Clinical trial NCT04744792: QoL of Colorectal Cancer Patients and Spouses
Official title: Quality of Life After Colorectal Surgery: A Prospective Study of Patients Compared With Their Spouses
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Life
Stoma Ileostomy
Stoma Colostomy
Rectum Cancer
Sigmoid Cancer
Keywords: Quality of Life, SF - 36, Rectal cancer, spouse
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2021-02-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who had a spouse, aged 18 or over, and underwent abdominoperineal excision, low anterior resection, anterior resection between march 2006 and november 2010 in Ankara University Department of general surgery.

Brief summary: The aim of the present prospective, comparative study was to compare the quality of life (QoL) of patients after colorectal surgery to the QoL of their spouses. The study included patients who underwent curative surgery for colorectal carcinoma (n = 100; abdominoperineal excision \[n = 33\], low anterior resection \[n = 33\], left hemicolectomy \[n = 34\]) and their spouses (n = 100). The patients and spouses completed the Medical Outcome Study 36-item Short Form Survey (SF-36) and the World Health Organization Disability Assessment Schedule II (WHODAS-II) preoperatively and at postoperative months 15 to 18. The QoL of patients and that of their spouses changed following surgery for colorectal cancer.

These changes were more significant among male patients' spouses.

Detailed description: There is no doubt that radical colorectal surgery improves the oncological outcomes of patients with cancer. However, the literature has clearly documented that social, physical, sexual, and psychological aspects of life, as well as religious worship, are severely impaired after this treatment. A significant portion of patients suffer from alterations in their quality of life (QoL), particularly after surgery on distal rectal tumors. Patients who require a stoma or who have low anterior resection syndrome may face difficulty adapting to their new anatomy, managing the stoma, defecating, and continuing normal activities in their sociocultural environment. Patients pay an immense price following both sphincter-saving and sphincter-sacrificing surgery. Moreover, these psychological and social difficulties, as well as sexual dysfunction, may affect patients' relationships with their spouses, who are generally the primary informal caregivers for patients with cancer. In addition to caring for their sick partners, the spouses also have to deal with their own anxiety, fatigue, and depression.The aim of the present prospective, comparative study was to compare the quality of life (QoL) of patients after colorectal surgery to the QoL of their spouses.

Groups

Patients and their spouses were grouped by the type of surgery they received:

abdominoperineal resection (APR), sphincter-saving resection with an anastomosis within 6 cm of the anal verge on rigid sigmoidoscopy (LAR), or anterior resection with anastomosis at or above 7 cm, including sigmoid colectomy (AR).

The study included patients who underwent curative surgery for colorectal carcinoma (n = 100; abdominoperineal excision \[n = 33\], low anterior resection \[n = 33\], left hemicolectomy \[n = 34\]) and their spouses (n = 100). The patients and spouses completed the Medical Outcome Study 36-item Short Form Survey (SF-36) and the World Health Organization Disability Assessment Schedule II (WHODAS-II) preoperatively and at postoperative months 15 to 18.

Counseling Surgical details, possible complications, and temporary or permanent stoma formation were explained preoperatively by the surgeon, and ostomy education was given by the stomatherapist. Religious education and counseling were also performed. Patients had direct access to doctors, the stomatherapist, appliance suppliers, and a religious leader (Imam) at the hospital during the study period.

Interviews Patients and spouses were interviewed at the Department of Surgery of Ibni Sina Hospital.

The coauthors of the study were trained to administer the questionnaires in a standard fashion and practiced by using the questionnaires on healthy volunteers before the study began.

Patients and spouses were interviewed in a private room by a person of the same gender. The same interviewer was used in the preoperative and postoperative period for each patient and spouse, but the interviewer was not blinded to the type of surgery that the patient had undergone. Patients were first asked to complete a demographic questionnaire designed to determine their age, gender, marital status, educational level, income level, and preoperative employment. The SF-36, WHODAS-II, and Ankara University Life Standards Questionnaire were administered together and consisted of a total of 92 items, which took approximately 35 to 45 minutes to complete. Both patients and spouses completed the SF-36, WHODAS-II, and Ankara University Life Standards Questionnaire preoperatively and at postoperative months 15 to 18.

Eligibility criteria: Inclusion Criteria:

1. curative surgery for colorectal adenocarcinoma
2. living with a spouse
3. aged over 18 years
4. Muslim faith.

Exclusion Criteria:

1) Other primary malignant tumors 4) Additional complicating or disabling disease that necessitated nursing assistance (e.g., mental illness) 5) Chemo-radiotherapy within 8 weeks prior to the interview 6) Admittance to a hospital except for stoma closure during the study period (no interview during stoma closure) 7) Major morbidity (e.g., anastomotic leakage, abdominal sepsis, stoma-related problems, and intensive care unit transfer) 8) Evidence of disease recurrence or metastasis, which was determined at the time of follow-up interviews

Primary outcomes:
measure: Quality of Life of patients and spouses
timeFrame: In the preoperative period
measure: Quality of Life of patients and spouses
timeFrame: postoperative 15th month
measure: Disability of patients and spouses
timeFrame: In the preoperative period
measure: Disability of patients and spouses
timeFrame: postoperative 15th month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ankara University School of Medicine Departmernt of General Surgery
name: cihangir Akyol
role: STUDY_DIRECTOR
References: