Cognitive ImpairmentNCT03736460
Cancer Related Cognitive Impairment After Chemotherapy: Evaluation of Potential Therapeutic Interventions
A study testing Mindfulness and Physical training in people with Cognitive Impairment, run by KU Leuven at 1 site in Belgium.
Trial summary
Background: Mindfulness has been applied to improve after cancer care by enhancing psychological well-being; however, little is known about its impact on cognitive impairment experienced by cancer patients after chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Cognitive Impairment
- What is being tested?
- Mindfulness and Physical training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Oct 2018to 30 Sep 2021
- 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of breast cancer at an early stage with or without solitary metastases (except solitary brain metastases)
- completed treatment (surgery and chemotherapy) minimum 6 months and maximum 5 years before
- significant cognitive complaints as measured by the Cognitive Failure questionnaire (CFQ total score > mean study Ponds + 1 SD or on 2 or more of the CFQ extra questions (T/E) > mean study Ponds + 1 SD; (Ponds, Van Boxtel, \& Jolles, 2006))
- have sufficient understanding of Dutch
Who cannot join
- a history of mental retardation, psychiatric and or neurological disorder
- previous participation in a mindfulness training
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven, 3000
Sabine Deprez, PhD, +32 16349027, sabine.deprez@uzleuven.be
Katleen Van der Gucht, PhD, +3216373183, katleen.vandergucht@kuleuven.be
About this study
Official title: A Mindfulness-based Intervention for Breast-cancer Patients With Cognitive Impairment After Chemotherapy: Study Protocol of a Three-Group Randomized Controlled Trial
Background: Mindfulness has been applied to improve after cancer care by enhancing psychological well-being; however, little is known about its impact on cognitive impairment experienced by cancer patients after chemotherapy. Mindfulness may be relevant in tackling cognitive impairment by decreasing emotional distress and fatigue, by decreasing inflammation, and by strengthening brain functional connectivity. The aim of the present study protocol is to evaluate the efficacy and mechanisms of a mindfulness-based intervention to reduce cognitive impairment in breast-cancer patients after chemotherapy.
Methods: The present study is a three-group randomized controlled trial with assessments at baseline, one-three weeks after the intervention and at three months follow-up. One hundred twenty breast cancer patients who ended treatment minimum 6 months and maximum 5 years before and who have cognitive complaints will be enrolled. They will be randomized into one of the following three study arms: (1) a mindfulness-based intervention group (n=40), (2) an active control condition based on physical training (n=40), or (3) a waitlist control group (n=40). Both the mindfulness-based intervention and the active control condition exist of four group sessions (3 hours for the mindfulness condition and 2 hours for the physical training) spread over 8 weeks. The primary outcomes will be cognitive complaints as measured by the cognitive failure questionnaire and changes in brain functional connectivity in the attention network. Secondary outcomes will be (1) levels of emotional distress, fatigue, mindfulness; (2) neurocognitive tests; (3) structural and functional brain changes using MR imaging, and (4) inflammation.
Discussion: The study will examine the impact of a mindfulness-based intervention on cognitive impairment in breast-cancer patients. If the findings of this study confirm the effectiveness of a mindfulness-based program to reduce cognitive impairment, it will be possible to improve quality of life for ex-cancer patients. We will inform health care providers about the potential use of a mindfulness-based intervention as a non-pharmaceutical, low-threshold mental health intervention to improve cognitive impairment after cancer.
- Conditions
- Cognitive Impairment
- Being tested
- Mindfulness, Physical training
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindfulnessBehavioural
The mindfulness-based intervention adheres to a standardized protocol developed from the MBSR curriculum (Kabat-Zinn, 1990). The program consists of four 3h group sessions spread over 8 weeks. Each session consists of guided experiential mindfulness exercises (e.g. focus on the breath, body scan, breathing space, mindful movement, sitting meditation), sharing of experiences of these exercises, reflection in small groups, psycho-education (e.g. stress, depression, fear of cancer recurrence, self-care) and review of home practices.
Physical trainingBehavioural
This intervention is based on the recommended levels of physical activity for adults aged 18 - 64 year from the World Health Organization. These recommendations are the same for women after a breast cancer treatment (Schmitz et al., 2010). Just as the mindfulness intervention this will consist of four 2h group sessions spread over 8 weeks. Each session will consist of psycho-education (e.g. basics of movement, advantages of physical activity, training-principles), endurance and resistance training, stretching, balance and relaxation exercises, sharing of experiences of these exercises and review of home practices.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-based intervention | Experimental | Not described Receives: Behavioral: Mindfulness |
| Physical training | Active comparator | Not described Receives: Behavioral: Physical training |
| Wait-list | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective cognitive function
Change in scores on the Cognitive failure questionnaire
Measured: Measurements will take place at baseline (i.e. one to three weeks before randomization), one to three weeks after the intervention and three months after the intervention.
Changes in brain functional connectivity in the attention network
fMRI imaging
Measured: Measurements will take place at baseline (i.e. one to three weeks before randomization), one to three weeks after the intervention and three months after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start1 Oct 2018
- Primary completion1 Mar 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katleen Van der Gucht, KU Leuven
- Investigators
- Sabine Deprez, PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03736460
- Sponsor's protocol ID
- S59396
- Status last verified
- Apr 2020
- First submitted
- 1 Nov 2018
- Last updated
- 22 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Van der Gucht K, Melis M, Ahmadoun S, Gebruers A, Smeets A, Vandenbulcke M, Wildiers H, Neven P, Kuppens P, Raes F, Sunaert S, Deprez S. A mindfulness-based intervention for breast cancer patients with cognitive impairment after chemotherapy: study protocol of a three-group randomized controlled trial. Trials. 2020 Mar 23;21(1):290. doi: 10.1186/s13063-020-4204-8.
PubMed 32293533
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mindfulness-based Intervention for Breast-cancer Patients With Cognitive Impairment After Chemotherapy: Study Protocol of a Three-Group Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03736460
- Acronym / sponsor ID
- S59396
- Conditions
- Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 9 Nov 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.
Background: Mindfulness has been applied to improve after cancer care by enhancing psychological well-being; however, little is known about its impact on cognitive impairment experienced by cancer patients after chemotherapy. Mindfulness may be relevant in tackling cognitive impairment by decreasing emotional distress and fatigue, by decreasing inflammation, and by strengthening brain functional connectivity. The aim of the present study protocol is to evaluate the efficacy and mechanisms of a mindfulness-based intervention to reduce cognitive impairment in breast-cancer patients after chemotherapy.
Methods: The present study is a three-group randomized controlled trial with assessments at baseline, one-three weeks after the intervention and at three months follow-up. One hundred twenty breast cancer patients who ended treatment minimum 6 months and maximum 5 years before and who have cognitive complaints will be enrolled. They will be randomized into one of the following three study arms: (1) a mindfulness-based intervention group (n=40), (2) an active control condition based on physical training (n=40), or (3) a waitlist control group (n=40). Both the mindfulness-based intervention and the active control condition exist of four group sessions (3 hours for the mindfulness condition and 2 hours for the physical training) spread over 8 weeks. The primary outcomes will be cognitive complaints as measured by the cognitive failure questionnaire and changes in brain functional connectivity in the attention network. Secondary outcomes will be (1) levels of emotional distress, fatigue, mindfulness; (2) neurocognitive tests; (3) structural and functional brain changes using MR imaging, and (4) inflammation.
Discussion: The study will examine the impact of a mindfulness-based intervention on cognitive impairment in breast-cancer patients. If the findings of this study confirm the effectiveness of a mindfulness-based program to reduce cognitive impairment, it will be possible to improve quality of life for ex-cancer patients. We will inform health care providers about the potential use of a mindfulness-based intervention as a non-pharmaceutical, low-threshold mental health intervention to improve cognitive impairment after cancer.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based intervention | Experimental | Behavioral: Mindfulness |
| Physical training | Active comparator | Behavioral: Physical training |
| Wait-list | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of breast cancer at an early stage with or without solitary metastases (except solitary brain metastases)
- completed treatment (surgery and chemotherapy) minimum 6 months and maximum 5 years before
- significant cognitive complaints as measured by the Cognitive Failure questionnaire (CFQ total score > mean study Ponds + 1 SD or on 2 or more of the CFQ extra questions (T/E) > mean study Ponds + 1 SD; (Ponds, Van Boxtel, \& Jolles, 2006))
- have sufficient understanding of Dutch
Key exclusion criteria (2 listed)
- a history of mental retardation, psychiatric and or neurological disorder
- previous participation in a mindfulness training
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 |
|---|---|---|
| MindfulnessThe mindfulness-based intervention adheres to a standardized protocol developed from the MBSR curriculum (Kabat-Zinn, 1990). The program consists of four 3h group sessions spread over 8 weeks. Each session consists of guided experiential mindfulness exercises (e.g. focus on the breath, body scan, breathing space, mindful movement, sitting meditation), sharing of experiences of these exercises, reflection in small groups, psycho-education (e.g. stress, depression, fear of cancer recurrence, self-care) and review of home practices. | Behavioural | Mindfulness-based intervention |
| Physical trainingThis intervention is based on the recommended levels of physical activity for adults aged 18 - 64 year from the World Health Organization. These recommendations are the same for women after a breast cancer treatment (Schmitz et al., 2010). Just as the mindfulness intervention this will consist of four 2h group sessions spread over 8 weeks. Each session will consist of psycho-education (e.g. basics of movement, advantages of physical activity, training-principles), endurance and resistance training, stretching, balance and relaxation exercises, sharing of experiences of these exercises and review of home practices. | Behavioural | Physical training |
Primary outcome
Subjective cognitive function
Time frame: Measurements will take place at baseline (i.e. one to three weeks before randomization), one to three weeks after the intervention and three months after the intervention.
Change in scores on the Cognitive failure questionnaire
Changes in brain functional connectivity in the attention network
Time frame: Measurements will take place at baseline (i.e. one to three weeks before randomization), one to three weeks after the intervention and three months after the intervention.
fMRI imaging
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2020.
- Derived from this study: PubMed 32293533Van der Gucht K, Melis M, Ahmadoun S, Gebruers A, Smeets A, Vandenbulcke M, Wildiers H, Neven P, Kuppens P, Raes F, Sunaert S, Deprez S. A mindfulness-based intervention for breast cancer patients with cognitive impairment after chemotherapy: study protocol of a three-group randomized controlled trial. Trials. 2020 Mar 23;21(1):290. doi: 10.1186/s13063-020-4204-8.
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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.
Sabine Deprez, PhD principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness and Physical training in people with Cognitive Impairment, run by KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 22 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katleen Van der Gucht, PhD (+3216373183, katleen.vandergucht@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective cognitive function (time frame: Measurements will take place at baseline (i.e. one to three weeks before randomization), one to three weeks after the intervention and three months after the intervention.). The study lists 2 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 NCT03736460, which also lists 1 linked publication.
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 22 Apr 2020.