Trial record 2 of 341 for:    Open Studies | neoplasms "quality of life"

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

This study is currently recruiting participants.
Verified December 2013 by Sahlgrenska University Hospital, Sweden
Sponsor:
Collaborators:
Swedish Cancer Foundation
The Swedish Society of Medicine
Assar Gabrielsson Foundation
The Gothenburg Medical Society
Information provided by (Responsible Party):
Eva Angenete, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier:
NCT01477229
First received: November 15, 2011
Last updated: December 12, 2013
Last verified: December 2013
  Purpose

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.


Condition
Rectal Cancer
Quality of Life
Surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quality of Life in RECTal Cancer - A Study Within the Scandinavian Surgical Outcomes Research Group

Resource links provided by NLM:


Further study details as provided by Sahlgrenska University Hospital, Sweden:

Primary Outcome Measures:
  • To describe QoL, symptoms and functional impairments in an unselected population of rectal cancer patients [ Time Frame: At diagnosis ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • To explore potential differences in QoL, symptoms and functional impairments between subgroups of the population [ Time Frame: At diagnosis ] [ Designated as safety issue: No ]
    and at 12 months, 36 months and 60 monts after diagnosis

  • To identify symptoms and functional impairments and other risk factors that have great impact on QoL [ Time Frame: At diagnosis ] [ Designated as safety issue: No ]
    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

  • To identify patient and environmental factors with an impact on QoL [ Time Frame: At diagnosis ] [ Designated as safety issue: No ]
    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

  • To analyse how clinical factors like oncologic result of operation, morbidity, recurrence and survival influence QoL [ Time Frame: At 12 months after start of the treatment ] [ Designated as safety issue: No ]
    This will be analyzed regardless of which, at 24 months after start of the treatment and at 60 months after start of the treatment

  • To initiate interventional studies when appropriate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    May be another time frame than the one registered. Depends on results from the QoL questionnaire

  • To generate basic descriptive data of the rectal cancer patient population: demography, socioeconomic data, disease stage at diagnosis, fashion of treatment, recurrence, survival [ Time Frame: At diagnosis ] [ Designated as safety issue: No ]
  • To analyse health economy aspects of QoL and morbidity in the patient population [ Time Frame: At diagnosis ] [ Designated as safety issue: No ]
    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

  • To explore the presence and impact of intrusive thoughts on QoL [ Time Frame: At 12 months ] [ Designated as safety issue: No ]
    May be analyzed both at 24 and 60 months as well

  • QoL in an unselected population of rectal cancer patients [ Time Frame: at 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1500
Study Start Date: February 2012
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01477229

Contacts
Contact: Dan Asplund, M.D. +46-31-3434000 dan.asplund@vgregion.se
Contact: Elisabeth Gonzaléz, R.N. +46-31-3434000 elisabeth.gonzales@vgregion.se

Locations
Sweden
Scandinavian Surgical Outcomes Research Group, SSORG, Göteborg Recruiting
Gothenburg, Sweden, 416 85
Contact: Elisabeth Gonzaléz, R.N.    +46-31-3434000    elisabeth.gonzales@vgregion.se   
Sub-Investigator: Dan Asplund, M.D.         
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Swedish Cancer Foundation
The Swedish Society of Medicine
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
  More Information

Additional Information:
No publications provided

Responsible Party: Eva Angenete, M.D., Ph.D, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT01477229     History of Changes
Other Study ID Numbers: QoLiRECT
Study First Received: November 15, 2011
Last Updated: December 12, 2013
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Sahlgrenska University Hospital, Sweden:
Rectal cancer
Quality of Life
Abdominoperineal Resection
Anterior Resection
Palliative cancer treatment
Radio chemotherapy

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on April 22, 2014