NCT04813965

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Mar 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2016

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 24, 2021

Completed
Last Updated

March 24, 2021

Status Verified

March 1, 2021

Enrollment Period

2.5 years

First QC Date

March 17, 2021

Last Update Submit

March 21, 2021

Conditions

Breast CancerCognitive SymptomsCognitive Decline

Keywords

Breast cancerChemotherapyCognitive symptomsSelf-affirmationHealth communicationNoceboStereotype threat

Outcome Measures

Primary Outcomes (4)

  • Between-group differences in mean change in the perceived frequency of cognitive symptoms from baseline to T1, and from baseline to T2.

    Six items of the revised Medical Outcomes Study - cognitive functioning subscale (MOS-cog; Stewart \& Ware, 1992) to measure the perceived frequency of cognitive symptoms. Participants indicated the frequency of experiencing a range of day-to-day problems in six aspects of cognitive functioning during the past week (including today). Higher mean scores indicate better perceived cognitive functioning (range 0-100).

    Prior to chemotherapy-initiation (baseline; T0), six months (T1), and twelve months (T2) later

  • Between-group differences in mean change in the perceived severity of cognitive symptoms from baseline to T1, and from baseline to T2.

    Two items of the M.D. Anderson Symptom Inventory Multiple Myeloma module (MDASI-MM part 1; Cleeland et al., 2000; Jones et al., 2013) to measure the perceived severity of cognitive symptoms. Patients reported the severity of two cognitive symptoms at their worst in the last 24 hours on a 0-10 scale, with 0 being 'not present' and 10 being 'as bad as you can imagine': difficulty remembering and difficulty paying attention (concentrating). Higher mean scores indicate more severe symptoms.

    Prior to chemotherapy-initiation (baseline; T0), six months (T1), and twelve months (T2) later

  • Between-group differences in mean change in verbal memory performance from baseline to T1, and from baseline to T2.

    Online, adapted version of the Groningen Fifteen Words Test (Rey, 1964) measuring immediate recall (range 0-45), delayed recall (range 0-15) and recognition (range 0-30). Higher scores indicate better performance.

    Prior to chemotherapy-initiation (baseline; T0), six months (T1), and twelve months (T2) later

  • Between-group differences in mean change in information processing speed and executive functioning from baseline to T1, and from baseline to T2.

    Online version of the Trail Making Test (TMT; Reitan \& Wolfson, 1985) part A and B (and TMT-B to TMT-A ratio B/A) to measure the speed of information processing and executive functioning. The score on each part represents the amount of time in seconds required to complete the task. Higher scores indicate worse information processing and executive functioning.

    Prior to chemotherapy-initiation (baseline; T0), six months (T1), and twelve months (T2) later

Secondary Outcomes (4)

  • Between-group differences in mean change in the levels of anxiety from baseline to T1, and from baseline to T2.

    Prior to chemotherapy-initiation (baseline; T0), six months (T1), and twelve months (T2) later

  • Between-group differences in mean change in the levels of depression from baseline to T1, and from baseline to T2.

    Prior to chemotherapy-initiation (baseline; T0), six months (T1), and twelve months (T2) later

  • Between-group differences in mean change in the perceived severity of other cancer-related symptoms from baseline to T1, and from baseline to T2.

    Prior to chemotherapy-initiation (baseline; T0), six months (T1), and twelve months (T2) later

  • Between-group differences in pre-existing knowledge (prior to the experiment) about the potential cognitive symptoms of cancer treatment measured at twelve months follow-up (T2).

    Measured at twelve months follow-up (T2)

Other Outcomes (13)

  • Between-group differences in mean change in the levels of the expected severity of cognitive symptoms from baseline to T1, and from baseline to T2.

    Prior to chemotherapy-initiation (baseline; T0), six months (T1), and twelve months (T2) later

  • Between-group differences in mean change in the levels of the expected severity of other cancer-related symptoms from baseline to T1, and from baseline to T2.

    Prior to chemotherapy-initiation (baseline; T0), six months (T1), and twelve months (T2) later

  • Between-group differences in mean change in the levels of motivation from baseline to T1, and from baseline to T2.

    Prior to chemotherapy-initiation (baseline; T0), six months (T1), and twelve months (T2) later

  • +10 more other outcomes

Study Arms (3)

Control

NO INTERVENTION

Participants in the control group received standard information on treatment side-effects.

Information without self-affirmation

EXPERIMENTAL

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.

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

Information with self-affirmation

EXPERIMENTAL

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.

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

Interventions

Written information about potential chemotherapy-related cognitive symptoms without self-affirmationOTHER
Also known as: Information
Information without self-affirmation
Written information about potential chemotherapy-related cognitive symptoms with self-affirmationOTHER
Also known as: Information+SA
Information with self-affirmation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary breast cancer diagnosis stage I-III
  • Scheduled to receive (neo) adjuvant chemotherapy
  • years or older
  • Sufficient command of the Dutch language
  • Internet access

You may not qualify if:

  • A history of neurological and psychiatric symptoms that influence cognitive functioning
  • Previous cancer diagnosis
  • Using drugs
  • Drinking more than three alcoholic drinks a day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Jacobs 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: 35491320DERIVED

MeSH Terms

Conditions

Breast NeoplasmsNeurobehavioral ManifestationsCognitive Dysfunction

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Enny Das, PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

  • Sanne B Schagen, PhD

    The Netherlands Cancer Institute

    PRINCIPAL INVESTIGATOR

  • Gabe S Sonke, PhD, MD

    The Netherlands Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
Health care professionals were blinded to group assignment, but due to the nature of the study, patients were not. However, patients were not informed about the main outcomes and specific hypotheses of the study, or about the study's experimental conditions and the content of the texts that they did not receive until after T2.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: A multicenter, randomized, controlled, prospective, online survey study was conducted. Before completing the study's online baseline survey (pre-chemotherapy; T0), participants were randomly assigned by the online survey program to receive either: standard information on side-effects (control condition), or standard information with additional written information about chemotherapy-related cognitive symptoms (information condition), or standard and additional information with a subsequent self-affirmative text (information+SA condition; SA=self-affirmation). The online experimental texts were presented to patients once, directly after randomization at baseline. At six months (T1) and twelve months (T2) follow-up, all groups received identical general introductions and online surveys, without any experimental manipulations. Outside of the trial, all patients received treatment information from their medical oncologist according to local practice as part of their usual care.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc, study coordinator/PhD candidate

Study Record Dates

First Submitted

March 17, 2021

First Posted

March 24, 2021

Study Start

March 20, 2014

Primary Completion

September 23, 2016

Study Completion

September 23, 2016

Last Updated

March 24, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share