Trial Outcomes & Findings for Telephonic Contact and Subsequent Physical Follow up Treated Lung Cancer Patients (NCT NCT01133067)

Last Updated: 2018-08-07

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

200 participants

Primary outcome timeframe

2 years

Results posted on

2018-08-07

Participant Flow

Participant milestones

Participant milestones
Measure	Total Cohort Single-arm Prospective cohort
Overall Study STARTED	200
Overall Study COMPLETED	61
Overall Study NOT COMPLETED	139

Reasons for withdrawal

Reasons for withdrawal
Measure	Total Cohort Single-arm Prospective cohort
Overall Study Death	136
Overall Study Lost to Follow-up	3

Baseline Characteristics

Telephonic Contact and Subsequent Physical Follow up Treated Lung Cancer Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total Cohort n=200 Participants Single-arm Prospective cohort
Age, Continuous	56 years n=99 Participants
Sex: Female, Male Female	33 Participants n=99 Participants
Sex: Female, Male Male	167 Participants n=99 Participants
Region of Enrollment India	200 participants n=99 Participants
Stage Stage I	20 participants n=99 Participants
Stage Stage II	25 participants n=99 Participants
Stage Stage III	152 participants n=99 Participants
Stage Stage IV	3 participants n=99 Participants
Histology Adenocarcinoma	80 participants n=99 Participants
Histology Squamous Carcinoma	67 participants n=99 Participants
Histology Other NSCLC	23 participants n=99 Participants
Histology Small Cell Carcinoma	30 participants n=99 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Total Cohort n=200 Participants Single-arm Prospective cohort
Concurrence Between the Telephonic Interview and the Physician Assessment	0.64 probability Interval 0.58 to 0.7

SECONDARY outcome

Timeframe: 2 years

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

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

Outcome measures

Outcome measures
Measure	Total Cohort n=200 Participants Single-arm Prospective cohort
Cost Analysis Average cost of travel	5117.10 Indian Rupees Standard Deviation 10370.91
Cost Analysis Average cost of lodging	3079.06 Indian Rupees Standard Deviation 6929.57

Adverse Events

Total Cohort

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. J.P. Agarwal

Dept. of Radiation Oncology, Tata Memorial Hospital

Phone: +91 22 24177000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place