Clinical trial NCT03448250: Evaluating a Novel Web-based Intervention for Breast Cancer Survivors
Official title: Evaluation of a Web-based Psychological Intervention as add-on to Care as Usual in Breast Cancer Survivors: Effect on Immune Status, Inflammation and Psychometric Outcome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Technical University of Dortmund
Sponsor class: OTHER
Collaborators: name: University of Leipzig
name: Gaia AG
First posted: 2018-02-28
Enrollment: 64
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 and free from disease recurrence. The present study will test the hypothesis that Optimune has an impact on immune status, markers of inflammation and psychometric outcomes. Therefore, 150 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 6 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 inflammatory parameters six 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 immune status, inflammation and psychometric outcomes, when offered as adjunct to care as usual.

In this study, the investigators will study 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 150 women with breast cancer who are past the active eradication phase and free from disease recurrence. 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 6 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), six months (T2), nine months (T3) and twelve months (T4).

Eligibility criteria: Inclusion Criteria:

Eligible are women who

* had breast cancer diagnosed less than 4 years ago, classified as T0-4, N0-1, M0
* completed acute treatment for breast cancer at least 6 month ago. This applies for surgery, chemotherapy or radiation, whichever occurred last. (Prophylactic treatment with anti-hormones like tamoxifen, aromatase-inhibitors or bisphosphonates is allowed).
* are competent in German language
* provide written consent to study procedures
* are willing to provide the discharge letter from oncology (to verify diagnosis and therapies)

Exclusion Criteria:

Women are not eligible if they

* have a prior history of breast cancer (other than the current one) or any other cancer except basal or squamous cell skin cancer
* suffer from the following autoimmune and/or inflammatory diseases: rheumatoid arthritis, lupus erythematodes, psoriasis, multiple sclerosis or inflammatory breast cancer
* have a history of schizophrenia, bipolar disorder, or an established diagnosis of borderline personality disorder
* have elevated current suicide risk
* routinely attend psychotherapy, either 1:1, group-therapy or web-based interaction (at least two sessions per month)
* practice 5 hours or more of vigorous physical activity per week (e.g. training for marathon)
* have cognitive impairment
* abuse alcohol or drugs

Primary outcomes:
measure: concentration of C-reactive protein (CRP)
timeFrame: Change from baseline to 6 months (also assessed at 12 months post-baseline)
measure: circulating Interleukin (IL) 6
timeFrame: Change from baseline to 6 months (also assessed at 12 months post-baseline)
measure: circulating Tumor necrosis factor (TNF)-α
timeFrame: Change from baseline to 6 months (also assessed at 12 months post-baseline)
measure: stimulated IL-6
timeFrame: Change from baseline to 6 months (also assessed at 12 months post-baseline)
measure: stimulated TNF-α
timeFrame: Change from baseline to 6 months (also assessed at 12 months post-baseline)
Secondary outcomes:
measure: Plasma Concentrations of Cytokines
timeFrame: Change from baseline to 6 months (also assessed at 12 months post-baseline)
measure: Concentration of secreted Cytokines after Phorbol-12-myristate-13-acetate (PMA) stimulation of peripheral blood mononuclear cells
timeFrame: Change from baseline to 6 months (also assessed at 12 months post-baseline)
measure: Concentration of secreted Cytokines after Lipopolysaccharide (LPS) Stimulation of peripheral blood mononuclear cells
timeFrame: Change from baseline to 6 months (also assessed at 12 months post-baseline)
measure: Circulating numbers of Lymphocytes, Monocytes, Granulocytes
timeFrame: Change from baseline to 6 months (also assessed at 12 months post-baseline)
measure: Phenotypic analysis of T and NK cell subsets
timeFrame: Change from baseline to 6 months (also assessed at 12 months post-baseline)
measure: Cortisol awakening response (CAR)
timeFrame: Change from baseline to 6 months (also assessed at 12 months post-baseline)
measure: Determination of cancer-related fatigue using the Brief Fatigue Inventory Questionnaire
timeFrame: Change from baseline to 3 months (also assessed at 6, 9 and 12 months post-baseline)
measure: Determination of cancer-related emotional stress
timeFrame: Change from baseline to 3 months (also assessed at 6, 9 and 12 months post-baseline)
measure: Determination of depression
timeFrame: Change from baseline to 3 months (also assessed at 6, 9 and 12 months post-baseline)
measure: Determination of anxiety
timeFrame: Change from baseline to 3 months (also assessed at 6, 9 and 12 months post-baseline)
measure: Determination of fear of progression
timeFrame: Change from baseline to 3 months (also assessed at 6, 9 and 12 months post-baseline)
measure: Determination of usefulness of the program
timeFrame: Assessed at 3, 6, 9 and 12 months
measure: Determination of Negative Effects
timeFrame: Assessed at 3, 6, 9 and 12 months
Other outcomes:
measure: Determination of recurrence of breast cancer (local relapse or remote metastasis)
timeFrame: Change from baseline to 3 months (also assessed at 6, 9 and 12 months post-baseline)
measure: Frequency of common cold or virus flu
timeFrame: Change from baseline to 3 months (also assessed at 6, 9 and 12 months post-baseline)
measure: Frequency of unscheduled medical encounters
timeFrame: Change from baseline to 3 months (also assessed at 6, 9 and 12 months post-baseline)
Locations:
city: Dortmund
country: Germany
facility: Technical University of Dortmund, Leibniz Research Centre for Working Environment and Human Factors
city: Leipzig
country: Germany
facility: University Medical Center Leipzig, Department of Medical Psychology and Medical Sociology, Section Psychosocial Oncology
Study officials:
affiliation: Leibniz Research Center (IfADo), TU Dortmund
name: Carsten Watzl, PhD
role: PRINCIPAL_INVESTIGATOR
References: