Quality of LifeNCT04744792
QoL of Colorectal Cancer Patients and Spouses
An observational study of Quality of Life and Stoma Ileostomy, run by Cihangir Akyol.
Trial 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 =… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life, Stoma Ileostomy, Stoma Colostomy
- What is being tested?
- Short Form - 36 and WHODAS-II
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2006to 1 Nov 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- curative surgery for colorectal adenocarcinoma
- living with a spouse
- aged over 18 years
- Muslim faith.
Who cannot join
- 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
About this study
Official title: Quality of Life After Colorectal Surgery: A Prospective Study of Patients Compared With Their Spouses
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.
Read the 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.
- Conditions
- Quality of Life, Stoma Ileostomy, Stoma Colostomy, Rectum Cancer, Sigmoid Cancer
- Being tested
- Short Form - 36, WHODAS-II
- Keywords
- Quality of Life, SF - 36, Rectal cancer, spouse
- Medical subject headings
- Rectal Neoplasms, Sigmoid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short Form - 36Other
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
WHODAS-IIOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients | All the patients who underwent anterior resection, low anterior resection and abdominoperineal resection between march 2006 and novenmer 2010 Receives: 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 Receives: Other: Short Form - 36; Other: WHODAS-II |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: postoperative 15th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start1 Mar 2006
- Primary completion1 Nov 2010
- Study completion1 Nov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cihangir Akyol
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cihangir Akyol, Ankara University
- Investigators
- cihangir Akyol, Study director, Ankara University School of Medicine Departmernt of General Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04744792
- Sponsor's protocol ID
- U1111-1264-6381
- Status last verified
- Feb 2021
- First submitted
- 4 Feb 2021
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life After Colorectal Surgery: A Prospective Study of Patients Compared With Their Spouses
- ClinicalTrials.gov ID
- NCT04744792
- Acronym / sponsor ID
- U1111-1264-6381
- Conditions
- Quality of Life, Stoma Ileostomy, Stoma Colostomy, Rectum Cancer, Sigmoid Cancer
- Keywords
- Quality of Life, SF - 36, Rectal cancer, spouse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Cihangir AkyolUniversity, hospital or other
- Study start
- 1 Mar 2006 (actual)
- Primary completion
- 1 Nov 2010 (actual)
- Study completion
- 1 Nov 2010 (actual)
- First posted
- 9 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Short Form - 36, Other: WHODAS-IIAll the patients who underwent anterior resection, low anterior resection and abdominoperineal resection between march 2006 and novenmer 2010 |
| Spouses | – | Other: Short Form - 36, Other: WHODAS-IISpouses of the patients who underwent anterior resection, low anterior resection and abdominoperineal resection between march 2006 and novenmer 2010 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- curative surgery for colorectal adenocarcinoma
- living with a spouse
- aged over 18 years
- Muslim faith.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short Form - 36Medical 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 | Other | Patients, Spouses |
| WHODAS-IIThe 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. | Other | Patients, Spouses |
Primary outcome
Quality of Life of patients and spouses
Time frame: In the preoperative period
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).
Quality of Life of patients and spouses
Time frame: postoperative 15th month
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).
Disability of patients and spouses
Time frame: In the preoperative period
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).
Disability of patients and spouses
Time frame: postoperative 15th month
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
cihangir Akyol study director
Ankara University School of Medicine Departmernt of General Surgery
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life and Stoma Ileostomy, run by Cihangir Akyol.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life of patients and spouses (time frame: In the preoperative period). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021.