| CTRI Number |
CTRI/2020/02/023511 [Registered on: 24/02/2020] Trial Registered Prospectively |
| Last Modified On: |
24/02/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to assess the Patient navigation and symptom reporting with patient reported outcome in lung cancer patient. |
|
Scientific Title of Study
|
A two-arm randomized open label prospective parallel design Phase III clinical trial to evaluate the efficacy of a multidisciplinary patient navigation program along with symptom-monitoring with patient-reported outcomes in advanced lung cancer patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vanita Noronha |
| Designation |
Professor, Medical Oncology, Tata Memorial Hospital |
| Affiliation |
Tata Memorial Hospital |
| Address |
Tata Memorial Hospital,
HBB 3rd floor, 303 Department of Medical Oncology,
Dr.E.Borges Marg,
Parel Mumbai-400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9769328047 |
| Fax |
02224171734 |
| Email |
vanita.noronha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vanita Noronha |
| Designation |
Professor, Medical Oncology, Tata Memorial Hospital |
| Affiliation |
Tata Memorial Hospital |
| Address |
Tata Memorial Hospital,
HBB 3rd floor, 303 Department of Medical Oncology,
Dr.E.Borges Marg,
Parel Mumbai-400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9769328047 |
| Fax |
02224171734 |
| Email |
vanita.noronha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vanita Noronha |
| Designation |
Professor, Medical Oncology, Tata Memorial Hospital |
| Affiliation |
Tata Memorial Hospital |
| Address |
Tata Memorial Hospital,
HBB 3rd floor, 303 Department of Medical Oncology,
Dr.E.Borges Marg,
Parel Mumbai-400012
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9769328047 |
| Fax |
02224171734 |
| Email |
vanita.noronha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Memorial Hospital, Dr E Borges Road, Parel, Mumbai-400012 |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Tata Memorial Hospital,
Dr.E Borges Road
Parel, Mumbai 400012 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not applicable |
Not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vanita Noronha |
Tata Memorial Hospital |
Tata Memorial Hospital,
HBB 3rd floor, 303 Department of Medical Oncology,
Dr.E.Borges Marg,
Parel Mumbai-400012
Mumbai
MAHARASHTRA |
9769328047
02224171734
vanita.noronha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee III, Tata Memorial Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C399||Malignant neoplasm of lower respiratory tract, part unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Navigator |
The overall job of the patient navigator will be to help coordinate the care of the patient, to function as a go-between for the doctor and the patient, and to help the patient with logistics.
In patients who do not have a biopsy/need review of outside biopsy or require any imaging tests or other diagnostic tests,the navigator will direct them to where the respective departments are located and how to go about the process of submission,scheduling, etc. If radiology dates are not available,then the patient will be directed to the Medical Superintendent for early dates.Patient navigation, symptom-monitoring and PRO in advanced lung CA.The navigator will also act as a guide to locate how to access the biopsy report in the Electronic Medical Records (EMR) of the hospital and will remind the patient to report back to the hospital immediately once the biopsy report becomes available. Navigator will keep a tab on these patients and call the patient every third day to ensure there is no default and to assess patient symptoms before the start of treatment. If the patient symptomatically worsens, the navigator will inform the treating physician regarding symptom deterioration, and the physician can then decide regarding whether to
start therapy early.
When the patient is planned for starting therapy, the patient navigator will direct the patient to the social worker for arranging finances, place of stay, transportation and various other logistics. If the patient continues to have issues with finances, stay and transportation after speaking with the social worker, the patient navigator will discuss with the social worker himself/herself and will attempt to resolve the issues with the resources available through the social service department and the various non-governmental organizations.The navigator will counsel the patient. He/she will also share his/her phone number and
contact information/email with the patient for emergency access.
The navigator will call the patient prior to every hospital visit and will meet him/her after the visit and guide him/her towards any services if so advised.
He/she will give the patient the symptom monitoring proforma to be filled by the patient weekly and submitted at time of the next visit.
The navigator will receive training to seamlessly coordinate and manage these myriad functions before she/he is allotted to any patient.Patient navigation, symptom-monitoring and PRO in advanced lung CA.
|
| Comparator Agent |
Standard Care |
Patients will be randomized to the standard care arm with no patient navigator and symptom-
monitoring at the discretion of the treating physician.All patients will receive standard oncologic therapy. The systemic therapy, i.e. chemotherapy or
tyrosine kinase inhibitor (TKI) will be continued until either disease progression or development
of intolerable side effects whichever occurs earlier. The patients, post discontinuation of first line
therapy, either TKI or chemotherapy, will receive further treatment in accordance with the
institutional guidelines. These patients will be followed up until death.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Suspected/diagnosed lung cancer patient
2.Planned for palliative intent therapy at Tata Memorial Center
3.Willing to give written informed consent |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Functional Assessment of Cancer Therapy–Lung (FACT-L) Quality of Life
measure |
FACT & QOL at Baseline & every 12 weeks.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Time to initiation of cancer treatment. 2.treatment completion
3. progression-free survival
4. number of emergency visits or unplanned visits,
dose intensity
5.time to deterioration of ECOG performance status,
6. Treatment adherence
7. symptom control between the two arms
8.percentage survival
9.overall survival (OS).
|
1. At Initiation
2. At end of 4 cycles or 3 months
3. PFE at Progression
4. At progression
5. At Progression
6. At Progression
7. At Progression
8. At 1 year
9. At death
|
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
27/02/2020 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Overview: - Navigation will start from the day of assignment which should be within 10 days of randomization.
- In patients who do not have a biopsy/need review of outside biopsy or require any imaging, the navigator will direct them to the respective departments and will instruct then on how to go about this. If radiology dates are not available, then patient will be directed to the Medical Superintendent for early dates.
- The patient navigator will also act as a guide to show the patient how to access the biopsy report and other test results in the Electronic Medical Records (EMR) of the hospital and to report immediately once available.
- The navigator will keep a tab on these patients and call the patient every third day to ensure that there is no default and to assess patient symptoms before the start of treatment. If the patient symptomatically worsens, he/she will inform the same to physician who then will decide whether to start therapy early.
- When the patient is planned to starting therapy, the patient navigator will direct the patient to the social worker for arranging finances, place of stay and transportation. If the patient continues to have issues with finances, stay and transportation after speaking with the social worker, the patient navigator will discuss with the social worker himself/herself and will attempt to resolve the issues with the resources available through the social service department and the various non-governmental organisations.
- The patient navigator will counsel the patient. He/she will also share his/her phone number and contact email with the patient for emergency access.
- At baseline before starting chemotherapy, the FACT-lung QOL questionnaire will be administered to the patient and then, every 12 weeks thereafter.
- She/he will call the patient prior to every hospital visit and will then meet the patient after the visit and guide him/her towards any services if so advised.
- He/she will give the symptom monitoring proforma to be filled by the patient weekly and submitted at the time of next visit.
- The navigator shall receive training to seamlessly coordinate and manage these myriad functions before she/he is allotted to any patient.
Enrollment: Subjects must meet all the inclusion criteria to be eligible for this study. Once the patient has been enrolled in the study, the subject will be assigned a subject study number, following which the patient will be randomized. The randomization procedure is explained in the ‘Allocation of arm’ section. Screening: No specific additional screening tests will be performed. Patients will undergo routine disease related and pre-chemotherapy testing as determined by the treating physician. Allocation of arm: 1. Sequence generation- Eligible subjects will be stratified according to the gender (male versus female), ECOG performance status (PS 0 or 1 versus > 2), age (< 55 versus > 55 years) and histopathology (adenocarcinoma versus others). Patients will then be randomly assigned on a 1:1 basis to the control arm or the study arm. Block randomization will be done centrally. An independent biostatistician will generate the randomization code, and the randomization log will be maintained by the study team.
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