and Quality of Life Survey 1 [Time frame: 2 years from study start]
- Patient Satisfaction and Quality of Life Survey 2 [Time frame: 2 years from study start]
- Patient Satisfaction and Quality of Life Survey 3 [Time frame: 2 years from study start]
Eligibility criteria
Inclusion criteria
- Patients are aged 18 years old or older with a diagnosis of symptomatic myeloma,
- Stable clinical status as deemed by responsible investigator,
- Personally (or caregiver) willing and deemed capable to self-administer with teaching,
- Previously received more than 4 injections of bortezomib within the hospital and/or cancer centre environment,
- Signed informed consent.
Exclusion criteria
- Currently participating in clinical trials that includes the use of bortezomib,
- History of allergic reactions to bortezomib,
- History of bleeding attributable to bortezomib,
- History of greater than or equal to grade 3 side effects attributable to bortezomib,
- Clinically deemed unlikely to be compliant with therapy by responsible investigator,
- Life expectancy anticipated to be less than 6 months,
- Deemed geographically inaccessible to receive care.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 2 centers
- Arthur J.E. Child Comprehensive Cancer Centre — Calgary
- Cross Cancer Institute — Edmonton
Identifiers
NCT: NCT04268199 · EASE