Overview
Breast cancer treatments are associated with frequent and sometimes severe adverse effects that may significantly impair quality of life and lead to functional disability. Chronic pain and cognitive impairment are common treatment-related complications. However, no study has yet investigated the influence of cancer treatment-related cognitive impairment on chronic pain in this population.
Primary Objective:
To evaluate the influence of cognitive impairment, defined as a significant alteration in the Global Composite Score (GCS), measured 6 months (±1 week) after completion of chemotherapy, on chronic pain over a one-year period following inclusion. Chronic pain is defined as persistent pain intensity ≥4.
The GCS includes 8 measures derived from cognitive tests assessing long-term memory, inhibition, cognitive flexibility, verbal fluency (categorical and phonemic), nonverbal fluency, working memory, and phasic attention.
The primary endpoint is the comparison of the percentage of patients with chronic pain between patients with and without cognitive impairment at 6 months after chemotherapy completion (T3).
Secondary Objectives:
- Compare the percentage of chronic pain in patients with and without cognitive impairment at T2 (±2 weeks after chemotherapy completion), based on persistent pain intensity ≥4/10 on the Brief Pain Inventory (BPI).
- Compare chronic pain characteristics and pain-related disability between patients with and without cognitive impairment at T2 and T3, including etiology, incidence, severity, localization, and disability. Pain characteristics will be assessed using the BPI, McGill Pain Questionnaire, DN4, NPSI, and a body diagram.
- Compare, at T2 and T3, cognitive test scores used to calculate the GCS in patients with chronic pain to determine whether impairment in specific cognitive functions has a greater influence on chronic pain.
- Compare the percentage of chronic pain in patients with cognitive complaints versus those without cognitive complaints at T2 and T3. Cognitive complaints will be assessed using the FACT-Cog and WMQ questionnaires.
- Evaluate the influence of cognitive impairment on pain coping strategies at T2 and T3 using the Coping Strategies Questionnaire (CSQ).
- Evaluate the influence of cognitive impairment on fatigue, anxiety, depressive symptoms, and sleep disturbances in patients with and without chronic pain at T2 and T3. Fatigue will be assessed using the MFI, sleep disturbances using the PSQI, and anxiety/depressive symptoms using the HADS.
Assessments will be performed at the following time points:
T1: before chemotherapy, but after surgery T2: after completion of chemotherapy (± 2 weeks) T3: 6 months after completion of chemotherapy (± 1 week)
Description
Benefits: Patients experiencing chronic pain may benefit from pain management at specialized pain centers (CETD - Ambroise Paré Hospital, Institut Curie, Saint-Cloud). Patients may also be referred to a Memory Resource and Research Center (CMRR) for management of cognitive impairment, or to community-based speech therapists or neuropsychologists.
Risks: There are no anticipated risks for breast cancer patients or control participants, as the study only involves neuropsychological testing and questionnaire completion.
Constraints: Participants will be required to attend study visits to complete neuropsychological assessments and questionnaires throughout the longitudinal follow-up period.
Eligibility
Inclusion criteria:
- Female patients aged 35 to 65 years
- Signed informed consent
- Affiliated with the French social security system or entitled beneficiary
- Able to read and understand French
- Willing to participate and able to comply with study procedures
- Diagnosed with non-metastatic, hormone receptor-positive breast cancer
- No prior chemotherapy exposure
- Adjuvant treatment setting after surgery)
- Receiving the same treatment sequence: surgery, chemotherapy (anthracycline- and taxane-based regimens), radiotherapy, and hormone therapy.
Exclusion criteria:
- Central nervous system disorders
- MMSE score \<26 assessed by the psychologist at the beginning of the inclusion visit (post-inclusion exclusion criterion if MMSE \<26)
- Use of tricyclic antidepressants at doses ≥75 mg/day; benzodiazepines or antipsychotics
- Morbid obesity
- Psychiatric disorders (psychosis, major depressive episode, according to DSM-5 diagnostic criteria as assessed by the MINI, or history of suicide attempt)
- Alcohol, drug, or psychoactive substance abuse (DSM-5 definition) within the past six months
- Persistent or intermittent chronic pain conditions (e.g., irritable bowel syndrome) prior to inclusion
- Cognitive or psychological disorders incompatible with protocol adherence and/or comprehension
- Ongoing legal dispute or compensation-seeking process
- Protected persons as defined in Articles L.1121-5 to L.1121-8 of the French Public Health Code: pregnant or breastfeeding women, prisoners or individuals under judicial or administrative detention, individuals receiving psychiatric care, minors, or adults under legal protection or unable to provide informed consent
