Behaviors and Mental Disorders

All Conditions

Cognitive Dysfunction

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

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.

Adapted Physical Activity Program

BOIFFARD Florence, MD

PACTEAU Valérie

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.

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.

Cancer Related Cognitive Impairment

Physical Activity, Cancer and Cognitive Function Disorders : Effects of an Adapted Physical Activity Program on Impaired Cognitive Function in the Management of Cancer

For inhibition, effect of APA program on cognitive functions is evaluated with Stroop task.

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.

For Episodic Memory Function, effect of APA program on cognitive functions is evaluated with MEM III test.

Evaluated with Global Physical Activity Questionnaire

Level of overall cognitive abilities: Montreal Cognitive Assessment (MOCA)

Level of education: questionnaire measuring the number of years of study

Level of Anxiety and Depression: Hospital and Anxiety Depression Scale (HADS).

Fatigue level: Multidimensional Fatigue Inventor (MFI)

University of Poitiers

Institut Cancerologie de l'Ouest

Cognition Disorders

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

Over 12 weeks this group will be instructed to complete 3 weekly sessions of Computerized Cognitive Training, in addition to a weekly 1 hour remote CO- OP (Meta cognitive strategy training) session. Each participant will set three occupational goals that will be the focus of the CO -OP treatment

This group will be instructed to complete 3 weekly sessions of Computerized Cognitive Training

The CO-OP is a client-centered, goal directed approach aimed at enabling individuals to identify strategies that will improve daily function. A Weekly (1hr) session is delivered remotely via video conferencing.

Cognitive orientation to daily occupational performance (CO-OP)

The BrainHQ training targets multiple cognitive domains. The training will be delivered remotely, using a web-based program. Training progresses in an adaptive, individualized manner, based on individual progression of each participant . Participants are required to practice a minimum of half hour, three times a week (total of 1.5hr)

Computerized Cognitive Training (BrainHQ, posit science)

Yafit Gilboa, PhD

Cancer survival rates have increased dramatically in recent years. However, many survivors report cognitive decline following treatment, which significantly impairs their quality of life. Online cognitive training programs have shown promise in improving cognitive functions in cancer survivors, but most studies report limited impact of training on everyday function. A complementary treatment approach is functional treatment delivered by occupational therapists, which directly targets daily function. Combining the two approaches has the potential to overcome the limitations of both approaches, enabling improved cognitive functions and transfer to daily function. Remotely-administrated interventions further make treatment accessible and cost-effective. The current study is aimed at testing the efficacy of a novel, combined, remotely-delivered treatment approach: Cognitive Retraining and Functional Treatment(CRAFT), using a Randomized Controlled Trial (RCT) design. 90 cancer survivors will be randomly assigned to receive 15 weeks of either the combined treatment, computerized training only, or treatment-as-usual. Outcomes will be assessed at completion, and following 3 months of no contact, to test immediate and enduring effects of treatment. Baseline predictors for treatment response will be further assessed.

Positive results in the proposed study could potentially change the therapeutic landscape for rehabilitation of cancer-related cognitive decline, which currently impair the lives of millions worldwide.

Randomization will take place only after the investigator will complete baseline assessment, so the assessment procedure wont be affected by group allocation. In addition, the investigator who will assess the outcomes post intervention and at 3 month follow up will be blind to the intervention allocation.

Combined Model of Online Remote Interventions for Cancer-Related Cognitive Impairment

A semi-structured interview used to assess the self-perception of clients' performance and satisfaction with their level of participation in daily functioning regarding the five most important problems they identified. The patient rates each problem on a 10-point scale indicating his level of performance (1= not able to do it at all, 10= able to do it extremely well) and level of satisfaction (1= not satisfied at all, 10 = extremely satisfied). Change is assessed by administering the interview at different time points.

Computerized Assessment will be used to assess neuro-cognitive function using five different tasks from posit science. Domains that will be assessed are sustained attention, visual working memory, speed of processing (visual and auditory) and flexibility

A self-report questionnaire for cancer patients with cognitive function issues. The tool includes 37-items assessing memory, concentration, language and thinking abilities. The items are grouped into 4 subscales: perceived cognitive impairment (PCI), perceived cognitive abilities (PCA), comments from others (OTH), and impact on quality of life (QOL). The items are rated on a 5-point Likert scale (0=never, 4 =several times a day) regarding the past 7 days, higher scores indicating greater QOL.

A patient reported quality of life questionnaire commonly used in cancer survivors. The tool consists of 21-statements on which the respondent is asked to think of the last week and determine his level of agreement to each statement on a 5-point scale (0=not at all, 4= very strongly agree), higher scores indicate greater QOL.

A self-report measure for the screening and severity of depressive symptomatology. The nine items in the questionnaire regard the frequency of symptoms within the last 2 weeks and are rated on a four-point Likert scale (0= not at all, 3=almost every day). The maximum score is 27, with higher scores reflecting more depressive symptoms.

A self-report measure used for the screening and severity of GAD, It includes 7 items describing the severity of the patient's anxiety over the past 2 weeks on a four- point Likert scale (0= not at all sure, 3= nearly every day). The sum score ranges from 0 to 21, with values of 5, 10, 15 indicated mild, moderate or severe anxiety symptoms

A self-report questionnaire used to assess rumination among adults. The RRS includes 22 items describing responses to depressed mood. Items are rated on a 4-point Likert scale (1= almost never, 4= almost always). A total score can be calculated, summing all 22 items scores (22-88), higher scores indicating more rumination.

A fatigue measure used to assess cancer patients at the active or survivor stage. The 13-item questionnaire utilizing a five-point Likert scale (0 = not at all, 4=very much so). The total score varies from 0 - 52, higher score indicating more fatigue

A self administered questionnaire used to evaluate self-efficacy. The questionnaire includes eight items that are rated on a five- point Likert scale (1= strongly disagree, 5=strongly agree). The total score ranges from 9 to 40, with higher scores reflecting better self-efficacy.

An observational measure, used to assess actual performance of client-selected activities. Score ranges between 1 (0% task completion) to 10 (100% of task completion) and is established by therapist thoroughly questioning client about performance using explicit questions.

A questionnaire used to measure co-presence and social presence of adults participating in technology based social interactions

A satisfaction questionnaire and interview were developed for the use of this study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cancer Related Cognitive Impairment	NCT03949322	Patients Treate...	Adapted Physica...	18 Years -	Institut Cancerologie de l'Ouest
Cancer Related Cognitive Impairment	NCT03949322	Patients Treate...	Adapted Physica...	18 Years -	Institut Cancerologie de l'Ouest
Combined Model of Online Remote Interventions for Cancer-Related Cognitive Impairment	NCT04210778	Cognitive Decli... Cancer	Cognitive orien... Computerized Co...	18 Years -	Hadassah Medical Organization
Combined Model of Online Remote Interventions for Cancer-Related Cognitive Impairment	NCT04210778	Cognitive Decli... Cancer	Cognitive orien... Computerized Co...	18 Years -	Hadassah Medical Organization

Spots Global Cancer Trial Database for cancer related cognitive impairment