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

Not Applicable

Recruiting

• Conditions: Cancer
• Interventions: Other: Chemotherapy

• Registration Number: NCT05599698
• Lead Sponsor: Bnai Zion Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-26
• Study First Submitted QC: 2022-10-28
• Study First Posted: 2022-10-31
• Study Start: 2022-11-15
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-12
• Last Update Posted: 2024-05-14
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
chemotherapy	Chemotherapy	chemotherapy

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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
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.
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
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.

Trial Locations

Locations (1)

Bnai Zion Medical Center; 🇮🇱 Haifa, Israel