Interventions for fatigued palliative cancer patients.

Patients with advanced or metastatic cancer can live with cancer for years, and this trajectory of palliative treatment is prolonged with improved oncological treatments. In addition to prolonging patients' lives, preserving their quality of life is the main aim during the palliative treatment. Fatigue has proven to be one of the symptoms significantly lowering the quality of life in cancer patients receiving palliative care. Until now there is no evidence based or generally accepted intervention to treat severe fatigue during the palliative trajectory. GET and CBT are two different and promising approaches to reduce fatigue. In this project we will test the direct and longer term effects of both interventions in a RCT in comparison with usual care on fatigue severity and quality of life.



Patients will be recruited from eight hospitals in the Netherlands: Radboud University Nijmegen Medical Centre (Nijmegen), Ziekenhuis Gelderse Vallei (Ede) and Maxima Medisch Centrum (Eindhoven/Veldhoven)Canisius

Wilhelmina ziekenhuis (Nijmegen), Isala (Zwolle), Jeroen

Bosch ziekenhuis (Den Bosch), VieCuri medisch centrum

(Venlo/Venray), Maasziekenhuis Pantein (Boxmeer). When accrual of patients is not sufficient in the three participating centres, other hospitals will be approached for participation.

Fatigue is an important symptom lowering the quality of life in patients with advanced or metastatic cancer. The efficacy of graded exercise therapy (GET) and cognitive behaviour therapy (CBT) in reducing severe fatigue in cancer survivors has been shown, but the effectiveness for cancer patients in the palliative trajectory has not been demonstrated in controlled studies.
Research questions:

1. What are the effects of GET and CBT in severely fatigued patients receiving palliative treatment for locally advanced or metastatic cancer on fatigue severity compared to usual care?

2. What are the mediators of the change in fatigue brought on by GET and CBT? More specifically, are (a) and increased level of physical activity and/or physical fitness; or (b) a change in fatigue related cognitions, mediators for the expected reduction in fatigue brought on by the two interventions?

1. T0 baseline assessment;

2. T1 following the intervention, approximately 3 months after T0;

3. T2 follow-up, 4 months after T0;

4. T3 follow-up, 6 months after T0.

1. Graded exercise therapy (GET): Patients assigned to this condition will receive GET in addition to usual care. The GET will consist of weekly sessions of two hours resistance and aerobic training with a physical therapist during 12 weeks. In a second weekly session patients will practice without specific support by a physical therapist. GET will take place in small groups of maximal 5 patients and will be individually adjusted to patients’ abilities.

2. Cognitive behaviour therapy (CBT): Patients in the CBT group will receive CBT for fatigue in addition to usual care. CBT will consist of ten individual one-hour sessions with a therapist over a period of 12 weeks. Based on the CBT for postcancer fatigue and CBT during curative cancer treatment a treatment protocol ‘CBT for fatigue in palliative cancer patients’ is developed. It consists of six modules aimed at factors that are thought to maintain fatigue. At baseline assessment it will be determined which factors are problematic for the particular patient. Relevant modules will be selected for each individual patient, which leads to a tailored-made intervention.

3. Care as usual: Patients assigned to this condition will receive care as usual. Patients will be treated for cancer in concordance with national and regional guidelines of the comprehensive cancer centres.