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


N/A
18 Years
N/A
Open (Enrolling)
Both
Rectal Cancer, Quality of Life, Surgery

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Trial Information

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


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

To describe QoL, symptoms and functional impairments in an unselected population of rectal cancer patients

Outcome Description:

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

Outcome Time Frame:

At diagnosis

Safety Issue:

Yes

Principal Investigator

Eva Angenete, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

SSORG - Scandinavian Surgical Outcomes Research Group and Sahlgrenska University Hospital in collaboration with Sahlgrenska Academy at University of Gothenburg

Authority:

Sweden: Regional Ethical Review Board

Study ID:

QoLiRECT

NCT ID:

NCT01477229

Start Date:

February 2012

Completion Date:

December 2017

Related Keywords:

  • Rectal Cancer
  • Quality of Life
  • Surgery
  • Rectal cancer
  • Quality of Life
  • Abdominoperineal Resection
  • Anterior Resection
  • Palliative cancer treatment
  • Radio chemotherapy
  • Rectal Neoplasms

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