Intervention:

Behavioural:

Questionnaires for patient/family caregiver interview

BIDHU K MOHANTI, MD

Jaspreet Kaur, MD

Bidhu K MOHANTI, MD

Jaspreet KAUR, MD

Sudhir K Khandelwal, MD

Ravindra M Pandey, PhD

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.

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.

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

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

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

This cancer survivorship survey will include adult cancer survivors post-therapy. Survivors of various neoplasms will be accrued for this survey.

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.

All India Institute of Medical Sciences, New Delhi

Professor Department of Radiation Oncology

Neoplasms

Digestive System Diseases

All Conditions

Behaviors and Mental Disorders

Rare Diseases

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Quality of Life

Oculocerebral Syndrome With Hypopigmentation

No intervention

Qiong Teng, MD

Colorectal cancer is one of the leading cancers worldwide. Although the majority of CRC cases are typically diagnosed in individuals older than 50 years of age, recent international studies have highlighted the importance of younger adults (\&lt; 50) are gradually increasing. Young cancer survivors often have poorer quality of life, disrupted social and sexual health, and increased mental health-related risks such as depression and anxiety. Especially for patients with rectal cancer, patients may suffer from sexual dysfunction, urinary system problems and loss of normal bowel function after radical resection of rectal tumors, and some patients may also need to undergo ostomy, which may have adverse effects on the quality of life and mental health of patients after surgery. Given that the incidence of colorectal cancer in young adults continues to rise worldwide, there is a need to better understand the impact of this particular disease on postoperative quality of life in young adults. This study intends to retrospectively analyze the clinical characteristics of the patients, and further summarize the impact of rectal cancer surgery on the quality of life of patients through follow-up.

Colorectal cancer (CRC) is the third most common malignancy worldwide and the second leading cause of cancer death. The incidence of CRC has remained stable or declined in high-income countries over the past decade, possibly due to a series of screening and prevention measures aimed at people aged 50-70 years. However, there is an increased incidence of rectal cancer in people younger than 50 years of age, which is known as young-onset RC (YO-RC). By 2030, YO-RC is expected to account for 23% of rectal cancers. In America, the proportion of people under 55 years of age newly diagnosed has increased from 11% in 1995 to 20% in 2019, and the incidence of RC in people under 50 years of age has increased by about 2% per year. Due to the early detection of routine physical examination, advances in imaging, improved surgical techniques, and advances in chemoradiotherapy, colorectal cancer mortality is on a downward trend, with overall mortality declining by 57% from 1970 to 2020. Therefore, those who are diagnosed with RC under the age of 50 are also called young-onset rectal cancer (YO-RC). Prognostic analyses of YO-RC have been mixed, with some studies suggesting worse survival outcomes in younger patients, while others have shown no difference between younger and older patients. In view of the difficulty of curing cancer and its complexity, traditional evaluation indicators such as survival time, remission period, treatment-related toxicity and tumor remission rate cannot comprehensively and accurately evaluate the medical outcome of cancer patients. More and more people pay attention to the QOL of patients after treatment, which can comprehensively, objectively and truly evaluate the medical outcome from the perspective of patients. Surgery is the basis of curative treatment for RC. Problems that arise after RC surgery can impair quality of life (QOL), such as fatigue, abdominal pain, changes in bowel function, and decreased sexual function. In addition, postoperative radiotherapy and chemotherapy can also reduce patients' QOL. It is important to note that YO-RC patients may experience very different psychosocial status (PS) than older patients, with mental health issues such as anxiety and depression being more prominent. At the same time, because YO-RC patients have higher requirements for postoperative QOL, it is necessary to adopt standardized quantitative scales to measure the postoperative situation of this group of people, so that clinicians can provide more effective interventions. Here, we used the questionnaires, developed by the European Organization for Research and Treatment of Cancer (EORTC), to assess the QOL of patients with CRC. Several standardized psychological and functional scales (previously applied to studies of other post-surgical tumors) were used to assess mental stress, body image anxiety, and work ability in patients after RC surgery. This study is the first to evaluate the five-year QOL and PS in YO-RC patients after surgery using multiple questionnaires. Based on our research results, the QOL and PS of patients can be better predicted, and then timely measures can be taken to help patients improve the QOL and relieve psychological pressure.

Quality of Life and Psychosocial Status of Young-onset Patients With Rectal Cancer

Quality of Life and Psychosocial Status of Young-onset Patients With Rectal Cancer After Surgery: a Cross-sectional Muti-questionnaire Survey

patients' psychosocial status after surgery

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Cancer Survivorship Issues: A Survey of Patients in India.AIIMS Study (CANSURVIVE)	NCT01304199	Cancer		18 Years - 75 Years	All India Institute of Medical Sciences, New Delhi
Quality of Life and Psychosocial Status of Young-onset Patients With Rectal Cancer	NCT06216834	Rectal Cancer	No intervention	18 Years - 50 Years	Shandong Provincial Hospital

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