CancerNCT05599698
Effects of Chemotherapy on Perceived Daily Performance and Executive Functions of Adults With Cancer
A study testing Chemotherapy in people with Cancer, run by Bnai Zion Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cancer
- What is being tested?
- Chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Nov 2022to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Abed Agbarya, MD contact
Israel1 site, 1 recruiting
- Recruiting
Bnai Zion Medical Center
Haifa
Abed Agbarya, MD, +972502062679, abed.agbarya@b-zion.org.il
About this study
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
- Being tested
- Chemotherapy
- Keywords
- executive functioning, daily functioning, chemotherapy, non-central nervous system malignancy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyOther
Standard chemotherapy protocols for adjuvant \& neoadjuvant treatment for different types of solid malignancies
| Study group | Role | What they receive |
|---|---|---|
| chemotherapy | Experimental | chemotherapy Receives: Other: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change between Pre-to post (three months) chemotherapy
Secondary outcomes (10)
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.
Measured: Change between Pre-to post (three months) chemotherapy
Backward Digit Span.
Assesses working memory capacity
Measured: 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
Measured: Change between Pre-to post (three months) chemotherapy
Color Trail Test - CTT
Assesses cognitive flexibility
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Post (three months) chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start15 Nov 2022
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bnai Zion Medical Center
- Sponsor type
- Other government
- Collaborators
- Tel Aviv University
- Responsible party
- Principal investigator, abed.agbarya, Bnai Zion Medical Center
- Investigators
- Abed Agbarya, MD, Principal investigator, abed.agbarya@b-zion.org.il
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05599698
- Sponsor's protocol ID
- 0106-22-BNZ
- Status last verified
- May 2024
- First submitted
- 26 Oct 2022
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Articles are planned for publication of the study protocol and final study results.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Chemotherapy on Perceived Daily Performance and Executive Functions of Adults With Cancer
- ClinicalTrials.gov ID
- NCT05599698
- Acronym / sponsor ID
- 0106-22-BNZ
- Conditions
- Cancer
- Keywords
- executive functioning, daily functioning, chemotherapy, non-central nervous system malignancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Bnai Zion Medical CenterOther government
- Collaborators
- Tel Aviv University
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 31 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chemotherapy | Experimental | Other: Chemotherapychemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChemotherapyStandard chemotherapy protocols for adjuvant \& neoadjuvant treatment for different types of solid malignancies | Other | chemotherapy |
Primary outcome
Change in scores of Canadian Occupational Performance Measure.
Time frame: 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.
10 secondary outcomes
Reintegration to Normal Living index.
Time frame: Change between Pre-to post (three months) chemotherapy
Backward Digit Span.
Time frame: 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)
Time frame: Change between Pre-to post (three months) chemotherapy
Color Trail Test - CTT
Time frame: Change between Pre-to post (three months) chemotherapy
Cognitive performance-based assessment will be assessed by the Weekly Calendar Planning Activity.
Time frame: Change between Pre-to post (three months) chemotherapy
Cognitive Self Efficacy FACT-Cognitive Function questionnaire
Time frame: Change between Pre-to post (three months) chemotherapy
Emotional Well-Being FACT-G questionnaire
Time frame: Change between Pre-to post (three months) chemotherapy
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
Time frame: 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
Time frame: Pre chemotherapy
Qualitative open-ended questions regarding perceived changes in participants' cognitive functioning following chemotherapy and how these changes affect their daily functioning
Time frame: Post (three months) chemotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Individual participant dataSharing planned: Yes. Articles are planned for publication of the study protocol and final study results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abed Agbarya, MD contact
Abed Agbarya, MD principal investigator
abed.agbarya@b-zion.org.il
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chemotherapy in people with Cancer, run by Bnai Zion Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact khawla loubani, PhD (+97240504564402, khawlaloubani@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in scores of Canadian Occupational Performance Measure. (time frame: Change between Pre-to post (three months) chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.