NeoplasmsNCT02837679
Oncogeriatric Intervention and Follow-up at Home
A study testing Geriatric Follow up in people with Neoplasms and Geriatric Assessment, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
The study is a randomized study of patients living in four municipalities in Eastern Jutland. After geriatric assessment half of the patients will be offered a tailor-made intervention in their homes. The follow-up will last for at least 90 days and include treatment of the patients' multimorbidity, e.g. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Neoplasms, Geriatric Assessment, Lung Neoplasms
- What is being tested?
- Geriatric Follow up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2016to Jan 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 70 years or older with cancer of the head and neck, upper gastro intestinal cancer, colo-rectal cancer or Lung cancer, refered to Aarhus University Hospital for evaluation regarding oncological treatment on the Oncology Department at Aarhus University
- Living in following municipalities: Odder (excl. of the island of Thunø), Faurskov, Skanderborg og Aarhus
- frail or vulnerable by CGA
- Signed informed consent. For incapacitated patients: informed consent by relatives
Who cannot join
- evaluated 'fit´ by CGA
- Referred to specialized palliative care at time of first visit at the Oncology department
- Do not wish to participate
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
The study is a randomized study of patients living in four municipalities in Eastern Jutland. After geriatric assessment half of the patients will be offered a tailor-made intervention in their homes. The follow-up will last for at least 90 days and include treatment of the patients' multimorbidity, e.g. of dehydration, anaemia, infections, and malnutrition. The other half of the patients, the results of the assessment and recommendations will be given to the patients and their general practitioner.
The primary efficacy variables are accomplishment of planned cancer treatment, reduction of complications and admissions to hospital and increased quality of life,.
If geriatric assessment and a tailor-made follow-up result in a better quality of life with less complications and admissions the offer may be extended to a longer period, younger age groups and other cancer diagnoses.
Read the detailed description
Cancer of the head and neck (HNC), lung (LC), upper gastrointestinal channel (CUGI) and colo-rectal cancer (CRC) accounts for approximately 40% of cancer incidence in elderly people (defined as ≥70 years) in Denmark (DK). The four cancers account for more than 50% of the annual cancer-related deaths in DK. Incidence and mortality of cancer increases with age. Comorbidity (simultaneous presence of several medical conditions) are more present in older cancer patients than in younger This means that older cancer patients are more vulnerable by physiological, psychological and social means than younger. Older cancer patients frequent develop side effects of cancer treatment than younger cancer patients.
Comprehensive Geriatric Assessment (CGA), is a comprehensive investigation and assessment of various aspects of a person's health, carried out by a multidisciplinary team in order to identify, quantify problems and follow up on the identified problems. CGA comprises collecting information on comorbidity, polypharmacy, physical, psychological and cognitive problems, nutritional status and social support. Problems in these areas implies a worse prognosis in terms of survival, response to treatment and side effects of cancer treatment .
CGA have shown to be able to identify novel health problems in about half of elderly patients with cancer. It has previously been shown that the focused palliative care of patients with lung cancer with a focus on optimization of medication and follow up on unresolved problems increases the quality of life, eases depressive symptoms and increases survival. CGA is shown to be an effective base for intervention in order to increase the survival of the elderly in general (with no known cancer), in order to increase the physical and cognitive status, and to reduce the need for changes in housing facilities. Geriatric intervention based on CGA called Comprehensive Geriatric Care (CGC).
Frailty is a condition that occurs as a result of declining physiological reserve, causing vulnerability to health stressors. One way of defining frailty is based on CGA, where patients are divided into "frail" "vulnerable/pre-frail" and "fit" by performing CGA :
Frail: patients who meet one or more of the following: dependence in Activities of Daily Living (ADL), severe comorbidity, cognitive dysfunction, depression, malnutrition, or more than 7 different fixed daily preparations on time for CGA, (multivitamin not included).
Fit patients: independent in ADL and Instrumental Activities of Daily Living (IADL), no or minimal comorbidity, Cognitively intact and no nutritional problems.
Vulnerable / pre-frail patients: Neither Fit nor frail. Frailty is a potentially reversible mode. It is known that elderly patients may develop frailty during cancer treatment.
From a previously conducted study of 217 elderly patients with HNC, LC, and CRC CUGI, we know that a large part of the patients are frail (52%) or vulnerable (35%). Only 13% are fit . But we do not know the effect of providing geriatric follow-up to this population with regards to complications of cancer treatment, including the ability to be able accomplish cancer treatment as planned and the possibility of reducing hospital stay.
A study carried out on patients discharged from the Emergency Department or Geriatric wards, have shown that it is possible to reduce the admission time by offering CGA related to admission and add follow-up with the CGC compared to only providing CGA for patients in the hospital. In the study, hospitalization was reduced by 55% It has not previously been shown if CGA in an outpatient setting and subsequent Geriatric follow up on the problems identified can reduce hospitalization time and increase the proportion who accomplish cancer treatment per protocol in older cancer patients until 1 status examination compared to patients who only get CGA in the outpatient setting, but do not get geriatric follow-up afterwards.
It's oncology practice at first outpatient attendance to define what type of cancer a patient must have, this includes both the type of treatment, the aim of treatment (neoadjuvant, adjuvant, curative or palliative (life-prolonging / palliative)), dose of treatment and duration of treatment before status examination.
Intervention CGC is an intervention that is tailored to the individual patient based on the problem areas identified by CGA and the problems that occur within 90 days of enrollment. It can include home visits, visits to Aarhus University Hospital (AUH) in outpatient settings, scheduled and on demand and telephone contact. Patients will be followed for 90 days of enrollment or until reference to specialized palliative care treatment or death. The geriatric intervention may consist of liquid treatment, blood transfusion, oral or intravenous antibiotic administration, oxygen therapy, pain management, social intervention, nutritional intervention and lifeline telephone number The geriatric intervention will be different from patient to patient. There may be many or few contacts of various kinds. During the 90 days the number and nature of contacts (telephone / attendance / home visits) will be recorded as the interventions that are performed will be registered (medication changes, social work, nutrition efforts and efforts to optimize Physical functioning) Contact between the oncogeriatric team and the patient can be taken at the initiative of oncogeriatric team, patient or relatives. The oncogeriatric team can initiate treatment or refer to another department, if necessary.
Controls For the control group, the result and the recommendations of the CGA, which has been given to patients regarding. for example medication changes, social intervention (eg. adaptation of home care), physical optimization for example. training and nutrition recommendations will be summarized for the patient and with the patient's acceptance sent to the practitioner. Otherwise, no follow-upis performed in the period by oncogeriatric team.
After 3 months, the intervention group and control Group are tested by CGA and quality of life questionnaires in order to compare with baseline results and comparing the control group with the intervention group.
Blinding It is not possible to blind subjects to randomization. Likewise, it is not possible to blind the geriatric team in charge of the follow-up for the result of the randomization. The person that test subjects after 3 months is blinded to the randomization. Oncologists do not get information about randomization.
- Conditions
- Neoplasms, Geriatric Assessment, Lung Neoplasms, Colorectal Neoplasms, Head and Neck Neoplasms, Gastrointestinal Neoplasms
- Being tested
- Geriatric Follow up
- Medical subject headings
- Neoplasms, Lung Neoplasms, Colorectal Neoplasms, Head and Neck Neoplasms, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geriatric Follow upOther
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Geriatric follow up Receives: Other: Geriatric Follow up |
| Control | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of admittance to initial planned oncological treatment
Oncological specialist evaluates if treatment is completed as planned or if eventual deviations are of minor or major character
Measured: An average of 12 weeks
Change in Quality of life (QoL)
Participants with a Mini-Mental State Examination (MMSE)-score of 25 and above are tested using European Organisation of Research and Treatment of Cancer (EORTC) Core Questionnaire (C30) in combination with Elderly questionnaire (ELD14).
Measured: 90 days
Change in Quality of life
Participants with a Mini-Mental State Examination (MMSE)-score below 25 are tested using "Depression List"
Measured: 90 days
Secondary outcomes (5)
90-day survival
Are patients still alive 90 days after geriatric contact?
Measured: Within 90 days from first geriatric contact
Physical performance, chair-stand-test
Physical performance is measured using chair-stand-test
Measured: Changes in physical performance from first geriatric contact to 90 days after
Physical performance, Barthel-100
Physical performance is measured using Barthel-100
Measured: Changes in physical performance from first geriatric contact to 90 days after
Physical performance, FAQ-IADL
Physical performance is measured using Functional Activities Questionnaire (FAQ)-IADL
Measured: Changes in physical performance from first geriatric contact to 90 days after
Length of hospital stay
Sum of hospital bed days in study period
Measured: Within 90 days from first geriatric contact
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study startJan 2016
- Primary completionSep 2019
- Study completionJan 2023 (estimated)
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 NeoplasmsStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Cancer Society
- Responsible party
- Principal investigator, Marianne Ørum, Aarhus University Hospital
- Investigators
- Marianne Ørum, MD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02837679
- Sponsor's protocol ID
- Onkogeriatri randomiseret
- Status last verified
- Apr 2020
- First submitted
- 27 Jun 2016
- Last updated
- 29 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Gregersen M, Jensen K, Orum M. The impact of multidisciplinary geriatric follow-up on quality of life in older, non-surgical prefrail and frail patients with cancer A randomized controlled trial. J Geriatr Oncol. 2024 Nov;15(8):102069. doi: 10.1016/j.jgo.2024.102069. Epub 2024 Sep 16.
PubMed 39288507
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. 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
- NCT02837679
- Acronym / sponsor ID
- Onkogeriatri randomiseret
- Conditions
- Neoplasms, Geriatric Assessment, Lung Neoplasms, Colorectal Neoplasms, Head and Neck Neoplasms, Gastrointestinal Neoplasms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- Danish Cancer Society
- Study start
- Jan 2016 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- Jan 2023 (estimated)
- First posted
- 19 Jul 2016 (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.
The study is a randomized study of patients living in four municipalities in Eastern Jutland. After geriatric assessment half of the patients will be offered a tailor-made intervention in their homes. The follow-up will last for at least 90 days and include treatment of the patients' multimorbidity, e.g. of dehydration, anaemia, infections, and malnutrition. The other half of the patients, the results of the assessment and recommendations will be given to the patients and their general practitioner.
The primary efficacy variables are accomplishment of planned cancer treatment, reduction of complications and admissions to hospital and increased quality of life,.
If geriatric assessment and a tailor-made follow-up result in a better quality of life with less complications and admissions the offer may be extended to a longer period, younger age groups and other cancer diagnoses.
Detailed description
Cancer of the head and neck (HNC), lung (LC), upper gastrointestinal channel (CUGI) and colo-rectal cancer (CRC) accounts for approximately 40% of cancer incidence in elderly people (defined as ≥70 years) in Denmark (DK). The four cancers account for more than 50% of the annual cancer-related deaths in DK. Incidence and mortality of cancer increases with age. Comorbidity (simultaneous presence of several medical conditions) are more present in older cancer patients than in younger This means that older cancer patients are more vulnerable by physiological, psychological and social means than younger. Older cancer patients frequent develop side effects of cancer treatment than younger cancer patients.
Comprehensive Geriatric Assessment (CGA), is a comprehensive investigation and assessment of various aspects of a person's health, carried out by a multidisciplinary team in order to identify, quantify problems and follow up on the identified problems. CGA comprises collecting information on comorbidity, polypharmacy, physical, psychological and cognitive problems, nutritional status and social support. Problems in these areas implies a worse prognosis in terms of survival, response to treatment and side effects of cancer treatment .
CGA have shown to be able to identify novel health problems in about half of elderly patients with cancer. It has previously been shown that the focused palliative care of patients with lung cancer with a focus on optimization of medication and follow up on unresolved problems increases the quality of life, eases depressive symptoms and increases survival. CGA is shown to be an effective base for intervention in order to increase the survival of the elderly in general (with no known cancer), in order to increase the physical and cognitive status, and to reduce the need for changes in housing facilities. Geriatric intervention based on CGA called Comprehensive Geriatric Care (CGC).
Frailty is a condition that occurs as a result of declining physiological reserve, causing vulnerability to health stressors. One way of defining frailty is based on CGA, where patients are divided into "frail" "vulnerable/pre-frail" and "fit" by performing CGA :
Frail: patients who meet one or more of the following: dependence in Activities of Daily Living (ADL), severe comorbidity, cognitive dysfunction, depression, malnutrition, or more than 7 different fixed daily preparations on time for CGA, (multivitamin not included).
Fit patients: independent in ADL and Instrumental Activities of Daily Living (IADL), no or minimal comorbidity, Cognitively intact and no nutritional problems.
Vulnerable / pre-frail patients: Neither Fit nor frail. Frailty is a potentially reversible mode. It is known that elderly patients may develop frailty during cancer treatment.
From a previously conducted study of 217 elderly patients with HNC, LC, and CRC CUGI, we know that a large part of the patients are frail (52%) or vulnerable (35%). Only 13% are fit . But we do not know the effect of providing geriatric follow-up to this population with regards to complications of cancer treatment, including the ability to be able accomplish cancer treatment as planned and the possibility of reducing hospital stay.
A study carried out on patients discharged from the Emergency Department or Geriatric wards, have shown that it is possible to reduce the admission time by offering CGA related to admission and add follow-up with the CGC compared to only providing CGA for patients in the hospital. In the study, hospitalization was reduced by 55% It has not previously been shown if CGA in an outpatient setting and subsequent Geriatric follow up on the problems identified can reduce hospitalization time and increase the proportion who accomplish cancer treatment per protocol in older cancer patients until 1 status examination compared to patients who only get CGA in the outpatient setting, but do not get geriatric follow-up afterwards.
It's oncology practice at first outpatient attendance to define what type of cancer a patient must have, this includes both the type of treatment, the aim of treatment (neoadjuvant, adjuvant, curative or palliative (life-prolonging / palliative)), dose of treatment and duration of treatment before status examination.
Intervention CGC is an intervention that is tailored to the individual patient based on the problem areas identified by CGA and the problems that occur within 90 days of enrollment. It can include home visits, visits to Aarhus University Hospital (AUH) in outpatient settings, scheduled and on demand and telephone contact. Patients will be followed for 90 days of enrollment or until reference to specialized palliative care treatment or death. The geriatric intervention may consist of liquid treatment, blood transfusion, oral or intravenous antibiotic administration, oxygen therapy, pain management, social intervention, nutritional intervention and lifeline telephone number The geriatric intervention will be different from patient to patient. There may be many or few contacts of various kinds. During the 90 days the number and nature of contacts (telephone / attendance / home visits) will be recorded as the interventions that are performed will be registered (medication changes, social work, nutrition efforts and efforts to optimize Physical functioning) Contact between the oncogeriatric team and the patient can be taken at the initiative of oncogeriatric team, patient or relatives. The oncogeriatric team can initiate treatment or refer to another department, if necessary.
Controls For the control group, the result and the recommendations of the CGA, which has been given to patients regarding. for example medication changes, social intervention (eg. adaptation of home care), physical optimization for example. training and nutrition recommendations will be summarized for the patient and with the patient's acceptance sent to the practitioner. Otherwise, no follow-upis performed in the period by oncogeriatric team.
After 3 months, the intervention group and control Group are tested by CGA and quality of life questionnaires in order to compare with baseline results and comparing the control group with the intervention group.
Blinding It is not possible to blind subjects to randomization. Likewise, it is not possible to blind the geriatric team in charge of the follow-up for the result of the randomization. The person that test subjects after 3 months is blinded to the randomization. Oncologists do not get information about randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Geriatric Follow upGeriatric follow up |
| Control | No intervention | –Usual care |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 70 years or older with cancer of the head and neck, upper gastro intestinal cancer, colo-rectal cancer or Lung cancer, refered to Aarhus University Hospital for evaluation regarding oncological treatment on the Oncology Department at Aarhus University
- Living in following municipalities: Odder (excl. of the island of Thunø), Faurskov, Skanderborg og Aarhus
- frail or vulnerable by CGA
- Signed informed consent. For incapacitated patients: informed consent by relatives
Key exclusion criteria (3 listed)
- evaluated 'fit´ by CGA
- Referred to specialized palliative care at time of first visit at the Oncology department
- Do not wish to participate
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 |
|---|---|---|
| Geriatric Follow up | Other | Intervention |
Primary outcome
Success rate of admittance to initial planned oncological treatment
Time frame: An average of 12 weeks
Oncological specialist evaluates if treatment is completed as planned or if eventual deviations are of minor or major character
Change in Quality of life (QoL)
Time frame: 90 days
Participants with a Mini-Mental State Examination (MMSE)-score of 25 and above are tested using European Organisation of Research and Treatment of Cancer (EORTC) Core Questionnaire (C30) in combination with Elderly questionnaire (ELD14).
Change in Quality of life
Time frame: 90 days
Participants with a Mini-Mental State Examination (MMSE)-score below 25 are tested using "Depression List"
5 secondary outcomes
90-day survival
Time frame: Within 90 days from first geriatric contact
Physical performance, chair-stand-test
Time frame: Changes in physical performance from first geriatric contact to 90 days after
Physical performance, Barthel-100
Time frame: Changes in physical performance from first geriatric contact to 90 days after
Physical performance, FAQ-IADL
Time frame: Changes in physical performance from first geriatric contact to 90 days after
Length of hospital stay
Time frame: Within 90 days from first geriatric contact
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2020.
- Derived from this study: PubMed 39288507Gregersen M, Jensen K, Orum M. The impact of multidisciplinary geriatric follow-up on quality of life in older, non-surgical prefrail and frail patients with cancer A randomized controlled trial. J Geriatr Oncol. 2024 Nov;15(8):102069. doi: 10.1016/j.jgo.2024.102069. Epub 2024 Sep 16.
- 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.
Marianne Ørum, MD principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Geriatric Follow up in people with Neoplasms and Geriatric Assessment, run by Aarhus University Hospital 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 3 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: status not confirmed, as of the sponsor's last update on 29 Apr 2020. 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?
Results are not available in the source record.
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?
Success rate of admittance to initial planned oncological treatment (time frame: An average of 12 weeks). 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?
On the ClinicalTrials.gov record for NCT02837679, 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 29 Apr 2020.