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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05599698
• Other study ID #: 0106-22-BNZ
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2022
• Est. completion date: March 30, 2024

Study information

• Verified date: February 2023
• Source: Bnai Zion Medical Center
• Contact: khawla loubani, PhD
• Phone: +97240504564402
• Email: khawlaloubani[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: March 30, 2024
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• Chemotherapy
Standard chemotherapy protocols for adjuvant & neoadjuvant treatment for different types of solid malignancies

Locations

Country	Name	City	State
Israel	Bnai Zion Medical Center	Haifa

Sponsors (2)

Lead Sponsor	Collaborator
Bnai Zion Medical Center	Tel Aviv University

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Demographic and medical data Questionnaire	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).	pre-chemotherapy
Primary	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	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
Secondary	Backward Digit Span.	Assesses working memory capacity	Change between Pre-to post (three months) chemotherapy
Secondary	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
Secondary	Color Trail Test - CTT	Assesses cognitive flexibility	Change between Pre-to post (three months) chemotherapy
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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