assessment of Quality of life (QOL) in colorectal cancer patients with colostomy

Recruiting

Conditions: Malignant neoplasm of colon, unspecified,

Registration Number: CTRI/2019/11/021967

Lead Sponsor: PGIMER CHANDIGARH

Brief Summary: Colorectal cancer is the third most commonly diagnosedcancer in males and the second in females, with approximately 1.8 million newcancer cases occurring in 2018 .It ranks third in terms of incidence andsecond leading in terms of mortality. Colorectal cancer incidence rates areabout 3-fold higher in transitioned versus transitioning countries. In India, colorectalcancer is the fourth most common malignancy in males and fifth most commonmalignancy in females.

Surgery remains the mainstay of curative treatment forcolorectal cancers. Despite significant advances in the detection and treatmentof colorectal cancers, significant number of patients requires an intestinalstoma. 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 repairedpart of the colon or rectum. Colostomies may be temporary or permanentdepending on the location of tumor and whether it is possible to obtain asafety margin of resection. Some colostomies may be reversed once the repairedtissue heals. Operations with urgent indications such as patients presentingwith symptoms of acute abdomen with perforation and peritonitis are oftenperformed in difficult conditions, and therefore the ending of the surgery byintestinal stoma is the safest procedure. A temporary stoma to protect theanastomosis is strongly recommended, particularly in case of a very lowcolo-anal anastomosis, an anastomosis in the obese male patient, and afterneo-adjuvant treatment . The stoma can be closed after 3-6 months,provided anastomosis is complete and leak is not identified by proctoscopy ordouble contrast imaging. In case of adjuvant treatment, closure of thestoma is attempted at 4-6 weeks after the end of treatment.

In oncology, QOLhas been defined as a personal sense of well-being encompassing amultidimensional perspective that covers the subjectiveperceptions 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 manyfactors in addition to those that are health-related, such as financial status,job satisfaction, and living conditions. When put into a health context as theduration or severity of morbidity accumulates, these factors influence QOL, andare often referred to as health related QOL . It is pertinent to considerpatientâ€™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 tothe severity of their disease, by laboratory values or imaging, but by how thedisease and possibly its treatment are perceived by the patient . There aremany 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 multiplefactors. QoL in colorectal cancer patients is associated with number offactors. It is important to identify the patient with a higher risk to have alow QoL and then intervene to the modifiable factors in order to improve QOL inCRC patients. An important consequenceof colorectal surgery is stoma. The presence of stoma adversely influences theQOL as compared to patients undergoing a sphincter-saving surgery . However,various studies did not find a significant difference between the two .

**Aimsand Objectives**

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

2.     Toassess the impact of socio-demographic; health-related; cancer-related,surgical procedures and lifestylefactors on QOL

**Detailedresearch methodology:**

**Study setting:** Department ofRadiotherapy & Oncology, Post Graduate Institute of Medical Education andResearch, Chandigarh

**Definitionof population:**

Histologically proven colorectal cancer patients with stoma

**Studydesign:**

Prospective hospital-based study

**Inclusioncriteria:**

1.     Diagnosisof primary colorectal carcinoma histologically confirmed and treated withradical resection

2.     Stomain situ

3.     Consentingfor participation and follow up

**Exclusioncriteria:**

1.     Residual/recurrent disease at present

2.     Widespread metastatic disease at initial presentation

3.     Previoushistory of malignancy other than colorectal cancer

4.     Anyother serious illness and or major organ dysfunction

**Sample size:**100patients

**Parameters& procedures:**

**Assessment**

Detailed history

Surgical details

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

a)     Cityof Hope QOL questionnaire for a patient with an ostomy

b)    EORTCQLQ-CR 29

c)     EORTCQLQ-C30

**Procedures:**

All registered Colorectal cancer patients with stomawill be contacted during their visits to the Radiotherapy department and askedabout 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 alongwith quality of life questionnaires. TheQOL will be assessed 3 months, 6 months and 1 year post surgery. Patientrelated, disease related and treatment related parameters will be noted asmentioned below:

**Measures:**

1. **Socio-demographicdata:** patientâ€™s age, educational status, occupation status, age atdiagnosis, marital status, andhousehold income at the time of diagnosis and at interview.

2. **Lifestylefactors â€“** physical activity, obesity, dietary intake, smoking, alcoholintake.

2. **Type ofsurgery -**abdominoperineal resection (APR), Hartmannâ€™s procedure or coloanalanastomosis (CAA), planned or unplanned surgery

3.**Neoadjuvanttreatment -**chemoradiation or chemotherapy before surgery; number of cyclesof chemotherapy, specific chemotherapy drugs used.

4. **Tumorrelated factors -**tumor, node, metastasis (TNM) stage; site oftumor(distance from the anal verge to the inferior margin); andcomplicationsand stoma

5. **City of Hopequestionnaire -** has two components. The first component comprises of 47forced-choice andopen ended items that relate to patient socio-demographiccharacteristics as well as work-relateditems, health insurance, sexualactivity, psychological support, clothing, diet, and daily ostomycare. Thesecond component contains 43 QOL items using 10-point scales. These QOLitemsare divided into the four domains or subscales- physical, psychological,social and spiritual well being. These QOL items are followed by a statementasking the patient to share a story about livingwith an ostomy, and include thegreat challenges encountered in having an ostomy.

6**. QOL CR-29â€“**EORTCcolorectal cancer module consists of four scales and 19 individual items

7. **QLQ-C30**â€“ 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).

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 100

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.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2.To assess the impact of socio-demographic; health-related; cancer-related ,surgical procedures and lifestyle factors on QOL	3 MONTH, 6 MONTH AND 12 MONTH
1.To assess the quality of life in patients of colorectal cancer with stoma.	3 MONTH, 6 MONTH AND 12 MONTH

Secondary Outcome Measures

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

Trial Locations

Locations (1): PGIMER CHANDIGARH
🇮🇳
Chandigarh, CHANDIGARH, India
PGIMER CHANDIGARH
🇮🇳Chandigarh, CHANDIGARH, India
DR DIVYA KHOSLA
Principal investigator
09117227475
dr_divya_khosla@yahoo.com