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Evaluating a Novel Web-based Intervention for Breast Cancer Survivors

NCT03448250 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2022-05-05

No results posted yet for this study

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

Interventions

BEHAVIORAL

Optimune

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

OTHER

Care-As-Usual

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

Sponsors & Collaborators

  • University of Leipzig

    collaborator OTHER

  • Gaia AG

    collaborator INDUSTRY

  • Technical University of Dortmund

    lead OTHER

Principal Investigators

  • Carsten Watzl, PhD · Leibniz Research Center (IfADo), TU Dortmund

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-16
Primary Completion
2021-09-30
Completion
2022-04-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03448250 on ClinicalTrials.gov