Rectal CancerQoLiRECTNCT01477229
Quality of Life in RECTal Cancer - a Prospective Multicenter Cohort Study
An observational study of Rectal Cancer and Quality of Life, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
Rectal cancer is a common type of cancer occuring more frequently in men but also common in women. Almost 60% of the patients survive 5-years and the treatment has been continuously developed in the last three decades. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Quality of Life, Surgery
- How many people
- 1,500 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2012to Dec 2025
- 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: All patients presenting at the participating hospitals (both University Hospitals and Community Hospitals) with newly diagnosed rectal cancer, regardless of stage at diagnosis and plans for treatment, will be eligible for inclusion.
Who may be able to join
- All patients presenting at the participating hospitals with newly diagnosed rectal cancer, regardless of stage at diagnosis and plans for treatment, will be eligible for inclusion.
Who cannot join
- Age below 18 years at diagnosis.
- No informed consent received or withdrawal of informed consent.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Scandinavian Surgical Outcomes Research Group, SSORG, Göteborg
Gothenburg, 416 85
About this study
Official title: Quality of Life in RECTal Cancer - A Study Within the Scandinavian Surgical Outcomes Research Group
Rectal cancer is a common type of cancer occuring more frequently in men but also common in women. Almost 60% of the patients survive 5-years and the treatment has been continuously developed in the last three decades. The aim of the QoLiRECT study is to increase the knowledge about symptoms, functional impairments, quality of life (QoL) and psychological and socioeconomic burden in an unselected population of rectal cancer patients.
Read the detailed description
Rectal cancer is more frequent in men than in women and is relatively uncommon before the age of 50. The prognosis for rectal cancer has improved over the last decades2. Almost 60% of all patients survive more than five years, and because of advances in early detection and treatment, this number is expected to increase in the future1. Treatment of rectal cancer varies depending on the stage of the disease at diagnosis. For some patients, operation is the only treatment. For others, surgery is combined with radiotherapy, chemotherapy or both. The two most common operative procedures are the sphincter-preserving anterior resection (AR) and the abdominoperineal resection (APR) - the latter results in a permanent colostomy. Patients with generalised disease at diagnosis receive palliative treatment, which may include chemotherapy and radiotherapy as well as surgery.
Rectal cancer comes with a high risk of local recurrence, i.e. return of the tumour within the pelvis after a presumed curative resection. Local recurrence is difficult to treat and often very painful and distressing for the patient. Some local recurrences will be candidates for second line surgery, as is also true for some distant metastases.
The aim of the QoLiRECT study is to increase the knowledge about symptoms, functional impairments, quality of life (QoL) and psychological and socioeconomic burden in an unselected population of rectal cancer patients. Symptoms such as incontinence, pain, fatigue and impaired sexual function3 are common with this disease. Bodily changes, caused by the treatment or the disease itself, may lead to functional impairments and psychological, social, emotional and economical restraints. Conventional outcome measures such as morbidity and survival reveal little about these things.
- Conditions
- Rectal Cancer, Quality of Life, Surgery
- Keywords
- Rectal cancer, Quality of Life, Abdominoperineal Resection, Anterior Resection, Palliative cancer treatment, Radio chemotherapy
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Abdominoperineal resection | Patients with low rectal cancers | |
| Anterior resection | Patients where it is possible to perform an anterior resection | |
| Preoperative chemo-radiation treatment | Patients with locally advanced rectal cancer | |
| Palliative treatment | Patients with systemic disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
To describe QoL, symptoms and functional impairments in an unselected population of rectal cancer patients
It will be evaluated at diagnosis, , i.e. at presentation of a plan for the treatment, at 12 months after start of the treatment, regardless of which, at 24 months after start of the treatment and at 60 months after start of the treatment
Measured: At diagnosis
Secondary outcomes (9)
To explore potential differences in QoL, symptoms and functional impairments between subgroups of the population
and at 12 months, 36 months and 60 monts after diagnosis
Measured: At diagnosis
To identify symptoms and functional impairments and other risk factors that have great impact on QoL
will also be assessed at 12 months after start of the treatment, regardless of which, at 24 months after start of the treatment and at 60 months after start of the treatment
Measured: At diagnosis
To identify patient and environmental factors with an impact on QoL
and at 12 months after start of the treatment, regardless of which, at 24 months after start of the treatment and at 60 months after start of the treatment
Measured: At diagnosis
To analyse how clinical factors like oncologic result of operation, morbidity, recurrence and survival influence QoL
This will be analyzed regardless of which, at 24 months after start of the treatment and at 60 months after start of the treatment
Measured: At 12 months after start of the treatment
To initiate interventional studies when appropriate
May be another time frame than the one registered. Depends on results from the QoL questionnaire
Measured: 12 months
To generate basic descriptive data of the rectal cancer patient population: demography, socioeconomic data, disease stage at diagnosis, fashion of treatment, recurrence, survival
Measured: At diagnosis
To analyse health economy aspects of QoL and morbidity in the patient population
and at 12 months after start of the treatment, regardless of which, at 24 months after start of the treatment and at 60 months after start of the treatment
Measured: At diagnosis
To explore the presence and impact of intrusive thoughts on QoL
May be analyzed both at 24 and 60 months as well
Measured: At 12 months
QoL in an unselected population of rectal cancer patients
Measured: at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startFeb 2012
- Primary completionSep 2015
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- 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
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Cancer Foundation, The Swedish Society of Medicine, Assar Gabrielsson Foundation
- Responsible party
- Principal investigator, Eva Angenete, Sahlgrenska University Hospital
- Investigators
- Eva Angenete, M.D., Ph.D., Principal investigator, SSORG - Scandinavian Surgical Outcomes Research Group and Sahlgrenska University Hospital in collaboration with Sahlgrenska Academy at University of Gothenburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01477229
- Sponsor's protocol ID
- QoLiRECT
- Acronym
- QoLiRECT
- Status last verified
- Dec 2023
- First submitted
- 15 Nov 2011
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Bjorklund Sand L, Larsson C, Gronkvist R, Haglind E, Angenete E. Persistent Sitting and Walking Difficulties After Abdominoperineal Excision and Anterior Resection: Results From the Quality of Life in Rectal Cancer Study. Dis Colon Rectum. 2025 Jun 1;68(6):704-712. doi: 10.1097/DCR.0000000000003710. Epub 2025 Mar 14.
PubMed 40085057Ehrencrona C, Li Y, Angenete E, Haglind E, Franzen S, Grimby-Ekman A, Bock D. Do beta-blockers reduce negative intrusive thoughts and anxiety in cancer survivors? - An emulated trial. BMC Cancer. 2024 Apr 11;24(1):447. doi: 10.1186/s12885-024-12236-3.
PubMed 38605350Asplund D, Heath J, Gonzalez E, Ekelund J, Rosenberg J, Haglind E, Angenete E. Self-reported quality of life and functional outcome in patients with rectal cancer--QoLiRECT. Dan Med J. 2014 May;61(5):A4841.
PubMed 24814743
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life in RECTal Cancer - A Study Within the Scandinavian Surgical Outcomes Research Group
- ClinicalTrials.gov ID
- NCT01477229
- Acronym / sponsor ID
- QoLiRECT / QoLiRECT
- Conditions
- Rectal Cancer, Quality of Life, Surgery
- Keywords
- Rectal cancer, Quality of Life, Abdominoperineal Resection, Anterior Resection, Palliative cancer treatment, Radio chemotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Collaborators
- Swedish Cancer Foundation, The Swedish Society of Medicine, Assar Gabrielsson Foundation
- Study start
- Feb 2012 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 22 Nov 2011 (estimated)
- 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.
Rectal cancer is a common type of cancer occuring more frequently in men but also common in women. Almost 60% of the patients survive 5-years and the treatment has been continuously developed in the last three decades. The aim of the QoLiRECT study is to increase the knowledge about symptoms, functional impairments, quality of life (QoL) and psychological and socioeconomic burden in an unselected population of rectal cancer patients.
Detailed description
Rectal cancer is more frequent in men than in women and is relatively uncommon before the age of 50. The prognosis for rectal cancer has improved over the last decades2. Almost 60% of all patients survive more than five years, and because of advances in early detection and treatment, this number is expected to increase in the future1. Treatment of rectal cancer varies depending on the stage of the disease at diagnosis. For some patients, operation is the only treatment. For others, surgery is combined with radiotherapy, chemotherapy or both. The two most common operative procedures are the sphincter-preserving anterior resection (AR) and the abdominoperineal resection (APR) - the latter results in a permanent colostomy. Patients with generalised disease at diagnosis receive palliative treatment, which may include chemotherapy and radiotherapy as well as surgery.
Rectal cancer comes with a high risk of local recurrence, i.e. return of the tumour within the pelvis after a presumed curative resection. Local recurrence is difficult to treat and often very painful and distressing for the patient. Some local recurrences will be candidates for second line surgery, as is also true for some distant metastases.
The aim of the QoLiRECT study is to increase the knowledge about symptoms, functional impairments, quality of life (QoL) and psychological and socioeconomic burden in an unselected population of rectal cancer patients. Symptoms such as incontinence, pain, fatigue and impaired sexual function3 are common with this disease. Bodily changes, caused by the treatment or the disease itself, may lead to functional impairments and psychological, social, emotional and economical restraints. Conventional outcome measures such as morbidity and survival reveal little about these things.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Abdominoperineal resection | – | –Patients with low rectal cancers |
| Anterior resection | – | –Patients where it is possible to perform an anterior resection |
| Preoperative chemo-radiation treatment | – | –Patients with locally advanced rectal cancer |
| Palliative treatment | – | –Patients with systemic disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients presenting at the participating hospitals (both University Hospitals and Community Hospitals) with newly diagnosed rectal cancer, regardless of stage at diagnosis and plans for treatment, will be eligible for inclusion.
Key inclusion criteria (1 listed)
- All patients presenting at the participating hospitals with newly diagnosed rectal cancer, regardless of stage at diagnosis and plans for treatment, will be eligible for inclusion.
Key exclusion criteria (2 listed)
- Age below 18 years at diagnosis.
- No informed consent received or withdrawal of informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To describe QoL, symptoms and functional impairments in an unselected population of rectal cancer patients
Time frame: At diagnosis
It will be evaluated at diagnosis, , i.e. at presentation of a plan for the treatment, at 12 months after start of the treatment, regardless of which, at 24 months after start of the treatment and at 60 months after start of the treatment
9 secondary outcomes
To explore potential differences in QoL, symptoms and functional impairments between subgroups of the population
Time frame: At diagnosis
To identify symptoms and functional impairments and other risk factors that have great impact on QoL
Time frame: At diagnosis
To identify patient and environmental factors with an impact on QoL
Time frame: At diagnosis
To analyse how clinical factors like oncologic result of operation, morbidity, recurrence and survival influence QoL
Time frame: At 12 months after start of the treatment
To initiate interventional studies when appropriate
Time frame: 12 months
To generate basic descriptive data of the rectal cancer patient population: demography, socioeconomic data, disease stage at diagnosis, fashion of treatment, recurrence, survival
Time frame: At diagnosis
To analyse health economy aspects of QoL and morbidity in the patient population
Time frame: At diagnosis
To explore the presence and impact of intrusive thoughts on QoL
Time frame: At 12 months
QoL in an unselected population of rectal cancer patients
Time frame: at 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Derived from this study: PubMed 40085057Bjorklund Sand L, Larsson C, Gronkvist R, Haglind E, Angenete E. Persistent Sitting and Walking Difficulties After Abdominoperineal Excision and Anterior Resection: Results From the Quality of Life in Rectal Cancer Study. Dis Colon Rectum. 2025 Jun 1;68(6):704-712. doi: 10.1097/DCR.0000000000003710. Epub 2025 Mar 14.
- Derived from this study: PubMed 38605350Ehrencrona C, Li Y, Angenete E, Haglind E, Franzen S, Grimby-Ekman A, Bock D. Do beta-blockers reduce negative intrusive thoughts and anxiety in cancer survivors? - An emulated trial. BMC Cancer. 2024 Apr 11;24(1):447. doi: 10.1186/s12885-024-12236-3.
- Derived from this study: PubMed 24814743Asplund D, Heath J, Gonzalez E, Ekelund J, Rosenberg J, Haglind E, Angenete E. Self-reported quality of life and functional outcome in patients with rectal cancer--QoLiRECT. Dan Med J. 2014 May;61(5):A4841.
- Study informationLink provided by the sponsor.
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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.
Eva Angenete, M.D., Ph.D. principal investigator
SSORG - Scandinavian Surgical Outcomes Research Group and Sahlgrenska University Hospital in collaboration with Sahlgrenska Academy at University of Gothenburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer and Quality of Life, run by Sahlgrenska University Hospital at 1 site in Sweden.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
To describe QoL, symptoms and functional impairments in an unselected population of rectal cancer patients (time frame: At diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01477229, which also lists 3 linked publications.
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 8 Dec 2023.