Unspecified Adult Solid Tumor, Protocol SpecificNCT00416481
Assessing Older Patients With Cancer
An observational study of Unspecified Adult Solid Tumor, Protocol Specific, run by Alliance for Clinical Trials in Oncology at 13 sites in United States.
Trial summary
RATIONALE: Questionnaires that measure the ability of older patients to think, learn, remember, and make judgments and carry out daily activities may improve the ability to plan treatment for patients with cancer. PURPOSE: This clinical trial is studying ways to assess older patients with cancer. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- quality of life questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 93 participants
- Where
- 13 sitesUnited States
- Study dates
- Dec 2006to Oct 2011
- Phase
- Observational
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients aged 65 years and older with a histologically confirmed malignancy enrolled on any cooperative group-sponsored cancer treatment trial.
DISEASE CHARACTERISTICS:
- Histologically confirmed malignancy at any stage
- Enrolled on any cooperative group-sponsored cancer treatment trial (treatment has not yet started), including trials on the Cancer Trials Support Unit
PATIENT CHARACTERISTICS:
- Any performance status allowed
- Must be able to follow directions in English
- Sufficient cognitive and psychological function to give consent
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210-1240
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
CCOP - Hematology-Oncology Associates of Central New York
East Syracuse, New York, 13057
Elkhart General Hospital
Elkhart, Indiana, 46515
Howard Community Hospital
Kokomo, Indiana, 46904
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, 46350
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
Lakeland Regional Cancer Care Center - St. Joseph
Saint Joseph, Michigan, 49085
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601
Memorial Hospital of South Bend
South Bend, Indiana, 46601
Michiana Hematology-Oncology, PC - South Bend
South Bend, Indiana, 46601
Saint Joseph Regional Medical Center
South Bend, Indiana, 46617
About this study
Official title: Development of a Geriatric Assessment Measure for Older Patients With Cancer
RATIONALE: Questionnaires that measure the ability of older patients to think, learn, remember, and make judgments and carry out daily activities may improve the ability to plan treatment for patients with cancer.
PURPOSE: This clinical trial is studying ways to assess older patients with cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the feasibility of administration of the geriatric assessment in elderly patients with cancer.
- Determine the percentage of patients able to complete the self-administered portion of the geriatric assessment without assistance.
- Determine the length of time necessary to complete the geriatric assessment.
- Determine the variance and number of missing items.
- Assess patient satisfaction with the questionnaire by identifying items that are distressing or difficult to comprehend.
- Assess the percentage of geriatric assessments that contain all three of the following items: Timed Up and Go Assessment, Blessed Orientation-Memory-Concentration Test, and healthcare professional-rated Karnofsky performance status.
Secondary
- Determine the proportion of patients who are able to complete the self-report portion of the questionnaire without assistance and the length of time needed to complete the geriatric assessment within patients of various sociodemographic factors and educational status.
OUTLINE: This is a multicenter study. Patients are stratified according to age (65 to 69 years vs 70 years and over).
Patients undergo assessments of cognition using the Blessed Orientation-Memory-Concentration Test; functional status using the Timed Up and Go Assessment (measures physical mobility); and performance status using the healthcare professional-rated Karnofsky performance scale. 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 treatment.
- Being tested
- quality of life questionnaires
- Keywords
- 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.
quality of life questionnairesBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Patient assessment | Patients undergo assessments of cognition and performance status using the healthcare professional-rated Karnofsky performance scale. 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 self-administered questionnaires that measure level of functioning and need for services. It also includes questionnaires that measure higher levels of physical functioning, performance related to survival and clinically significant illness and measures of comorbidity and the impact on daily activities. Lastly, questionnaires are administered to measure the impact of cancer on patients' social functioning and perceived availability of social support.
Patients then begin planned treatment. Receives: Behavioral: quality of life questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean and median time to complete the entire geriatric assessment
Measured: Up to 3 years
Mean number of missing items in each subscale and the distribution of missing items
Measured: Up to 3 years
Percentage of patients who identify a scale to be upsetting or difficult to understand
Measured: Up to 3 years
Percentage of Geriatric Assessments for which all three items (Timed Up and Go Assessment, Blessed Orientation-Memory-Concentration Test, and the healthcare professional-rated Karnofsky performance status) are completed
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2006 (estimated)
- Study startDec 2006
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- More trials run by Alliance for Clinical Trials in OncologyThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Alice B. Kornblith, PhD, Study chair, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00416481
- Sponsor's protocol ID
- CALGB-360401
- Other IDs
- CALGB-360401, CDR0000523527
- Status last verified
- Jul 2016
- First submitted
- 27 Dec 2006
- Last updated
- 13 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Hurria A, Cirrincione CT, Muss HB, Kornblith AB, Barry W, Artz AS, Schmieder L, Ansari R, Tew WP, Weckstein D, Kirshner J, Togawa K, Hansen K, Katheria V, Stone R, Galinsky I, Postiglione J, Cohen HJ. Implementing a geriatric assessment in cooperative group clinical cancer trials: CALGB 360401. J Clin Oncol. 2011 Apr 1;29(10):1290-6. doi: 10.1200/JCO.2010.30.6985. Epub 2011 Feb 28.
PubMed 21357782
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Geriatric Assessment Measure for Older Patients With Cancer
- ClinicalTrials.gov ID
- NCT00416481
- Acronym / sponsor ID
- CALGB-360401
- Keywords
- unspecified adult solid tumor, protocol specific
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Alliance for Clinical Trials in OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2006
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 28 Dec 2006 (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: Questionnaires that measure the ability of older patients to think, learn, remember, and make judgments and carry out daily activities may improve the ability to plan treatment for patients with cancer.
PURPOSE: This clinical trial is studying ways to assess older patients with cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the feasibility of administration of the geriatric assessment in elderly patients with cancer.
- Determine the percentage of patients able to complete the self-administered portion of the geriatric assessment without assistance.
- Determine the length of time necessary to complete the geriatric assessment.
- Determine the variance and number of missing items.
- Assess patient satisfaction with the questionnaire by identifying items that are distressing or difficult to comprehend.
- Assess the percentage of geriatric assessments that contain all three of the following items: Timed Up and Go Assessment, Blessed Orientation-Memory-Concentration Test, and healthcare professional-rated Karnofsky performance status.
Secondary
- Determine the proportion of patients who are able to complete the self-report portion of the questionnaire without assistance and the length of time needed to complete the geriatric assessment within patients of various sociodemographic factors and educational status.
OUTLINE: This is a multicenter study. Patients are stratified according to age (65 to 69 years vs 70 years and over).
Patients undergo assessments of cognition using the Blessed Orientation-Memory-Concentration Test; functional status using the Timed Up and Go Assessment (measures physical mobility); and performance status using the healthcare professional-rated Karnofsky performance scale. 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 treatment.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient assessment | – | Behavioral: quality of life questionnairesPatients undergo assessments of cognition and performance status using the healthcare professional-rated Karnofsky performance scale. 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 self-administered questionnaires that measure level of functioning and need for services. It also includes questionnaires that measure higher levels of physical functioning, performance related to survival and clinically significant illness and measures of comorbidity and the impact on daily activities. Lastly, questionnaires are administered to measure the impact of cancer on patients' social functioning and perceived availability of social support. Patients then begin planned treatment. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients aged 65 years and older with a histologically confirmed malignancy enrolled on any cooperative group-sponsored cancer treatment trial.
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 |
|---|---|---|
| quality of life questionnaires | Behavioural | Patient assessment |
Primary outcome
Mean and median time to complete the entire geriatric assessment
Time frame: Up to 3 years
Mean number of missing items in each subscale and the distribution of missing items
Time frame: Up to 3 years
Percentage of patients who identify a scale to be upsetting or difficult to understand
Time frame: Up to 3 years
Percentage of Geriatric Assessments for which all three items (Timed Up and Go Assessment, Blessed Orientation-Memory-Concentration Test, and the healthcare professional-rated Karnofsky performance status) are completed
Time frame: Up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2016.
- Results publication: PubMed 21357782Hurria A, Cirrincione CT, Muss HB, Kornblith AB, Barry W, Artz AS, Schmieder L, Ansari R, Tew WP, Weckstein D, Kirshner J, Togawa K, Hansen K, Katheria V, Stone R, Galinsky I, Postiglione J, Cohen HJ. Implementing a geriatric assessment in cooperative group clinical cancer trials: CALGB 360401. J Clin Oncol. 2011 Apr 1;29(10):1290-6. doi: 10.1200/JCO.2010.30.6985. Epub 2011 Feb 28.
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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.
Alice B. Kornblith, PhD study chair
Dana-Farber Cancer Institute
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unspecified Adult Solid Tumor, Protocol Specific, run by Alliance for Clinical Trials in Oncology at 13 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: finished, as of the sponsor's last update on 13 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean and median time to complete the entire geriatric assessment (time frame: Up to 3 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00416481, which also lists 1 linked publication.
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 13 Jul 2016.