Intervention:

Behavioural:

Questionnaires for patient/family caregiver interview

BIDHU K MOHANTI, MD

Jaspreet Kaur, MD

Bidhu K MOHANTI, MD

Jaspreet KAUR, MD

Sudhir K Khandelwal, MD

Ravindra M Pandey, PhD

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.

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.

Cancer Survivorship Issues: A Survey of Patients in India.AIIMS Study (CANSURVIVE)

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

Behavioral:MINI-international neuro-psychiatric questionnaire(modified for local use)

This cancer survivorship survey will include adult cancer survivors post-therapy. Survivors of various neoplasms will be accrued for this survey.

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.

All India Institute of Medical Sciences, New Delhi

Professor Department of Radiation Oncology

Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Breast Neoplasms

Melanoma

Prostatic Neoplasms

Lung Neoplasms

Uterine Cervical Neoplasms

Skin Diseases

Urogenital Neoplasms

Genital Diseases

Urogenital Diseases

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Neuroendocrine Tumor

Neuroepithelioma

This study aims to establish a holistic framework for continuous cancer survival surveillance in Russian regions with high-quality population-based cancer registry data. The data from the population-based cancer registries of the Northwestern regions of Russia will be used to assess net and cause-specific survival trends.

The main sources of cancer incidence data in Russia are population-based cancer registries (PBCR). National recommendations guide the content of corresponding variables stored in PBCRs. Data were collected for the following regions: Arkhangelsk Oblast and Nenets Autonomous Okrug (combined), Republic of Karelia, Komi Republic, Vologda Oblast, Kaliningrad Oblast, Leningrad Oblast, Murmansk Oblast, Novgorod Oblast, Pskov Oblast, and St. Petersburg. Quality assessment procedures will be applied to the population-based cancer registries (PBCRs) datasets. Essential variables will be extracted following the recommended list of ENCR/IACR.

The list of variables consists of two classes: original variables present in PBCRs datasets and synthetic variables calculated based on the original variables. "IARC/IACR Tools for Cancer Registries" (IARC tools) software was used for the data cleaning, conversion to ICD-O-3, and multiple primaries assessment. Duplicates were removed by applying IARC/IACR/ENCR multiple primary rules. The analysis is limited to twenty years: 2000 - 2021.

The Federal State Statistics Service (FSSS) is the primary regional and national mortality data source. However, the raw data from this source has several drawbacks. The main problem is the absence of the distribution of persons with undetermined ages and/or causes of death. The data sets for this research are obtained from the Russian Fertility and Mortality Database (RFMD) of the Center for Demographic Research of the New Economic School. The RFMD database is based on the FSSS data but has a higher data quality due to the redistribution of deaths with the abovementioned characteristics. This source's population and mortality data contained the following variables: region, year, sex, age (5-year age groups from 0 to 85+), and cause of death.

Population data was obtained from the same source. The data were based on the 1989, 2002 and 2010 population censuses. It has been extrapolated to other years using annual statistics on mortality and births.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Cancer Survivorship Issues: A Survey of Patients in India.AIIMS Study (CANSURVIVE)	NCT01304199	Cancer		18 Years - 75 Years	All India Institute of Medical Sciences, New Delhi
Survival Monitoring in Russian Cancer Registries	NCT06043947	Melanoma Breast Cancer Oncology Colon Cancer Prostate Cancer Survivorship Lung Cancer Cervix Cancer		0 Years - 100 Years	N.N. Petrov National Medical Research Center of Oncology

Spots Global Cancer Trial Database for survivorship survey