CancerCANSURVIVENCT01304199
Cancer Survivorship Issues: A Survey of Patients in India.AIIMS Study (CANSURVIVE)
An observational study of Cancer, run by All India Institute of Medical Sciences at 1 site in India.
Trial summary
The purpose of this study is to assess the various aspects of life in the cancer survivors in India. Cancer survivor is defined as "an individual diagnosed with cancer and who has survived the disease and treatment, and for the rest of his/her life". Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cancer
- How many people
- 200 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2011to Dec 2013
- Phase
- Observational
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will evaluate the cancer patients visiting Dr BRAIRCH,AIIMS,New Delhi,India after a cancer diagnosis and the cancer treatments have been completed. The patients will be entered into this study(survey) during the follow up visits to the clinic. Patients will be evaluated and assessed for their cancer survivorship issues on the basis of a questionnaire (CSQ) developed by the investigators after the literature review. The mental status of the survivors is assessed by a MINI- international neuro-psychiatric interview, suitably modified to incorporate the CSQ in this survey.
Who may be able to join
- Patients who were treated with curative intent and are on hospital follow up visit.
- Patients aged above 18 years and of both sexes.
- Patients who have no evidence of disease at the time of collecting information.
- Patients or family carers who are able to comprehend and communicate.
- Cancer diagnosed and treated at AIIMS, at least 3 months before entry into the study.
Who cannot join
- Patients who refuse to provide informed consent for this study.
- Patients treated for cancer outside AIIMS.
- Patients who have recurrence or disease failure for which they are or are not receiving salvage therapy.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
All India Institute of Medical Sciences Dr.B.R.A.Institute Rotary Cancer Hospital
New Delhi, National Capital Territory of Delhi, 110029
Bidhu K MOHANTI, MD, +91-11-26593399, drbkmohanti@gmail.com
Jaspreet KAUR, MD, +919810966061, drjaspreet.ro@gmail.com
About this study
The purpose of this study is to assess the various aspects of life in the cancer survivors in India. Cancer survivor is defined as "an individual diagnosed with cancer and who has survived the disease and treatment, and for the rest of his/her life".
Cancer survivors are at increased risk of developing various physical and psychosocial conditions, which require to be identified and attended within the cancer care system.
Survivorship research is seen as addressing the medical, functional, and health related issues of individuals diagnosed with cancer, as well as that of their families.
Read the detailed description
It is estimated that approximately 25 million people are living as cancer survivors worldwide. The cancer survivors are those individuals who live beyond a cancer diagnosis and its therapy. Within the existing health care system, the cancer care models are largely focused on diagnostic methods, treatment aspects, cure, and disease failure and survival rates. There is very little research and intervention approaches for the after-effects of cancer diagnosis and treatments for an individual cancer patient. Cancer survivors are at increased risk of developing various physical and psychosocial conditions, which require to be identified and attended within the cancer care system. In the developing countries like India, the cancer cure rates are improving due to improvements in comprehensive diagnostic and treatment strategies. Cancer survivorship research will be valuable to enhance our understanding and care approaches to these vulnerable individuals in our society. There is lack of evaluation tools which can completely fit to assess all issues such as physical, social, financial, mental aspects of a cancer survivor.
Hence the investigators of this observational study have prepared an empirical cancer survivorship questionnaire (CSQ) which will document the patient's disease and treatment details and obtain subjective responses from the patient(and/or family care giver) related to the physical, functional, social, economic and mental aspects of daily living of a cancer survivor. In order to assess the mental status of the survivors, the investigators have also included the widely used and internationally accepted MINI (Mini-international neuropsychiatry interview) version along with the CSQ in this survey. Researchers and clinicians working in non-profit and academic setting such as this institution are allowed to make copies of this MINI questionnaire for the purpose of clinical and research use. For the present study, MINI version is suitably modified to exclude the items which are already in the CSQ, and certain items are reframed for the socio-cultural requirement. Both the CSQ (45 items) and MINI-modified (13 items) will be applied simultaneously in this survey as a direct face to face response documentation from the patient (cancer survivor), along with his/her family member. Patients will be chosen for this cross-sectional survey during the follow-up visit to a cancer clinic of this hospital, at least 3 months after the completion of cancer diagnosis and therapy. Each participant is expected to complete the survey at the first encounter, however, a provision is made to report any missing information at later visit.
An interim analysis will be carried out after the survey of first 50 patients to observe the trends in the findings. However, this will not impact the further accrual, except for making some changes in the survey parameters if at all needed.
- Conditions
- Cancer
- Keywords
- Cancer survivor, Neoplasms, Treatments, Physical status, Psychosocial status, Survivorship survey, Survivorship care, Research, Cancer patient
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adult Cancer Survivors | Intervention: Behavioural: Questionnaires for patient/family caregiver interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
To study the cancer survivorship experience(as binary responses)
Behavioral: Questionnaires and medical records. The cancer survivors' physical, social, economic and psychological issues will be assessed as verbal response.The survey questionnaires will document the sequelae of cancer and its treatment during the face to face interview and by collecting information from the individual cancer survivor's medical records
Measured: 1 year
To assess the mental status of cancer survivors
Behavioral:MINI-international neuro-psychiatric questionnaire(modified for local use)
Measured: 1 year
Secondary outcomes (2)
To identify the differences if any, in the cancer survivorship issues by age(Less than 50 or greater than 50 years)
This cancer survivorship survey will include adult cancer survivors post-therapy. Survivors of various neoplasms will be accrued for this survey.
Measured: up to 6 months after patient accrual
To define follow up care for cancer survivors in India.
This survey of 200 adult cancer survivors will analyse various issues-physical, social, psychological and economic which adversely impact the life of cancer survivors in India.
This analysis will help in evolving a feasible approach towards implementation of follow up care practice for cancer survivors.
Measured: up to 6 months after patient accrual
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionJul 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bidhu Kalyan Mohanti, All India Institute of Medical Sciences
- Investigators
- BIDHU K MOHANTI, MD, Study chair, All India Institute of Medical SciencesJaspreet Kaur, MD, Study director, All India Institute of Medical SciencesSudhir K Khandelwal, MD, Study director, All India Institute of Medical SciencesRavindra M Pandey, PhD, Study director, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01304199
- Sponsor's protocol ID
- IEC/NP-252/2010
- Acronym
- CANSURVIVE
- Status last verified
- Jul 2012
- First submitted
- 24 Feb 2011
- Last updated
- 12 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Mohanti BK, Kaur J. Living experiences of Indian adult cancer survivors--a brief report. Asian Pac J Cancer Prev. 2015;16(2):507-12. doi: 10.7314/apjcp.2015.16.2.507.
PubMed 25684479
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Survivorship Issues: A Survey of Patients in India.AIIMS Study (CANSURVIVE)
- ClinicalTrials.gov ID
- NCT01304199
- Acronym / sponsor ID
- CANSURVIVE / IEC/NP-252/2010
- Conditions
- Cancer
- Keywords
- Cancer survivor, Neoplasms, Treatments, Physical status, Psychosocial status, Survivorship survey, Survivorship care, Research
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 25 Feb 2011 (estimated)
- 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.
The purpose of this study is to assess the various aspects of life in the cancer survivors in India. Cancer survivor is defined as "an individual diagnosed with cancer and who has survived the disease and treatment, and for the rest of his/her life".
Cancer survivors are at increased risk of developing various physical and psychosocial conditions, which require to be identified and attended within the cancer care system.
Survivorship research is seen as addressing the medical, functional, and health related issues of individuals diagnosed with cancer, as well as that of their families.
Detailed description
It is estimated that approximately 25 million people are living as cancer survivors worldwide. The cancer survivors are those individuals who live beyond a cancer diagnosis and its therapy. Within the existing health care system, the cancer care models are largely focused on diagnostic methods, treatment aspects, cure, and disease failure and survival rates. There is very little research and intervention approaches for the after-effects of cancer diagnosis and treatments for an individual cancer patient. Cancer survivors are at increased risk of developing various physical and psychosocial conditions, which require to be identified and attended within the cancer care system. In the developing countries like India, the cancer cure rates are improving due to improvements in comprehensive diagnostic and treatment strategies. Cancer survivorship research will be valuable to enhance our understanding and care approaches to these vulnerable individuals in our society. There is lack of evaluation tools which can completely fit to assess all issues such as physical, social, financial, mental aspects of a cancer survivor.
Hence the investigators of this observational study have prepared an empirical cancer survivorship questionnaire (CSQ) which will document the patient's disease and treatment details and obtain subjective responses from the patient(and/or family care giver) related to the physical, functional, social, economic and mental aspects of daily living of a cancer survivor. In order to assess the mental status of the survivors, the investigators have also included the widely used and internationally accepted MINI (Mini-international neuropsychiatry interview) version along with the CSQ in this survey. Researchers and clinicians working in non-profit and academic setting such as this institution are allowed to make copies of this MINI questionnaire for the purpose of clinical and research use. For the present study, MINI version is suitably modified to exclude the items which are already in the CSQ, and certain items are reframed for the socio-cultural requirement. Both the CSQ (45 items) and MINI-modified (13 items) will be applied simultaneously in this survey as a direct face to face response documentation from the patient (cancer survivor), along with his/her family member. Patients will be chosen for this cross-sectional survey during the follow-up visit to a cancer clinic of this hospital, at least 3 months after the completion of cancer diagnosis and therapy. Each participant is expected to complete the survey at the first encounter, however, a provision is made to report any missing information at later visit.
An interim analysis will be carried out after the survey of first 50 patients to observe the trends in the findings. However, this will not impact the further accrual, except for making some changes in the survey parameters if at all needed.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult Cancer Survivors | – | –Intervention: Behavioural: Questionnaires for patient/family caregiver interview |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will evaluate the cancer patients visiting Dr BRAIRCH,AIIMS,New Delhi,India after a cancer diagnosis and the cancer treatments have been completed. The patients will be entered into this study(survey) during the follow up visits to the clinic. Patients will be evaluated and assessed for their cancer survivorship issues on the basis of a questionnaire (CSQ) developed by the investigators after the literature review. The mental status of the survivors is assessed by a MINI- international neuro-psychiatric interview, suitably modified to incorporate the CSQ in this survey.
Key inclusion criteria (5 listed)
- Patients who were treated with curative intent and are on hospital follow up visit.
- Patients aged above 18 years and of both sexes.
- Patients who have no evidence of disease at the time of collecting information.
- Patients or family carers who are able to comprehend and communicate.
- Cancer diagnosed and treated at AIIMS, at least 3 months before entry into the study.
Key exclusion criteria (3 listed)
- Patients who refuse to provide informed consent for this study.
- Patients treated for cancer outside AIIMS.
- Patients who have recurrence or disease failure for which they are or are not receiving salvage therapy.
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
To study the cancer survivorship experience(as binary responses)
Time frame: 1 year
Behavioral: Questionnaires and medical records. The cancer survivors' physical, social, economic and psychological issues will be assessed as verbal response.The survey questionnaires will document the sequelae of cancer and its treatment during the face to face interview and by collecting information from the individual cancer survivor's medical records
To assess the mental status of cancer survivors
Time frame: 1 year
Behavioral:MINI-international neuro-psychiatric questionnaire(modified for local use)
2 secondary outcomes
To identify the differences if any, in the cancer survivorship issues by age(Less than 50 or greater than 50 years)
Time frame: up to 6 months after patient accrual
To define follow up care for cancer survivors in India.
Time frame: up to 6 months after patient accrual
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2012.
- Derived from this study: PubMed 25684479Mohanti BK, Kaur J. Living experiences of Indian adult cancer survivors--a brief report. Asian Pac J Cancer Prev. 2015;16(2):507-12. doi: 10.7314/apjcp.2015.16.2.507.
- Office of Cancer Survivorship CCPS, Cancer Control \& Population Sciences.National Cancer Institute 6130 Executive Boulevard Room 6134 Executive Plaza North Rockville, Maryland 20852 Phone: 301-594-6776 Fax: 301-594-6787Link provided by the sponsor.
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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.
BIDHU K MOHANTI, MD study chair
All India Institute of Medical Sciences
Jaspreet Kaur, MD study director
All India Institute of Medical Sciences
Sudhir K Khandelwal, MD study director
All India Institute of Medical Sciences
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 Cancer, run by All India Institute of Medical Sciences 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 3 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: status not confirmed, as of the sponsor's last update on 12 Jul 2012. 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?
Contact BIDHU K MOHANTI, MD (+919871045812, drbkmohanti@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To study the cancer survivorship experience(as binary responses) (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01304199, which also lists 1 linked publication.
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 12 Jul 2012.