Cancer
Conditions
Keywords
executive functioning, daily functioning, chemotherapy, non-central nervous system malignancy
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.
Interventions
OTHERChemotherapy
Standard chemotherapy protocols for adjuvant & neoadjuvant treatment for different types of solid malignancies
Sponsors
Tel Aviv University
Bnai Zion Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in scores of Canadian Occupational Performance Measure. | Change between Pre-to post (three months) chemotherapy | 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
| Measure | Time frame | Description |
|---|---|---|
| Reintegration to Normal Living index. | Change between Pre-to post (three months) chemotherapy | 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. | Change between Pre-to post (three months) chemotherapy | 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) | Change between Pre-to post (three months) chemotherapy | Assesses dual tasking by performing two tasks concurrently |
| Color Trail Test - CTT | Change between Pre-to post (three months) chemotherapy | Assesses cognitive flexibility |
| Cognitive performance-based assessment will be assessed by the Weekly Calendar Planning Activity. | Change between Pre-to post (three months) chemotherapy | A performance-based assessment that examines the influence of subtle executive function difficulties on person's ability to perform a multiple-step activity. |
| Emotional Well-Being FACT-G questionnaire | Change between Pre-to post (three months) chemotherapy | 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) | Change between Pre-to post (three months) chemotherapy | 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 | Pre chemotherapy | 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 | Post (three months) chemotherapy | 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. |
| Cognitive Self Efficacy FACT-Cognitive Function questionnaire | Change between Pre-to post (three months) chemotherapy | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Demographic and medical data Questionnaire | pre-chemotherapy | 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). |
Countries
Israel
Contacts
Primary Contactkhawla loubani, PhD
Backup ContactAbed Agbarya, MD
Outcome results
None listed