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Telephonic Contact and Subsequent Physical Follow up Treated Lung Cancer Patients

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01133067
Acronym
TELE001
Enrollment
200
Registered
2010-05-28
Start date
2010-07-31
Completion date
2016-07-31
Last updated
2018-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

lung cancer, followup, physical follow up, telephonic followup

Brief summary

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

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.

Interventions

None listed

Sponsors

Tata Memorial Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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 -

Design outcomes

Primary

MeasureTime frameDescription
Concurrence Between the Telephonic Interview and the Physician Assessment2 yearsThe 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.

Secondary

MeasureTime frameDescription
Cost Analysis2 yearsOn average, each patient spent INR 5117.10 on travel and INR 3079.06 on lodging per follow up visit.

Countries

India

Participant flow

Participants by arm

ArmCount
Total Cohort
Single-arm Prospective cohort
200
Total200

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyDeath136
Overall StudyLost to Follow-up3

Baseline characteristics

CharacteristicTotal Cohort
Age, Continuous56 years
Histology
Adenocarcinoma
80 participants
Histology
Other NSCLC
23 participants
Histology
Small Cell Carcinoma
30 participants
Histology
Squamous Carcinoma
67 participants
Region of Enrollment
India
200 participants
Sex: Female, Male
Female
33 Participants
Sex: Female, Male
Male
167 Participants
Stage
Stage I
20 participants
Stage
Stage II
25 participants
Stage
Stage III
152 participants
Stage
Stage IV
3 participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 200
serious
Total, serious adverse events
0 / 200

Outcome results

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.

Time frame: 2 years

ArmMeasureValue (NUMBER)
Total CohortConcurrence Between the Telephonic Interview and the Physician Assessment0.64 probability
Secondary

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

Population: Patients of lung cancer treated with curative intent and on follow up with our institution

ArmMeasureGroupValue (MEAN)Dispersion
Total CohortCost AnalysisAverage cost of travel5117.10 Indian RupeesStandard Deviation 10370.91
Total CohortCost AnalysisAverage cost of lodging3079.06 Indian RupeesStandard Deviation 6929.57

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026