Downsides of Being Well-Informed: Tracking and Preventing Chemotherapy-Related Cognitive Problems in Breast-Cancer Patients

Downsides of Being Well-Informed: Tracking and Preventing Chemotherapy-Related Cognitive Problems in Breast-Cancer Patients - Communicating chemotherapy-associated cognitive problems

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40145

Enrollment

600

Registered

2013-07-08

Start date

2014-03-20

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cognitive difficulties after chemotherapy

Interventions

Patients will be randomly assigned to one of three experimental conditions: the experimental condition, the intervention condition and the control condition. These groups will receive different info

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Newly diagnosed breast cancer patients (mamma carcinoma), - (Neo-)adjuvant chemotherapy treatment, - Age 18 years or older, - Dutch-speaking and reading, - Access to the Internet.

Exclusion criteria

Exclusion criteria: - History of neurological and psychiatric symptoms that may influence cognitive functioning, - History of cancer, - Alcohol or drug abuse.

Design outcomes

Primary

Measure	Time frame
This study has two main endpoints: 1). Cognitive performance (memory, processing speed and executive function as measured with the Trail-Making Test and 15-words test). 2). Self-reported cognitive complaints (as measured with the MOS Cognitive Functioning Scale and M.D. Anderson Symptom Inventory).	—

Secondary

Measure	Time frame
Secundary study parameters will be measured with online questionnaires and are based on literature about information and stereotype threat effects and on the international standards in the research field of cancer and cognition (ICCTF: International Cognition and Cancer Task Force). Literature on stereotype threat and information effects (for example Nocebo effects) shows that the following concepts are important to include in this study: Mediating processes: - Activation of a cognition stereotype (measured with a word completion task) - Motivation level during test - Level of worry about performance - Ego depletion - Expectations of side effects Moderating processes: - Stigma consciousness - Identification with the group - Identification with the domain - Stereotype endorsement - Cancer specific distress - Emotion regulation - Information seeking behavior - Stereotype self-relevance Covariates: - Pre-existing knowledge of cognitive problems after chemotherapy - Level of general complaints - Depression and anxiety - Demographic variables	—

Measure

Time frame

Secundary study parameters will be measured with online questionnaires and are based on literature about information and stereotype threat effects and on the international standards in the research field of *cancer and cognition* (ICCTF: International Cognition and Cancer Task Force). Literature on stereotype threat and information effects (for example Nocebo effects) shows that the following concepts are important to include in this study: Mediating processes: - Activation of a cognition stereotype (measured with a word completion task) - Motivation level during test - Level of worry about performance - Ego depletion - Expectations of side effects Moderating processes: - Stigma consciousness - Identification with the group - Identification with the domain - Stereotype endorsement - Cancer specific distress - Emotion regulation - Information seeking behavior - Stereotype self-relevance Covariates: - Pre-existing knowledge of cognitive problems after chemotherapy - Level of general complaints - Depression and anxiety - Demographic variables

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)