NCT02321813

Brief Summary

The purpose of the study is to determine whether a quality of life pathway with defined diagnostic and therapeutic options improves quality of life in colorectal cancer patients during follow-up.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable quality-of-life

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable quality-of-life

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 22, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

September 25, 2017

Status Verified

September 1, 2017

Enrollment Period

2.8 years

First QC Date

December 11, 2014

Last Update Submit

September 21, 2017

Conditions

Quality of LifeColorectal Neoplasms

Keywords

quality of lifecolorectal cancerdefinitive RCTcomplex intervention

Outcome Measures

Primary Outcomes (1)

  • proportion of patients in both groups with diseased quality of life (<50 points in at least one dimension)

    1 year after the date of primary surgery for colorectal cancer

Secondary Outcomes (1)

  • rates of patients with diseased quality of life in each dimension of the profile

    0 (0-2 days before clinical discharge), 3, 6, 12, and 18 months after primary surgery for colorectal cancer

Study Arms (2)

intervention group

EXPERIMENTAL

In the quality of life pathway results of the quality of life (QoL) measure are transferred to a QoL-profile. Three experts with various professional background use the individual patient's QoL-profile and clinical and sociodemographic information in order to generate a QoL-report including therapy recommendation which is sent to the coordinating practitioner. Specific therapeutic options for the treatment of diseased QoL have been identified: pain therapy, psychotherapy, social support, nutrition counseling, stoma care, physiotherapy, fitness. To provide continuous medical education, quality circles for each therapy option haven been founded. Coordinating practitioners receive a list with addresses of all quality circle members.

Behavioral: quality of life pathway

control group

PLACEBO COMPARATOR

In control group QoL is also measured but the coordinating practitioner neither receives a QoL-profile nor a QoL-report.

Other: placebo control

Interventions

quality of life pathwayBEHAVIORAL

Quality of life measurement, diagnosis and tailored therapy (pain therapy, psychotherapy, social support, nutrition, stoma care, physiotherapy, fitness)

intervention group
placebo controlOTHER

Quality of life measurement

control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • primary colorectal cancer
  • operated in one of four participating certified cancer centres for colorectal cancer (Krankenhaus Barmherzige Brüder, Department of Surgery, Regensburg; Germany; Caritas-Krankenhaus St. Josef, Department of Surgery, Regensburg; Germany; Klinikum Neumarkt., Department of Surgery, Neumarkt; Germany; Klinikum St. Elisabeth Straubing, Department of Surgery, Straubing, Germany), documented in a population-based cancer registry (Tumor Center Regensburg e.V.)
  • informed consent.

You may not qualify if:

  • coordinating practitioner not implemented
  • patient from district outside the study region (rural districts Regensburg, Neumarkt, Straubing, Straubing-Bogen, Kelheim, Schwandorf)
  • patient unable to fill out the questionnaire for physical, psychological or language reasons (including dementia)
  • age under 18 years
  • pregnancy
  • QoL clinician unavailable
  • refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tumor Center Regensburg e.V., An-Institute of the University of Regensburg

Regensburg, Bavaria, 93053, Germany

Location

Related Publications (5)

  • Klinkhammer-Schalke M, Koller M, Steinger B, Ehret C, Ernst B, Wyatt JC, Hofstadter F, Lorenz W; Regensburg QoL Study Group. Direct improvement of quality of life using a tailored quality of life diagnosis and therapy pathway: randomised trial in 200 women with breast cancer. Br J Cancer. 2012 Feb 28;106(5):826-38. doi: 10.1038/bjc.2012.4. Epub 2012 Feb 7.

    PMID: 22315052BACKGROUND

  • Klinkhammer-Schalke M, Koller M, Ehret C, Steinger B, Ernst B, Wyatt JC, Hofstadter F, Lorenz W; Regensburg QoL Study Group. Implementing a system of quality-of-life diagnosis and therapy for breast cancer patients: results of an exploratory trial as a prerequisite for a subsequent RCT. Br J Cancer. 2008 Aug 5;99(3):415-22. doi: 10.1038/sj.bjc.6604505.

    PMID: 18665187BACKGROUND

  • Klinkhammer-Schalke M, Koller M, Wyatt JC, Steinger B, Ehret C, Ernst B, Hofstadter F, Lorenz W. Quality of life diagnosis and therapy as complex intervention for improvement of health in breast cancer patients: delineating the conceptual, methodological, and logistic requirements (modeling). Langenbecks Arch Surg. 2008 Jan;393(1):1-12. doi: 10.1007/s00423-007-0210-5. Epub 2007 Jul 28.

    PMID: 17661076BACKGROUND

  • Klinkhammer-Schalke M, Steinger B, Koller M, Zeman F, Furst A, Gumpp J, Obermaier R, Piso P, Lindberg-Scharf P; Regensburg QoL Study Group. Diagnosing deficits in quality of life and providing tailored therapeutic options: Results of a randomised trial in 220 patients with colorectal cancer. Eur J Cancer. 2020 May;130:102-113. doi: 10.1016/j.ejca.2020.01.025. Epub 2020 Mar 13.

    PMID: 32179445DERIVED

  • Klinkhammer-Schalke M, Lindberg P, Koller M, Wyatt JC, Hofstadter F, Lorenz W, Steinger B. Direct improvement of quality of life in colorectal cancer patients using a tailored pathway with quality of life diagnosis and therapy (DIQOL): study protocol for a randomised controlled trial. Trials. 2015 Oct 14;16:460. doi: 10.1186/s13063-015-0972-y.

    PMID: 26467994DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Monika Klinkhammer-Schalke, MD, Ass. Prof.

    Tumor Center Regensburg e.V., An-Institute of the University of Regensburg, Germany

    STUDY CHAIR

  • Michael Koller, Ph.D., Prof.

    Center for Clinical Trials, University Regensburg, Germany

    PRINCIPAL INVESTIGATOR

  • Wilfried Lorenz, MD, Prof. Ɨ

    Tumor Center Regensburg e.V., An-Institute of the University of Regensburg, Germany

    PRINCIPAL INVESTIGATOR

  • Ferdinand Hofstädter, MD, Prof.

    Johannes Kepler University Linz, Medical Faculty, Austria

    PRINCIPAL INVESTIGATOR

  • Jeremy C Wyatt, MD, Prof.

    Leeds Institute of Health Sciences, University of Leeds, UK

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr.med. Monika Klinkhammer-Schalke

Study Record Dates

First Submitted

December 11, 2014

First Posted

December 22, 2014

Study Start

January 1, 2014

Primary Completion

November 1, 2016

Study Completion

June 1, 2017

Last Updated

September 25, 2017

Record last verified: 2017-09

Locations

DE(1)