Effects of Chemotherapy on Perceived Daily Performance and Executive Functions of Adults With Cancer

Study Overview
=================
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.

Official Title
-----------------
Effects of Chemotherapy on Perceived Daily Performance and Executive Functions of Adults With Cancer

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Other: Chemotherapy


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: chemotherapy<br>chemotherapy | Other: Chemotherapy<br>* Standard chemotherapy protocols for adjuvant & neoadjuvant treatment for different types of solid malignancies<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change between Pre-to post (three months) chemotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change between Pre-to post (three months) chemotherapy | 
| Backward Digit Span. | Assesses working memory capacity | Change between Pre-to post (three months) chemotherapy | 
| 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 | Change between Pre-to post (three months) chemotherapy | 
| Color Trail Test - CTT | Assesses cognitive flexibility | Change between Pre-to post (three months) chemotherapy | 
| 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. | Change between Pre-to post (three months) chemotherapy | 
| 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. | Change between Pre-to post (three months) chemotherapy | 
| 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. | Change between Pre-to post (three months) chemotherapy | 
| 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. | Change between Pre-to post (three months) chemotherapy | 
| 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. | Pre chemotherapy | 
| 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. | Post (three months) chemotherapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
executive functioning, daily functioning, chemotherapy, non-central nervous system malignancy