Clinical trial NCT05599698: Effects of Chemotherapy on Perceived Daily Performance and Executive Functions of Adults With Cancer
Official title: Effects of Chemotherapy on Perceived Daily Performance and Executive Functions of Adults With Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Keywords: executive functioning
daily functioning
chemotherapy
non-central nervous system malignancy
Lead sponsor: Bnai Zion Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Tel Aviv University
First posted: 2022-10-31
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine changes in perceived daily performance and executive functioning following chemotherapy in individuals with non-central nervous system cancers.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed with a primary non-central nervous system malignancy (lung, breast, colon, ulcer, urinary tract, canine tumors).
* Stages I-III.
* Pre-commencement of adjuvant (post-surgery) or neoadjuvant (prior to surgery) chemotherapy.
* Understand and read Hebrew.
* Have at least 12 years of education.

Exclusion Criteria:

* Diagnosed with central nervous system malignancies.
* Had a previous malignancy.
* Have or had metastatic disease.
* Have a history of a neurological condition or severe depression.

Primary outcomes:
measure: Change in scores of Canadian Occupational Performance Measure.
timeFrame: Change between Pre-to post (three months) chemotherapy
Secondary outcomes:
measure: Reintegration to Normal Living index.
timeFrame: Change between Pre-to post (three months) chemotherapy
measure: Backward Digit Span.
timeFrame: Change between Pre-to post (three months) chemotherapy
measure: Dual Tasking by performing two tasks concurrently (motor by the Box & Blocks Test and cognitive by backward subtraction for one minute)
timeFrame: Change between Pre-to post (three months) chemotherapy
measure: Color Trail Test - CTT
timeFrame: Change between Pre-to post (three months) chemotherapy
measure: Cognitive performance-based assessment will be assessed by the Weekly Calendar Planning Activity.
timeFrame: Change between Pre-to post (three months) chemotherapy
measure: Cognitive Self Efficacy FACT-Cognitive Function questionnaire
timeFrame: Change between Pre-to post (three months) chemotherapy
measure: Emotional Well-Being FACT-G questionnaire
timeFrame: Change between Pre-to post (three months) chemotherapy
measure: Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
timeFrame: Change between Pre-to post (three months) chemotherapy
measure: Qualitative open-ended questions regarding perceived changes in participants' cognitive functioning following cancer diagnosis and how these changes affect their daily functioning
timeFrame: Pre chemotherapy
measure: Qualitative open-ended questions regarding perceived changes in participants' cognitive functioning following chemotherapy and how these changes affect their daily functioning
timeFrame: Post (three months) chemotherapy
Other outcomes:
measure: Demographic and medical data Questionnaire
timeFrame: pre-chemotherapy
Locations:
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
Study officials:
affiliation: abed.agbarya@b-zion.org.il
name: Abed Agbarya, MD
role: PRINCIPAL_INVESTIGATOR
References: