Evaluating a Novel Web-based Intervention for Breast Cancer Survivors
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The trial aims to evaluate the effectiveness of a novel web-based intervention (Optimune),
      which was designed to introduce relevant cognitive-behavioral therapy (CBT) techniques to
      women with breast cancer who are past the active eradication phase. The present study will
      test the hypothesis that Optimune has an impact on lifestyle parameters and psychometric
      outcomes. Therefore, 360 woman with breast cancer will be recruited and randomized to two
      groups: (1) a control group, in which they may engage with any treatment (Care-as-Usual, CAU)
      and receive access to Optimune after a delay of 3 months (i.e., CAU/wait list control group),
      or (2) to a treatment group that immediately receives 12-month access to Optimune and may
      also use CAU. The primary outcome measure is the effect on quality of life, physical activity
      and diet three month post-baseline.
    

Detailed description: 
      Depression and fatigue is common in breast cancer survivors and its presence is associated
      with personal suffering, increased inflammatory activity, and worse prognosis. While in the
      phase of acute treatment many women receive short-term psychological support to better cope
      with the situation, this is not standard of care in the years following. Web-based
      psychological interventions are easily accessible and preliminary evidence suggests that such
      interventions can be effective. However, no trial has yet examined whether a CBT-based
      internet intervention designed to meet the needs of breast cancer survivors can achieve
      effects on lifestyle parameters and psychometric outcomes, when offered as adjunct to care as
      usual.

      In this study, the investigators will investigate treatment effects of the novel web-based
      program Optimune when added to treatment as usual. Beyond established CBT techniques
      targeting depression, anxiety, and fatigue, this intervention specifically includes elements
      that have shown effects on markers of immune status and inflammation, including sleep and
      stress management (e.g., mindfulness-based techniques) and lifestyle optimization (dietary
      and physical activity advice). The delivery and training of content is continuously
      individualized to match users' preferences and needs, based on responses within the program.
      The intervention is delivered via the internet and protected by individually assigned
      passwords. The program can be accessed for 365 days after registration.

      This randomized controlled trial will include 360 women with breast cancer who are past the
      active eradication phase. Participants will be recruited from various settings, including
      web-based advertisement and internet forums/groups. Participants will be randomly assigned to
      either (1) a control group, in which they receive care as usual (CAU) and are given access to
      the web-based intervention (Optimune) after a delay of 3 months (i.e., CAU/wait list control
      group), or (2) a treatment group that may also use CAU and in addition immediately receives
      12-month access to the web-based intervention (Optimune). Measurements are collected at
      pre-treatment (T0) three months (T1) and six months (T2).
    

Intervention name(s): Optimune; Care-As-Usual
Intervention type(s): Behavioral; Other
Intervention description(s): Optimune is a web-based psychological intervention developed for women with breast cancer.; Participants are free to continue to engage with any treatment they require (i.e., CAU).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment