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CompletedNCT01133067TELE001Updated Aug 7, 2018Results posted

Telephonic Contact and Subsequent Physical Follow up Treated Lung Cancer Patients

An observational study in Lung Cancer, sponsored by Tata Memorial Hospital. Completed at 1 site in India. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2018-08-07.

Sponsored by Tata Memorial Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years to 90 Years
Sex
All
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Study summary

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

Read the 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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Conditions studied

  • Lung Cancer

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Keywords

  • lung cancer
  • followup
  • physical follow up
  • telephonic followup
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In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 200 is close to the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Tata Memorial Hospital is the lead sponsor of 97 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
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.

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

Exclusion Criteria:

  1. All patients for palliative intention
  2. Patients with less than two contact telephone numbers -
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (actual)
06

What researchers measure

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.

    Time frame: 2 years

Secondary outcomes

  1. Cost Analysis

    On average, each patient spent INR 5117.10 on travel and INR 3079.06 on lodging per follow up visit.

    Time frame: 2 years

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Results

Posted Aug 7, 2018

Participant flow

Participant flow — Overall Study
MilestoneTotal Cohort
Started200
Completed61
Not completed139
Withdrew: Death136
Withdrew: Lost to follow-up3

Outcome measures

PrimaryConcurrence 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.

Time frame:
2 years
Reported as:
Number · probability
Concurrence Between the Telephonic Interview and the Physician Assessment
probabilityTotal Cohort
Concurrence Between the Telephonic Interview and the Physician Assessment0.64 (0.58 to 0.70)
SecondaryCost Analysis

On average, each patient spent INR 5117.10 on travel and INR 3079.06 on lodging per follow up visit.

Time frame:
2 years
Reported as:
Mean · Indian Rupees
Cost Analysis
Indian RupeesTotal Cohort
Average cost of travel5117.10 ± 10370.91
Average cost of lodging3079.06 ± 6929.57

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Total Cohort—0/200 (0%)0/200 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Total Cohort
Median56 (50 to 63)
Sex: Female, Male
Sex: Female, Male(Participants)Total Cohort
Female33
Male167
Region of Enrollment
Region of Enrollment(participants)Total Cohort
India200
Stage
Stage(participants)Total Cohort
Stage I20
Stage II25
Stage III152
Stage IV3
Histology
Histology(participants)Total Cohort
Adenocarcinoma80
Squamous Carcinoma67
Other NSCLC23
Small Cell Carcinoma30
08

Study locations

1 site
  • Tata Memorial Hospital
    Mumbai, MS 400012, India
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01133067
Lead sponsor
Tata Memorial Hospital
Responsible party
J P AGARWAL (Professor Radiation Oncology, Tata Memorial Hospital) — Principal investigator
First posted
May 28, 2010
Start date
Jul 2010
Primary completion
Jul 2016
Completion
Jul 2016
Results posted
Aug 7, 2018
Last update
Aug 7, 2018

Study contacts

JP AGARWAL, MD
principal investigator · Tata Memorial Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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