Cancer Related Cognitive Impairment
APACO
Physical Activity, Cancer and Cognitive Function Disorders : Effects of an Adapted Physical Activity Program on Impaired Cognitive Function in the Management of Cancer
1 other identifier
interventional
26
1 country
1
Brief Summary
Various recent scientific data testify to the cognitive deficiencies of cancer patients, called Cancer-Related Cognitive Impairments (CRCI) (Noal, Daireaux \& Joly, 2010). At the same time, regular physical activity (aerobic, muscle building, and yoga) has been shown to decrease CRCIs, although commonly used cognitive measures are self-reported (Zimmer et al., 2016). The investigators will develop an interventional study using objective measures of cognition to confirm the cause-and-effect relationship, and specify the orientation of the cognitive effects of the adapted physical activities. The main and original objective will be to determine if the cognitive functions most affected by CRCI (episodic memory, inhibition, treatment speed) can be optimized in patients undergoing treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 28, 2019
CompletedFirst Submitted
Initial submission to the registry
May 7, 2019
CompletedFirst Posted
Study publicly available on registry
May 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedMay 14, 2019
May 1, 2019
3 months
May 7, 2019
May 13, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Effect of an APA program on cognitive functions (inhibition)
For inhibition, effect of APA program on cognitive functions is evaluated with Stroop task.
8 weeks
Effect of an APA program on cognitive functions (speed function of information processing)
For speed function of information processing, effect of APA program on cognitive functions is evaluated with XO letters comparison test. During the XO letters comparison test, the participants will have to check the maximum number of identical or different boxes according to the combination of the two letters presented (XO, OX, XX or OO) in 30 seconds.
8 weeks
Effect of an APA program on cognitive functions (Episodic Memory Function)
For Episodic Memory Function, effect of APA program on cognitive functions is evaluated with MEM III test.
8 weeks
Secondary Outcomes (6)
To determine if the APA program modifies PA (Physical Activity) patterns in daily life
8 weeks
To determine if the APA program modifies PA (Physical Activity) patterns in daily life
8 weeks
Determine which PA pattern is the best predictor of cognitive performance improvement following the APA program, , by controlling the effect of cognitive risk factors.
8 weeks
Determine which PA pattern is the best predictor of cognitive performance improvement following the APA program, , by controlling the effect of cognitive risk factors.
8 weeks
Determine which PA pattern is the best predictor of cognitive performance improvement following the APA program, , by controlling the effect of cognitive risk factors.
8 weeks
- +1 more secondary outcomes
Study Arms (1)
Adapted Physical Activity Program
EXPERIMENTALPatients in the experimental group take part in a program of Adapted Physical Activity lasting 6 weeks, with 2 sessions per week.
Interventions
The sessions in this program are similar to the adapted physical activity sessions already offered by sports therapy practitioners. This is an aerobic exercise session, with Nordic walking, and a combined session of muscle building and breathing exercises.
Eligibility Criteria
You may qualify if:
- Male or female\> or = 18 years old
- Any patient being treated for a cancerous condition and managed by adjuvant chemotherapy.
- Any type of cancer
- Beneficiary of a social protection scheme
- Having as mother tongue the French language
- Patient information and obtaining express consent
You may not qualify if:
- Protected subjects known as vulnerable (major under legal protection, adults unable to express their consent, subject admitted to a health and social institution).
- Minor subjects
- Pregnant women, likely to be pregnant or breastfeeding
- Subjects with sensory disabilities affecting vision or hearing
- Neurological or psychiatric antecedents
- Persons deprived of liberty or guardianship (including trusteeship).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Institut Cancerologie de l'Ouestlead
- University of Poitierscollaborator
Study Sites (1)
Institut de Cancérologie de l'Ouest
Saint-Herblain, 44800, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
BOIFFARD Florence, MD
Institut de Cancérologie de l'Ouest
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2019
First Posted
May 14, 2019
Study Start
February 28, 2019
Primary Completion
June 1, 2019
Study Completion
September 1, 2019
Last Updated
May 14, 2019
Record last verified: 2019-05