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

Quality of Life Clinical Trial

— QoLiRECT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01477229
• Other study ID #: QoLiRECT
• Status: Active, not recruiting
• Start date: February 2012
• Est. completion date: December 2025

Study information

• Verified date: December 2023
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1500
• Est. completion date: December 2025
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Quality of Life
• Rectal Cancer
• Rectal Neoplasms
• Surgery

Locations

Country	Name	City	State
Sweden	Scandinavian Surgical Outcomes Research Group, SSORG, Göteborg	Gothenburg

Sponsors (5)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden	Assar Gabrielsson Foundation, Swedish Cancer Foundation, The Gothenburg Medical Society, The Swedish Society of Medicine

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	To initiate interventional studies when appropriate	May be another time frame than the one registered. Depends on results from the QoL questionnaire	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	QoL in an unselected population of rectal cancer patients		at 12 months