Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: An Explorative Study on Physiological and Neurophysiological Determinants of Fatigue in Cancer Survivors
Brief Summary: Postcancer fatigue is a severe and invalidating problem, impairing quality of life. About 20 to 40% of the patients remain fatigued, at least one year after successful cancer treatment. Fortunately, there is an effective treatment for postcancer fatigue; cognitive behavior therapy. However, no cause for postcancer fatigue has been identified yet. The aim of the study is to identify factors that (partly) cause postcancer fatigue to improve the theoretical understanding of fatigue and to improve the diagnostics of fatigue, predict therapy outcome, and facilitate other treatment options.

In this study, disease-free fatigued cancer patients, who finished treatment for cancer at least one year and maximally ten years ago, will be approached for this study. They will be compared to non-fatigued patients.

First, a baseline assessment will take place. Magnetic resonance imaging of the brains will be performed to assess brain volume and magnetic resonance spectroscopy will be performed to measure the concentrations of specific substances in the brains. Changes in the volume of parts of the brains have been observed in (non-cancer) patients with the chronic fatigue syndrome (CFS), in comparison with healthy controls. In addition, abnormal concentrations of specific substances have been observed in patients with CFS compared to healthy controls. To assess muscle fatigue, a two-minute endurance test of the upper arm will be administered at maximal voluntary contraction. Next to differences in the brains, CFS patients showed (central) muscle fatigue. A maximal exercise test on a bicycle will be performed to assess physical fitness. Physical activity in fatigued cancer survivors is decreased, compared to healthy controls. It is not known whether physical deconditioning originated during the cancer treatment is the reason why these patients are still less active. In addition, patients and controls will wear an actometer for two weeks to register baseline daily physical activity and for an additional 5 days after the maximal exercise test, to assess the effect of exercise on the daily physical activity. Finally, patients and controls will complete standardized questionnaires and will perform neurological/psychological tests, like a reaction time test and a short time memory task, at baseline.

The results of the non-fatigued and the fatigued patients will be compared at baseline. For the non-fatigued participants, the study will be finished after the baseline measurements. The fatigued participants will start with cognitive behavior therapy immediately after the baseline measurements or after 6 months, depending on the randomization.

At the end of the therapy, after six months, or after 6 months of waiting for cognitive behavior therapy, a second assessment will take place, comparable to the baseline measurements. These results will be compared with the baseline situation to analyze the effect of cognitive behavior therapy on the (possible) causes of postcancer fatigue.


Options:
A: Arm Label: Fatigued patients: Immediate start CBT; Type: OTHER; Interventions: Behavioral: immediate CBT | Arm Label: fatigues patients: delayed CBT (after 6 months); Type: OTHER; Interventions: Behavioral: Delayed CBT | Arm Label: non-fatiqued controls; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: immediate CBT; Assigned to Arm(s): Fatigued patients: Immediate start CBT | Intervention Type: BEHAVIORAL; Name: Delayed CBT; Assigned to Arm(s): fatigues patients: delayed CBT (after 6 months)
B: Arm Label: Facebook-based Self-help Comparison; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Facebook-based Self-help Comparison | Arm Label: Facebook-based Messages/Website; Type: EXPERIMENTAL; Interventions: Behavioral: Facebook-based Messages/Website | Intervention Type: BEHAVIORAL; Name: Facebook-based Messages/Website; Assigned to Arm(s): Facebook-based Messages/Website | Intervention Type: BEHAVIORAL; Name: Facebook-based Self-help Comparison; Assigned to Arm(s): Facebook-based Self-help Comparison
C: Arm Label: Exercise; Type: EXPERIMENTAL; Interventions: Behavioral: Aerobic Exercise Training | Arm Label: Usual Care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Aerobic Exercise Training; Assigned to Arm(s): Exercise
D: Arm Label: resistance and endurance exercise; Type: EXPERIMENTAL; Interventions: Behavioral: exercise and relaxation | Arm Label: relaxation; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: exercise and relaxation | Intervention Type: BEHAVIORAL; Name: exercise and relaxation; Assigned to Arm(s): relaxation, resistance and endurance exercise

Answer: A