- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01304199
Cancer Survivorship Issues: A Survey of Patients in India.AIIMS Study (CANSURVIVE) (CANSURVIVE)
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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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Delhi
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New Delhi, Delhi, India, 110029
- Reclutamiento
- All India Institute of Medical Sciences Dr.B.R.A.Institute Rotary Cancer Hospital
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Contacto:
- Jaspreet KAUR, MD
- Número de teléfono: +919810966061
- Correo electrónico: drjaspreet.ro@gmail.com
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Contacto:
- Bidhu K MOHANTI, MD
- Número de teléfono: +91-11-26593399
- Correo electrónico: drbkmohanti@gmail.com
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Investigador principal:
- BIDHU K MOHANTI, MD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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.
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Adult Cancer Survivors
Intervention: Behavioural: Questionnaires for patient/family caregiver interview |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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To study the cancer survivorship experience(as binary responses)
Periodo de tiempo: 1 year
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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
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1 year
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To assess the mental status of cancer survivors
Periodo de tiempo: 1 year
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Behavioral:MINI-international neuro-psychiatric questionnaire(modified for local use)
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1 year
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
To identify the differences if any, in the cancer survivorship issues by age(Less than 50 or greater than 50 years)
Periodo de tiempo: up to 6 months after patient accrual
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This cancer survivorship survey will include adult cancer survivors post-therapy.
Survivors of various neoplasms will be accrued for this survey.
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up to 6 months after patient accrual
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To define follow up care for cancer survivors in India.
Periodo de tiempo: up to 6 months after patient accrual
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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. |
up to 6 months after patient accrual
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: BIDHU K MOHANTI, MD, All India Institute of Medical Sciences, New Delhi
- Director de estudio: Jaspreet Kaur, MD, All India Institute of Medical Sciences, New Delhi
- Director de estudio: Sudhir K Khandelwal, MD, All India Institute of Medical Sciences, New Delhi
- Director de estudio: Ravindra M Pandey, PhD, All India Institute of Medical Sciences, New Delhi
Publicaciones y enlaces útiles
Publicaciones Generales
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- IEC/NP-252/2010
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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