Abstract
BackgroundFatigue is a common and debilitating symptom for patients with incurable cancer receiving systemic treatment with palliative intent. There is evidence that non-pharmacological interventions such as graded exercise therapy (GET) or cognitive behaviour therapy (CBT) reduce cancer-related fatigue in disease-free cancer patients and in patients receiving treatment with curative intent. These interventions may also result in a reduction of fatigue in patients receiving treatment with palliative intent, by improving physical fitness (GET) or changing fatigue-related cognitions and behaviour (CBT). The primary aim of our study is to assess the efficacy of GET or CBT compared to usual care (UC) in reducing fatigue in patients with incurable cancer.MethodsThe TIRED study is a multicentre three-armed randomised controlled trial (RCT) for incurable cancer patients receiving systemic treatment with palliative intent. Participants will be randomised to GET, CBT, or UC. In addition to UC, the GET group will participate in a 12-week supervised exercise programme. The CBT group will receive a 12-week CBT intervention in addition to UC. Primary and secondary outcome measures will be assessed at baseline, post-intervention (14 weeks), and at follow-up assessments (18 and 26 weeks post-randomisation). The primary outcome measure is fatigue severity (Checklist Individual Strength subscale fatigue severity). Secondary outcome measures are fatigue (EORTC-QLQ-C30 subscale fatigue), functional impairments (Sickness Impact Profile total score, EORTC-QLQ-C30 subscale emotional functioning, subscale physical functioning) and quality of life (EORTC-QLQ-C30 subscale QoL). Outcomes at 14 weeks (primary endpoint) of either treatment arm will be compared to those of UC participants. In addition, outcomes at 18 and 26 weeks (follow-up assessments) of either treatment arm will be compared to those of UC participants.DiscussionTo our knowledge, the TIRED study is the first RCT investigating the efficacy of GET and CBT on reducing fatigue during treatment with palliative intent in incurable cancer patients. The results of this study will provide information about the possibility and efficacy of GET and CBT for severely fatigued incurable cancer patients.Trial registrationNTR3812; date of registration: 23/01/2013.
Highlights
Fatigue is a common and debilitating symptom for patients with incurable cancer receiving systemic treatment with palliative intent
Aims of the TIRED study We designed a multicentre randomised controlled trial (RCT) to test the efficacy of either graded exercise therapy (GET) or cognitive behaviour therapy (CBT) compared to Usual Care (UC) in reducing fatigue in incurable cancer patients receiving systemic treatment with palliative intent
Graded exercise and cognitive behavioural interventions seem promising in reducing fatigue severity based on their effectiveness in disease-free cancer patients and patients receiving cancer treatment with curative intent
Summary
Design A non-blinded multicentre RCT (the TIRED study) will be conducted to evaluate the efficacy of GET and CBT compared to UC for severely fatigued incurable cancer patients receiving cancer treatment with palliative intent. Participants randomised to CBT will complete a set of additional questionnaires prior to the first intervention session to assess potential perpetuating factors (see Table 2). Sample size calculation Based on the primary outcome measure of the TIRED study, efficacy of one or both interventions is demonstrated when mean fatigue severity (CIS-fatigue) in participants assigned to GET and/or CBT is significantly lower at T1 compared to participants assigned to UC. ANCOVA will be performed for the secondary outcomes (fatigue, quality of life, and functional impairments), with baseline score (T0) on the dependent measure as covariate. In these exploratory analyses a p-level of 0.05 will be used.
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