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The ONE-MIND Study: Rationale and protocol for assessing the effects of ONlinE MINDfulness-based cancer recovery for the prevention of fatigue and other common side effects during chemotherapy.

European journal of cancer care
July 1, 2019
Linda E Carlson et al. (9 authors)
Clinical Trial ProtocolJournal ArticleHuman StudyClinical
Study Details

Study Goal

The researchers aimed to determine if an online group Mindfulness-Based Cancer Recovery (MBCR) program delivered during chemotherapy could reduce fatigue (primary outcome) and improve secondary symptoms like sleep disturbance, pain, and quality of life.

Results Summary

The abstract does not report specific results, but the study design suggests it will evaluate the efficacy of MBCR in reducing fatigue and other symptoms post-chemotherapy, with potential implications for adjunctive symptom management during treatment.

Population

Breast or colorectal cancer patients undergoing common chemotherapy regimens in Calgary, Canada.

Effective Dosage

12 real-time interactive weekly sessions.

Duration

12 weeks.

Interactions

None mentioned.

Extracted Claims (6)
InterventionDirectionEndpointPopulationDosageImpactClaim #
Mindfulness-based cancer recovery (MBCR)
decrease
symptoms including fatigue, insomnia, pain and nausea/vomiting
cancer patients
-
is an evidence-based intervention for treating
#1
online group MBCR programme delivered during CT
decrease
fatigue
cancer patients
-
managing
#2
online group MBCR programme delivered during CT
neutral
sleep disturbance, pain, nausea/vomiting, mood, stress and QoL
cancer patients
-
includes secondary outcomes
#3
online group MBCR programme delivered during CT
neutral
cognitive function, white blood cell counts and return to work
cancer patients
-
includes exploratory outcomes
#4
online MBCR delivered during CT
decrease
fatigue
cancer patients' post-CT
-
significantly reduces
#5
online MBCR delivered during CT
neutral
secondary symptoms
cancer patients
-
impacts
#6
Abstract

Cancer patients often experience poor quality of life (QoL) during chemotherapy (CT) treatments due to side effects including fatigue, insomnia, pain and nausea/vomiting. Mindfulness-based cancer recovery (MBCR) is an evidence-based intervention for treating such symptoms, but has not been investigated as an adjunctive treatment during CT. This study aims to determine the efficacy of an online group MBCR programme delivered during CT in 12 real-time interactive weekly sessions for managing fatigue (primary outcome). Secondary outcomes include sleep disturbance, pain, nausea/vomiting, mood, stress and QoL. Exploratory outcomes include cognitive function, white blood cell counts and return to work. The study is a two-armed randomised controlled waitlist trial with 2:1 allocation to treatment (online group MBCR during CT) or control (waitlist usual care; online MBCR following CT completion) with a target sample size of N = 178. Participants are breast or colorectal cancer patients undergoing common CT regimens in Calgary, Canada. Online assessments using validated self-reported instruments will take place at baseline, post-MBCR, post-CT and 12 months' post-baseline. If online MBCR delivered during CT significantly reduces fatigue in cancer patients' post-CT and also impacts secondary symptoms, this would provide evidence for including mindfulness training as an adjunctive symptom management therapy during CT.

Medical Subject Headings (MeSH)
AdolescentAdultAgedAntineoplastic AgentsBreast NeoplasmsChemotherapy, AdjuvantColorectal NeoplasmsFatigueFemaleHumansInternetMaleMiddle AgedMindfulnessPatient SelectionRandomized Controlled Trials as TopicReturn to WorkSample SizeTelerehabilitationTreatment OutcomeYoung Adult
Study Links
Quality Scores
SafetyNot Assessed
Efficacy75/10
Quality85/10
Citation Metrics
Total Citations18
Citations/Year3.0
Relative Citation Ratio1.10
NIH Percentile53.8%
Research Impact Scores
APT Score0.75
Weight Score2.34
Normalized Score0.67
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