NCT01304199

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 25, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

July 12, 2012

Status Verified

July 1, 2012

Enrollment Period

2.5 years

First QC Date

February 24, 2011

Last Update Submit

July 11, 2012

Conditions

Keywords

Cancer survivorNeoplasmsTreatmentsPhysical statusPsychosocial statusSurvivorship surveySurvivorship careResearchCancer patient

Outcome Measures

Primary Outcomes (2)

  • To study the cancer survivorship experience(as binary responses)

    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

    1 year

  • To assess the mental status of cancer survivors

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

    1 year

Secondary Outcomes (2)

  • To identify the differences if any, in the cancer survivorship issues by age(Less than 50 or greater than 50 years)

    up to 6 months after patient accrual

  • To define follow up care for cancer survivors in India.

    up to 6 months after patient accrual

Study Arms (1)

Adult Cancer Survivors

Intervention: Behavioural: Questionnaires for patient/family caregiver interview

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

New Delhi, National Capital Territory of Delhi, 110029, India

RECRUITING

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Neoplasms

Study Officials

  • BIDHU K MOHANTI, MD

    All India Institute of Medical Sciences

    STUDY CHAIR
  • Jaspreet Kaur, MD

    All India Institute of Medical Sciences

    STUDY DIRECTOR
  • Sudhir K Khandelwal, MD

    All India Institute of Medical Sciences

    STUDY DIRECTOR
  • Ravindra M Pandey, PhD

    All India Institute of Medical Sciences

    STUDY DIRECTOR

Central Study Contacts

BIDHU K MOHANTI, MD

CONTACT

Jaspreet Kaur, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Department of Radiation Oncology

Study Record Dates

First Submitted

February 24, 2011

First Posted

February 25, 2011

Study Start

January 1, 2011

Primary Completion

July 1, 2013

Study Completion

December 1, 2013

Last Updated

July 12, 2012

Record last verified: 2012-07

Locations