Quality of Life in RECTal Cancer - a Prospective Multicenter Cohort Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Quality of Life in RECTal Cancer - A Study Within the Scandinavian Surgical Outcomes Research Group

Conditions
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Rectal Cancer, Quality of Life, Surgery

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Age below 18 years at diagnosis. No informed consent received or withdrawal of informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Abdominoperineal resection<br>Patients with low rectal cancers | |
| Anterior resection<br>Patients where it is possible to perform an anterior resection | |
| Preoperative chemo-radiation treatment<br>Patients with locally advanced rectal cancer | |
| Palliative treatment<br>Patients with systemic disease | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | At diagnosis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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 | 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 |  | 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 | At diagnosis | 
| To explore the presence and impact of intrusive thoughts on QoL | May be analyzed both at 24 and 60 months as well | At 12 months | 
| QoL in an unselected population of rectal cancer patients |  | at 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rectal cancer, Quality of Life, Abdominoperineal Resection, Anterior Resection, Palliative cancer treatment, Radio chemotherapy