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

NCT ID: NCT01477229

Last Updated: 2023-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-29

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Rectal Cancer Quality of Life Surgery

Keywords

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Rectal cancer Quality of Life Abdominoperineal Resection Anterior Resection Palliative cancer treatment Radio chemotherapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Abdominoperineal resection

Patients with low rectal cancers

No interventions assigned to this group

Anterior resection

Patients where it is possible to perform an anterior resection

No interventions assigned to this group

Preoperative chemo-radiation treatment

Patients with locally advanced rectal cancer

No interventions assigned to this group

Palliative treatment

Patients with systemic disease

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swedish Cancer Foundation

OTHER

Sponsor Role collaborator

The Swedish Society of Medicine

OTHER

Sponsor Role collaborator

Assar Gabrielsson Foundation

UNKNOWN

Sponsor Role collaborator

Sahlgrenska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Eva Angenete

M.D., Ph.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eva Angenete, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

SSORG - Scandinavian Surgical Outcomes Research Group and Sahlgrenska University Hospital in collaboration with Sahlgrenska Academy at University of Gothenburg

Locations

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Scandinavian Surgical Outcomes Research Group, SSORG, Göteborg

Gothenburg, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 40085057 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38605350 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24814743 (View on PubMed)

Other Identifiers

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QoLiRECT

Identifier Type: -

Identifier Source: org_study_id