OPEN Research Support
head

PhD-student
Lise Nottelmann
Department of Oncology, Vejle Hospital


Projekt styring
Projekt status    Sampling ongoing
 
Data indsamlingsdatoer
Start 01.12.2014  
Slut 30.06.2023  
 



A RCT on early, integrated, specialized palliative rehabilitation for patients with newly diagnosed advanced cancer

Short summary

This study evaluates a palliative rehabilitation program integrated with standard oncology care. The patients are randomized to standard oncology care or standard oncology care plus a consultation with palliative care professionals. The purpose is to investigate whether patients with a cancer that cannot be readily removed by surgery, achieve an improvement in quality of life and symptom control by getting an individually customized 12-week palliative rehabilitation program shortly after diagnosis. 


Rationale

Danish cancer patients have unmet palliative needs (physical, mental, social or existential issues related to living with a serious illness).

WHO-recommendations from 2002 state that palliative care should be offered to the patients early in the disease trajectory, integrated with the disease-specific treatment (standard oncology treatment). Several international studies indicate that this is beneficial for the patients. Yet the scientific evidence is still sparse.
At Vejle Hospital a new offer of palliative rehabilitation has been launched. Palliative care professionals offer the patients help with symptoms / problems and the possibility of partially or completely rebuilding functions related to activities of daily life. There is a need for this new offer to be investigated in a systematic way.
The purpose of this study is to investigate whether patients with a cancer that cannot be readily removed by surgery, achieve an improvement in quality of life and symptom control by getting an individually customized rehabilitation program shortly after diagnosis. All or part of the program is organized as a group intervention, which is new in Denmark.


Description of the cohort

Adult patients with solid tumors who receive standard oncology care at Department of Oncology, Vejle. The patients have been diagnosed with advanced cancer less than 8 weeks before entering the study (for patients with metastatic prostatic cancer they have been referred to standard oncology treatment for the first time less than 8 weeks before entering the study). 


Data and biological material

Questionnaire data (EORTC-QLQ-C30 and HADS plus a supplement question at baseline exploring which symptom / problem the patient wants to be helped with the most. And questions at follow-up exploring whether or not the patient has been helped with his problem of choice.

Baseline data: WHO Performance Status, gender, age, diagnosis, date of primary diagnosis, cancer stage, marital status and educational background.

Data on content of the intervention is registered using a "contact sheet" (the content of the individual palliative rehabilitation program)

Serious adverse events are registered.

Cross-over is registered.

Register data (LPR and CPR) in order to evaluate survival and economic consequences.


Collaborating researchers and departments

Department of Oncology, Vejle Hospital and Institute for Regional Health Research, University of Southern Denmark

  • Consultant Lars Henrik Jensen, MD, PhD

Department of Oncology, Vejle Hospital

  • Consultant Tove Vejlgaard, MD (retired but still affiliated with the project)

Section for Health Services Research, Department of Public Health, University of Copenhagen and Palliative Research Unit, Bispebjerg Hospital

  • Professor, Consultant and Head of Research Unit Mogens Grønvold

Palliative Research Unit, Bispebjerg Hospital

  • Statistician Morten Aagaard Petersen