Breast CancerOPTIMUNENCT03643640
Evaluating a Novel Web-based Intervention for Breast Cancer Survivors
A study testing Optimune and Care-As-Usual in people with Breast Cancer, run by Technical University of Dortmund at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Optimune and Care-As-Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Sep 2018to 1 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
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)
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Technical University of Dortmund, Leibniz Research Centre for Working Environment and Human Factors
Dortmund, 44139
University Medical Center Leipzig, Department of Medical Psychology and Medical Sociology, Section Psychosocial Oncology
Leipzig, 04103
About this study
Official title: 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.
Read the 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).
- Conditions
- Breast Cancer
- Being tested
- Optimune, Care-As-Usual
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OptimuneBehavioural
Optimune is a web-based psychological intervention developed for women with breast cancer.
Care-As-UsualOther
Participants are free to continue to engage with any treatment they require (i.e., CAU).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Other: Care-As-Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of Quality of Life using the WHOQOL-BREF
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.
Measured: Change from baseline to 3 months (also assessed at 6 months post-baseline)
Determination of Physical Activity using the International Physical Activity Questionnaire
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.
Measured: Change from baseline to 3 months (also assessed at 6 months post-baseline)
Determination of Diet Quality using the Food Quality Questionnaire
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.
Measured: Change from baseline to 3 months (also assessed at 6 months post-baseline)
Secondary outcomes (8)
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
Measured: Change from baseline to 3 months (also assessed at 6 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.
Measured: 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.
Measured: Change from baseline to 3 months (also assessed at 6 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.
Measured: Change from baseline to 3 months (also assessed at 6 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.
Measured: Change from baseline to 3 months (also assessed at 6 months post-baseline)
Determination of insomnia
Insomnia will be measured using the standardized - ISI (Insomnia Severity Index), Scale Range: 0 - 28, higher values indicating increasing severity of insomnia
Measured: Change from baseline to 3 months (also assessed at 6 months post-baseline)
Determination of usefulness of the program
Usefulness of the program will be measured by a questionnaire
Measured: Assessed at 3 and 6 months
Determination of Negative Effects
Negative Effects will be measured using the standardized INEP (Inventory for the Assessment of Negative Effects of Psychotherapy) questionnaire.
Measured: Assessed at 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study start1 Sep 2018
- Primary completion1 Jun 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Dortmund
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leipzig, Gaia AG
- Responsible party
- Principal investigator, Carsten Watzl, Technical University of Dortmund
- Investigators
- Carsten Watzl, PhD, Principal investigator, Leibniz Research Center (IfADo), TU Dortmund
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03643640
- Sponsor's protocol ID
- Optimune Trial Add-on
- Acronym
- OPTIMUNE
- Status last verified
- Oct 2020
- First submitted
- 21 Aug 2018
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual participant data shall be made available upon request for projects such as meta-analyses after completion of the study
Publications
Holtdirk F, Mehnert A, Weiss M, Mayer J, Meyer B, Brode P, Claus M, Watzl C. Results of the Optimune trial: A randomized controlled trial evaluating a novel Internet intervention for breast cancer survivors. PLoS One. 2021 May 7;16(5):e0251276. doi: 10.1371/journal.pone.0251276. eCollection 2021.
PubMed 33961667Holtdirk F, Mehnert A, Weiss M, Meyer B, Watzl C. Protocol for the Optimune trial: a randomized controlled trial evaluating a novel Internet intervention for breast cancer survivors. Trials. 2020 Jan 29;21(1):117. doi: 10.1186/s13063-019-3987-y.
PubMed 31996235
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Web-based Psychological Intervention as add-on to Care as Usual in Breast Cancer Survivors: Effect on Lifestyle and Psychometric Outcome
- ClinicalTrials.gov ID
- NCT03643640
- Acronym / sponsor ID
- OPTIMUNE / Optimune Trial Add-on
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Technical University of DortmundUniversity, hospital or other
- Collaborators
- University of Leipzig, Gaia AG
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 23 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optimune | Experimental | Behavioral: OptimuneOptimune 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. |
| Care-as-Usual | Active comparator | Other: Care-As-UsualAs 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). |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OptimuneOptimune is a web-based psychological intervention developed for women with breast cancer. | Behavioural | Optimune |
| Care-As-UsualParticipants are free to continue to engage with any treatment they require (i.e., CAU). | Other | Care-as-Usual |
Primary outcome
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.
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.
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.
8 secondary outcomes
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)
Determination of cancer-related emotional stress
Time frame: Change from baseline to 3 months (also assessed at 6, 9 and 12 months post-baseline)
Determination of depression
Time frame: 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)
Determination of fear of progression
Time frame: 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)
Determination of usefulness of the program
Time frame: Assessed at 3 and 6 months
Determination of Negative Effects
Time frame: Assessed at 3 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Derived from this study: PubMed 33961667Holtdirk F, Mehnert A, Weiss M, Mayer J, Meyer B, Brode P, Claus M, Watzl C. Results of the Optimune trial: A randomized controlled trial evaluating a novel Internet intervention for breast cancer survivors. PLoS One. 2021 May 7;16(5):e0251276. doi: 10.1371/journal.pone.0251276. eCollection 2021.
- Derived from this study: PubMed 31996235Holtdirk F, Mehnert A, Weiss M, Meyer B, Watzl C. Protocol for the Optimune trial: a randomized controlled trial evaluating a novel Internet intervention for breast cancer survivors. Trials. 2020 Jan 29;21(1):117. doi: 10.1186/s13063-019-3987-y.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carsten Watzl, PhD principal investigator
Leibniz Research Center (IfADo), TU Dortmund
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimune and Care-As-Usual in people with Breast Cancer, run by Technical University of Dortmund at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of Quality of Life using the WHOQOL-BREF (time frame: Change from baseline to 3 months (also assessed at 6 months post-baseline)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03643640, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.