Lung CancerTELE001NCT01133067
Telephonic Contact and Subsequent Physical Follow up Treated Lung Cancer Patients
An observational study of Lung Cancer, run by Tata Memorial Hospital at 1 site in India.
Trial summary
Does the routine clinical practice of follow up after primary treatment in lung cancer patients has any utility. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lung Cancer
- How many people
- 200 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2010to Jul 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- All patients for palliative intention
- Patients with less than two contact telephone numbers -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Lung Cancer
- Keywords
- lung cancer, followup, physical follow up, telephonic followup
- Medical subject headings
- Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2010 (estimated)
- Study startJul 2010
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, J P AGARWAL, Tata Memorial Hospital
- Investigators
- JP AGARWAL, MD, Principal investigator, Tata Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01133067
- Sponsor's protocol ID
- PROJECT NO 754
- Acronym
- TELE001
- Status last verified
- Nov 2017
- First submitted
- 27 May 2010
- Last updated
- 7 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Telephonic Contact and Subsequent Physical Follow up of Radically Treated Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT01133067
- Acronym / sponsor ID
- TELE001 / PROJECT NO 754
- Conditions
- Lung Cancer
- Keywords
- lung cancer, followup, physical follow up, telephonic followup
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Tata Memorial HospitalOther government
- Study start
- Jul 2010
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 28 May 2010 (estimated)
- Results
- Posted 7 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- All patients for palliative intention
- Patients with less than two contact telephone numbers -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Cost Analysis
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JP AGARWAL, MD principal investigator
Tata Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Tata Memorial Hospital at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concurrence Between the Telephonic Interview and the Physician Assessment (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2018.