NCT01477229

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

November 15, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 22, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
10.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

December 8, 2023

Status Verified

December 1, 2023

Enrollment Period

3.6 years

First QC Date

November 15, 2011

Last Update Submit

December 7, 2023

Conditions

Rectal CancerQuality of LifeSurgery

Keywords

Rectal cancerQuality of LifeAbdominoperineal ResectionAnterior ResectionPalliative cancer treatmentRadio chemotherapy

Outcome Measures

Primary Outcomes (1)

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

    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

    At diagnosis

Secondary Outcomes (9)

  • To explore potential differences in QoL, symptoms and functional impairments between subgroups of the population

    At diagnosis

  • To identify symptoms and functional impairments and other risk factors that have great impact on QoL

    At diagnosis

  • To identify patient and environmental factors with an impact on QoL

    At diagnosis

  • To analyse how clinical factors like oncologic result of operation, morbidity, recurrence and survival influence QoL

    At 12 months after start of the treatment

  • To initiate interventional studies when appropriate

    12 months

  • +4 more secondary outcomes

Study Arms (4)

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

Eligibility Criteria

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

You may not qualify if:

  • Age below 18 years at diagnosis.
  • No informed consent received or withdrawal of informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Scandinavian Surgical Outcomes Research Group, SSORG, Göteborg

Gothenburg, 416 85, Sweden

Location

Related Publications (3)

  • Bjorklund Sand L, Larsson C, Gronkvist R, Haglind E, Angenete E. Persistent Sitting and Walking Difficulties After Abdominoperineal Excision and Anterior Resection: Results From the Quality of Life in Rectal Cancer Study. Dis Colon Rectum. 2025 Jun 1;68(6):704-712. doi: 10.1097/DCR.0000000000003710. Epub 2025 Mar 14.

    PMID: 40085057DERIVED

  • Ehrencrona C, Li Y, Angenete E, Haglind E, Franzen S, Grimby-Ekman A, Bock D. Do beta-blockers reduce negative intrusive thoughts and anxiety in cancer survivors? - An emulated trial. BMC Cancer. 2024 Apr 11;24(1):447. doi: 10.1186/s12885-024-12236-3.

    PMID: 38605350DERIVED

  • Asplund D, Heath J, Gonzalez E, Ekelund J, Rosenberg J, Haglind E, Angenete E. Self-reported quality of life and functional outcome in patients with rectal cancer--QoLiRECT. Dan Med J. 2014 May;61(5):A4841.

    PMID: 24814743DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Ph.D

Study Record Dates

First Submitted

November 15, 2011

First Posted

November 22, 2011

Study Start

February 1, 2012

Primary Completion

September 1, 2015

Study Completion

December 1, 2025

Last Updated

December 8, 2023

Record last verified: 2023-12

Locations

SE(1)