Protocol for the Optimune trial: a randomized controlled trial evaluating a novel Internet intervention for breast cancer survivors

Franziska Holtdirk, Anja Mehnert, Mario Weiss, Björn Meyer, Carsten Watzl, Franziska Holtdirk, Anja Mehnert, Mario Weiss, Björn Meyer, Carsten Watzl

Abstract

Introduction: 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. 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.

Methods: This 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).

Discussion: Results 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 registration: ClinicalTrials.gov, NCT03643640. Registered on 23 August 2018.

Keywords: Breast cancer; Depression; Internet interventions.

Conflict of interest statement

BM, MW and FH are affiliated with Gaia, the e-Health company that funds this trial and that developed, owns and operates the Internet intervention that the trial evaluates. MW is Chief Executive Officer and founder of Gaia, BM is employed full-time as research director and FH is employed full-time as research associate. The other authors (AM and CW) declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flowchart of the study design

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