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

November 9, 2017 updated by: J P AGARWAL, Tata Memorial Hospital

A Prospective Study of Telephonic Contact and Subsequent Physical Follow up of Radically Treated Lung Cancer Patients

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

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • MS
      • Mumbai, MS, India, 400012
        • Tata Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concurrence Between the Telephonic Interview and the Physician Assessment
Time Frame: 2 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost Analysis
Time Frame: 2 years
On average, each patient spent INR 5117.10 on travel and INR 3079.06 on lodging per follow up visit.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tata Memorial Hospital

Investigators

  • Principal Investigator: JP AGARWAL, MD, Tata Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

May 27, 2010

First Submitted That Met QC Criteria

May 27, 2010

First Posted (Estimate)

May 28, 2010

Study Record Updates

Last Update Posted (Actual)

August 7, 2018

Last Update Submitted That Met QC Criteria

November 9, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROJECT NO 754

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lung Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe