Cancer Related Cognitive Impairment

NCT ID: NCT03949322

Last Updated: 2019-05-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-28
• Study Completion Date: 2019-09-30

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.

Detailed Description

1. 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.

2. 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Adapted Physical Activity Program

Patients in the experimental group take part in a program of Adapted Physical Activity lasting 6 weeks, with 2 sessions per week.

Group Type: EXPERIMENTAL

Adapted Physical Activity Program

Intervention Type: BEHAVIORAL

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.

Interventions

Adapted Physical Activity Program

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Male or female> or = 18 years old

2. Any patient being treated for a cancerous condition and managed by adjuvant chemotherapy.

3. Any type of cancer

4. Beneficiary of a social protection scheme

5. Having as mother tongue the French language

6. Patient information and obtaining express consent

Exclusion Criteria

1. Protected subjects known as vulnerable (major under legal protection, adults unable to express their consent, subject admitted to a health and social institution).

2. Minor subjects

3. Pregnant women, likely to be pregnant or breastfeeding

4. Subjects with sensory disabilities affecting vision or hearing

5. Neurological or psychiatric antecedents

6. Persons deprived of liberty or guardianship (including trusteeship).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Poitiers

OTHER

Sponsor Role: collaborator

Institut Cancerologie de l'Ouest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

BOIFFARD Florence, MD

Role: PRINCIPAL_INVESTIGATOR

Institut de Cancérologie de l'Ouest

Locations

Institut de Cancérologie de l'Ouest

Saint-Herblain, , France

Site Status: RECRUITING

Countries

France

Central Contacts

BOIFFARD Florence, MD

Role: CONTACT

florence.boiffard@ico.unicancer.fr

+33240679900

PACTEAU Valérie

Role: CONTACT

valerie.pacteau@ico.unicancer.fr

+33240679908

Facility Contacts

BOIFFARD Florence, MD

Role: primary

florence.boiffard@ico.unicancer.fr

+33240679900

Other Identifiers

ICO-N-2018-21

Identifier Type: -

Identifier Source: org_study_id