Evaluation of intervention strategies to manage fatigue during active treatment and to prevent persistent fatigue after curative treatment for cancer.

Fatigue is a nearly universal symptom in patients receiving cancer treatment. Up to 99 percent of all cancer patients have to deal with some degree of fatigue during treatment.
Based on the literature and our own experience it can be concluded that one year after successful cancer treatment severe fatigue persists in at least 40% of the survivors. Looking at heightened fatigue we found even a percentage of 60%. Cancer patients as well as cancer survivors who experience severe fatigue can not participate fully anymore in the roles and activities that make life meaningful. Little research has been done in this domain and the exact mechanisms involved are still unknown. Controlled studies concerning the elements for combating fatigue during active treatment are lacking. Nevertheless, activity enhancement and psychosocial interventions have the strongest evidence as a base for managing fatigue during active cancer treatment.
At this moment the Expert Centre Chronic Fatigue is conducting an intervention study to reduce fatigue and functional impairment in cancer survivors. Preliminary data of this study show positive effects. Preventing fatigue in cancer survivors by an intervention in an earlier stage would be more desirable. Therefore the purpose of this study is to evaluate whether an intervention (a minimal or a more intensive one) during treatment of cancer is effective in managing fatigue during cancer treatment and whether these interventions can prevent fatigue becoming persistent, one year after the curative treatment has ended.
Furthermore, this study will also look at the early determinants of persistent fatigue after curative treatment for cancer, so it will provide us a more complete understanding of the course of fatigue from the start of the treatment.

1. What are the effects of a minimal intervention given by a nurse and a more intensive psychological intervention on managing fatigue during active treatment of cancer compared to no intervention? Will a minimal intervention be sufficient or is a more intensive treatment necessary in managing fatigue during active treatment of cancer?

2. What are the effects of a minimal and a more intensive psychological intervention during active treatment of cancer on persistent fatigue in disease-free cancer patients one year after completion of treatment of cancer?

3. Which factors, somatic and/or psychological, during treatment of cancer have predictive value for persistent fatigue in disease-free cancer patients one year after completion of treatment of cancer?

Intervention 1: Minimal intervention:

The minimal intervention consists of a booklet with easily understood general information about two components. In two one hour session the research nurse will explain the booklet and help the patient to applicate this to their situation. General information about fatigue during active treatment will be given.
The second component consists of physical activity instructions. In the second session also the adherence of the patients to the instructions will be discussed.

Intervention 2: cognitive behaviour therapy (CBT) :

The patients randomised to the CBT condition will also get and discuss the booklet given in the minimal intervention condition. Additional they get individual treatment that consists of 10 sessions with a psychotherapist of the Expert Centre Chronic Fatigue in about six months. In the treatment program seven phases can be discerned. The importance of each phase depends on the relevance for the individual patient, which is determined by multidimensional individual assessment.
- Phase one consists of learning to cope with emotions evoked by having a life-threatening disease and for which the patient undergoes an intensive treatment.
- Secondly, non-helping cognitions around the disease, its treatment and to perform a physical activity program will be disputed. More helping cognitions will be installed in order to start and maintain the activity program.
- Third, the patients will be teached how to get a more regular sleep/wake cycle, adaptation to the new cancer treatment situation, to look at their sleep pattern and normalize them. This implies going to bed and getting up at fixed times. When sleeping disturbances are present, new sleeping habits as well as alternating rest and activity will be learned.
- Phase four consists of a physical activity program in which patients learn to regulate activities according to one’s limit. Patients will be asked to select a physical activity that they can perform every day. Systematic increase of physical and, if necessary, mental activities will take place. Also in this condition the activities are left under control of the patient to permit individualized adaptation to effects of the cancer treatment and age. Patients have to find the right balance between periods of rest and periods of activity.
- Fifth, support of others, emotionally or instrumentally, will be regulated. A relevant person of the patient will be included in the therapy process.
- Sixth, stimulation of activities that improve mental functioning. This means engaging in activities that give mental rest and relief. This can help the patient to distract from thoughts of worrying, concerns, pain and stimulate positive thoughts. Distraction can be found in activities that are based on the interest of a patients, like creative activities, activities of fascination, activities that give a sense of being away.
- Seventh, integrating the learned way of thinking and behaving in daily life, in agreement with the individual aims. Which means a return of regularity in daily activities.
During all phases, use of simple diaries with various instructions will help patients to increase self management and self control.