A randomized controlled trial of web-based cognitive behavioral therapy for severely fatigued breast cancer survivors (CHANGE-study): study protocol

Abstract

BackgroundAbout one third of breast cancer survivors suffer from persistent severe fatigue after completion of curative cancer treatment. Face-to-face cognitive behavioral therapy (F2F CBT), especially designed for fatigue in cancer survivors, was found effective in reducing fatigue. However, this intervention is intensive and treatment capacity is limited. To extend treatment options, a web-based version of CBT requiring less therapist time was developed. This intervention is aimed at changing fatigue-perpetuating cognitions and behaviors. The efficacy of web-based CBT will be examined in a multicenter randomized controlled trial.MethodsIn total, 132 severely fatigued breast cancer survivors will be recruited and randomized to either an intervention condition or care as usual (ratio 1:1). Participants will be assessed at baseline and 6 months thereafter. The intervention group will receive web-based CBT, consisting of three F2F sessions and maximally eight web-based modules over a period of 6 months. The care as usual group will be on a waiting list for regular F2F CBT. The total duration of the waiting list is 6 months. The primary outcome of the study is fatigue severity. Secondary outcomes are functional impairments, psychological distress and quality of life.DiscussionIf web-based CBT is effective, it will provide an additional treatment option for fatigue in breast cancer survivors. Web-based CBT is expected to be less time-consuming for therapists than regular F2F CBT, which would result in an increased treatment capacity. Moreover, the intervention would become more easily accessible for a larger number of patients, and patients can save travel time and costs.Trial registrationDutch Trial Registry - NTR4309Electronic supplementary materialThe online version of this article (doi:10.1186/s12885-015-1787-7) contains supplementary material, which is available to authorized users.

Quality of life in breast cancer survivors

“…23,24 This study found that even patients with a KPS of 40% received some type of treatment despite the patient's lower FC and increased propensity to poorer QoL. 2,7 Therefore, quantification of physical function is becoming an important element in the verification of health--related QoL, considering that cancer is often associated with decreased physical capacity, which interferes with daily activities, especially for those with metastases. [23][24][25] Most patients in our study had metastases, mainly locoregional, which is similar to findings by Montazeri et al 25 that patients with advanced cancer may have poorer QoL.…”

“…However, due to new technologies and treatments, the number of women living with the disease increases every year, which explains the growing interest in quality of life (QoL) of breast cancer patients. [1][2][3][4][5] The number of breast cancer survivors is increasing around the world; thus, it is important to improve the health-related QoL of this population. Ability to perform daily activities, patient satisfaction and levels of functionality are all essential to determining QoL in breast cancer survivors.…”

The efficacy of Internet‐based cognitive behavioral therapy for severely fatigued survivors of breast cancer compared with care as usual: A randomized controlled trial

“…16 Based on a study that examined the efficacy of a minimal intervention for patients with medically unexplained chronic fatigue, we assumed a clinically relevant difference in fatigue severity between the intervention and control condition of 6 points. 16 Based on a study that examined the efficacy of a minimal intervention for patients with medically unexplained chronic fatigue, we assumed a clinically relevant difference in fatigue severity between the intervention and control condition of 6 points.…”

“…16 The RCT was reviewed and approved by the Arnhem-Nijmegen Medical Research Ethics Committee (NL43781.091.13) and the ethics committees of the participating hospitals. After 6 months, participants completed the second assessment online.…”

“…16 The percentages of indicated modules were calculated, as well as the percentages of patients who had opened these modules. Participants were defined as treatment dropouts if they had agreed with their therapist to discontinue ICBT prematurely.…”