Clinical trial · Interventional
Breast Cancer Patients' Cognitive Symptoms After Information About Chemotherapy-Related Cognitive Symptoms
Downsides of Being Well-Informed: Tracking and Preventing Chemotherapy-Related Cognitive Problems in Breast Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Previous cross-sectional studies have shown that informing cancer patients about potential chemotherapy-related cognitive symptoms may negatively affect perceived cognitive symptoms and verbal memory performance. A multicenter, randomized study in newly diagnosed breast cancer patients receiving (neo) adjuvant chemotherapy was performed to evaluate this Adverse Information Effect (AIE) over time and investigated whether inviting patients to self-affirm can reduce such AIEs on perceived cognitive symptoms and cognitive test performance.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cognitive Decline | — | UNRESOLVED | — |
| Cognitive Symptoms | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Written information about potential chemotherapy-related cognitive symptoms without self-affirmation | Other | — | UNRESOLVED |
| Written information about potential chemotherapy-related cognitive symptoms with self-affirmation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- Control
- description
- Participants in the control group received standard information on treatment side-effects.
- type
- EXPERIMENTAL
- label
- Information without self-affirmation
- description
- Before completing the study's online baseline survey (pre-chemotherapy), participants in the information group received standard information with additional written information about potential chemotherapy-related cognitive symptoms.
- interventionNames
- Other: Written information about potential chemotherapy-related cognitive symptoms without self-affirmation
- type
- EXPERIMENTAL
- label
- Information with self-affirmation
- description
- Before completing the study's online baseline survey (pre-chemotherapy), participants in the information+SA group (SA=self-affirmation) received standard and additional written information about potential chemotherapy-related cognitive symptoms with a subsequent self-affirmative text.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Primary breast cancer diagnosis stage I-III * Scheduled to receive (neo) adjuvant chemotherapy * 18 years or older * Sufficient command of the Dutch language * Internet access Exclusion Criteria: * A history of neurological and psychiatric symptoms that influence cognitive functioning * Previous cancer diagnosis * Using drugs * Drinking more than three alcoholic drinks a day
References
Publications (1)
- DERIVEDJacobs W, Schagen SB, Brouwer SM, Kieffer JM, Baas IO, Los M, Sonke GS, Das E. The Effects of Being Informed About Chemotherapy-Related Cognitive Symptoms With And Without Self-Affirmation on Perceived Cognitive Symptoms of Breast Cancer Patients: A Randomized Prospective, Longitudinal Study. Clin Breast Cancer. 2022 Jul;22(5):439-454. doi: 10.1016/j.clbc.2022.03.001. Epub 2022 Mar 26. PMID 35491320