Evaluating a Novel Web-based Intervention for Breast Cancer Survivors

NCT ID: NCT03448250

Last Updated: 2022-05-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-16
• Study Completion Date: 2022-04-30

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).

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Optimune

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.

Group Type: EXPERIMENTAL

Optimune

Intervention Type: BEHAVIORAL

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

Care-as-Usual

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).

Group Type: ACTIVE_COMPARATOR

Care-As-Usual

Intervention Type: OTHER

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

Interventions

Optimune

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

Intervention Type: BEHAVIORAL

Care-As-Usual

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Leipzig

OTHER

Sponsor Role: collaborator

Gaia AG

INDUSTRY

Sponsor Role: collaborator

Technical University of Dortmund

OTHER

Sponsor Role: lead

Responsible Party

Carsten Watzl

Scientific Director, IfADo

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carsten Watzl, PhD

Role: PRINCIPAL_INVESTIGATOR

Leibniz Research Center (IfADo), TU Dortmund

Locations

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

Dortmund, , Germany

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

Leipzig, , Germany

Countries

Germany

Other Identifiers

Optimune Trial

Identifier Type: -

Identifier Source: org_study_id