Breast CancerCONTEXTNCT04813965
Breast Cancer Patients' Cognitive Symptoms After Information About Chemotherapy-Related Cognitive Symptoms
A study testing Written information about potential chemotherapy-related cognitive symptoms without self-affirmation and Written information about potential chemotherapy-related cognitive symptoms with self-affirmation in people with Breast Cancer and Cognitive Symptoms, run by Radboud University Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Cognitive Symptoms, Cognitive Decline
- What is being tested?
- Written information about potential chemotherapy-related cognitive symptoms without self-affirmation and Written information about potential chemotherapy-related cognitive symptoms with self-affirmation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- No sites listed yet
- Study dates
- 20 Mar 2014to 23 Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- A history of neurological and psychiatric symptoms that influence cognitive functioning
- Previous cancer diagnosis
- Using drugs
- Drinking more than three alcoholic drinks a day
About this study
Official title: Downsides of Being Well-Informed: Tracking and Preventing Chemotherapy-Related Cognitive Problems in Breast Cancer Patients
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.
Read the detailed description
Rationale:
Although information about their treatment and its side-effects is requested by cancer patients, is vital for informed decision making and can positively impact patients' health outcomes and illness perceptions, this kind of information can also adversely impact perceived cognitive symptoms and cognitive test performance. Previous 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.
Main objectives and hypotheses:
The overall aim of the study was to investigate the occurrence and duration of AIEs on the perceived frequency of cognitive symptoms, the perceived severity of cognitive symptoms and cognitive performance in breast cancer patients, and to examine ways to reduce such AIEs. First, evaluated the effect of providing breast cancer patients with additional factual written information about potential chemotherapy-related cognitive symptoms before chemotherapy-initiation on perceived cognitive symptoms and cognitive performance was evaluated, and the duration of such effects was assessed. Building on previous findings that breast cancer patients showed an increase in perceived cognitive symptoms and a decrease in verbal memory performance after receiving cognitive side-effect information, it was hypothesized that communicating about potential chemotherapy-related cognitive symptoms will result in AIEs, and it was explored to what extent these AIEs persist over time. Second, this study aimed to translate the beneficial effects of self-affirmation to the oncology domain, and examined the efficacy of a text-integrated self-affirmation intervention in reducing the impact of AIEs on perceived cognitive symptoms and cognitive performance in breast cancer patients when communicating about chemotherapy-related cognitive symptoms. It was hypothesized that a textual self-affirmation intervention would reduce AIEs in breast cancer patients, building on evidence from health promotion and stereotype threat research outside the oncology domain that individuals' self-concepts can be affirmed via text-integrated health messages and that allowing individuals the opportunity for self-affirmation can reduce stereotype threat effects.
The main research questions were:
- Does written information about potential chemotherapy-related cognitive symptoms presented only once before treatment-initiation affect short- and longer-term perceived cognitive symptoms (the perceived frequency and severity of cognitive symptoms) and cognitive performance (verbal memory performance, information processing speed, executive functioning) in newly diagnosed breast cancer patients scheduled for (neo) adjuvant chemotherapy?
- Does providing newly diagnosed breast cancer patients with a text integrated self-affirmation intervention after being informed about potential chemotherapy-related cognitive symptoms reduce AIEs on short- and longer-term perceived cognitive symptoms and cognitive performance?
Study procedure and outcome measures:
Before (neo) adjuvant chemotherapy, 160 newly diagnosed breast cancer patients were randomly allocated to receive either standard information on side-effects (control condition), or standard information with additional 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). Online-questionnaires were completed before chemotherapy (baseline, T0), 6-months (T1) and 12-months (T2) later to measure the perceived frequency (MOS-cog) and severity (MDASI-cog) of cognitive symptoms. Patients also completed two online neuro-psychological tests (Trail Making Test; TMT, and 15 Words test) to measure verbal memory performance, information processing speed and executive functioning. Additionally, several potential underlying mechanisms and risk factors of AIEs were examined, such as cancer related distress and performance worries. Baseline-to-follow-up analyses were performed using a mixed-effects modeling approach to compare groups over time.
- Conditions
- Breast Cancer, Cognitive Symptoms, Cognitive Decline
- Being tested
- Written information about potential chemotherapy-related cognitive symptoms without self-affirmation, Written information about potential chemotherapy-related cognitive symptoms with self-affirmation
- Keywords
- Breast cancer, Chemotherapy, Cognitive symptoms, Self-affirmation, Health communication, Nocebo, Stereotype threat
- Medical subject headings
- Breast Neoplasms, Neurobehavioral Manifestations, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Written information about potential chemotherapy-related cognitive symptoms without self-affirmationOther
Also called Information
Written information about potential chemotherapy-related cognitive symptoms with self-affirmationOther
Also called Information+SA
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Written information about potential chemotherapy-related cognitive symptoms with self-affirmation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Dutch version of the Hospital Anxiety and Depression Scale (HADS; Spinhoven et al., 1997; Zigmond \& Snaith, 1983) to measure levels of anxiety. Higher sum scores (range 0-21) indicate higher levels of anxiety.
Measured: 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.
Dutch version of the Hospital Anxiety and Depression Scale (HADS; Spinhoven et al., 1997; Zigmond \& Snaith, 1983) to measure levels of depression. Higher sum scores (range 0-21) indicate higher levels of depression.
Measured: 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.
Twelve items of the thirteen-item core M. D. Anderson Symptom Inventory (MDASI; part 1; Cleeland et al., 2000) to measure the perceived severity of other cancer-related symptoms. Participants reported the severity of twelve symptoms at their worst in the last 24 hours hours on a 0-10 scale, with 0 being 'not present' and 10 being 'as bad as you can imagine.' Difficulty remembering was excluded. Higher mean scores indicate more severe symptoms.
Measured: 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).
Participants indicated on one item (range 1-5) at the end of the T2 survey whether they had knowledge about the potential cognitive side-effects of cancer treatment prior to the experiment to measure pre-existing knowledge. Higher scores indicate more pre-existing knowledge.
Measured: Measured at twelve months follow-up (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start20 Mar 2014
- Primary completion23 Sep 2016
- Study completion23 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- The Netherlands Cancer Institute, St. Antonius Hospital, Meander Medical Center, Ziekenhuisgroep Twente, Isala, Deventer Ziekenhuis, Rijnstate Hospital, Franciscus Gasthuis, St Jansdal Hospital, UMC Utrecht
- Responsible party
- Principal investigator, Wendy Jacobs, Radboud University Medical Center
- Investigators
- Enny Das, PhD, Principal investigator, Radboud University Medical CenterSanne B Schagen, PhD, Principal investigator, The Netherlands Cancer InstituteGabe S Sonke, PhD, MD, Principal investigator, The Netherlands Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04813965
- Sponsor's protocol ID
- M13WEL
- Other IDs
- 2016-8178, 2011.WO34.C123, NL43939.031.13
- Acronym
- CONTEXT
- Status last verified
- Mar 2021
- First submitted
- 17 Mar 2021
- Last updated
- 24 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35491320
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Downsides of Being Well-Informed: Tracking and Preventing Chemotherapy-Related Cognitive Problems in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT04813965
- Acronym / sponsor ID
- CONTEXT / M13WEL
- Conditions
- Breast Cancer, Cognitive Symptoms, Cognitive Decline
- Keywords
- Breast cancer, Chemotherapy, Cognitive symptoms, Self-affirmation, Health communication, Nocebo, Stereotype threat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- The Netherlands Cancer Institute, St. Antonius Hospital, Meander Medical Center, Ziekenhuisgroep Twente, Isala, Deventer Ziekenhuis, Rijnstate Hospital, Franciscus Gasthuis, St Jansdal Hospital, UMC Utrecht
- Study start
- 20 Mar 2014 (actual)
- Primary completion
- 23 Sep 2016 (actual)
- Study completion
- 23 Sep 2016 (actual)
- First posted
- 24 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Rationale:
Although information about their treatment and its side-effects is requested by cancer patients, is vital for informed decision making and can positively impact patients' health outcomes and illness perceptions, this kind of information can also adversely impact perceived cognitive symptoms and cognitive test performance. Previous 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.
Main objectives and hypotheses:
The overall aim of the study was to investigate the occurrence and duration of AIEs on the perceived frequency of cognitive symptoms, the perceived severity of cognitive symptoms and cognitive performance in breast cancer patients, and to examine ways to reduce such AIEs. First, evaluated the effect of providing breast cancer patients with additional factual written information about potential chemotherapy-related cognitive symptoms before chemotherapy-initiation on perceived cognitive symptoms and cognitive performance was evaluated, and the duration of such effects was assessed. Building on previous findings that breast cancer patients showed an increase in perceived cognitive symptoms and a decrease in verbal memory performance after receiving cognitive side-effect information, it was hypothesized that communicating about potential chemotherapy-related cognitive symptoms will result in AIEs, and it was explored to what extent these AIEs persist over time. Second, this study aimed to translate the beneficial effects of self-affirmation to the oncology domain, and examined the efficacy of a text-integrated self-affirmation intervention in reducing the impact of AIEs on perceived cognitive symptoms and cognitive performance in breast cancer patients when communicating about chemotherapy-related cognitive symptoms. It was hypothesized that a textual self-affirmation intervention would reduce AIEs in breast cancer patients, building on evidence from health promotion and stereotype threat research outside the oncology domain that individuals' self-concepts can be affirmed via text-integrated health messages and that allowing individuals the opportunity for self-affirmation can reduce stereotype threat effects.
The main research questions were:
- Does written information about potential chemotherapy-related cognitive symptoms presented only once before treatment-initiation affect short- and longer-term perceived cognitive symptoms (the perceived frequency and severity of cognitive symptoms) and cognitive performance (verbal memory performance, information processing speed, executive functioning) in newly diagnosed breast cancer patients scheduled for (neo) adjuvant chemotherapy?
- Does providing newly diagnosed breast cancer patients with a text integrated self-affirmation intervention after being informed about potential chemotherapy-related cognitive symptoms reduce AIEs on short- and longer-term perceived cognitive symptoms and cognitive performance?
Study procedure and outcome measures:
Before (neo) adjuvant chemotherapy, 160 newly diagnosed breast cancer patients were randomly allocated to receive either standard information on side-effects (control condition), or standard information with additional 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). Online-questionnaires were completed before chemotherapy (baseline, T0), 6-months (T1) and 12-months (T2) later to measure the perceived frequency (MOS-cog) and severity (MDASI-cog) of cognitive symptoms. Patients also completed two online neuro-psychological tests (Trail Making Test; TMT, and 15 Words test) to measure verbal memory performance, information processing speed and executive functioning. Additionally, several potential underlying mechanisms and risk factors of AIEs were examined, such as cancer related distress and performance worries. Baseline-to-follow-up analyses were performed using a mixed-effects modeling approach to compare groups over time.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants in the control group received standard information on treatment side-effects. |
| Information without self-affirmation | Experimental | Other: Written information about potential chemotherapy-related cognitive symptoms without self-affirmationBefore 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. |
| Information with self-affirmation | Experimental | Other: Written information about potential chemotherapy-related cognitive symptoms with self-affirmationBefore 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- A history of neurological and psychiatric symptoms that influence cognitive functioning
- Previous cancer diagnosis
- Using drugs
- Drinking more than three alcoholic drinks a day
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Written information about potential chemotherapy-related cognitive symptoms without self-affirmationAlso: Information | Other | Information without self-affirmation |
| Written information about potential chemotherapy-related cognitive symptoms with self-affirmationAlso: Information+SA | Other | Information with self-affirmation |
Primary outcome
Between-group differences in mean change in the perceived frequency of cognitive symptoms from baseline to T1, and from baseline to T2.
Time frame: Prior to chemotherapy-initiation (baseline; T0), six months (T1), and twelve months (T2) later
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).
Between-group differences in mean change in the perceived severity of cognitive symptoms from baseline to T1, and from baseline to T2.
Time frame: Prior to chemotherapy-initiation (baseline; T0), six months (T1), and twelve months (T2) later
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.
Between-group differences in mean change in verbal memory performance from baseline to T1, and from baseline to T2.
Time frame: Prior to chemotherapy-initiation (baseline; T0), six months (T1), and twelve months (T2) later
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.
Between-group differences in mean change in information processing speed and executive functioning from baseline to T1, and from baseline to T2.
Time frame: Prior to chemotherapy-initiation (baseline; T0), six months (T1), and twelve months (T2) later
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.
4 secondary outcomes
Between-group differences in mean change in the levels of anxiety from baseline to T1, and from baseline to T2.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Measured at twelve months follow-up (T2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
- Derived from this study: PubMed 35491320Jacobs 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enny Das, PhD principal investigator
Radboud University Medical Center
Sanne B Schagen, PhD principal investigator
The Netherlands Cancer Institute
Gabe S Sonke, PhD, MD principal investigator
The Netherlands Cancer Institute
Questions about this trial
What is this clinical trial studying?
A study testing Written information about potential chemotherapy-related cognitive symptoms without self-affirmation and Written information about potential chemotherapy-related cognitive symptoms with self-affirmation in people with Breast Cancer and Cognitive Symptoms, run by Radboud University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Between-group differences in mean change in the perceived frequency of cognitive symptoms from baseline to T1, and from baseline to T2. (time frame: Prior to chemotherapy-initiation (baseline; T0), six months (T1), and twelve months (T2) later). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04813965, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2021.