An interventional study of Optimune and Care-As-Usual in Breast Cancer, sponsored by Technical University of Dortmund. Terminated at 2 sites in Germany. Open to female participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-05-05.
Sponsored by Technical University of Dortmund · Not applicable, Interventional, and Treatment
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.
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).
Eligible are women who
Exclusion Criteria:
Women are not eligible if they
Optimune is an web-based psychological intervention for women with breast cancer. 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, stress management (e.g., mindfulness-based techniques) and lifestyle optimization (dietary and physical activity advice). Content is continuously adapted to users' concerns and needs. It contains interactive dialogues that can be accessed via computer or smart-phone, illustrations, audio files and motivating text messages. Optional daily text messages with motivational content accompany the program. The program can be accessed for 365 days after registration.
Behavioral: Optimune
As in the experimental arm, participants are free to continue to engage with any treatment they require (i.e., CAU). However, they will receive access to Optimune six months post-baseline (i.e., wait list with respect to Optimune access).
Other: Care-As-Usual
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).
concentration of C-reactive protein (CRP)
Plasma concentration of C-reactive protein (CRP)
Time frame: Change from baseline to 6 months (also assessed at 12 months post-baseline)
circulating Interleukin (IL) 6
Plasma concentration of IL-6
Time frame: Change from baseline to 6 months (also assessed at 12 months post-baseline)
circulating Tumor necrosis factor (TNF)-α
Plasma concentration of TNF-α
Time frame: Change from baseline to 6 months (also assessed at 12 months post-baseline)
stimulated IL-6
Concentration of secreted IL-6 after stimulation of peripheral blood mononuclear cells with Lipopolysaccharide (LPS)
Time frame: Change from baseline to 6 months (also assessed at 12 months post-baseline)
stimulated TNF-α
Concentration of secreted TNF-α after stimulation of peripheral blood mononuclear cells with Lipopolysaccharide (LPS)
Time frame: Change from baseline to 6 months (also assessed at 12 months post-baseline)
Plasma Concentrations of Cytokines
Circulating levels (pg/ml) of IL-1β, IFN- α, IFN-γ, MCP-1, IL-8, IL-10, IL-12p70, IL-17A, IL-18, IL-23, and IL-33 will be measured using cytometric bead array (CBA)
Time frame: Change from baseline to 6 months (also assessed at 12 months post-baseline)
Concentration of secreted Cytokines after Phorbol-12-myristate-13-acetate (PMA) stimulation of peripheral blood mononuclear cells
Concentrations (pg/ml) of secreted of IL-1β, Interferon (IFN)-α, IFN-γ, TNF-α, MCP-1, IL-6, IL-8, IL-10, IL-12p70, IL-17A, IL-18, IL-23, and IL-33 after stimulation of peripheral blood mononuclear cells with Phorbol-12-myristate-13-acetate (PMA) will be measured using a cytometric bead array (CBA).
Time frame: Change from baseline to 6 months (also assessed at 12 months post-baseline)
Concentration of secreted Cytokines after Lipopolysaccharide (LPS) Stimulation of peripheral blood mononuclear cells
Concentrations (pg/ml) of secreted of IL-1β, IFN- α, IFN-γ, TNF- α, MCP-1, IL-6, IL-8, IL-10, IL-12p70, IL-17A, IL-18, IL-23, and IL-33 after stimulation of peripheral blood mononuclear cells with LPS will be measured using cytometric bead array (CBA)
Time frame: Change from baseline to 6 months (also assessed at 12 months post-baseline)
Circulating numbers of Lymphocytes, Monocytes, Granulocytes
Circulating numbers of Lymphocytes, Monocytes, and Granulocytes (per ul blood) will be measured by 'TruCount' Flow Cytometry.
Time frame: Change from baseline to 6 months (also assessed at 12 months post-baseline)
Phenotypic analysis of T and NK cell subsets
We will analyze the distribution of T cell and NK cell subsets by 11 color Flow Cytometry (using the following antibody panels: Panel 1 ("NK + T cells + Treg + memory + homing"): KLRG1, CD3, Zombie Yellow, CD8, CD28, CD57, CD56, CD62L, CD197, CD45RA, CD4. Panel 2 ("NK + T activation + memory"): KLRG1, CD3, Zombie Yellow, NKG2C, CD56, CD57, CD25, DNAM-1, CD69.
Time frame: Change from baseline to 6 months (also assessed at 12 months post-baseline)
Cortisol awakening response (CAR)
Cortisol concentrations from saliva samples taken at time of awakening and 30 and 45 min. after awakening will be measured to determine the Cortisol awakening response (CAR)
Time frame: Change from baseline to 6 months (also assessed at 12 months post-baseline)
Determination of cancer-related fatigue using the Brief Fatigue Inventory Questionnaire
Fatigue will be measured using the Brief Fatigue Inventory Questionnaire (BFI-9) questionnaire. Scale Range: 0 to 90. The BFI is a 9-item, 11-point rating scale. The first three questions measure fatigue severity from 0, indicating "no fatigue," to 10, indicating "as bad as you can imagine," at current, usual, and worst levels. The following six questions assess fatigue interference with daily activities. Response options range from 0, indicating "does not interfere," to 10, indicating, "completely interferes." Interpretation: A global fatigue score can be obtained by averaging all the items on the BFI. Higher scores on the BFI correspond to greater self-reported levels of fatigue
Time frame: Change from baseline to 3 months (also assessed at 6, 9 and 12 months post-baseline)
Determination of cancer-related emotional stress
Cancer-related emotional stress will be measured using the standardized IES-R (Impact of Event Scale) Questionnaire. Scale Range: 0 to 88 The IES-R is a 22-item self-report measure that assesses subjective distress caused by traumatic events. Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). The IES-R yields a total score (ranging from 0 to 88) and subscale scores can also be calculated for the Intrusion, Avoidance, and Hyperarousal subscales. Interpretation: Higher scores correspond to greater self-reported levels of post-traumatic stress.
Time frame: Change from baseline to 3 months (also assessed at 6, 9 and 12 months post-baseline)
Determination of depression
Depression will be measured using the standardized PHQ-9 (Patient Health Questionnaire). Scale Range: 0 to 27 The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. PHQ-9 scores of 5, 10, 15, and 20 represents mild, moderate, moderately severe and severe depression. Interpretation: Higher scores correspond to greater self-reported levels of depression.
Time frame: Change from baseline to 3 months (also assessed at 6, 9 and 12 months post-baseline)
Determination of anxiety
Anxiety will be measured using the standardized GAD-7 (Generalized Anxiety Disorder) questionnaire. Scale Range: 0 to 21 The GAD-7 is an instrument for screening, diagnosing, monitoring and measuring the severity of anxiety. GAD-7 scores of 5, 10, and 15 represents mild, moderate, and severe anxiety. Interpretation: Higher scores correspond to greater self-reported levels of anxiety.
Time frame: Change from baseline to 3 months (also assessed at 6, 9 and 12 months post-baseline)
Determination of fear of progression
Fear of progression will be measured using the standardized PA-F12 (Fear of progression) questionnaire. Scale Range: 12 - 60 The PAF-12 items are scored on a five-point Likert Scale ranging from 1 ('never') to 5 ('very often'), higher values indicating higher levels of anxiety. Interpretation: Higher scores correspond to greater self-reported levels of fear of progression.
Time frame: Change from baseline to 3 months (also assessed at 6, 9 and 12 months post-baseline)
Determination of usefulness of the program
Usefulness of the program will be measured by a questionnaire
Time frame: Assessed at 3, 6, 9 and 12 months
Determination of Negative Effects
Negative Effects will be measured using the standardized INEP (Inventory for the Assessment of Negative Effects of Psychotherapy) questionnaire.
Time frame: Assessed at 3, 6, 9 and 12 months
Determination of recurrence of breast cancer (local relapse or remote metastasis)
Recurrence of breast cancer (local relapse or remote metastasis) will be determined by a questionnaire
Time frame: Change from baseline to 3 months (also assessed at 6, 9 and 12 months post-baseline)
Frequency of common cold or virus flu
Frequency of common cold or virus flu will be determined by a questionnaire
Time frame: Change from baseline to 3 months (also assessed at 6, 9 and 12 months post-baseline)
Frequency of unscheduled medical encounters
Frequency of unscheduled medical encounters will be determined by a questionnaire
Time frame: Change from baseline to 3 months (also assessed at 6, 9 and 12 months post-baseline)
Plan to share: Yes — Anonymized individual participant data shall be made available upon request for projects such as meta-analyses after completion of the study
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Technical University of Dortmund