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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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20 June 2023 |
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Main ID: |
NCT03367637 |
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Date of registration:
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05/12/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Novel mHealth Approach to Assess and Manage Palliative Care Needs for Cancer Patients in Kigali
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Scientific title:
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A Novel mHealth Approach to Assess and Manage Palliative Care Needs for Cancer Patients in Kigali |
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Date of first enrolment:
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January 1, 2018 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT03367637 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Single (Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Rwanda
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Contacts
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Name:
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Aparna Parikh, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Massachusetts General Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- At least 18 years old;
- Diagnosed with advanced cancer and in moderate or severe pain, as defined by use of
World Health Organization (WHO) as requiring step 2 drugs (Tramadol or Codeine) or WHO
step 3 drugs (narcotics other than Codeine) to manage their pain.
- Eligible patients or their primary care giver must have a smartphone and/or have a
family member that lives at home with a smartphone; and
Exclusion Criteria:
- Projected life expectancy of <3 months at the time of enrollment, to be estimated by
their healthcare provider
- Patients enrolled in the smartphone application development phases (earlier than RCT)
of the study
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cancer Pain
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Intervention(s)
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Other: Smart Phone based symptom evaluation application
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Other: Standard palliative care
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Primary Outcome(s)
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Difference in pain score as measured by the expanded African Palliative Care Outcomes Scale (APCA POS)
[Time Frame: 6 weeks, 3 months]
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Secondary Outcome(s)
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Difference in other symptoms and quality of life (QOL) scores from the remaining portion of the expanded APCA POS individually and as composite score.
[Time Frame: 6 weeks, 3 months]
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Secondary ID(s)
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2017P002380
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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