Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

QoLiCOL - Quality of Life in Colon Cancer (QoLiCOL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02530593
Recruitment Status : Recruiting
First Posted : August 21, 2015
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Eva Angenete, Sahlgrenska University Hospital, Sweden

Brief Summary:
All patients presenting at participating hospitals during the recruitment period with a newly diagnosed colon cancer, regardless of stage and planned treatment, will be eligible for inclusion. They will answer a questionnaire on health related quality of life, physical symptoms, functional impairments and socioeconomic status at diagnosis and after 12, 36 months. Clinical data including recurrence, survival, surgical treatment, oncologic result (pathology report) and adjuvant treatment will be collected from the Swedish ColoRectal Cancer Registry (SCRCR)

Condition or disease Intervention/treatment
Colonic Neoplasm Behavioral: There is no intervention, only observation

Detailed Description:
QoLiCOL is an explorative, prospective, longitudinal, non-interventional, international, multicenter study of health-related quality of life, physical symptoms, functional impairments and socioeconomic burden in colon cancer patients. All patients presenting at participating hospitals during the recruitment period with a newly diagnosed rectal cancer, regardless of stage and planned treatment, will be eligible for inclusion. Patients will be followed for 3 years. They will be asked to answer questionnaires at three different time points during follow-up: at diagnosis and after 12 and 36 months. Clinical data, including recurrence, surgical treatment, oncologic result (pathology report) and adjuvant treatment will be collected from the national quality registry for rectal cancer in Denmark and Sweden. As these registries differ in some areas between the countries, additional data will be collected through short CRF:s.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: QoLiCOL - Quality of Life in Colon Cancer
Study Start Date : June 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Group/Cohort Intervention/treatment
Patients with colon cancer
All patients presenting with a newly diagnosed colon cancer regardless of tumour stage
Behavioral: There is no intervention, only observation



Primary Outcome Measures :
  1. QoL in colon cancer patients [ Time Frame: 3 years ]
    The primary end-point is to describe QoL, symptoms and functional impairments in an unselected population of colon cancer patients


Secondary Outcome Measures :
  1. Generate basic descriptive data of the patient population, such as demography, socioeconomic data, disease stage at diagnosis, type of treatment, recurrence and survival [ Time Frame: 3 years ]
  2. Compare differences in QoL between patients with different tumour levels [ Time Frame: 3 years ]
  3. Detect differences in QoL in patients over time after colon cancer treatment [ Time Frame: 3 years ]
  4. Evaluate the effect of complications after colon cancer surgery on the patients socioeconomic situation [ Time Frame: 3 years ]
  5. Evaluate the effect of coping strategies on QoL after initiated treatment [ Time Frame: 3 years ]
  6. Describe patient expectations at diagnosis of colon cancer [ Time Frame: 3 years ]
  7. Identify differences in QoL between patients in different groups regarding gender, age and education level [ Time Frame: 3 years ]
  8. Analyse how clinical factors like oncologic result of operation, morbidity, recurrence and survival influence QoL [ Time Frame: 3 years ]
  9. Identify areas of improvement in treatment and patient care [ Time Frame: 3 years ]
  10. Enable initiation interventional studies when appropriate [ Time Frame: 3 years ]
  11. Analyse health economy aspects of QoL and morbidity in the patient population [ Time Frame: 3 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with colon cancer prior to treatment initiation.
Criteria

Inclusion Criteria:

  • Colon cancer newly diagnosed.
  • Planned treatment presented

Exclusion Criteria:

  • No Colon cancer diagnosis,
  • below 18 years of age,
  • no informed consent or withdrawn informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02530593


Contacts
Layout table for location contacts
Contact: Eva Angenete, M.D., Ph.D. +46313438410 eva.angenete@vgregion.se

Locations
Layout table for location information
Sweden
Sahlgrenska University Hospital/Östra Recruiting
Göteborg, Sweden, 416 85
Contact: Eva Angenete, M.D., Ph.D.    +46.31.3438410    eva.angenete@vgregion.se   
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Investigators
Layout table for investigator information
Principal Investigator: Eva Angenete, M.D., Ph.D. SSORG

Layout table for additonal information
Responsible Party: Eva Angenete, Principal Investigator, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT02530593     History of Changes
Other Study ID Numbers: QoLiCOL
First Posted: August 21, 2015    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Layout table for MeSH terms
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases