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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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12 December 2020 |
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Main ID: |
NCT03210129 |
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Date of registration:
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26/06/2017 |
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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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Motivational Interviewing to Increase Physical Activity Behaviour in Cancer Patients
MIPAClux |
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Scientific title:
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Motivational Interviewing to Increase Physical Activity Behaviour in Breast, Endometrial and Colorectal Cancer Patients in the Grand-Duchy of Luxembourg: a Pilot Randomized Controlled Trial |
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Date of first enrolment:
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July 6, 2017 |
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Target sample size:
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25 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03210129 |
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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: Prevention. Masking: Double (Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Luxembourg
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Contacts
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Name:
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Alexis Lion, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Luxembourg Institute of Health |
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Name:
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Laurent Malisoux, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Luxembourg Institute of Health |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- breast, endometrial or colorectal cancer
- cancer stage = stage III
- > 3 months after primary treatment
- < 24 months after primary treatment
- ECOG performance score < 2
- Signed Informed consent
Exclusion Criteria:
- recurrent cancer
- history of other types of cancer
- second primary tumor
- planned surgery within the duration of the study
- known or obvious cognitive or psychiatric impairments
- positive pregnancy test
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 of Colon
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Endometrial Cancer
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Cancer, Breast
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Intervention(s)
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Behavioral: Motivational interviewing
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Primary Outcome(s)
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Change in physical activity behavior
[Time Frame: week 1, week 14 and week 26]
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Secondary Outcome(s)
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Body mass index
[Time Frame: week 1, week 14 and week 26]
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Cost-effectiveness of the intervention
[Time Frame: week 1 (quality of life and cost questionnaires), week 4 (quality of life questionnaire), week 8 (quality of life questionnaire) week 14 (quality of life and cost questionnaires) and week 26 (quality of life and cost questionnaires)]
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30 seconds chair test
[Time Frame: week 1, week 14 and week 26]
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Ramped Bruce Protocol test
[Time Frame: week 1, week 14 and week 26]
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Southampton protocol
[Time Frame: week 1, week 14 and week 26]
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Secondary ID(s)
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DoPH_SMRL_20161208
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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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