Telephonic Contact and Subsequent Physical Follow up Treated Lung Cancer Patients (TELE001)
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| First Received Date ICMJE | May 27, 2010 | ||||||||
| Last Updated Date | June 16, 2011 | ||||||||
| Start Date ICMJE | July 2010 | ||||||||
| Estimated Primary Completion Date | May 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Concurrence between the telephonic interview and the physician assessment [ Time Frame: 2 years ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01133067 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Telephonic Contact and Subsequent Physical Follow up Treated Lung Cancer Patients | ||||||||
| Official Title ICMJE | A Prospective Study of Telephonic Contact and Subsequent Physical Follow up of Radically Treated Lung Cancer Patients | ||||||||
| Brief Summary | Does the routine clinical practice of follow up after primary treatment in lung cancer patients has any utility. |
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| Detailed Description | Patients of cancer, after their primary treatment are subsequently called for follow up visits to assess the disease status. This has two important implications from the point of view of resource management. One, patients often have to travel long distances to report to the hospital and have to take care of other logistics such as their accommodation, local travel and food. Further often the patient travels with 1-2 attendants which adds to the logistic burden. Also, these patients of follow up also contribute to the load on existing hospital services. Many authors have speculated that follow-up visits generate anxiety about possible disease recurrence. On the other hand, many others have suggested that although there may be a transient increase in anxiety, patients are ultimately reassured by this practice. Hence, there is no firm evidence for the practice and the need for follow up in oncology care. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | All curative lung cancer patients after there intial primary treatment who have already been given scheduled appointment shall be called telephonically every 3 months. A set of questions shall be asked to the patient in his /her vernacular during the telephonic interview.After the telephonic interview, the patients shall then report to the cancer care specialist at the Hospital for the due follow up visit. |
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| Condition ICMJE | Lung Cancer | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 200 | ||||||||
| Estimated Completion Date | August 2012 | ||||||||
| Estimated Primary Completion Date | May 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 90 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | India | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01133067 | ||||||||
| Other Study ID Numbers ICMJE | PROJECT NO 754 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | J P AGARWAL, TATA MEMORIAL HOSPITAL | ||||||||
| Study Sponsor ICMJE | Tata Memorial Hospital | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Tata Memorial Hospital | ||||||||
| Verification Date | June 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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