Clinical trial NCT01477229: Quality of Life in RECTal Cancer - a Prospective Multicenter Cohort Study
Official title: Quality of Life in RECTal Cancer - A Study Within the Scandinavian Surgical Outcomes Research Group
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Rectal Cancer
Quality of Life
Surgery
Keywords: Rectal cancer
Quality of Life
Abdominoperineal Resection
Anterior Resection
Palliative cancer treatment
Radio chemotherapy
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
Collaborators: name: Swedish Cancer Foundation
name: The Swedish Society of Medicine
name: Assar Gabrielsson Foundation
First posted: 2011-11-22
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: To describe QoL, symptoms and functional impairments in an unselected population of rectal cancer patients
timeFrame: At diagnosis
Secondary outcomes:
measure: To explore potential differences in QoL, symptoms and functional impairments between subgroups of the population
timeFrame: At diagnosis
measure: To identify symptoms and functional impairments and other risk factors that have great impact on QoL
timeFrame: At diagnosis
measure: To identify patient and environmental factors with an impact on QoL
timeFrame: At diagnosis
measure: To analyse how clinical factors like oncologic result of operation, morbidity, recurrence and survival influence QoL
timeFrame: At 12 months after start of the treatment
measure: To initiate interventional studies when appropriate
timeFrame: 12 months
measure: To generate basic descriptive data of the rectal cancer patient population: demography, socioeconomic data, disease stage at diagnosis, fashion of treatment, recurrence, survival
timeFrame: At diagnosis
measure: To analyse health economy aspects of QoL and morbidity in the patient population
timeFrame: At diagnosis
measure: To explore the presence and impact of intrusive thoughts on QoL
timeFrame: At 12 months
measure: QoL in an unselected population of rectal cancer patients
timeFrame: at 12 months
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Scandinavian Surgical Outcomes Research Group, SSORG, Göteborg
Study officials:
affiliation: SSORG - Scandinavian Surgical Outcomes Research Group and Sahlgrenska University Hospital in collaboration with Sahlgrenska Academy at University of Gothenburg
name: Eva Angenete, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Asplund 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.