Cognitive Processing Slowness as a Marker of Cognitive Impairment in Non-central Nervous System Cancer Patients (RIVAGE)

Cancer is a frequent disease considering that one person out of three will be confronted with it in their lifetime. Cancer patients often express complaints related to cognitive impairment as an outcome of their oncological treatment. These cognitive disorders have a significant impact on the patient's and their carer's quality of life. Therefore, it appears necessary to have a reliable, quick and simple tool in order to detect cognitive impairment.

The rationale of this study relies on 3 main points :

• The cognitive complaint frequently reported by cancer patients
• The difficulty in reliably demonstrating the cause of this complaint through conventional neuropsychological tests
• The interest of cognitive processing speed as an indicator of cognitive dysfunction

The primary objective of the study is to evaluate a potential variation of cognitive processing speed at the Saint-Louis Lille Battery (SSLIB) between the beginning and during (4 months after the beginning) the oncological treatment of adults with breast cancer or colon cancer.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer; Cognitive Impairment; Colon Cancer
• Intervention / Treatment: Other: Saint-Louis Lille Battery (SSLIB)

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Catherine Belin, Dr; Phone Number: +33171207466; Email: catherine.belin@aphp.fr
• Study Contact Backup: Name: Matthieu Resche Rigon, Pr; Phone Number: +33142499742; Email: matthieu.resche-rigon@u-paris.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults patients with breast cancer or colon cancer

Description

Inclusion Criteria:

• Beginning an oncological treatment for breast or colon cancer
• Patients of age ≥ 20 and ≤ 70 years old
• Cancer diagnosis announcement delivered since less than 3 weeks (+/- a week)
• Patient affiliated to French social security

Exclusion Criteria:

• Patient's opposition to the study
• Notion of an abnormal cerebral scan or MRI
• Drug use (alcohol, narcotics…)
• Chronic (≥ 15 days) treatment with corticosteroids > 1mg/kg/j (prednisone or equivalent)
• Ocular pathology or cognitive disorder impairing comprehension and reading abilities
• Patients under curatorship, guardianship or under the protection of justice

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Saint-Louis Lille Battery (SSLIB); Saint-Louis Lille Battery (SSLIB) is composed of three tests studying the speed of cognitive processing and proposed to the subjects on a tactile tablet. These three tasks are: (a) Reaction time tasks specifically developed for this study b) A digital adaptation of the WAIS-IV code subtest c) A digital version of the Trail Making Test (A and B)	Other: Saint-Louis Lille Battery (SSLIB); Saint-Louis Lille Battery (SSLIB) composed of three tests studying the speed of cognitive processing and proposed to the subjects on a tactile tablet. These three tasks are: (a) Reaction time tasks specifically developed for this study b) A digital adaptation of the WAIS-IV code subtest c) A digital version of the Trail Making Test (A and B)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients for which there is a variation of reaction time between the beginning and during the oncological treatment at M4	The variation will be defined as follows : Mild if the reaction times vary for only one of the Saint-Louis Lille Battery (SLLIB) tests; Moderate if the variation appears on two of the SLLIB tests; Severe if the variation appears on three of the SLLIB tests	At 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients for which there is a variation of reaction time between the beginning and after the end of the oncological treatment (M12)	The variation will be defined as follows : Mild if the reaction times vary for only one of the Saint-Louis Lille Battery (SLLIB) tests; Moderate if the variation appears on two of the SLLIB tests; Severe if the variation appears on three of the SLLIB tests	At 12 months
Proportion of patients for which there is a variation of reaction time between M4 and M12	The variation will be defined as follows : Mild if the reaction times vary for only one of the Saint-Louis Lille Battery (SLLIB) tests; Moderate if the variation appears on two of the SLLIB tests; Severe if the variation appears on three of the SLLIB tests	At 12 months
Anxiety and depression levels	Anxiety and depression levels will be assessed using the Hamilton Anxiety Depression scale : The HAD scale is a self-assessment scale for detecting states of depression and anxiety in the setting of an hospital medical outpatient clinic. HADS is a self-administered scale of 14 items which assessed levels of depression and anxiety, divided into 2 subscales of 7 items (Anxiety or HADS-A, Depression or HADS-D). Each item is scored on a scale of 0 to 3. A score is generated for each of the two sub-scales (sum of the 7 items, ranging from 0 to 21). Limit scores, for each of the scores, distinguish: non-cases or asymptomatic ones (score ≤ 7); probable or borderline cases (score 8-10); clearly or clinically symptomatic cases (score ≥ 11).	At inclusion
Anxiety and depression levels	Anxiety and depression levels will be assessed using the Hamilton Anxiety Depression scale : The HAD scale is a self-assessment scale for detecting states of depression and anxiety in the setting of an hospital medical outpatient clinic. HADS is a self-administered scale of 14 items which assessed levels of depression and anxiety, divided into 2 subscales of 7 items (Anxiety or HADS-A, Depression or HADS-D). Each item is scored on a scale of 0 to 3. A score is generated for each of the two sub-scales (sum of the 7 items, ranging from 0 to 21). Limit scores, for each of the scores, distinguish: non-cases or asymptomatic ones (score ≤ 7); probable or borderline cases (score 8-10); clearly or clinically symptomatic cases (score ≥ 11).	At 4 months
Anxiety and depression levels	Anxiety and depression levels will be assessed using the Hamilton Anxiety Depression scale : The HAD scale is a self-assessment scale for detecting states of depression and anxiety in the setting of an hospital medical outpatient clinic. HADS is a self-administered scale of 14 items which assessed levels of depression and anxiety, divided into 2 subscales of 7 items (Anxiety or HADS-A, Depression or HADS-D). Each item is scored on a scale of 0 to 3. A score is generated for each of the two sub-scales (sum of the 7 items, ranging from 0 to 21). Limit scores, for each of the scores, distinguish: non-cases or asymptomatic ones (score ≤ 7); probable or borderline cases (score 8-10); clearly or clinically symptomatic cases (score ≥ 11).	At 12 months
Cognitive complaint	Cognitive complaint will be assessed using the FACT-Cog questionnaire	At inclusion
Cognitive complaint	Cognitive complaint will be assessed using the FACT-Cog questionnaire	At 4 months
Cognitive complaint	Cognitive complaint will be assessed using the FACT-Cog questionnaire	At 12 months
Quality of life assessed with the QLQ-C30 questionnaire	Quality of life evaluated using questionnaire "European Organization for Research and Treatment of Cancer Quality of Life Questionnaire" (EORTC QLQ-C30- v3). The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. A high score for a functional scale represents a high/healthy level of functioning. A high score for the global health status/ QoL represents a high QoL and a high score for a symptom scale/item represents a high level of symptomatology/problems.	At inclusion
Quality of life assessed with the QLQ-C30 questionnaire	Quality of life evaluated using questionnaire "European Organization for Research and Treatment of Cancer Quality of Life Questionnaire" (EORTC QLQ-C30- v3). The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. A high score for a functional scale represents a high/healthy level of functioning. A high score for the global health status/ QoL represents a high QoL and a high score for a symptom scale/item represents a high level of symptomatology/problems.	At 4 months
Quality of life assessed with the QLQ-C30 questionnaire	Quality of life evaluated using questionnaire "European Organization for Research and Treatment of Cancer Quality of Life Questionnaire" (EORTC QLQ-C30- v3). The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. A high score for a functional scale represents a high/healthy level of functioning. A high score for the global health status/ QoL represents a high QoL and a high score for a symptom scale/item represents a high level of symptomatology/problems.	At 12 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2023
• Primary Completion (Anticipated): August 1, 2025
• Study Completion (Anticipated): April 1, 2026

Study Registration Dates

• First Submitted: February 22, 2023
• First Submitted That Met QC Criteria: February 22, 2023
• First Posted (Actual): March 3, 2023

Study Record Updates

• Last Update Posted (Actual): March 3, 2023
• Last Update Submitted That Met QC Criteria: February 22, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neoplasms; Neoplasms by Site; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Nervous System Neoplasms
• Other Study ID Numbers: APHP220816

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No