Evaluating a Novel Web-based Intervention for Breast Cancer Survivors (OPTIMUNE)

October 6, 2020 updated by: Carsten Watzl, Technical University of Dortmund

Evaluation of a Web-based Psychological Intervention as add-on to Care as Usual in Breast Cancer Survivors: Effect on Lifestyle and Psychometric Outcome

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. The present study will test the hypothesis that Optimune has an impact on lifestyle parameters and psychometric outcomes. Therefore, 360 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 3 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 quality of life, physical activity and diet three month post-baseline.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 lifestyle parameters and psychometric outcomes, when offered as adjunct to care as usual.

In this study, the investigators will investigate 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 360 women with breast cancer who are past the active eradication phase. 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 3 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) and six months (T2).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
360

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Dortmund, Germany, 44139
        • Technical University of Dortmund, Leibniz Research Centre for Working Environment and Human Factors
      • Leipzig, Germany, 04103
        • University Medical Center Leipzig, Department of Medical Psychology and Medical Sociology, Section Psychosocial Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Eligible are women who

  • had breast cancer diagnosed less than 5 years ago
  • completed acute treatment for breast cancer at least 1 month ago. This applies for surgery, chemotherapy or radiation, whichever occurred last. (Prophylactic treatment with anti-hormones like tamoxifene, 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Behavioral: Optimune
Optimune is a web-based psychological intervention developed for women with breast cancer.
Active Comparator: 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).
Other: Care-As-Usual
Participants are free to continue to engage with any treatment they require (i.e., CAU).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Determination of Quality of Life using the WHOQOL-BREF
Time Frame: Change from baseline to 3 months (also assessed at 6 months post-baseline)

Quality of Life will be measured using the World Health Organization Quality of Life Questionnaire (WHOQOL-BREF), which is a shorter version of the original instrument. Scale Range: 26 to 130.

The WHOQOL-BREF is a 26-item, 5-point rating scale. It measures the following broad domains: physical health, psychological health, social relationships, and environment. Response options range from 1, indicating "very dissatisfied" to 5, indicating "very satisfied" and relate to the last two weeks.

Higher scores on the WHOQOL-BREF correspond to higher self-reported levels of quality of life.
Change from baseline to 3 months (also assessed at 6 months post-baseline)
Determination of Physical Activity using the International Physical Activity Questionnaire
Time Frame: Change from baseline to 3 months (also assessed at 6 months post-baseline)

Physical Activity will be measured using the short version of the International Physical Activity Questionnaire (IPAQ - short).

The short version of the IPAQ is a 7-item questionnaire that assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives. Open-ended questions surrounding individuals' last 7-day recall of physical activity are considered to estimate total physical activity min/week and time spent sitting.

Interpretation: Three levels (categories) of physical activity are proposed: low, moderate and high.
Change from baseline to 3 months (also assessed at 6 months post-baseline)
Determination of Diet Quality using the Food Quality Questionnaire
Time Frame: Change from baseline to 3 months (also assessed at 6 months post-baseline)

Diet Quality will be measured using the Food Quality Questionnaire (FQQ). Scale Range: 0 to 39.

The FQQ is a 10-item, 5-point rating scale. The FQQ is a short food frequency questionnaire, which includes 10 food items on a 5-point rating scale. It focuses on fruit, vegetables, high-sugar foods, processed food, meat and drinks. The aim of the tool is to measure diet quality. Response options range from 0, indicating "daily" to 3" indicating, "once or never". Interpretation: A global diet quality score can be obtained by averaging all the items on the FQQ.
Change from baseline to 3 months (also assessed at 6 months post-baseline)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Determination of cancer-related emotional stress
Time Frame: Change from baseline to 3 months (also assessed at 6, 9 and 12 months post-baseline)

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.
Change from baseline to 3 months (also assessed at 6, 9 and 12 months post-baseline)
Determination of cancer-related fatigue using the Brief Fatigue Inventory Questionnaire
Time Frame: Change from baseline to 3 months (also assessed at 6 months post-baseline)

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
Change from baseline to 3 months (also assessed at 6 months post-baseline)
Determination of depression
Time Frame: Change from baseline to 3 months (also assessed at 6 months post-baseline)

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.
Change from baseline to 3 months (also assessed at 6 months post-baseline)
Determination of anxiety
Time Frame: Change from baseline to 3 months (also assessed at 6 months post-baseline)

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.
Change from baseline to 3 months (also assessed at 6 months post-baseline)
Determination of fear of progression
Time Frame: Change from baseline to 3 months (also assessed at 6 months post-baseline)

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.
Change from baseline to 3 months (also assessed at 6 months post-baseline)
Determination of insomnia
Time Frame: Change from baseline to 3 months (also assessed at 6 months post-baseline)
Insomnia will be measured using the standardized - ISI (Insomnia Severity Index), Scale Range: 0 - 28, higher values indicating increasing severity of insomnia
Change from baseline to 3 months (also assessed at 6 months post-baseline)
Determination of usefulness of the program
Time Frame: Assessed at 3 and 6 months
Usefulness of the program will be measured by a questionnaire
Assessed at 3 and 6 months
Determination of Negative Effects
Time Frame: Assessed at 3 and 6 months
Negative Effects will be measured using the standardized INEP (Inventory for the Assessment of Negative Effects of Psychotherapy) questionnaire.
Assessed at 3 and 6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Determination of recurrence of breast cancer (local relapse or remote metastasis)
Time Frame: Change from baseline to 3 months (also assessed at 6 months post-baseline)
Recurrence of breast cancer (local relapse or remote metastasis) will be determined by a questionnaire
Change from baseline to 3 months (also assessed at 6 months post-baseline)
Frequency of common cold or virus flu
Time Frame: Change from baseline to 3 months (also assessed at 6 months post-baseline)
Frequency of common cold or virus flu will be determined by a questionnaire
Change from baseline to 3 months (also assessed at 6 months post-baseline)
Frequency of unscheduled medical encounters
Time Frame: Change from baseline to 3 months (also assessed at 6 months post-baseline)
Frequency of unscheduled medical encounters will be determined by a questionnaire
Change from baseline to 3 months (also assessed at 6 months post-baseline)
Body Mass Index
Time Frame: Change from baseline to 3 months (also assessed at 6 months post-baseline)
Height and weight will be determined by a questionnaire
Change from baseline to 3 months (also assessed at 6 months post-baseline)
Psychotherapy
Time Frame: Change from baseline to 3 months (also assessed at 6 months post-baseline)
A questionnaire will determine if a psychotherapy has started during the trial
Change from baseline to 3 months (also assessed at 6 months post-baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Technical University of Dortmund

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Leipzig
Gaia AG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Carsten Watzl, PhD, Leibniz Research Center (IfADo), TU Dortmund

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 23, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 8, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Optimune Trial Add-on

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Anonymized individual participant data shall be made available upon request for projects such as meta-analyses after completion of the study

IPD Sharing Time Frame

after completion of the study

IPD Sharing Access Criteria

available upon request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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