Colorectal cancer is the third most commonly diagnosed cancer in males and the second in females, with approximately 1.8 million new cancer cases occurring in 2018 .It ranks third in terms of incidence and second leading in terms of mortality. Colorectal cancer incidence rates are about 3-fold higher in transitioned versus transitioning countries. In India, colorectal cancer is the fourth most common malignancy in males and fifth most common malignancy in females.

Surgery remains the mainstay of curative treatment for colorectal cancers. Despite significant advances in the detection and treatment of colorectal cancers, significant number of patients requires an intestinal stoma. During this procedure, the colon is connected to a hole in the abdomen (called a stoma) to divert stool away from a damaged or surgically repaired part of the colon or rectum. Colostomies may be temporary or permanent depending on the location of tumor and whether it is possible to obtain a safety margin of resection. Some colostomies may be reversed once the repaired tissue heals. Operations with urgent indications such as patients presenting with symptoms of acute abdomen with perforation and peritonitis are often performed in difficult conditions, and therefore the ending of the surgery by intestinal stoma is the safest procedure. A temporary stoma to protect the anastomosis is strongly recommended, particularly in case of a very low colo-anal anastomosis, an anastomosis in the obese male patient, and after neo-adjuvant treatment . The stoma can be closed after 3-6 months, provided anastomosis is complete and leak is not identified by proctoscopy or double contrast imaging.  In case of adjuvant treatment, closure of the stoma is attempted at 4-6 weeks after the end of treatment.

In oncology, QOL has been defined as a personal sense of well-being encompassing a multidimensional perspective that covers the subjective perceptions of the positive and negative aspects of cancer patients’ symptoms. It includes physical, psychological, social, and spiritual dimensions or domains, and also importantly, disease symptoms and side effects of treatment .QOL is affected by many factors in addition to those that are health-related, such as financial status, job satisfaction, and living conditions. When put into a health context as the duration or severity of morbidity accumulates, these factors influence QOL, and are often referred to as health related QOL . It is pertinent to consider patient’s QOL to understand the effect of disease on their day to day living, and the burden of illness on patient and family. This is not always related to the severity of their disease, by laboratory values or imaging, but by how the disease and possibly its treatment are perceived by the patient . There are many psychosocial factors that need to be taken into consideration as well as symptom-related aspects of QOL .

QOL in colorectal cancer patients is associated with multiple factors. QoL in colorectal cancer patients is associated with number of factors. It is important to identify the patient with a higher risk to have a low QoL and then intervene to the modifiable factors in order to improve QOL in CRC patients.  An important consequence of colorectal surgery is stoma. The presence of stoma adversely influences the QOL as compared to patients undergoing a sphincter-saving surgery . However, various studies did not find a significant difference between the two .

Aims and Objectives

1.     To assess the quality of life in patients of colorectal cancer with stoma.

2.     To assess the impact of socio-demographic; health-related; cancer-related ,surgical procedures and  lifestyle factors on QOL

Detailed research methodology:

Study setting:  Department of Radiotherapy & Oncology, Post Graduate Institute of Medical Education and Research, Chandigarh

Definition of population:

Histologically proven colorectal cancer patients with stoma

Study design:

Prospective hospital-based study

Inclusion criteria:

1.     Diagnosis of primary colorectal carcinoma histologically confirmed and treated with radical resection

2.     Stoma in situ

3.     Consenting for participation and follow up

Exclusion criteria:

1.     Residual/ recurrent disease at present

2.     Wide spread metastatic disease at initial presentation

3.     Previous history of malignancy other than colorectal cancer

4.     Any other serious illness and or major organ dysfunction

Sample size:100 patients

Parameters & procedures:

Assessment

Detailed history

Surgical details

Assessment of QOL at 3 months, 6 months and 1 yearpost surgery by modules

a)     City of Hope QOL questionnaire for a patient with an ostomy

b)    EORTC QLQ-CR 29

c)     EORTC QLQ-C30

Procedures:

All registered Colorectal cancer patients with stoma will be contacted during their visits to the Radiotherapy department and asked about whether if they are interested in participating in the study or not. Subjects who will express interest will be given a copy of consent form along with quality of life questionnaires.  The QOL will be assessed 3 months, 6 months and 1 year post surgery. Patient related, disease related and treatment related parameters will be noted as mentioned below:

Measures:

1. Socio-demographic data: patient’s age, educational status, occupation status, age at diagnosis, marital status, andhousehold income at the time of diagnosis and at interview.

2. Lifestyle factors – physical activity, obesity, dietary intake, smoking, alcohol intake.

2. Type of surgery -abdominoperineal resection (APR), Hartmann’s procedure or coloanal anastomosis (CAA), planned or unplanned surgery

3.Neoadjuvant treatment -chemoradiation or chemotherapy before surgery; number of cycles of chemotherapy, specific chemotherapy drugs used.

4. Tumor related factors -tumor, node, metastasis (TNM) stage; site of tumor(distance from the anal verge to the inferior margin); andcomplications and stoma

5. City of Hope questionnaire - has two components. The first component comprises of 47 forced-choice andopen ended items that relate to patient socio-demographic characteristics as well as work-relateditems, health insurance, sexual activity, psychological support, clothing, diet, and daily ostomycare. The second component contains 43 QOL items using 10-point scales. These QOL itemsare divided into the four domains or subscales- physical, psychological, social and spiritual well being. These QOL items are followed by a statement asking the patient to share a story about livingwith an ostomy, and include the great challenges encountered in having an ostomy.

6. QOL CR-29–EORTC colorectal cancer module consists of four scales and 19 individual items

7. QLQ-C30 – composed of 30 items distributed among 6 functional scales (physical, role, emotional, cognitive and social functions); 3 symptom scales (fatigue, pain, nausea/vomiting)and 6 single items (dyspnea, sleep disturbance, appetite loss, diarrhea, constipation and financial impact).