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.
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 Type
OBSERVATIONAL
Enrollment
1,500
Scandinavian Surgical Outcomes Research Group, SSORG, Göteborg
Gothenburg, Sweden
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
Time frame: At diagnosis
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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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
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
Time frame: At diagnosis
To explore the presence and impact of intrusive thoughts on QoL
May be analyzed both at 24 and 60 months as well
Time frame: At 12 months
QoL in an unselected population of rectal cancer patients
Time frame: at 12 months