Know Cancer

or
forgot password

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


N/A
18 Years
75 Years
Open (Enrolling)
Both
Cancer

Thank you

Trial Information

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


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

To study the cancer survivorship experience(as binary responses)

Outcome Description:

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

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

BIDHU K MOHANTI, MD

Investigator Role:

Study Chair

Investigator Affiliation:

All India Institute of Medical Sciences, New Delhi

Authority:

India: Institutional Review Board

Study ID:

IEC/NP-252/2010

NCT ID:

NCT01304199

Start Date:

January 2011

Completion Date:

December 2013

Related Keywords:

  • Cancer
  • Cancer survivor
  • Neoplasms
  • Treatments
  • Physical status
  • Psychosocial status
  • Survivorship survey
  • Survivorship care
  • Research
  • Cancer patient

Name

Location