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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT00960466 |
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Date of registration:
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14/08/2009 |
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Primary sponsor: |
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Public title:
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Distress Thermometer Intervention Trial
DiTIT |
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Scientific title:
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Evaluating the Effect of Monitoring Cancer Patients Using the Distress Thermometer on Levels of Distress and Health Service Costs - a Randomised Controlled Trial |
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Date of first enrolment:
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October 2009 |
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Target sample size:
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220 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00960466 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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William Hollingworth, 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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University of Bristol |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Primary solid tumour diagnosis within the last 12 months
- Scheduled for outpatient external RT fractions over a period of at least 2 weeks or
scheduled outpatient CT regimen over 2 or more cycles
- Patient aged >= 18 and <85 years
- Ability to read and communicate in English (personally or via translator)
Exclusion Criteria:
- Receiving neoadjuvant CT
- Patient declines consent
- Clinical presentation dictates treatment by a specific therapist not trained in use
of the Distress Thermometer
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cancer
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Intervention(s)
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Behavioral: Distress Thermometer and Problems List
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Behavioral: Usual psychosocial support
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Primary Outcome(s)
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Profile of Mood States (POMS)
[Time Frame: 1, 6, 12 months post randomisation]
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Secondary Outcome(s)
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EQ-5D
[Time Frame: 1,6,12 months post randomisation]
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European Organisation for Research and Treatment of Cancer (EORTC - QLQ 30) cancer-related quality of life measure
[Time Frame: 1,6, 12 months post randomisation]
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Mortality
[Time Frame: 12 months post randomisation]
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Resource Use
[Time Frame: 12 months post randomisation]
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Trent Patient Satisfaction Questionnaire
[Time Frame: 1, 6 months post randomisation]
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Secondary ID(s)
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NIHR # PB-PG-0807-13387
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ON/2007/2744
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REC # 08/H0101/224
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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