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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01133067
Other study ID # PROJECT NO 754
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 2010
Est. completion date July 2016

Study information

Verified date November 2017
Source Tata Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Does the routine clinical practice of follow up after primary treatment in lung cancer patients has any utility.


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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date July 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

1. All patients of lung cancer treated with a radical aim (e.g surgery, Chemoradiation, surgery followed by adjuvant treatment or any other combination)

2. Patients should have completed radical /adjuvant treatment, if any

3. Patients of both SCLC and NSCLC

4. Patients with at least two telephone numbers (landline/mobile/both)

5. Patients willing to participate

Exclusion Criteria:

1. All patients for palliative intention

2. Patients with less than two contact telephone numbers -

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
India Tata Memorial Hospital Mumbai MS

Sponsors (1)

Lead Sponsor Collaborator
Tata Memorial Hospital

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Concurrence Between the Telephonic Interview and the Physician Assessment The Prevalence and bias adjusted Kappa (PABAK) score for concurrence between telephonic and physician assessment of disease status of each patient at each follow up visit was analysed. 2 years
Secondary Cost Analysis On average, each patient spent INR 5117.10 on travel and INR 3079.06 on lodging per follow up visit. 2 years
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