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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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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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
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

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

Other trials in United States

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.

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 groups in NCT00477958
Study groupRoleWhat they receive
Geriatric Assessment ToolExperimentalNot 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.

  1. 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)

  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.

  1. First posted24 May 2007 (estimated)
  2. Study start20 Dec 2006
  3. Primary completion17 Feb 2027 (estimated)
  4. Study completion17 Feb 2027 (estimated)

Resources

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)
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

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