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

NCT05599698 | Recruiting

• 1 other identifier: 0106-22-BNZ
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

executive functioning; daily functioning; chemotherapy; non-central nervous system malignancy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Reintegration to Normal Living index.

  Change between Pre-to post (three months) chemotherapy

• Backward Digit Span.

  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)

  Change between Pre-to post (three months) chemotherapy

• Color Trail Test - CTT

  Change between Pre-to post (three months) chemotherapy

• Cognitive performance-based assessment will be assessed by the Weekly Calendar Planning Activity.

  Change between Pre-to post (three months) chemotherapy

Other Outcomes (1)

• Demographic and medical data Questionnaire

  pre-chemotherapy

Study Arms (1)

chemotherapy

EXPERIMENTAL

chemotherapy

Other: Chemotherapy

Interventions

Chemotherapy OTHER

Standard chemotherapy protocols for adjuvant \& neoadjuvant treatment for different types of solid malignancies

chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bnai Zion Medical Center: lead
• Tel Aviv University: collaborator

Study Sites (1)

Bnai Zion Medical Center

Haifa, Israel

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Abed Agbarya, MD

  abed.agbarya@b-zion.org.il

  PRINCIPAL INVESTIGATOR

Central Study Contacts

khawla loubani, PhD

CONTACT

+97240504564402; khawlaloubani@gmail.com

Abed Agbarya, MD

CONTACT

abed.agbarya@b-zion.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: October 31, 2022
• Study Start: November 15, 2022
• Primary Completion: September 30, 2025
• Study Completion: December 30, 2025
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 24 - 30 months

Locations

IL (1)