Breast Cancer Patients' Cognitive Symptoms After Information About Chemotherapy-Related Cognitive Symptoms

NCT04813965 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2021-03-24

No results posted yet for this study

Summary

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

Interventions

OTHER

Written information about potential chemotherapy-related cognitive symptoms without self-affirmation

OTHER

Written information about potential chemotherapy-related cognitive symptoms with self-affirmation

Sponsors & Collaborators

  • The Netherlands Cancer Institute

    collaborator OTHER
  • St. Antonius Hospital

    collaborator OTHER
  • Meander Medical Center

    collaborator OTHER
  • Ziekenhuisgroep Twente

    collaborator OTHER
  • Isala

    collaborator OTHER
  • Deventer Ziekenhuis

    collaborator OTHER
  • Rijnstate Hospital

    collaborator OTHER
  • Franciscus Gasthuis

    collaborator OTHER
  • St Jansdal Hospital

    collaborator OTHER
  • UMC Utrecht

    collaborator OTHER
  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Enny Das, PhD · Radboud University Medical Center

  • Sanne B Schagen, PhD · The Netherlands Cancer Institute

  • Gabe S Sonke, PhD, MD · The Netherlands Cancer Institute

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-20
Primary Completion
2016-09-23
Completion
2016-09-23

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04813965 on ClinicalTrials.gov