Gastrointestinal CancerPROSENCT05158907
Patient Reported Scale vs CTCAE Grading: A Prospective Comparator Study
A study testing Patient reported Adverse event scale in people with Gastrointestinal Cancer, run by Tata Medical Center at 1 site in India.
Trial summary
Over a million new cancer cases are diagnosed in India each year. This huge burden coupled with inadequate infrastructural facilities is adversely affecting the quality of patient care. As a side effect it is adding to cost of health care which patient is paying from his/her own pocket. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Cancer
- What is being tested?
- Patient reported Adverse event scale
- How many people
- 220 participants
- Where
- 1 siteIndia
- Study dates
- 23 Nov 2021to 28 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female with more than 18years of age.
- Provide written informed consent
- Diagnosed with Gastrointestinal cancer (both colorectal and non-colorectal cancer of all histological types) and are planned for adjuvant or palliative combination chemotherapy with or without Targeted therapy and Immunotherapy.
- Patients who have been fully recovered from cancer surgery, if any.
- Residing within 50km radius of TMC.
- Patient or their family member who can read, write and comprehend Bangla, Hindi or English language.
Who cannot join
- Patients not residing in India e.g. patients from neighbouring countries like Bangladesh, Nepal, Bhutan.
- Patients whose comorbid conditions like diabetes, hypertension, hypo/hyperthyroidism, heart ailment are not under control.
- Patient who is not willing to start or continue the medicines for their comorbid conditions.
- Patients with psychomotor comorbid conditions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Reported Scale vs CTCAE Grading for Reporting Chemotherapy Related Adverse Effects: A Prospective Comparator Study
Over a million new cancer cases are diagnosed in India each year. This huge burden coupled with inadequate infrastructural facilities is adversely affecting the quality of patient care. As a side effect it is adding to cost of health care which patient is paying from his/her own pocket. Total care of cancer patients taking chemotherapy is interrupted by several obstacles some of which can be prevented or detected early and treated. Most of the patients experience toxicity during cancer chemotherapy but the reporting remains inadequate as patients are not aware how to report or the physicians, many a times, are extremely busy to record and act on them early. We assume that using patient reported adverse event (AE) scale is more practical and easier to use for reporting AEs. This intervention, we feel, can pick more AEs which can lead to early intervention by the physician and ultimately reducing the cost of treatment to patients. We plan to include adult patients (>18years) having Gastro-intestinal cancers (both colorectal and non-colorectal cancers) who are scheduled to receive combination chemotherapy medicines with both curative and non-curative intent (in patients with advanced cancers). Patients will be given an AE scale and will be asked to fill it at home during each chemotherapy cycle, for upto 4 cycles. The physician will also ask them about the AE during the next clinic visit and record the AEs as per the widely accepted AE scale (Common Terminology Criteria for Adverse Events-CTCAE) for reporting. The patient reported AE scale will then be compared and analyzed with standard CTCAE using relevant statistical methods.
Read the detailed description
Population and setting: This study will be conducted at Tata Medical Center (TMC), Kolkata. Patients in TMC are managed using evidence-based treatment protocols and through multidisciplinary teams. Patients in this study will be drawn from those attending the cancer clinics. Adult patients (>18years age) receiving combination anti-cancer chemotherapy for gastro-intestinal cancers (colorectal and non-colorectal) will be enrolled.
Trial design: This is a single centre prospective study. Patients who provide written consent for the study will be enrolled. Most commonly used standard combination chemotherapy regimens used in our clinic will be taken in this study i.e., weekly (e.g., Paclitaxel-Carboplatin, Gemcitabine-Cisplatin), biweekly (e.g. FOLFOX/FOLFIRI/ FOLFOXIRI/FLOT/DCF/GEMOX), once every three weeks (e.g. Capox/CapIri/mDCF) or once every 4 weeks (e.g. ETOCIS/Capecitabine-Temozolomide) with or without Targeted therapy (e.g. Bevacizumab/Cetuximab/Panitumumab) and/or Immunotherapy (e.g. Pembrolizumab/ Nivolumab/Atezolizumab/Ipilimumab). No single agent chemotherapy will be considered. Patients will be stratified to type of combination chemotherapy with high and low probability of causing severe toxicities. This will be based on our experience in clinical practice. Chemotherapy combinations with high probability are FOLFOXIRI, FLOT, Capiri (Xeliri), mDCF and with low probability are FOLFOX, FOLFIRI, GEMOX, Gemcitabine-Cisplatin, Paclitaxel-Carboplatin, CapOx, ETOCIS, Capecitabine-Temozolomide.
Intervention: Consenting patients will be given a patient reported AE (PRAE) scale with numbers from 0 (Nil) to 10 (most severe) before start of each chemotherapy cycle. This AE scale will have pre-defined symptom related AEs with the provision of adding some more by the patient if they have those symptoms. The PRAE scale will be like a Visual Analogue Scale (VAS) and the patients will be given instructions how to record AEs that they experience after each chemotherapy cycle, until the first radiological assessment is done (palliative settings) or after 4 cycles of chemotherapy in adjuvant settings. They will be asked to take the scale home to record the adverse effects and give it a number (as per VAS), depending on the severity. They will be told to record all the AEs (whenever they experience), even if same AE happens more than once during a particular chemotherapy. Only the most severe one will be analysed. When patient reports for the next cycle of chemotherapy he/she will be asked to deposit the PRAE scale with the study co-ordinator before meeting the treating physician and a new copy of a blank scale will be given to him/her for the next cycle. In the clinic, as a standard practice, the doctor will ask the patient about the AEs experienced with the previous chemotherapy and record them as per the CTCAE, grade, version 5. The clinician will not get the opportunity to see the patient reported scale until the end of patient's participation in the study. All the study participants, at the start of chemotherapy and before each chemotherapy cycle, will be informed, as a standard practice, to report to the emergency or contact nearest local clinic/hospital if the AE is severe or can't be managed at home. The response by patients will be analysed for the pre-defined outcomes. The management of side effects is beyond the scope of this study and will be managed as per the standard clinical practice in TMC. The cost of which will be borne by the patient or his/her insurance company.
- Conditions
- Gastrointestinal Cancer
- Being tested
- Patient reported Adverse event scale
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient reported Adverse event scaleOther
Participants will be given a patient reported AE scale with numbers from 0 to 10 before start of each chemotherapy cycle. The PRAE scale will be like a Visual Analogue Scale and the patients will be given instructions how to record AEs that they experience after each chemotherapy cycle, until the first radiological assessment is done (palliative settings) or after 4 cycles of chemotherapy in adjuvant settings. Participants will take scale home to record the adverse effects and give it a number. Only the most severe will be analyzed. When patient reports for the next cycle of chemotherapy they will be asked to deposit the scale before meeting the physician. The physician will ask patient about the AEs experienced with the chemotherapy and record them using CTCAE grade. The study participants, at the start of chemotherapy cycle, will be informed, as a standard practice, to report to the emergency or contact nearest local clinic/hospital if the AE is severe or can't be managed at home.
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in detection rate of adverse effects of patient reported adverse effect (AE) scale versus the standard CTCAE grading by a physician.
Proposed AE scale will be compared with standard CTCAE scale
Measured: 1 year
Secondary outcomes (4)
Patient Compliance to filling the patient reported AE scale.
Will see how many patients will be able to fill the new scale
Measured: 1 year
Early intervention using patient reported AE scale and preventing severity of AE in the subsequent chemotherapy cycles.
Whether AE scale can prevent severity of adverse events
Measured: 1 year
Timely chemotherapy dose adjustments using patient reported adverse effect scale
Chemotherapy doses can be adjusted if early adverse effects can be picked using AE scale.
Measured: 1 year
Reduction in cost of cancer care using patient reported AE scale.
Whether cost of cancer can be reduced using the proposed scale
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start23 Nov 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion28 Feb 2024 (estimated)
Why it stopped: Patient recruitment is slow
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patient reported adverse event scale will be given to study participants
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tata Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tanuj Chawla, Tata Medical Center
- Investigators
- Tanuj Chawla, MD, Principal investigator, Tata Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05158907
- Sponsor's protocol ID
- 2021/TMC/239/IRB50
- Acronym
- PROSE
- Status last verified
- Apr 2023
- First submitted
- 2 Dec 2021
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Reported Scale vs CTCAE Grading for Reporting Chemotherapy Related Adverse Effects: A Prospective Comparator Study
- ClinicalTrials.gov ID
- NCT05158907
- Acronym / sponsor ID
- PROSE / 2021/TMC/239/IRB50
- Conditions
- Gastrointestinal Cancer
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Patient recruitment is slow
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Tata Medical CenterUniversity, hospital or other
- Study start
- 23 Nov 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 15 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Over a million new cancer cases are diagnosed in India each year. This huge burden coupled with inadequate infrastructural facilities is adversely affecting the quality of patient care. As a side effect it is adding to cost of health care which patient is paying from his/her own pocket. Total care of cancer patients taking chemotherapy is interrupted by several obstacles some of which can be prevented or detected early and treated. Most of the patients experience toxicity during cancer chemotherapy but the reporting remains inadequate as patients are not aware how to report or the physicians, many a times, are extremely busy to record and act on them early. We assume that using patient reported adverse event (AE) scale is more practical and easier to use for reporting AEs. This intervention, we feel, can pick more AEs which can lead to early intervention by the physician and ultimately reducing the cost of treatment to patients. We plan to include adult patients (>18years) having Gastro-intestinal cancers (both colorectal and non-colorectal cancers) who are scheduled to receive combination chemotherapy medicines with both curative and non-curative intent (in patients with advanced cancers). Patients will be given an AE scale and will be asked to fill it at home during each chemotherapy cycle, for upto 4 cycles. The physician will also ask them about the AE during the next clinic visit and record the AEs as per the widely accepted AE scale (Common Terminology Criteria for Adverse Events-CTCAE) for reporting. The patient reported AE scale will then be compared and analyzed with standard CTCAE using relevant statistical methods.
Detailed description
Population and setting: This study will be conducted at Tata Medical Center (TMC), Kolkata. Patients in TMC are managed using evidence-based treatment protocols and through multidisciplinary teams. Patients in this study will be drawn from those attending the cancer clinics. Adult patients (>18years age) receiving combination anti-cancer chemotherapy for gastro-intestinal cancers (colorectal and non-colorectal) will be enrolled.
Trial design: This is a single centre prospective study. Patients who provide written consent for the study will be enrolled. Most commonly used standard combination chemotherapy regimens used in our clinic will be taken in this study i.e., weekly (e.g., Paclitaxel-Carboplatin, Gemcitabine-Cisplatin), biweekly (e.g. FOLFOX/FOLFIRI/ FOLFOXIRI/FLOT/DCF/GEMOX), once every three weeks (e.g. Capox/CapIri/mDCF) or once every 4 weeks (e.g. ETOCIS/Capecitabine-Temozolomide) with or without Targeted therapy (e.g. Bevacizumab/Cetuximab/Panitumumab) and/or Immunotherapy (e.g. Pembrolizumab/ Nivolumab/Atezolizumab/Ipilimumab). No single agent chemotherapy will be considered. Patients will be stratified to type of combination chemotherapy with high and low probability of causing severe toxicities. This will be based on our experience in clinical practice. Chemotherapy combinations with high probability are FOLFOXIRI, FLOT, Capiri (Xeliri), mDCF and with low probability are FOLFOX, FOLFIRI, GEMOX, Gemcitabine-Cisplatin, Paclitaxel-Carboplatin, CapOx, ETOCIS, Capecitabine-Temozolomide.
Intervention: Consenting patients will be given a patient reported AE (PRAE) scale with numbers from 0 (Nil) to 10 (most severe) before start of each chemotherapy cycle. This AE scale will have pre-defined symptom related AEs with the provision of adding some more by the patient if they have those symptoms. The PRAE scale will be like a Visual Analogue Scale (VAS) and the patients will be given instructions how to record AEs that they experience after each chemotherapy cycle, until the first radiological assessment is done (palliative settings) or after 4 cycles of chemotherapy in adjuvant settings. They will be asked to take the scale home to record the adverse effects and give it a number (as per VAS), depending on the severity. They will be told to record all the AEs (whenever they experience), even if same AE happens more than once during a particular chemotherapy. Only the most severe one will be analysed. When patient reports for the next cycle of chemotherapy he/she will be asked to deposit the PRAE scale with the study co-ordinator before meeting the treating physician and a new copy of a blank scale will be given to him/her for the next cycle. In the clinic, as a standard practice, the doctor will ask the patient about the AEs experienced with the previous chemotherapy and record them as per the CTCAE, grade, version 5. The clinician will not get the opportunity to see the patient reported scale until the end of patient's participation in the study. All the study participants, at the start of chemotherapy and before each chemotherapy cycle, will be informed, as a standard practice, to report to the emergency or contact nearest local clinic/hospital if the AE is severe or can't be managed at home. The response by patients will be analysed for the pre-defined outcomes. The management of side effects is beyond the scope of this study and will be managed as per the standard clinical practice in TMC. The cost of which will be borne by the patient or his/her insurance company.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (care provider, investigator)
- Model description
- Patient reported adverse event scale will be given to study participants
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female with more than 18years of age.
- Provide written informed consent
- Diagnosed with Gastrointestinal cancer (both colorectal and non-colorectal cancer of all histological types) and are planned for adjuvant or palliative combination chemotherapy with or without Targeted therapy and Immunotherapy.
- Patients who have been fully recovered from cancer surgery, if any.
- Residing within 50km radius of TMC.
Key exclusion criteria (4 listed)
- Patients not residing in India e.g. patients from neighbouring countries like Bangladesh, Nepal, Bhutan.
- Patients whose comorbid conditions like diabetes, hypertension, hypo/hyperthyroidism, heart ailment are not under control.
- Patient who is not willing to start or continue the medicines for their comorbid conditions.
- Patients with psychomotor comorbid conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient reported Adverse event scaleParticipants will be given a patient reported AE scale with numbers from 0 to 10 before start of each chemotherapy cycle. The PRAE scale will be like a Visual Analogue Scale and the patients will be given instructions how to record AEs that they experience after each chemotherapy cycle, until the first radiological assessment is done (palliative settings) or after 4 cycles of chemotherapy in adjuvant settings. Participants will take scale home to record the adverse effects and give it a number. Only the most severe will be analyzed. When patient reports for the next cycle of chemotherapy they will be asked to deposit the scale before meeting the physician. The physician will ask patient about the AEs experienced with the chemotherapy and record them using CTCAE grade. The study participants, at the start of chemotherapy cycle, will be informed, as a standard practice, to report to the emergency or contact nearest local clinic/hospital if the AE is severe or can't be managed at home. | Other | – |
Primary outcome
Improvement in detection rate of adverse effects of patient reported adverse effect (AE) scale versus the standard CTCAE grading by a physician.
Time frame: 1 year
Proposed AE scale will be compared with standard CTCAE scale
4 secondary outcomes
Patient Compliance to filling the patient reported AE scale.
Time frame: 1 year
Early intervention using patient reported AE scale and preventing severity of AE in the subsequent chemotherapy cycles.
Time frame: 1 year
Timely chemotherapy dose adjustments using patient reported adverse effect scale
Time frame: 1 year
Reduction in cost of cancer care using patient reported AE scale.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Individual participant dataSharing planned: No
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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.
Tanuj Chawla, MD principal investigator
Tata Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient reported Adverse event scale in people with Gastrointestinal Cancer, run by Tata Medical Center 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 6 inclusion and 4 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: paused, as of the sponsor's last update on 19 Apr 2023. 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?
Results are not available in the source record.
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?
Improvement in detection rate of adverse effects of patient reported adverse effect (AE) scale versus the standard CTCAE grading by a physician. (time frame: 1 year). 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 19 Apr 2023; AzTrials last refreshed its copy on 29 Oct 2026.