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

S

Sahlgrenska University Hospital

Status

Active, not recruiting

Conditions

Quality of Life
Surgery
Rectal Cancer

Study type

Observational

Funder types

Other

Identifiers

NCT01477229
QoLiRECT

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

1,500 participants in 4 patient groups

Abdominoperineal resection
Description:
Patients with low rectal cancers
Anterior resection
Description:
Patients where it is possible to perform an anterior resection
Preoperative chemo-radiation treatment
Description:
Patients with locally advanced rectal cancer
Palliative treatment
Description:
Patients with systemic disease

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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