Cognitive/Functional EffectsNCT00477958
Assessment Tool for Older Patients With Cancer
A study testing questionnaire administration, cognitive assessment and psychosocial assessment and care in people with Cognitive/Functional Effects and Psychosocial Effects of Cancer and Its Treatment, run by City of Hope Medical Center at 8 sites in United States.
Trial summary
RATIONALE: A study that assesses the ability of older patients to think, learn, remember, make judgments, and carry out daily activities may help doctors plan treatment for older patients with cancer. PURPOSE: This clinical trial is studying an assessment tool in older patients with cancer. Read more about this study
- Who is it for?
- Ages 65 to 120 years
- Conditions the study is for
- Cognitive/Functional Effects, Psychosocial Effects of Cancer and Its Treatment, Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- questionnaire administration, cognitive assessment and psychosocial assessment and care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,062 participants
- Where
- 8 sitesUnited States
- Study dates
- 20 Dec 2006to 17 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 to 120 years
- All sexes
- No healthy volunteers
- Older adult
DISEASE CHARACTERISTICS:
- Pathologically confirmed cancer
- Receiving chemotherapy for either adjuvant treatment or metastatic disease prior to beginning a new chemotherapy regimen
PATIENT CHARACTERISTICS:
- Must be able to understand English
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior enrollment in this trial
- No concurrent enrollment on a phase I clinical trial
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Tower Cancer Research Foundation
Beverly Hills, California, 90211
Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
City of Hope Medical Center
Duarte, California, 91010-3000
Yale Cancer Center
New Haven, Connecticut, 06520-8028
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Orange, California, 92868
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, 14642
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157-1096
About this study
Official title: Determining the Utility of an Assessment Tool for Older Patients With Cancer
RATIONALE: A study that assesses the ability of older patients to think, learn, remember, make judgments, and carry out daily activities may help doctors plan treatment for older patients with cancer.
PURPOSE: This clinical trial is studying an assessment tool in older patients with cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine whether a geriatric assessment tool can predict toxicity to chemotherapy, defined as grade 3 or 4 toxicity, hospitalization, dose delay or reduction, or discontinuation of chemotherapy due to toxicity, in elderly patients with cancer.
Secondary
- Explore the longitudinal impact of cancer and chemotherapy treatment on geriatric assessment parameters.
OUTLINE: Patients undergo assessments of functional status using the Timed Up and Go Assessment (measures physical mobility) and Karnofsky Physician-Rated Performance Rating Scale; and cognition using the Blessed Orientation-Memory-Concentration Test. These assessments are performed by healthcare personnel. Body mass index and the percentage of unintentional weight loss and the number of falls in the past 6 months are also assessed.
Patients also complete the following self-administered questionnaires: Instrumental Activities of Daily Living (measures level of functioning and need for services); Activities of Daily Living (measures higher levels of physical functioning); Karnofsky Self-Reported Performance Rating Scale (related to survival and clinically significant illness); Physical Health Section of the Older American Resources and Services Questionnaire (measures comorbidity and the impact on daily activities); Hospital Anxiety and Depression Scale; Medical Outcomes Study (MOS) Social Activity Limitations Measure (measures the impact of cancer on patients' social functioning); and MOS Social Support Survey Emotional/Information and Tangible Subscales (measures perceived availability of social support).
Patients then begin planned chemotherapy.
After completion of chemotherapy (or a maximum of 12 months from study entry), patients undergo assessments and complete self-administered questionnaires as described above.
PROJECTED ACCRUAL: A total of 750 patients will be accrued for this study.
- Conditions
- Cognitive/Functional Effects, Psychosocial Effects of Cancer and Its Treatment, Unspecified Adult Solid Tumor, Protocol Specific
- Being tested
- questionnaire administration, cognitive assessment, psychosocial assessment and care
- Keywords
- cognitive/functional effects, psychosocial effects of cancer and its treatment, unspecified adult solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire administrationOther
Questionnaire administered prior to chemotherapy and within 30 days of completion of chemotherapy.
cognitive assessmentProcedure or surgery
Cognitive assessment to be obtained prior to chemotherapy and within 30 days of completion of chemotherapy.
psychosocial assessment and careProcedure or surgery
Psychosocial assessment and care to be obtained prior to chemotherapy and within 30 days of completion of chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Geriatric Assessment Tool | Experimental | Not described Receives: Other: questionnaire administration; Procedure: cognitive assessment; Procedure: psychosocial assessment and care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to predict toxicity to chemotherapy, defined as grade 3-4 toxicity, hospitalization, dose delay or reduction, or discontinuation of chemotherapy due to toxicity, as measured by a geriatric assessment tool
Measured: Prior to chemotherapy and within 30 days of completion of chemotherapy.
Secondary outcomes (1)
Longitudinal impact of cancer and chemotherapy treatment on geriatric assessment parameters
Measured: Prior to chemotherapy and within 30 days of completion of chemotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2007 (estimated)
- Study start20 Dec 2006
- Primary completion17 Feb 2027 (estimated)
- Study completion17 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive/Functional EffectsStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,062 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Dale William, MD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00477958
- Sponsor's protocol ID
- 06170
- Other IDs
- P30CA033572, CHNMC-06170, MSKCC-06034, CDR0000540332
- Status last verified
- Oct 2026
- First submitted
- 23 May 2007
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Utility of an Assessment Tool for Older Patients With Cancer
- ClinicalTrials.gov ID
- NCT00477958
- Acronym / sponsor ID
- 06170
- Conditions
- Cognitive/Functional Effects, Psychosocial Effects of Cancer and Its Treatment, Unspecified Adult Solid Tumor, Protocol Specific
- Keywords
- cognitive/functional effects, psychosocial effects of cancer and its treatment, unspecified adult solid tumor, protocol specific
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,062 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 20 Dec 2006 (actual)
- Primary completion
- 17 Feb 2027 (estimated)
- Study completion
- 17 Feb 2027 (estimated)
- First posted
- 24 May 2007 (estimated)
- 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.
RATIONALE: A study that assesses the ability of older patients to think, learn, remember, make judgments, and carry out daily activities may help doctors plan treatment for older patients with cancer.
PURPOSE: This clinical trial is studying an assessment tool in older patients with cancer.
Detailed description
OBJECTIVES:
Primary
- Determine whether a geriatric assessment tool can predict toxicity to chemotherapy, defined as grade 3 or 4 toxicity, hospitalization, dose delay or reduction, or discontinuation of chemotherapy due to toxicity, in elderly patients with cancer.
Secondary
- Explore the longitudinal impact of cancer and chemotherapy treatment on geriatric assessment parameters.
OUTLINE: Patients undergo assessments of functional status using the Timed Up and Go Assessment (measures physical mobility) and Karnofsky Physician-Rated Performance Rating Scale; and cognition using the Blessed Orientation-Memory-Concentration Test. These assessments are performed by healthcare personnel. Body mass index and the percentage of unintentional weight loss and the number of falls in the past 6 months are also assessed.
Patients also complete the following self-administered questionnaires: Instrumental Activities of Daily Living (measures level of functioning and need for services); Activities of Daily Living (measures higher levels of physical functioning); Karnofsky Self-Reported Performance Rating Scale (related to survival and clinically significant illness); Physical Health Section of the Older American Resources and Services Questionnaire (measures comorbidity and the impact on daily activities); Hospital Anxiety and Depression Scale; Medical Outcomes Study (MOS) Social Activity Limitations Measure (measures the impact of cancer on patients' social functioning); and MOS Social Support Survey Emotional/Information and Tangible Subscales (measures perceived availability of social support).
Patients then begin planned chemotherapy.
After completion of chemotherapy (or a maximum of 12 months from study entry), patients undergo assessments and complete self-administered questionnaires as described above.
PROJECTED ACCRUAL: A total of 750 patients will be accrued for this study.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Geriatric Assessment Tool | Experimental | Other: questionnaire administration, Procedure: cognitive assessment, Procedure: psychosocial assessment and care |
Who may qualify
- Ages
- 65 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
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 |
|---|---|---|
| questionnaire administrationQuestionnaire administered prior to chemotherapy and within 30 days of completion of chemotherapy. | Other | Geriatric Assessment Tool |
| cognitive assessmentCognitive assessment to be obtained prior to chemotherapy and within 30 days of completion of chemotherapy. | Procedure or surgery | Geriatric Assessment Tool |
| psychosocial assessment and carePsychosocial assessment and care to be obtained prior to chemotherapy and within 30 days of completion of chemotherapy. | Procedure or surgery | Geriatric Assessment Tool |
Primary outcome
Ability to predict toxicity to chemotherapy, defined as grade 3-4 toxicity, hospitalization, dose delay or reduction, or discontinuation of chemotherapy due to toxicity, as measured by a geriatric assessment tool
Time frame: Prior to chemotherapy and within 30 days of completion of chemotherapy.
1 secondary outcome
Longitudinal impact of cancer and chemotherapy treatment on geriatric assessment parameters
Time frame: Prior to chemotherapy and within 30 days of completion of chemotherapy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
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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.
Dale William, MD principal investigator
City of Hope Medical Center
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing questionnaire administration, cognitive assessment and psychosocial assessment and care in people with Cognitive/Functional Effects and Psychosocial Effects of Cancer and Its Treatment, run by City of Hope Medical Center at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: under way, not looking for participants, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability to predict toxicity to chemotherapy, defined as grade 3-4 toxicity, hospitalization, dose delay or reduction, or discontinuation of chemotherapy due to toxicity, as measured by a geriatric assessment tool (time frame: Prior to chemotherapy and within 30 days of completion of 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 15 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.