Breast CancerRIVAGENCT05754060
Cognitive Processing Slowness as a Marker of Cognitive Impairment in Non-central Nervous System Cancer Patients
An observational study of Breast Cancer and Colon Cancer, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Breast Cancer, Colon Cancer, Cognitive Impairment
- What is being tested?
- Saint-Louis Lille Battery (SSLIB)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2023to 1 Apr 2026
- Phase
- Observational
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults patients with breast cancer or colon cancer
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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 :
Read more
- 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.
- Conditions
- Breast Cancer, Colon Cancer, Cognitive Impairment
- Being tested
- Saint-Louis Lille Battery (SSLIB)
- Medical subject headings
- Breast Neoplasms, Colonic Neoplasms, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saint-Louis Lille Battery (SSLIB)Other
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)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Saint-Louis Lille Battery (SSLIB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At 4 months
Secondary outcomes (11)
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
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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).
Measured: At 12 months
Cognitive complaint
Cognitive complaint will be assessed using the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) questionnaire v3.
It is made up 37 items divided in four subscales: perceived cognitive impairments (PCI); perceived cognitive abilities ; impact of perceived cognitive impairment on Quality Of Life; and comments from others on cognitive function. It ranges from 0 to 148. The higher the score, the better the cognitive function.
Measured: At inclusion
Cognitive complaint
Cognitive complaint will be assessed using the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) questionnaire v3.
It is made up 37 items divided in four subscales: perceived cognitive impairments (PCI); perceived cognitive abilities ; impact of perceived cognitive impairment on Quality Of Life; and comments from others on cognitive function. It ranges from 0 to 148. The higher the score, the better the cognitive function.
Measured: At 4 months
Cognitive complaint
Cognitive complaint will be assessed using the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) questionnaire v3.
It is made up 37 items divided in four subscales: perceived cognitive impairments (PCI); perceived cognitive abilities ; impact of perceived cognitive impairment on Quality Of Life; and comments from others on cognitive function. It ranges from 0 to 148. The higher the score, the better the cognitive function.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start1 Apr 2023 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05754060
- Sponsor's protocol ID
- APHP220816
- Acronym
- RIVAGE
- Status last verified
- Feb 2023
- First submitted
- 22 Feb 2023
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Processing Slowness as a Marker of Cognitive Impairment in Non-central Nervous System Cancer Patients
- ClinicalTrials.gov ID
- NCT05754060
- Acronym / sponsor ID
- RIVAGE / APHP220816
- Conditions
- Breast Cancer, Colon Cancer, Cognitive Impairment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 3 Mar 2023 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Saint-Louis Lille Battery (SSLIB) | – | Other: 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) |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults patients with breast cancer or colon cancer
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| 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) | Other | Saint-Louis Lille Battery (SSLIB) |
Primary outcome
Proportion of patients for which there is a variation of reaction time between the beginning and during the oncological treatment at M4
Time frame: At 4 months
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
11 secondary outcomes
Proportion of patients for which there is a variation of reaction time between the beginning and after the end of the oncological treatment (M12)
Time frame: At 12 months
Proportion of patients for which there is a variation of reaction time between M4 and M12
Time frame: At 12 months
Anxiety and depression levels
Time frame: At inclusion
Anxiety and depression levels
Time frame: At 4 months
Anxiety and depression levels
Time frame: At 12 months
Cognitive complaint
Time frame: At inclusion
Cognitive complaint
Time frame: At 4 months
Cognitive complaint
Time frame: At 12 months
Quality of life assessed with the QLQ-C30 questionnaire
Time frame: At inclusion
Quality of life assessed with the QLQ-C30 questionnaire
Time frame: At 4 months
Quality of life assessed with the QLQ-C30 questionnaire
Time frame: At 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Colon Cancer, run by Assistance Publique - Hôpitaux de Paris.
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 4 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 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Catherine Belin, Dr (+33171207466, catherine.belin@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients for which there is a variation of reaction time between the beginning and during the oncological treatment at M4 (time frame: At 4 months). 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 8 Mar 2023.