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Telephonic Contact and Subsequent Physical Follow up Treated Lung Cancer Patients (TELE001)

This study is currently recruiting participants.
Verified June 2011 by Tata Memorial Hospital
Sponsor:
Information provided by:
Tata Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01133067
First received: May 27, 2010
Last updated: June 16, 2011
Last verified: June 2011
History of Changes
  Purpose

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


Condition
Lung Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study of Telephonic Contact and Subsequent Physical Follow up of Radically Treated Lung Cancer Patients

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Tata Memorial Hospital:

Primary Outcome Measures:
  • Concurrence between the telephonic interview and the physician assessment [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Validation of the telephonic questionnaire grand score with the disease free and overall survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Cost analysis [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: July 2010
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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 -
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01133067

Contacts
Contact: J P AGARWAL, MD +91 22 24177164 agarwaljp@tmc.gov.in
Contact: ANUSHEEL MUNSHI, MD +91 22 24177144 anusheel8@hotmail.com

Locations
India
Tata Memorial Hospital Recruiting
Mumbai, MS, India, 400012
Contact: JP AGARWAL, MD     +91 22 24177164     agarwaljp@tmc.gov.in    
Contact: ANUSHEEL MUNSHI, MD     +91 22 24177144     anusheel8@hotmail.com    
Principal Investigator: JP AGARWAL, MD            
Sub-Investigator: ANUSHEEL MUNSHI, MD            
Sponsors and Collaborators
Tata Memorial Hospital
Investigators
Principal Investigator: JP AGARWAL, MD Tata Memorial Hospital
  More Information

No publications provided

Responsible Party: J P AGARWAL, TATA MEMORIAL HOSPITAL
ClinicalTrials.gov Identifier: NCT01133067     History of Changes
Other Study ID Numbers: PROJECT NO 754
Study First Received: May 27, 2010
Last Updated: June 16, 2011
Health Authority: India: Indian Council of Medical Research

Keywords provided by Tata Memorial Hospital:
lung cancer
followup
physical follow up
telephonic followup

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013