ElderlyNCT02072733
Suitability of an Organization With an Onco-geriatric Team to a Whole Region (Region Midt) of Denmark
A study testing Comprehensive geriatric assessment in people with Elderly and Cancer, run by University of Aarhus at 1 site in Denmark.
Trial summary
A Feasibility study Geriatric assessment applied to patients with cancer of the head and neck, lung cancer, upper gastrointestinal cancer or colo-rectal cancer. On the day of planning the oncologic treatment Comprehensive Geriatric Assessment (CGA) will be offered to patients aged 70 years and up. Read more about this study
- Who is it for?
- Ages 70 to 130 years
- What is being tested?
- Comprehensive geriatric assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2015to Dec 2015
- 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 70 to 130 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 70 years or older
- Patients from Central Denmark Region (Region Midtjylland)
- Lung cancer, Upper Gastrointestinal Cancer, cancer of head and neck and Colo-Rectal Cancer
- referred for assessment of treatment to the oncological department at Aarhus University Hospital.
Who cannot join
- Patients referred to specialized palliative care at the first visit to the oncological outpatient clinic.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oncogeriatric Intervention and Follow-up at Home to Improve Quality of Life and the Possibility to Accomplish Cancer Treatment in Multimorbid Elderly
A Feasibility study Geriatric assessment applied to patients with cancer of the head and neck, lung cancer, upper gastrointestinal cancer or colo-rectal cancer. On the day of planning the oncologic treatment Comprehensive Geriatric Assessment (CGA) will be offered to patients aged 70 years and up. Based on the CGA a tailored multidisciplinary intervention is planned with the patients. The study aims 1) to investigate if it is feasible to offer CGA to all elderly (+70 years) patients with the relevant cancer diagnoses as mentioned above in The Central Denmark Region (Region Midt) , 2) to estimate the proportion of frail, vulnerable or fit elderly cancer patients, 3) to investigate the impact of a CGA on the planned oncologic treatment intensity, and 4) to investigate the ability of CGA to predict complications to cancer treatment within a three months period.
Read the detailed description
Aim:
The study aims 1)to investigate if it is feasible to offer CGA to all elderly (+70 years) patients with the relevant cancer diagnoses as mentioned above in The Central Denmark Region (Region Midt) , 2) to estimate the proportion of frail, vulnerable or fit elderly cancer patients, 3) to investigate the impact of a CGA on the planned oncologic treatment intensity and 4)to investigate the ability of CGA to predict complications to cancer treatment within a three months period.
Method:
All patients referred to the oncology Departement aged 70 years or more with cancer of the head and neck, lung cancer, upper gastrointestinal cancer or colo-rectal cancer, Living in the Central Denmark Region (Region Midt) are offered af Comprehensive Geriatric Assessment (CGA) on the day of the visit to the oncology outpatient Clinic. Prior to the first visit to the oncology department, the patients are informed that a CGA is planned..The CGA will take place at the outpatient clinic. The results of the CGA, the eventual medical changes and recommendations regarding e.g. initiation of nutritional supplementation, home-care referral or referral to e.g. physiotherapist will be forwarded to the general practitioner and to the oncologist in charge of the treatment.
Outcome:
- The possibility of offering CGA to elderly cancer patients in a larger area, the proportion of patients offered CGA by the oncogeriatric team compared to the actual number of elderly cancer patients assessed by oncologists during a three months period.
- The number of frail vs. vulnerable vs. fit persons is estimated from hospital records and the CGA observations. Their dependency in Activities of Daily Living (ADL) and Instrumental Activities og Daily Living (IADL), their cognitive, depressive and nutritional status and the medication problems are registered as well as the changes in patient´s medication.
- The impact of CGA on the oncologist´s treatment plan.
- The Complications, defined as discontinuation of treatment, hospitalization for other reasons than planned cancer treatment, or death, within the first three month following CGA.
- Being tested
- Comprehensive geriatric assessment
- Keywords
- frailty, oncogeriatrics, Multidisciplinary intervention, multimorbidity, Comprehensive geriatric assessment, patients
- Medical subject headings
- Neoplasms, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive geriatric assessmentOther
Intervention is planned to be based on the findings of the geriatric assessment and could include optimizing on comorbidity, planning of physical exercise, improvement of the social situation and nutritional status.
| Study group | Role | What they receive |
|---|---|---|
| geriatric assessment | Other | The intervention is individual and based on the Comprehensive Geriatric assessment (CGA) : collection of information on comorbidity, polypharmacy, physical, psychological and cognitive functions, nutrition as well as social status and support.
The results of the CGA, the eventual medical changes and recommendations regarding e.g. initiation of nutritional supplementation, home-care referral or referral to e.g. physiotherapist will be forwarded to the general practitioner and to the oncologist in charge of the treatment Receives: Other: Comprehensive geriatric assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Description of the proportion of patients who is available for CGA presented in percentage. Proportion of patients missed for CGA due to organisational issues or rejection to participate in the geriatric evaluation is presented in percentage.
Measured: 3 months
Secondary outcomes (1)
frailty status
Patient characteristics according to CGA status is presented in percentage
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2014 (estimated)
- Study startJan 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Cancer Society
- Responsible party
- Sponsor
- Investigators
- Else Marie Damsgaard, Professor, Study chair, Geriatric Department Aarhus University Hospital Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02072733
- Sponsor's protocol ID
- Oncogeriatric feasibility
- Status last verified
- Dec 2015
- First submitted
- 19 Feb 2014
- Last updated
- 11 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oncogeriatric Intervention and Follow-up at Home to Improve Quality of Life and the Possibility to Accomplish Cancer Treatment in Multimorbid Elderly
- ClinicalTrials.gov ID
- NCT02072733
- Acronym / sponsor ID
- Oncogeriatric feasibility
- Keywords
- frailty, oncogeriatrics, Multidisciplinary intervention, multimorbidity, Comprehensive geriatric assessment, patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Danish Cancer Society
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 27 Feb 2014 (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.
A Feasibility study Geriatric assessment applied to patients with cancer of the head and neck, lung cancer, upper gastrointestinal cancer or colo-rectal cancer. On the day of planning the oncologic treatment Comprehensive Geriatric Assessment (CGA) will be offered to patients aged 70 years and up. Based on the CGA a tailored multidisciplinary intervention is planned with the patients. The study aims 1) to investigate if it is feasible to offer CGA to all elderly (+70 years) patients with the relevant cancer diagnoses as mentioned above in The Central Denmark Region (Region Midt) , 2) to estimate the proportion of frail, vulnerable or fit elderly cancer patients, 3) to investigate the impact of a CGA on the planned oncologic treatment intensity, and 4) to investigate the ability of CGA to predict complications to cancer treatment within a three months period.
Detailed description
Aim:
The study aims 1)to investigate if it is feasible to offer CGA to all elderly (+70 years) patients with the relevant cancer diagnoses as mentioned above in The Central Denmark Region (Region Midt) , 2) to estimate the proportion of frail, vulnerable or fit elderly cancer patients, 3) to investigate the impact of a CGA on the planned oncologic treatment intensity and 4)to investigate the ability of CGA to predict complications to cancer treatment within a three months period.
Method:
All patients referred to the oncology Departement aged 70 years or more with cancer of the head and neck, lung cancer, upper gastrointestinal cancer or colo-rectal cancer, Living in the Central Denmark Region (Region Midt) are offered af Comprehensive Geriatric Assessment (CGA) on the day of the visit to the oncology outpatient Clinic. Prior to the first visit to the oncology department, the patients are informed that a CGA is planned..The CGA will take place at the outpatient clinic. The results of the CGA, the eventual medical changes and recommendations regarding e.g. initiation of nutritional supplementation, home-care referral or referral to e.g. physiotherapist will be forwarded to the general practitioner and to the oncologist in charge of the treatment.
Outcome:
- The possibility of offering CGA to elderly cancer patients in a larger area, the proportion of patients offered CGA by the oncogeriatric team compared to the actual number of elderly cancer patients assessed by oncologists during a three months period.
- The number of frail vs. vulnerable vs. fit persons is estimated from hospital records and the CGA observations. Their dependency in Activities of Daily Living (ADL) and Instrumental Activities og Daily Living (IADL), their cognitive, depressive and nutritional status and the medication problems are registered as well as the changes in patient´s medication.
- The impact of CGA on the oncologist´s treatment plan.
- The Complications, defined as discontinuation of treatment, hospitalization for other reasons than planned cancer treatment, or death, within the first three month following CGA.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| geriatric assessment | Other | Other: Comprehensive geriatric assessmentThe intervention is individual and based on the Comprehensive Geriatric assessment (CGA) : collection of information on comorbidity, polypharmacy, physical, psychological and cognitive functions, nutrition as well as social status and support. The results of the CGA, the eventual medical changes and recommendations regarding e.g. initiation of nutritional supplementation, home-care referral or referral to e.g. physiotherapist will be forwarded to the general practitioner and to the oncologist in charge of the treatment |
Who may qualify
- Ages
- 70 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 70 years or older
- Patients from Central Denmark Region (Region Midtjylland)
- Lung cancer, Upper Gastrointestinal Cancer, cancer of head and neck and Colo-Rectal Cancer
- referred for assessment of treatment to the oncological department at Aarhus University Hospital.
Key exclusion criteria (1 listed)
- Patients referred to specialized palliative care at the first visit to the oncological outpatient clinic.
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 |
|---|---|---|
| Comprehensive geriatric assessmentIntervention is planned to be based on the findings of the geriatric assessment and could include optimizing on comorbidity, planning of physical exercise, improvement of the social situation and nutritional status. | Other | geriatric assessment |
Primary outcome
Feasibility
Time frame: 3 months
Description of the proportion of patients who is available for CGA presented in percentage. Proportion of patients missed for CGA due to organisational issues or rejection to participate in the geriatric evaluation is presented in percentage.
1 secondary outcome
frailty status
Time frame: 3 months
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 11 Apr 2017.
- Individual participant dataSharing planned: No
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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.
Else Marie Damsgaard, Professor study chair
Geriatric Department Aarhus University Hospital Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive geriatric assessment in people with Elderly and Cancer, run by University of Aarhus at 1 site in Denmark.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 11 Apr 2017. 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 Denmark. 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?
Feasibility (time frame: 3 months). 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 11 Apr 2017.