Cancer Related Cognitive Impairment After Chemotherapy: Evaluation of Potential Therapeutic Interventions

NCT03736460 | Unknown

• 1 other identifier: S59396
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Impairment

Outcome Measures

Primary Outcomes (2)

• Subjective cognitive function

  Change in scores on the Cognitive failure questionnaire

  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

  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.

Study Arms (3)

Mindfulness-based intervention

EXPERIMENTAL

Behavioral: Mindfulness

Physical training

ACTIVE COMPARATOR

Behavioral: Physical training

Wait-list

NO INTERVENTION

Interventions

Mindfulness BEHAVIORAL

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.

Mindfulness-based intervention

Physical training BEHAVIORAL

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.

Physical training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

Related Publications (1)

• 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.

  PMID: 32293533 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Mindfulness; Physical Conditioning, Human

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Sabine Deprez, PhD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katleen Van der Gucht, PhD

CONTACT

+3216373183; katleen.vandergucht@kuleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Investigator at Leuven Mindfulness Centre | KU Leuven

Study Record Dates

• First Submitted: November 1, 2018
• First Posted: November 9, 2018
• Study Start: October 1, 2018
• Primary Completion: March 1, 2021
• Study Completion: September 30, 2021
• Last Updated: April 22, 2020

Record last verified: 2020-04

Locations

BE (1)