Quality of life in rectal cancer patients (QoLiRECT)

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.

Hypotheses

- Rectal cancer and its treatment lead to decreased QoL.

- Some treatment strategies causes lower QoL than others.

- Rectal cancer-specific symptoms and treatment-specific effects influence QoL.

- Some effects and symptoms have greater impact on QoL than others.

- Functional impairments of rectal cancer patients influence QoL.

- Psychological symptoms including intrusive thoughts influence QoL.

- Stage of disease at diagnosis influences QoL during treatment and follow-up.

- Patient expectations/experiences at diagnosis influence QoL during treatment and follow-up.

- Patient expectation of cure of the rectal cancer influences QoL.

- Gender, age and education level influence QoL during treatment and follow up.

- High occurrence and intensity of intrusive thoughts about the rectal cancer diagnosis and its treatment is associated with lower QoL.

- Early closure of temporary loop ileostomy after anterior resection is associated with higher QoL than late closure.

- Pre-treatment QoL influences QoL during follow-up as well as survival.

- Significant changes in symptoms and function may not be detected with conventional  QoL instruments.

- Our questionnaire may result in deeper understanding of the factors determining QoL than conventional QoL instruments and may lead to identification of areas for improvement in treatment and patient care.

Endpoints

Primary:

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

Secondary:

To explore potential differences in QoL, symptoms and functional impairments between subgroups of the population.
To identify symptoms, functional impairments and other risk factors that have great impact on QoL.
To identify patient and environmental factors with an impact on QoL.
To analyse how clinical factors like oncologic result of operation, morbidity,  recurrence and survival influence QoL.
To identify areas of improvement in treatment and patient care.
To initiate interventional studies when appropriate.
To generate basic descriptive data of the patient population, such as demography, socioeconomic data, disease stage at diagnosis, type of treatment, recurrence, survival etc.
To analyse health economy aspects of QoL and morbidity in the patient population.
To explore the presence and impact of intrusive thoughts on QoL in the patient  population.

Inclusion/exclusion

Inclusion criteria:

All patients presenting at the participating hospitals with a 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.

Inclusion of patients:

Aiming at including 1500 patients.

Participating hospitals:

Sweden: Karlstad, Skövde, Borås, Norra Älvsborgssjukhus, Sahlgrenska Universitetssjukhuset, Karolinska Institutet, Västerås, Örebro, Helsingborg, Mora, Blekinge sjukhuset (Karlshamn och Karlskrona)

Denmark: Herlev, Roskilde, Hvidovre,

Documents

Protocol (click on name to view/download): QoLiRECT

Publication:

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

Contact

Principal investigator:

Eva Angenete

Deputy investigator:

Eva Haglind

Questions:

Doctoral student Dan Asplund (Dan.asplund@vgregion.se), research nurse Elisabeth Gonzalez (Elisabeth.gonzales@vgregion.se) or research nurse Carina Rosander (carina.rosander@vgregion.se)