Evaluating a Novel Web-based Intervention for Breast Cancer Survivors

NCT03448250 | Terminated

• 1 other identifier: Optimune Trial
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (5)

• concentration of C-reactive protein (CRP)

  Plasma concentration of C-reactive protein (CRP)

  Change from baseline to 6 months (also assessed at 12 months post-baseline)

• circulating Interleukin (IL) 6

  Plasma concentration of IL-6

  Change from baseline to 6 months (also assessed at 12 months post-baseline)

• circulating Tumor necrosis factor (TNF)-α

  Plasma concentration of TNF-α

  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)

  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)

  Change from baseline to 6 months (also assessed at 12 months post-baseline)

Secondary Outcomes (13)

• Plasma Concentrations of Cytokines

  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

  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

  Change from baseline to 6 months (also assessed at 12 months post-baseline)

• Circulating numbers of Lymphocytes, Monocytes, Granulocytes

  Change from baseline to 6 months (also assessed at 12 months post-baseline)

• Phenotypic analysis of T and NK cell subsets

  Change from baseline to 6 months (also assessed at 12 months post-baseline)

Other Outcomes (3)

• Determination of recurrence of breast cancer (local relapse or remote metastasis)

  Change from baseline to 3 months (also assessed at 6, 9 and 12 months post-baseline)

• Frequency of common cold or virus flu

  Change from baseline to 3 months (also assessed at 6, 9 and 12 months post-baseline)

• Frequency of unscheduled medical encounters

  Change from baseline to 3 months (also assessed at 6, 9 and 12 months post-baseline)

Study Arms (2)

Optimune

EXPERIMENTAL

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

Care-as-Usual

ACTIVE COMPARATOR

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

Interventions

Optimune BEHAVIORAL

Optimune is a web-based psychological intervention developed for women with breast cancer.

Optimune

Care-As-Usual OTHER

Participants are free to continue to engage with any treatment they require (i.e., CAU).

Care-as-Usual

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Technical University of Dortmund: lead
• University of Leipzig: collaborator
• Gaia AG: collaborator

Study Sites (2)

Technical University of Dortmund, Leibniz Research Centre for Working Environment and Human Factors

Dortmund, 44139, Germany

Location

University Medical Center Leipzig, Department of Medical Psychology and Medical Sociology, Section Psychosocial Oncology

Leipzig, 04103, Germany

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Carsten Watzl, PhD

  Leibniz Research Center (IfADo), TU Dortmund

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific Director, IfADo

Study Record Dates

• First Submitted: February 7, 2018
• First Posted: February 28, 2018
• Study Start: March 16, 2018
• Primary Completion: September 30, 2021
• Study Completion: April 30, 2022
• Last Updated: May 5, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: after completion of the study
• Access Criteria: available upon request

Locations

DE (2)