| CTRI Number |
CTRI/2017/08/009358 [Registered on: 14/08/2017] Trial Registered Prospectively |
| Last Modified On: |
16/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Utility of telephone based questionnaire in detecting oral cancer recurrences |
|
Scientific Title of Study
|
A prospective observational study to evaluate the value of nurse led telephone based questionnaire in detecting recurrences in patients who have completed curative-intent treatment for oral cancers |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sudhir Nair |
| Designation |
Associate Professor |
| Affiliation |
Tata Memorial Centre |
| Address |
Department of Head Neck Oncology, 12th floor, Homi Bhabha Block, Tata Memorial Centre, Parel, Mumbai
Mumbai MAHARASHTRA 400012 India |
| Phone |
|
| Fax |
|
| Email |
sudhirvr@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Sudhir Nair |
| Designation |
Associate Professor |
| Affiliation |
Tata Memorial Centre |
| Address |
Department of Head Neck Oncology, 12th floor, Homi Bhabha Block, Tata Memorial Centre, Parel, Mumbai
Mumbai MAHARASHTRA 400012 India |
| Phone |
|
| Fax |
|
| Email |
sudhirvr@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Sudhir Nair |
| Designation |
Associate Professor |
| Affiliation |
Tata Memorial Centre |
| Address |
Department of Head Neck Oncology, 12th floor, Homi Bhabha Block, Tata Memorial Centre, Parel, Mumbai
Mumbai MAHARASHTRA 400012 India |
| Phone |
|
| Fax |
|
| Email |
sudhirvr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata memorial centre, Dr E Borges Marg, Parel, Mumbai 400012 |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Centre |
| Address |
Tata Memorial Centre, Parel Mumbai, Maharashtra 400012 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sudhir Nair |
Tata Memorial Centre |
Dept of Head & Neck Oncology, 12 th floor, Homi Bhabha Block, Parel, Mumbai Mumbai MAHARASHTRA |
9769617780
sudhirvr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee II |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx, Patients of oral cancer who hve completed their curative intent treatment and are on follow up, |
|
|
Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients having diagnosed oral cancer
2. Completed potentially curative treatment
3. On follow up for >2 months and <2 years after finishing treatment
|
|
| ExclusionCriteria |
| Details |
Exclusion Criteria
1. ECOG>2 (recurrence may not be treated with curative intent)
2. <18 years, > 80 years (<18 – for consent, > 80 as recurrence may not be treated with curative intent)
3. Patients already diagnosed with recurrent disease
4. Already assessed once for the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sensitivity of a nurse led telephonic questionnaire to pick up recurrences |
at 2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To estimate the proportion of asymptomatic patients with recurrent disease on routine (intensive) follow up
2. Salvage rate- of patients detected with recurrence
3. DFS at 2 years of patients having recurrence – the patients detected to have recurrence will be followed for two years and the disease free survival noted
4. Patients’ acceptability of following up 6 monthly
|
2 years |
|
|
Target Sample Size
|
Total Sample Size="400" Sample Size from India="400"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2017 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Oral cancers are the
commonest cancers in the Indian sub-continent. After finishing oncologic
treatment these patients are generally followed up three monthly for first two
years, six monthly for next three years and annually thereafter. In any
oncology set up, follow up assessment of such patients forms the major work
load in the out-patient department. It has been observed that patients can
identify new symptoms indicating recurrence. Symptoms mentioned by patients
help in diagnosing majority of recurrences (66-80%) No change was seen
in DFS and OS between the groups where recurrence was detected by patient
versus the doctor. In a study, where they evaluated 3645 patient visits, it was
found that recurrence/ second primary was suspected in 5% of the patients. 79%
of the patients suspected to have a recurrence had identified new symptoms
themselves. In absence of symptoms, recurrence was rare and seen in only 1.2%
of the patients. A study on head and neck cancer patients showed that
recurrence was suspected in only 10% of patients seen routinely and in 68% of
those who requested for a consultation. They found that 56% of those who
requested for a consultation actually had a recurrence, whereas recurrence was
found to be there in only 0.3% of asymptomatic patients. There are other
studies which have shown that when followed up for 5 years, loco-regional
recurrence may be seen in 25-50% of the patients and second primaries in
3-5% of the cases. According to another study, ‘numbers needed to see’ to
detect one asymptomatic recurrence was 99. It has been seen that even when
patients are followed up intensively, salvage therapy remains feasible in only
20-65% of them The salvage rates depend upon the
sub-site and whether the recurrences are local or regional or loco-regional.
Local recurrences generally fare better than regional ones. It has also been
observed that patients tend to wait for their regular follow up rather than
present early when they detect a symptom. When patients with recurrences who
have been salvaged are followed up 3 and 5 year overall survival has been found
to be about 52.6% and 48% respectively. Majority of the data available
is from the more developed countries. In Indian sub-continent, the patients are
not that well educated and don’t have ample resources to make frequent long
distance trips for frequent surveillance. Data is scarce regarding the exact proportion
of asymptomatic patients who are detected with recurrence on routine clinical
examination, the salvage rates of patients detected to have recurrent disease
and the outcomes of salvage treatment. We intend to gather data related to
asymptomatic recurrences and the sensitivity of telephone based questionnaire
in detecting recurrences in patients of oral cancer after finishing the
curative intent treatment.
Hypothesis:
A nurse led telephone-based interview can reliably identify patients at risk
for recurrence on follow up after radical treatment with oral cancers
|