QoL of Colorectal Cancer Patients and Spouses

NCT04744792 | Completed

• 1 other identifier: U1111-1264-6381
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Quality of Life; Stoma Ileostomy; Stoma Colostomy; Rectum Cancer; Sigmoid Cancer

Keywords

Quality of Life, SF - 36, Rectal cancer, spouse

Outcome Measures

Primary Outcomes (4)

• Quality of Life of patients and spouses

  Medical outcomes: 36-item short form health survey (SF-36) The SF-36 was used as a measure of health-related QoL because it is an internationally recognized global measure. It comprises 36 items that measure perceived health on eight scales (i.e., physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role, and mental health) with higher scores (range 0-100) reflecting better perceived health. Additionally, two summary scores can be obtained: the physical component summary score (PCS) and the mental component summary score (MCS).

  In the preoperative period

• Quality of Life of patients and spouses

  Medical outcomes: 36-item short form health survey (SF-36) The SF-36 was used as a measure of health-related QoL because it is an internationally recognized global measure. It comprises 36 items that measure perceived health on eight scales (i.e., physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role, and mental health) with higher scores (range 0-100) reflecting better perceived health. Additionally, two summary scores can be obtained: the physical component summary score (PCS) and the mental component summary score (MCS).

  postoperative 15th month

• Disability of patients and spouses

  The World Health Organization disability assessment schedule II (WHODAS-II) The WHODAS-II is an instrument developed by the World Health Organization to assess behavioral limitations and restrictions regarding participation in specific activity domains experienced by an individual independent of their medical diagnosis. The conceptual frame of reference of this instrument is the International Classification of Functioning, Disability, and Health (ICF). Specifically, the instrument is a 36-item, generic, multidimensional questionnaire designed to evaluate the functioning of the individual in six activity domains (i.e., understanding and communicating, getting around, self-care, getting along with people, life activities, and participation in society).

  In the preoperative period

• Disability of patients and spouses

  The World Health Organization disability assessment schedule II (WHODAS-II) The WHODAS-II is an instrument developed by the World Health Organization to assess behavioral limitations and restrictions regarding participation in specific activity domains experienced by an individual independent of their medical diagnosis. The conceptual frame of reference of this instrument is the International Classification of Functioning, Disability, and Health (ICF). Specifically, the instrument is a 36-item, generic, multidimensional questionnaire designed to evaluate the functioning of the individual in six activity domains (i.e., understanding and communicating, getting around, self-care, getting along with people, life activities, and participation in society).

  postoperative 15th month

Study Arms (2)

Patients

All the patients who underwent anterior resection, low anterior resection and abdominoperineal resection between march 2006 and novenmer 2010

Other: Short Form - 36; Other: WHODAS-II

Spouses

Spouses of the patients who underwent anterior resection, low anterior resection and abdominoperineal resection between march 2006 and novenmer 2010

Other: Short Form - 36; Other: WHODAS-II

Interventions

Short Form - 36 OTHER

Medical outcomes: 36-item short form health survey (SF-36) The SF-36 was used as a measure of health-related QoL because it is an internationally recognized global measure. It comprises 36 items that measure perceived health on eight scales (i.e., physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role, and mental health) with higher scores (range 0-100) reflecting better perceived health. Additionally, two summary scores can be obtained: the physical component summary score (PCS) and the mental component summary score (MCS). In addition, this tool has been validated in Turkish patients

Patients; Spouses

WHODAS-II OTHER

The World Health Organization disability assessment schedule II (WHODAS-II) The WHODAS-II is an instrument developed by the World Health Organization to assess behavioral limitations and restrictions regarding participation in specific activity domains experienced by an individual independent of their medical diagnosis. The conceptual frame of reference of this instrument is the International Classification of Functioning, Disability, and Health (ICF). Specifically, the instrument is a 36-item, generic, multidimensional questionnaire designed to evaluate the functioning of the individual in six activity domains (i.e., understanding and communicating, getting around, self-care, getting along with people, life activities, and participation in society). This questionnaire has been validated in Turkish patients.

Patients; Spouses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• curative surgery for colorectal adenocarcinoma
• living with a spouse
• aged over 18 years
• Muslim faith.

You may not qualify if:

• \) 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

Sponsors & Collaborators

• Cihangir Akyol: lead

MeSH Terms

Conditions

Rectal Neoplasms; Sigmoid Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Colonic Neoplasms; Colonic Diseases; Sigmoid Diseases

Study Officials

• cihangir Akyol

  Ankara University School of Medicine Departmernt of General Surgery

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Proffessor

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: February 9, 2021
• Study Start: March 1, 2006
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: February 9, 2021

Record last verified: 2021-02