Clinical trial NCT01304199: Cancer Survivorship Issues: A Survey of Patients in India.AIIMS Study (CANSURVIVE)
Official title: Cancer Survivorship Issues: A Survey of Patients in India.AIIMS Study (CANSURVIVE)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Keywords: Cancer survivor
Neoplasms
Treatments
Physical status
Psychosocial status
Survivorship survey
Survivorship care
Research
Cancer patient
Lead sponsor: All India Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2011-02-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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".

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: To study the cancer survivorship experience(as binary responses)
timeFrame: 1 year
measure: To assess the mental status of cancer survivors
timeFrame: 1 year
Secondary outcomes:
measure: To identify the differences if any, in the cancer survivorship issues by age(Less than 50 or greater than 50 years)
timeFrame: up to 6 months after patient accrual
measure: To define follow up care for cancer survivors in India.
timeFrame: up to 6 months after patient accrual
Other outcomes:
Locations:
city: New Delhi
country: India
facility: All India Institute of Medical Sciences Dr.B.R.A.Institute Rotary Cancer Hospital
state: Delhi
Study officials:
affiliation: All India Institute of Medical Sciences
name: BIDHU K MOHANTI, MD
role: STUDY_CHAIR
affiliation: All India Institute of Medical Sciences
name: Jaspreet Kaur, MD
role: STUDY_DIRECTOR
affiliation: All India Institute of Medical Sciences
name: Sudhir K Khandelwal, MD
role: STUDY_DIRECTOR
affiliation: All India Institute of Medical Sciences
name: Ravindra M Pandey, PhD
role: STUDY_DIRECTOR
References:
citation: 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.