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

This study is currently recruiting participants.
Verified July 2012 by All India Institute of Medical Sciences, New Delhi
Sponsor:
Information provided by (Responsible Party):
Bidhu Kalyan Mohanti, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier:
NCT01304199
First received: February 24, 2011
Last updated: July 11, 2012
Last verified: July 2012
  Purpose

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.


Condition
Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Cancer Survivorship Issues: A Survey of Patients in India.AIIMS Study (CANSURVIVE)

Resource links provided by NLM:


Further study details as provided by All India Institute of Medical Sciences, New Delhi:

Primary Outcome Measures:
  • To study the cancer survivorship experience(as binary responses) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Behavioral:MINI-international neuro-psychiatric questionnaire(modified for local use)


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    This cancer survivorship survey will include adult cancer survivors post-therapy. Survivors of various neoplasms will be accrued for this survey.

  • To define follow up care for cancer survivors in India. [ Time Frame: up to 6 months after patient accrual ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 200
Study Start Date: January 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Adult Cancer Survivors

Intervention:

Behavioural:

Questionnaires for patient/family caregiver interview


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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01304199

Contacts
Contact: BIDHU K MOHANTI, MD +919871045812 drbkmohanti@gmail.com
Contact: Jaspreet Kaur, MD +919810966061 drjaspreet.ro@gmail.com

Locations
India
All India Institute of Medical Sciences Dr.B.R.A.Institute Rotary Cancer Hospital Recruiting
New Delhi, Delhi, India, 110029
Contact: Bidhu K MOHANTI, MD    +91-11-26593399    drbkmohanti@gmail.com   
Contact: Jaspreet KAUR, MD    +919810966061    drjaspreet.ro@gmail.com   
Principal Investigator: BIDHU K MOHANTI, MD         
Sponsors and Collaborators
All India Institute of Medical Sciences, New Delhi
Investigators
Study Chair: BIDHU K MOHANTI, MD All India Institute of Medical Sciences, New Delhi
Study Director: Jaspreet Kaur, MD All India Institute of Medical Sciences, New Delhi
Study Director: Sudhir K Khandelwal, MD All India Institute of Medical Sciences, New Delhi
Study Director: Ravindra M Pandey, PhD All India Institute of Medical Sciences, New Delhi
  More Information

Additional Information:
No publications provided

Responsible Party: Bidhu Kalyan Mohanti, Professor Department of Radiation Oncology, All India Institute of Medical Sciences, New Delhi
ClinicalTrials.gov Identifier: NCT01304199     History of Changes
Other Study ID Numbers: IEC/NP-252/2010
Study First Received: February 24, 2011
Last Updated: July 11, 2012
Health Authority: India: Institutional Review Board

Keywords provided by All India Institute of Medical Sciences, New Delhi:
Cancer survivor
Neoplasms
Treatments
Physical status
Psychosocial status
Survivorship survey
Survivorship care
Research
Cancer patient

ClinicalTrials.gov processed this record on April 17, 2014