MedDataX Logo

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

NCT ID: NCT01304199

Last Updated: 2012-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Adult Cancer Survivors

Intervention:

Behavioural:

Questionnaires for patient/family caregiver interview

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

All India Institute of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Bidhu Kalyan Mohanti

Professor Department of Radiation Oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

BIDHU K MOHANTI, MD

Role: STUDY_CHAIR

All India Institute of Medical Sciences

Jaspreet Kaur, MD

Role: STUDY_DIRECTOR

All India Institute of Medical Sciences

Sudhir K Khandelwal, MD

Role: STUDY_DIRECTOR

All India Institute of Medical Sciences

Ravindra M Pandey, PhD

Role: STUDY_DIRECTOR

All India Institute of Medical Sciences

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

All India Institute of Medical Sciences Dr.B.R.A.Institute Rotary Cancer Hospital

New Delhi, National Capital Territory of Delhi, India

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

India

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

BIDHU K MOHANTI, MD

Role: CONTACT

Phone: +919871045812

Email: [email protected]

Jaspreet Kaur, MD

Role: CONTACT

Phone: +919810966061

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Bidhu K MOHANTI, MD

Role: primary

Jaspreet KAUR, MD

Role: backup

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 25684479 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://cancercontrol.cancer.gov/ocs/

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: 301-594-6787

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IEC/NP-252/2010

Identifier Type: -

Identifier Source: org_study_id