Abstract
IntroductionDepression and fatigue are common in breast cancer survivors, and their presence is associated with personal suffering and worse prognosis. While many women receive short-term psychological support in the acute treatment phase, this is rarely available in subsequent phases. Internet interventions for breast cancer survivors could provide additional psychological support, as they are easily accessible and may be effective. However, no trial has yet examined the effectiveness of an Internet intervention that provides cognitive behavioural therapy techniques plus lifestyle advice for this population. This trial aims to test whether Optimune, a novel Internet intervention we developed for that purpose, leads to improvements in quality of life and relevant lifestyle habits over the course of 3 to 6 months.MethodsThis randomized controlled trial (RCT) will include 360 female breast cancer survivors who have completed the active tumour eradication phase. Participants will be recruited from various settings, including web-based advertisements and Internet forums in German-speaking countries. The main inclusion criteria are a breast cancer diagnosis less than 5 years ago and completion of acute treatment at least 1 month ago, as verified by discharge letter from an oncology treatment centre. Participants will be randomly assigned to either (1) a control group, in which they receive care as usual (CAU) and are given access to Optimune after a delay of 3 months (CAU/wait list control), or (2) a treatment group that may also use CAU and will receive 12-month access to Optimune immediately after randomization. The three primary endpoints are quality of life, physical activity and diet quality, assessed with the World Health Organization Quality of Life Questionnaire, the International Physical Activity Questionnaire and the Food Quality Questionnaire, at 3 months post-baseline; secondary outcomes include cancer-related fatigue, emotional stress, depression, anxiety, fear of progression, insomnia, usefulness of the programme and negative treatment effects. Online assessments are conducted at baseline (T0), 3 months (T1) and 6 months (T2).DiscussionResults of this RCT are expected to extend the body of knowledge with regard to the effectiveness of CBT-based Internet interventions for female breast cancer survivors.Trial registrationClinicalTrials.gov, NCT03643640. Registered on 23 August 2018.
Highlights
Depression and fatigue are common in breast cancer survivors, and their presence is associated with personal suffering and worse prognosis
Results of this randomized controlled trial (RCT) are expected to extend the body of knowledge with regard to the effectiveness of CBTbased Internet interventions for female breast cancer survivors
The present study aims to make a contribution to the literature on Internet interventions for breast cancer survivors, and to test the effectiveness of a potential new treatment option that may help improve the quality of care for this group
Summary
Depression and fatigue are common in breast cancer survivors, and their presence is associated with personal suffering and worse prognosis. While many women receive short-term psychological support in the acute treatment phase, this is rarely available in subsequent phases. The German guidelines for the treatment of breast cancer [3] delineate several acute treatment options, including surgery, radiation and aggressive combination chemotherapy. When these treatments are completed and patients are considered cancer-free, they are typically discharged from a phase of intense treatment to a phase of standardized monitoring for recurrence, with only a few specific therapies, such as treatment with antihormones, aromatase inhibitors or bisphosphonates. While many women receive short-term psychological support in the phase of acute treatment, this is rarely the case in subsequent phases. There is evidence that breast cancer survivors have higher levels of inflammation [8,9,10], which may contribute to their commonly elevated levels of depression, fatigue and anxiety [8, 9, 11]
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