Effects of Chemotherapy on Perceived Daily Performance and Executive Functions of Adults With Cancer
Primary Purpose
Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Cancer focused on measuring executive functioning, daily functioning, chemotherapy, non-central nervous system malignancy
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.
Sites / Locations
- Bnai Zion Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
chemotherapy
Arm Description
chemotherapy
Outcomes
Primary Outcome Measures
Change in scores of Canadian Occupational Performance Measure.
Canadian Occupational Performance Measure - COPM assesses perceived daily performance and performance satisfaction with meaningful daily activities.
During the pre-chemotherapy assessment, participants will identify up to five activities that they prioritize as meaningful for them. Each of these activities is then rated on a 10-point scale for perceived performance (1=not able to do at all, 10=able to do extremely well) and similarly for satisfaction with performance. The final scores of the COPM are the average scores for total performance and for satisfaction (higher scores indicate better performance or satisfaction with performance). During the post-chemotherapy assessment, the participants will rate the same activities they prioritized in the pre-chemotherapy assessment.
Secondary Outcome Measures
Reintegration to Normal Living index.
Assesses daily participation in recreational and social activities, movement within the community, and degree of comfort the individual has in his/her role in the family and with other relationships.
Backward Digit Span.
Assesses working memory capacity
Dual Tasking by performing two tasks concurrently (motor by the Box & Blocks Test and cognitive by backward subtraction for one minute)
Assesses dual tasking by performing two tasks concurrently
Color Trail Test - CTT
Assesses cognitive flexibility
Cognitive performance-based assessment will be assessed by the Weekly Calendar Planning Activity.
A performance-based assessment that examines the influence of subtle executive function difficulties on person's ability to perform a multiple-step activity.
Cognitive Self Efficacy FACT-Cognitive Function questionnaire
FACT-Cognitive Function questionnaire Version 3 assesses cognitive functioning in individuals with cancer. For assessing cognitive self-efficacy we will use the cognitive self-abilities subscale (CogPCA) of the questionnaire, which includes 7 statements with responses given on a 5-point Likert scale (from 0, never; to 4, several times a day). The score range= 0-28 with higher scores indicating higher difficulties.
Emotional Well-Being FACT-G questionnaire
Emotional Well-Being will be assessed by the emotional well-being subscale from the FACT-G (General) questionnaire (https://www.facit.org/). The EWB scale includes six statements with responses given on a 5-point Likert scale (from 0, not at all; to 4, very much). The score range= 0-24 with higher scores indicating higher emotional deficits.
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
Fatigue will be assessed by the FACIT Fatigue questionnaire FACIT-F, Version 4 which includes 13 statements with responses given on a 5-point Likert scale (from 0, not at all; to 4, very much). The score range= 0-52 with higher scores indicating more fatigue.
Qualitative open-ended questions regarding perceived changes in participants' cognitive functioning following cancer diagnosis and how these changes affect their daily functioning
Open ended questions will be presented on a sheet of paper and the participants will be asked to write their answers bellow together with the accessor. Reporting does not include a score on a scale.
Qualitative open-ended questions regarding perceived changes in participants' cognitive functioning following chemotherapy and how these changes affect their daily functioning
Open ended questions will be presented on a sheet of paper and the participants will be asked to write their answers bellow together with the accessor. Reporting does not include a score on a scale.
Full Information
NCT ID
NCT05599698
First Posted
October 26, 2022
Last Updated
February 17, 2023
Sponsor
Bnai Zion Medical Center
Collaborators
Tel Aviv University
1. Study Identification
Unique Protocol Identification Number
NCT05599698
Brief Title
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
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2022 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
March 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bnai Zion Medical Center
Collaborators
Tel Aviv University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer
Keywords
executive functioning, daily functioning, chemotherapy, non-central nervous system malignancy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
chemotherapy
Arm Type
Experimental
Arm Description
chemotherapy
Intervention Type
Other
Intervention Name(s)
Chemotherapy
Intervention Description
Standard chemotherapy protocols for adjuvant & neoadjuvant treatment for different types of solid malignancies
Primary Outcome Measure Information:
Title
Change in scores of Canadian Occupational Performance Measure.
Description
Canadian Occupational Performance Measure - COPM assesses perceived daily performance and performance satisfaction with meaningful daily activities.
During the pre-chemotherapy assessment, participants will identify up to five activities that they prioritize as meaningful for them. Each of these activities is then rated on a 10-point scale for perceived performance (1=not able to do at all, 10=able to do extremely well) and similarly for satisfaction with performance. The final scores of the COPM are the average scores for total performance and for satisfaction (higher scores indicate better performance or satisfaction with performance). During the post-chemotherapy assessment, the participants will rate the same activities they prioritized in the pre-chemotherapy assessment.
Time Frame
Change between Pre-to post (three months) chemotherapy
Secondary Outcome Measure Information:
Title
Reintegration to Normal Living index.
Description
Assesses daily participation in recreational and social activities, movement within the community, and degree of comfort the individual has in his/her role in the family and with other relationships.
Time Frame
Change between Pre-to post (three months) chemotherapy
Title
Backward Digit Span.
Description
Assesses working memory capacity
Time Frame
Change between Pre-to post (three months) chemotherapy
Title
Dual Tasking by performing two tasks concurrently (motor by the Box & Blocks Test and cognitive by backward subtraction for one minute)
Description
Assesses dual tasking by performing two tasks concurrently
Time Frame
Change between Pre-to post (three months) chemotherapy
Title
Color Trail Test - CTT
Description
Assesses cognitive flexibility
Time Frame
Change between Pre-to post (three months) chemotherapy
Title
Cognitive performance-based assessment will be assessed by the Weekly Calendar Planning Activity.
Description
A performance-based assessment that examines the influence of subtle executive function difficulties on person's ability to perform a multiple-step activity.
Time Frame
Change between Pre-to post (three months) chemotherapy
Title
Cognitive Self Efficacy FACT-Cognitive Function questionnaire
Description
FACT-Cognitive Function questionnaire Version 3 assesses cognitive functioning in individuals with cancer. For assessing cognitive self-efficacy we will use the cognitive self-abilities subscale (CogPCA) of the questionnaire, which includes 7 statements with responses given on a 5-point Likert scale (from 0, never; to 4, several times a day). The score range= 0-28 with higher scores indicating higher difficulties.
Time Frame
Change between Pre-to post (three months) chemotherapy
Title
Emotional Well-Being FACT-G questionnaire
Description
Emotional Well-Being will be assessed by the emotional well-being subscale from the FACT-G (General) questionnaire (https://www.facit.org/). The EWB scale includes six statements with responses given on a 5-point Likert scale (from 0, not at all; to 4, very much). The score range= 0-24 with higher scores indicating higher emotional deficits.
Time Frame
Change between Pre-to post (three months) chemotherapy
Title
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
Description
Fatigue will be assessed by the FACIT Fatigue questionnaire FACIT-F, Version 4 which includes 13 statements with responses given on a 5-point Likert scale (from 0, not at all; to 4, very much). The score range= 0-52 with higher scores indicating more fatigue.
Time Frame
Change between Pre-to post (three months) chemotherapy
Title
Qualitative open-ended questions regarding perceived changes in participants' cognitive functioning following cancer diagnosis and how these changes affect their daily functioning
Description
Open ended questions will be presented on a sheet of paper and the participants will be asked to write their answers bellow together with the accessor. Reporting does not include a score on a scale.
Time Frame
Pre chemotherapy
Title
Qualitative open-ended questions regarding perceived changes in participants' cognitive functioning following chemotherapy and how these changes affect their daily functioning
Description
Open ended questions will be presented on a sheet of paper and the participants will be asked to write their answers bellow together with the accessor. Reporting does not include a score on a scale.
Time Frame
Post (three months) chemotherapy
Other Pre-specified Outcome Measures:
Title
Demographic and medical data Questionnaire
Description
The questionnaire will include the following details: age (years), education (years), sex (female, male), marital status (married, not married, divorced, widow), number of children, work status (employed, not employed, independent), dominant hand (right, left), socioeconomic level (income level), type/stage of cancer (1,2,3), disease characteristics (e.g., size of the tumor, number of affected lymph nodes), details of treatments received (e.g., types of surgery chemotherapy regimens, date of chemo commencement, number of cycles completed).
Time Frame
pre-chemotherapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
khawla loubani, PhD
Phone
+97240504564402
Email
khawlaloubani@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Abed Agbarya, MD
Email
abed.agbarya@b-zion.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abed Agbarya, MD
Organizational Affiliation
abed.agbarya@b-zion.org.il
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bnai Zion Medical Center
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abed Agbarya, MD
Phone
+972502062679
Email
abed.agbarya@b-zion.org.il
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Articles are planned for publication of the study protocol and final study results.
IPD Sharing Time Frame
24 - 30 months
Learn more about this trial
Effects of Chemotherapy on Perceived Daily Performance and Executive Functions of Adults With Cancer
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