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QoLiCOL - Quality of Life in Colon Cancer (QoLiCOL)

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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

Tracking Information
First Submitted Date August 19, 2015
First Posted Date August 21, 2015
Last Update Posted Date April 4, 2019
Study Start Date June 2015
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 20, 2015)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02530593 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 20, 2015)
  • 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 ]
  • Compare differences in QoL between patients with different tumour levels [ Time Frame: 3 years ]
  • Detect differences in QoL in patients over time after colon cancer treatment [ Time Frame: 3 years ]
  • Evaluate the effect of complications after colon cancer surgery on the patients socioeconomic situation [ Time Frame: 3 years ]
  • Evaluate the effect of coping strategies on QoL after initiated treatment [ Time Frame: 3 years ]
  • Describe patient expectations at diagnosis of colon cancer [ Time Frame: 3 years ]
  • Identify differences in QoL between patients in different groups regarding gender, age and education level [ Time Frame: 3 years ]
  • Analyse how clinical factors like oncologic result of operation, morbidity, recurrence and survival influence QoL [ Time Frame: 3 years ]
  • Identify areas of improvement in treatment and patient care [ Time Frame: 3 years ]
  • Enable initiation interventional studies when appropriate [ Time Frame: 3 years ]
  • Analyse health economy aspects of QoL and morbidity in the patient population [ Time Frame: 3 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title QoLiCOL - Quality of Life in Colon Cancer
Official Title QoLiCOL - Quality of Life in Colon Cancer
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)
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with colon cancer prior to treatment initiation.
Condition Colonic Neoplasm
Intervention Behavioral: There is no intervention, only observation
Study Groups/Cohorts Patients with colon cancer
All patients presenting with a newly diagnosed colon cancer regardless of tumour stage
Intervention: Behavioral: There is no intervention, only observation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 20, 2015)
1500
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Eva Angenete, M.D., Ph.D. +46313438410 eva.angenete@vgregion.se
Listed Location Countries Sweden
Removed Location Countries  
 
Administrative Information
NCT Number NCT02530593
Other Study ID Numbers QoLiCOL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Eva Angenete, Sahlgrenska University Hospital, Sweden
Study Sponsor Sahlgrenska University Hospital, Sweden
Collaborators Not Provided
Investigators
Principal Investigator: Eva Angenete, M.D., Ph.D. SSORG
PRS Account Sahlgrenska University Hospital, Sweden
Verification Date April 2019