NCT01133067

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 28, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

August 7, 2018

Completed
Last Updated

August 7, 2018

Status Verified

November 1, 2017

Enrollment Period

6 years

First QC Date

May 27, 2010

Results QC Date

October 20, 2016

Last Update Submit

November 9, 2017

Conditions

Keywords

lung cancerfollowupphysical follow uptelephonic followup

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Cost Analysis

    2 years

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • All patients of lung cancer treated with a radical aim (e.g surgery, Chemoradiation, surgery followed by adjuvant treatment or any other combination)
  • Patients should have completed radical /adjuvant treatment, if any
  • Patients of both SCLC and NSCLC
  • Patients with at least two telephone numbers (landline/mobile/both)
  • Patients willing to participate

You may not qualify if:

  • All patients for palliative intention
  • Patients with less than two contact telephone numbers -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tata Memorial Hospital

Mumbai, MS, 400012, India

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Dr. J.P. Agarwal
Organization
Dept. of Radiation Oncology, Tata Memorial Hospital

Study Officials

  • JP AGARWAL, MD

    Tata Memorial Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Radiation Oncology

Study Record Dates

First Submitted

May 27, 2010

First Posted

May 28, 2010

Study Start

July 1, 2010

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

August 7, 2018

Results First Posted

August 7, 2018

Record last verified: 2017-11

Locations