Unspecified Adult Solid Tumor, Protocol SpecificNCT01005693
Screening Tools to Predict Treatment Outcome in Older Cancer Patients Who Are Undergoing Treatment
A study testing questionnaire administration, cognitive assessment and examination in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Ziekenhuis Netwerk Antwerpen (ZNA) at 4 sites in Belgium.
Trial summary
RATIONALE: Questionnaires that measure how well older patients think, learn, remember, and make judgments and carry out daily activities may improve the ability to plan treatment for 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?
- questionnaire administration, cognitive assessment and examination
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 4 sitesBelgium
- Study dates
- Oct 2009to Oct 2011
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed cancer
- Undergoing out-patient care
- Planning to undergo primary chemotherapeutic treatment or treatment with targeted agents for curative or palliative intent
- No symptomatic brain metastases
PATIENT CHARACTERISTICS:
- Able to understand the Flemish language, give informed consent, and be followed at the investigational site
- Must be considered eligible for trial participation by the Investigator
- No severe known dementia
- No pre-existing major neurological or psychiatric problems
- No refusal of the standard anticancer strategy as defined by the service instruction book
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
4 sites in 1 country.
Belgium4 sites, 4 recruiting
- Recruiting
Onze Lieve Vrouw Ziekenhuis Aalst
Aalst, B-9300
Contact Person
- Recruiting
Ziekenhuis Netwerk Antwerpen Middelheim
Antwerp, B-2020
Contact Person, 32-3-280-2339
- Recruiting
Ziekenhuis Netwerk Antwerpen Stuivenberg
Antwerp, B-2060
Contact Person
- Recruiting
Virga Jesse Hospital
Hasselt, 3500
Contact Person
About this study
Official title: Impact of Frailty in Senior Cancer Patients: Feasibility and Value of Screening Tools and Geriatric Intervention and Predictive Value of a Screening Tool in Relation to Treatment Outcome
RATIONALE: Questionnaires that measure how well older patients 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 testing for fitness to undergo chemotherapy to see how well it works in predicting treatment outcomes in older patients with cancer.
Read the detailed description
OBJECTIVES:
- To assess the feasibility of applying screening tools (Groningen Frailty Indicator [GFI] and G8) and their relationship to treatment outcome in older patients with cancer undergoing standard treatment versus geriatric interventions.
- To compare the screening tools (GFI and G8) with a comprehensive geriatric assessment (CGA).
- To evaluate the predictive value of the screening tool to undergo standard anticancer treatment in terms of toxicity.
- To identify patients that can benefit from a geriatric intervention in order to be able to undergo standard anticancer treatment.
OUTLINE: This is a multicenter study.
All patients complete screening questionnaires (GFI, G8, and the standardized CGA which consists of the ADL (Katz index) and IADL; the Timed Up and Go; the Cancer and Leukemia Group B adaptation of Charlson Co-morbidity; the Mini Nutritional Assessment; the RAND Social Support Survey Instrument; the Folstein Mini Mental State Examination; and the Geriatric Depression Scale) before the start of anticancer treatment, prior to each course of treatment, and after 1 month of treatment. Patients also undergo physical and cognitive performance measures by a trained member of the research team. Patients are assigned to a group based on fitness for treatment. They may be reassigned after each round of assessments.
- Group 1 (fit to undergo standard treatment): Patients undergo standard treatment.
- Group 2 (vulnerable): Patients receive specialized care and individualized treatment.
- Group 3 (frail): Patients receive palliative care and no anticancer chemotherapy or targeted agents.
Patients' medical history, vital signs, performance status, physical examination, and body weight are obtained and recorded. In patients receiving anticancer treatment, all adverse events are graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) and recorded and serious adverse events will be reported according to European Rules.
- Being tested
- questionnaire administration, cognitive assessment, examination, management of therapy complications
- 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.
questionnaire administrationOther
cognitive assessmentProcedure or surgery
examinationProcedure or surgery
management of therapy complicationsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of applying screening tools (Groningen Frailty Indicator [GFI] and G8) in older patients with cancer
Comparison of the screening tools (GFI and G8) with a comprehensive geriatric assessment (CGA)
Predictive value of the screening tool to undergo standard anticancer treatment in terms of toxicity according to the NCI-CTC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionOct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies 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
- Supportive care
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziekenhuis Netwerk Antwerpen (ZNA)
- Sponsor type
- University, hospital or other
- Investigators
- Dirk Schrijvers, MD, PhD, Principal investigator, Ziekenhuis Netwerk Antwerpen (ZNA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01005693
- Sponsor's protocol ID
- ZNA-2008-FOD-GER001
- Other IDs
- CDR0000658351, EU-20985
- Status last verified
- May 2010
- First submitted
- 30 Oct 2009
- Last updated
- 15 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Frailty in Senior Cancer Patients: Feasibility and Value of Screening Tools and Geriatric Intervention and Predictive Value of a Screening Tool in Relation to Treatment Outcome
- ClinicalTrials.gov ID
- NCT01005693
- Acronym / sponsor ID
- ZNA-2008-FOD-GER001
- Keywords
- unspecified adult solid tumor, protocol specific
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Ziekenhuis Netwerk Antwerpen (ZNA)University, hospital or other
- Study start
- Oct 2009
- Primary completion
- Oct 2011 (estimated)
- First posted
- 2 Nov 2009 (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 how well older patients 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 testing for fitness to undergo chemotherapy to see how well it works in predicting treatment outcomes in older patients with cancer.
Detailed description
OBJECTIVES:
- To assess the feasibility of applying screening tools (Groningen Frailty Indicator [GFI] and G8) and their relationship to treatment outcome in older patients with cancer undergoing standard treatment versus geriatric interventions.
- To compare the screening tools (GFI and G8) with a comprehensive geriatric assessment (CGA).
- To evaluate the predictive value of the screening tool to undergo standard anticancer treatment in terms of toxicity.
- To identify patients that can benefit from a geriatric intervention in order to be able to undergo standard anticancer treatment.
OUTLINE: This is a multicenter study.
All patients complete screening questionnaires (GFI, G8, and the standardized CGA which consists of the ADL (Katz index) and IADL; the Timed Up and Go; the Cancer and Leukemia Group B adaptation of Charlson Co-morbidity; the Mini Nutritional Assessment; the RAND Social Support Survey Instrument; the Folstein Mini Mental State Examination; and the Geriatric Depression Scale) before the start of anticancer treatment, prior to each course of treatment, and after 1 month of treatment. Patients also undergo physical and cognitive performance measures by a trained member of the research team. Patients are assigned to a group based on fitness for treatment. They may be reassigned after each round of assessments.
- Group 1 (fit to undergo standard treatment): Patients undergo standard treatment.
- Group 2 (vulnerable): Patients receive specialized care and individualized treatment.
- Group 3 (frail): Patients receive palliative care and no anticancer chemotherapy or targeted agents.
Patients' medical history, vital signs, performance status, physical examination, and body weight are obtained and recorded. In patients receiving anticancer treatment, all adverse events are graded according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) and recorded and serious adverse events will be reported according to European Rules.
Study design
- Primary purpose
- Supportive care
Who may qualify
- Ages
- 65 years and older
- 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 administration | Other | – |
| cognitive assessment | Procedure or surgery | – |
| examination | Procedure or surgery | – |
| management of therapy complications | Procedure or surgery | – |
Primary outcome
Feasibility of applying screening tools (Groningen Frailty Indicator [GFI] and G8) in older patients with cancer
Comparison of the screening tools (GFI and G8) with a comprehensive geriatric assessment (CGA)
Predictive value of the screening tool to undergo standard anticancer treatment in terms of toxicity according to the NCI-CTC
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2013.
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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.
Dirk Schrijvers, MD, PhD principal investigator
Ziekenhuis Netwerk Antwerpen (ZNA)
4 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 examination in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Ziekenhuis Netwerk Antwerpen (ZNA) at 4 sites in Belgium.
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: status not confirmed, as of the sponsor's last update on 15 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of applying screening tools (Groningen Frailty Indicator [GFI] and G8) in older patients with cancer. The study lists 3 primary outcomes in all. 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 May 2013.