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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Quality of Life; Rectal Cancer; Surgery

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.

• Study Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden, 416 85
    • Scandinavian Surgical Outcomes Research Group, SSORG, Göteborg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sahlgrenska University Hospital, Sweden
• Collaborators: The Swedish Society of Medicine; Swedish Cancer Foundation; Assar Gabrielsson Foundation; The Gothenburg Medical Society
• Investigators: Principal Investigator: Eva Angenete, M.D., Ph.D., SSORG - Scandinavian Surgical Outcomes Research Group and Sahlgrenska University Hospital in collaboration with Sahlgrenska Academy at University of Gothenburg

Publications and helpful links

General Publications

• 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.

Helpful Links

• Study information

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2012
• Primary Completion (Actual): September 1, 2015
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: November 15, 2011
• First Submitted That Met QC Criteria: November 18, 2011
• First Posted (Estimated): November 22, 2011

Study Record Updates

• Last Update Posted (Actual): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Quality of Life; Rectal cancer; Anterior Resection; Radio chemotherapy; Abdominoperineal Resection; Palliative cancer treatment
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: QoLiRECT