RESUMO
BACKGROUND: Informing patients about chemotherapy-related cognitive symptoms (CRCS) may increase perceived cognitive symptoms. This longitudinal randomized study evaluated this Adverse Information Effect (AIE) in breast cancer patients and examined whether self-affirmation (SA) can reduce AIEs (ClinicalTrials.gov identifier: NCT04813965). PATIENTS AND METHODS: Before (neo) adjuvant chemotherapy, 160 newly diagnosed breast cancer patients were randomly allocated to receive: standard information on side-effects (control), standard information with additional information about CRCS (information), or standard and additional information with a subsequent self-affirmative text (information+SA). Online-questionnaires assessed the perceived frequency (MOS-cog) and severity (MDASI-cog) of cognitive symptoms before chemotherapy (baseline, T0), and 2.5-months (T1) and 6.5-months (T2) post-chemotherapy. Higher scores indicate less frequent, and more severe symptoms, respectively. Baseline-to-follow-up analyses using a mixed-effects modeling approach compared groups over time. RESULTS: At T0-T2, 148, 140 and 133 patients responded, respectively (attrition rates: 8%, 5%, 5%). Frequency (ES = -0.36, P =.003) and severity (ES = 0.54, P <.001) of symptoms worsened from baseline to T1, without differences between groups. At T2, symptom frequency remained stable for informed (ES=-0.3, P =.021) and self-affirmed (ES=-0.3, P =.019) patients, but returned to baseline levels for controls. At T2, symptom severity remained increased for informed patients (ES = 0.3, P =.006), but normalized for self-affirmed patients (ES = 0.2, P =.178) and controls. CONCLUSION: No AIEs occurred until T2. The initial overall increase in perceived cognitive symptoms recovered at T2 for controls, but not for patients who received additional information about CRCS. Self-affirmation attenuated these longer-term AIEs for the perceived severity but not the frequency of symptoms.
Assuntos
Neoplasias da Mama , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Neoplasias da Mama/psicologia , Quimioterapia Adjuvante/efeitos adversos , Cognição , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/etiologia , Feminino , Humanos , Estudos Longitudinais , Estudos ProspectivosRESUMO
RATIONALE: Nocebo studies show that informing patients about treatment side effects can adversely impact expectancies and symptom reporting. OBJECTIVE: The current study examined how to inform patients fully about treatment side effects without increasing their occurrence. Extending theoretical assumptions about self-affirmation from the social-psychological to the medical domain, we tested whether allowing cancer patients to self-affirm prior to informing them about potential cognitive decline reduced the occurrence of Adverse Information Effects (AIE) on cognitive problem reporting (CPR) and verbal memory performance. METHOD: Participants were 90 Dutch and Belgian gastrointestinal cancer patients with and without chemotherapy experience. Patients were randomized across three experimental conditions (information about chemotherapy-related cognitive problems with or without self-affirmation; no-information control) before completing an online questionnaire. Data were collected from May until August 2015. Main dependent variables were CPR and verbal memory performance. Stigma consciousness was included as a moderator. RESULTS: Informing patients about chemotherapy-related cognitive problems increased CPR and decreased scores on two out of three memory measures. Self-affirmation reduced these AIE. Stigma conscious patients reported more problems in the information than the self-affirmation group. CONCLUSIONS: Nocebo effects may be reduced by allowing patients the opportunity to restore their self-integrity at the implicit level. Self-affirmation has the potential to reduce AIE in patient populations without withholding relevant information about potential treatment side effects.