Clinical trial NCT03736460: Cancer Related Cognitive Impairment After Chemotherapy: Evaluation of Potential Therapeutic Interventions
Official title: A Mindfulness-based Intervention for Breast-cancer Patients With Cognitive Impairment After Chemotherapy: Study Protocol of a Three-Group Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cognitive Impairment
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2018-11-09
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* a history of mental retardation, psychiatric and or neurological disorder
* previous participation in a mindfulness training

Primary outcomes:
measure: Subjective cognitive function
timeFrame: 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.
measure: Changes in brain functional connectivity in the attention network
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
affiliation: UZ Leuven
name: Sabine Deprez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.