Patients Treated for CancerAPACONCT03949322
Cancer Related Cognitive Impairment
A study testing Adapted Physical Activity Program in people with Patients Treated for Cancer, run by Institut Cancerologie de l'Ouest at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Treated for Cancer
- What is being tested?
- Adapted Physical Activity Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteFrance
- Study dates
- 28 Feb 2019to Sep 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Institut de Cancérologie de l'Ouest
Saint-Herblain, 44800
BOIFFARD Florence, MD, +33240679900, florence.boiffard@ico.unicancer.fr
About this study
Official title: Physical Activity, Cancer and Cognitive Function Disorders : Effects of an Adapted Physical Activity Program on Impaired Cognitive Function in the Management of Cancer
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.
Read the detailed description
- Inclusion procedure and saving selection failures Participation in this study will be offered to patients during their care in day hospital (= inclusion visit). Any patient giving express consent to participation and meeting the criteria for inclusion and non-inclusion will then be included in the study. Each patient will then be identified by his or her initials as a patient number in the study, directly on the basis of collecting the data from the study.
- Study progress for patients Data collection takes place over two different periods. Each period lasts 12 weeks. The Adapted Physical Activity (APA) program is 8 weeks old.
The first period will run from mid-January to early April (first cohort) to collect data from the first patients in the experimental group.
The second period will be from mid-February to the end of April. During this one, it will be necessary to collect the data of the last patients of the experimental group (second cohort) The first two weeks of each period (weeks 1 and 2, weeks 4 and 5) are dedicated to recruiting patients.
During the pre-test session, carried out week 3 for the first cohort and weeks 6 for the second, the patients will carry out different tests and questionnaires: General Information Questionnaires, Education, MoCA (Montreal Cognitive Assessment), GPAQ (Global Physical Activity Questionnaire), Stroop test, test of MEM3 (Echelle Clinique de Mémoire), letter comparison test, HADS (Hospital and Anxiety Depression Scale), and the MFI (Multidimensional Fatigue Inventory). Patients should also wear an actimeter for one week from the day of recruitment.
Patients then take part in a program of Adapted Physical Activity lasting 8 weeks, with 2 sessions per week. The sessions of this program are similar to the APA 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-based exercises.
In the post-test session, which was conducted week 12 for the first cohort and week 15 for the second, some questionnaires and tests are again administered: GPAQ, Stroop test, MEM3 test, letter comparison test, HADS and the MFI. Patients should also wear an actimeter the week before the day of the post-test.
The forecast schedule may be slightly modified depending on unforeseen circumstances and constraints that may occur.
- Conditions
- Patients Treated for Cancer
- Being tested
- Adapted Physical Activity Program
- Keywords
- physical activity, cancer Related Cognitive Impairment
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted Physical Activity ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Adapted Physical Activity Program | Experimental | Patients in the experimental group take part in a program of Adapted Physical Activity lasting 6 weeks, with 2 sessions per week. Receives: Behavioral: Adapted Physical Activity Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of an APA program on cognitive functions (inhibition)
For inhibition, effect of APA program on cognitive functions is evaluated with Stroop task.
Measured: 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.
Measured: 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.
Measured: 8 weeks
Secondary outcomes (6)
To determine if the APA program modifies PA (Physical Activity) patterns in daily life
Evaluated with Global Physical Activity Questionnaire
Measured: 8 weeks
To determine if the APA program modifies PA (Physical Activity) patterns in daily life
Evaluated with Actimeter
Measured: 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.
Level of overall cognitive abilities: Montreal Cognitive Assessment (MOCA)
Measured: 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.
Level of education: questionnaire measuring the number of years of study
Measured: 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.
Level of Anxiety and Depression: Hospital and Anxiety Depression Scale (HADS).
Measured: 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.
Fatigue level: Multidimensional Fatigue Inventor (MFI)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start28 Feb 2019
- Primary completionJun 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Treated for CancerStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Collaborators
- University of Poitiers
- Responsible party
- Sponsor
- Investigators
- BOIFFARD Florence, MD, Principal investigator, Institut de Cancérologie de l'Ouest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03949322
- Sponsor's protocol ID
- ICO-N-2018-21
- Acronym
- APACO
- Status last verified
- May 2019
- First submitted
- 7 May 2019
- Last updated
- 14 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity, Cancer and Cognitive Function Disorders : Effects of an Adapted Physical Activity Program on Impaired Cognitive Function in the Management of Cancer
- ClinicalTrials.gov ID
- NCT03949322
- Acronym / sponsor ID
- APACO / ICO-N-2018-21
- Conditions
- Patients Treated for Cancer
- Keywords
- physical activity, cancer Related Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Collaborators
- University of Poitiers
- Study start
- 28 Feb 2019 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 14 May 2019 (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.
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.
Detailed description
- Inclusion procedure and saving selection failures Participation in this study will be offered to patients during their care in day hospital (= inclusion visit). Any patient giving express consent to participation and meeting the criteria for inclusion and non-inclusion will then be included in the study. Each patient will then be identified by his or her initials as a patient number in the study, directly on the basis of collecting the data from the study.
- Study progress for patients Data collection takes place over two different periods. Each period lasts 12 weeks. The Adapted Physical Activity (APA) program is 8 weeks old.
The first period will run from mid-January to early April (first cohort) to collect data from the first patients in the experimental group.
The second period will be from mid-February to the end of April. During this one, it will be necessary to collect the data of the last patients of the experimental group (second cohort) The first two weeks of each period (weeks 1 and 2, weeks 4 and 5) are dedicated to recruiting patients.
During the pre-test session, carried out week 3 for the first cohort and weeks 6 for the second, the patients will carry out different tests and questionnaires: General Information Questionnaires, Education, MoCA (Montreal Cognitive Assessment), GPAQ (Global Physical Activity Questionnaire), Stroop test, test of MEM3 (Echelle Clinique de Mémoire), letter comparison test, HADS (Hospital and Anxiety Depression Scale), and the MFI (Multidimensional Fatigue Inventory). Patients should also wear an actimeter for one week from the day of recruitment.
Patients then take part in a program of Adapted Physical Activity lasting 8 weeks, with 2 sessions per week. The sessions of this program are similar to the APA 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-based exercises.
In the post-test session, which was conducted week 12 for the first cohort and week 15 for the second, some questionnaires and tests are again administered: GPAQ, Stroop test, MEM3 test, letter comparison test, HADS and the MFI. Patients should also wear an actimeter the week before the day of the post-test.
The forecast schedule may be slightly modified depending on unforeseen circumstances and constraints that may occur.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adapted Physical Activity Program | Experimental | Behavioral: Adapted Physical Activity ProgramPatients in the experimental group take part in a program of Adapted Physical Activity lasting 6 weeks, with 2 sessions per week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Adapted Physical Activity ProgramThe 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. | Behavioural | Adapted Physical Activity Program |
Primary outcome
Effect of an APA program on cognitive functions (inhibition)
Time frame: 8 weeks
For inhibition, effect of APA program on cognitive functions is evaluated with Stroop task.
Effect of an APA program on cognitive functions (speed function of information processing)
Time frame: 8 weeks
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.
Effect of an APA program on cognitive functions (Episodic Memory Function)
Time frame: 8 weeks
For Episodic Memory Function, effect of APA program on cognitive functions is evaluated with MEM III test.
6 secondary outcomes
To determine if the APA program modifies PA (Physical Activity) patterns in daily life
Time frame: 8 weeks
To determine if the APA program modifies PA (Physical Activity) patterns in daily life
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2019.
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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.
BOIFFARD Florence, MD principal investigator
Institut de Cancérologie de l'Ouest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted Physical Activity Program in people with Patients Treated for Cancer, run by Institut Cancerologie de l'Ouest at 1 site in France.
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 6 inclusion and 6 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 14 May 2019. 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 France. 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 BOIFFARD Florence, MD (+33240679900, florence.boiffard@ico.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of an APA program on cognitive functions (inhibition) (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2019.