FrailtyPROGNOSIS-RCTNCT04686851
Predictive Value of Geriatric Oncology Screening and Geriatric Assessment in Older Patients With Solid Cancers
A study testing Comprehensive Geriatric Assessment and follow-up in people with Frailty and Cancer, run by Odense University Hospital at 1 site in Denmark.
Trial summary
A Randomized Clinical Trial examining the effects of Comprehensive Geriatric Assessment as an add on to oncologic treatment. Participants included are cancer patients found eligible for oncologic treatment, age 70 or more, and screened frail with the Geriatric 8 screening tool. Read more about this study
- Who is it for?
- Ages 70 years and older
- What is being tested?
- Comprehensive Geriatric Assessment and follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 322 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2020to 1 Jun 2024
- 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
- Age ≥ 70 years
- Living in the region of Southern Denmark
- Newly diagnosed solid tumours assessed eligible for antineoplastic treatment
- Vulnerable or frail (G8 ≤ 14)
Who cannot join
- Inability to speak or understand Danish
- Inability to give informed consent
- Already consulting geriatric outpatient clinic
- Already receiving active treatment for other coexisting solid tumours, haematologic cancers, or non-melanoma skin cancer or has received oncologic treatment the past year
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Odense University Hospital
Odense, Southern Denmark, 5000
Jesper Ryg, MD, Prof., 60152610 ext. 0045, jesper.ryg@rsyd.dk
About this study
Official title: Predictive Value of Geriatric Oncology Screening and Geriatric Assessment in Older Patients With Solid Cancers (PROGNOSIS-RCT)
A Randomized Clinical Trial examining the effects of Comprehensive Geriatric Assessment as an add on to oncologic treatment. Participants included are cancer patients found eligible for oncologic treatment, age 70 or more, and screened frail with the Geriatric 8 screening tool.
Read the detailed description
This study aims to examine the effects of Comprehensive Geriatric Assessment and interventions on prognosis in the older frail cancer patient in a Randomized Clinical Trial design.
Patients screened frail with the Geriatric 8 screening tool, aged 70 or more, and found eligible for oncologic treatment, will be included. We plan to enrol a total of 322 cancer patients for 12 months. Participants will be allocated randomly to either interventional or control group.
Participants in the interventional group will be offered a Comprehensive Geriatric Assessment and intervention at the start-up of cancer treatment. The Comprehensive Geriatric Assessment will be an add on to standardized cancer treatment offered at the Oncologic Outpatient Clinic at Odense University Hospital.
Comprehensive Geriatric Assessment will be performed by a team consisting of a doctor, nurse and physiotherapist. If needed, referral to a dietician or an occupational therapist for further evaluation will be made. The health issues are assessed using validated tests based on a Danish version of the Geriatric Core Dataset (G-CODE). Follow-up on Comprehensive Geriatric Assessment is scheduled for one month after initial evaluation.
The randomized groups will be compared with respect to primary and secondary endpoints.
- Being tested
- Comprehensive Geriatric Assessment and follow-up
- Keywords
- Frailty, Aged, Neoplasms, Cancer Patients, Geriatric Screening, Geriatric 8, Geriatric Assessment, Randomized Clinical Trial
- Medical subject headings
- Frailty, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Geriatric Assessment and follow-upOther
All patients will receive standardized oncological treatment according to national guidelines. For patients randomized to the intervention arm, a full Comprehensive Geriatric Assessment (CGA) and corresponding interventions on identified health issues will be performed alongside oncologic treatment. The domains are assessed using validated tests based on a Danish version of the Geriatric Core Dataset (G-CODE). The domains are cognition, mood, comorbidity, functional status, physical status, polypharmacy, nutrition, fall risc and social support. The CGA will be performed by the PhD-student (geriatric resident) or a geriatrician together with geriatric nurses at the Department of Geriatric Medicine, OUH. Nutritional status and interventions are assessed by a dietician. A physical therapist will evaluate the physical performance as part of the CGA.
Follow-up on initial treatment plan is scheduled to one month after baseline CGA.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Comprehensive Geriatric Assessment and follow-up as add on to standard oncologic care Receives: Other: Comprehensive Geriatric Assessment and follow-up |
| Control | No intervention | standard oncologic care according to national guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
physical function for patients receiving palliative oncologic treatment
measured by 30 seconds Chair Stand Test, number of repetitions in a 30 seconds time period.
Measured: 3 months
unplanned hospital admissions for patients receiving adjuvant oncologic treatment
number of unplanned hospitalisations including admissions to Oncologic Department, Emergency Department and Medical Departments. Data will be retrieved trough review of electronic medical records.
Measured: 6 months
Secondary outcomes (14)
Physical functional for patients receiving curative oncologic treatment
measured by 30 seconds Chair Stand Test, number of repetitions in a 30 seconds time period.
Measured: 3 months
Physical functional for patients receiving curative oncologic treatment
measured by 30 seconds Chair Stand Test, number of repetitions in a 30 seconds time period.
Measured: 6 months
Physical functional for patients receiving palliative oncologic treatment
measured by 30 seconds Chair Stand Test, number of repetitions in a 30 seconds time period.
Measured: 6 months
number of unplanned hospital admissions for patients receiving palliative oncologic treatment
Number of unplanned hospitalisations including admissions to Oncologic Department, Emergency Department and Medical Departments. Data will be retrieved trough review of electronic medical records.
Measured: 6 months
Health-related Quality of life
Measured by EORTC-QLQ-C30
Measured: 12 months
Health-related Quality of life
Measured by EORTC-QLQ-ELD14
Measured: 12 months follow-up
Elderly Functional Index Score (ELFI-score)
Self reported functioning score. It is a composite score derived from the three scales "physical functioning", "Role functioning" and Social Functioning", from the quality of life questionnaire EORTC-QLQ-C30 and the scale "Mobility" from the quality of life questionnaire EORTC-QLQ-ELD-14. The range is (12-48), with a higher score being a better outcome.
Measured: 6 months
Number of patients who experience oncologic treatment toxicity
Treatment toxicity grade 3+ evaluated with Common Terminology Criteria for Adverse Events
Measured: 6 months
Number of patients with adherence to initial oncologic treatment plan
Registration of dose reductions, discontinuations and delays of intended cancer treatment.
Measured: 6 months
Degree of Polypharmacy (PP)
Degree of polypharmacy. Polypharmacy is defined as daily use of more than 5 prescription drugs.
Measured: 3 months
Number of potential Inappropriate Medications (PIM)
Using the Screening Tool for Older Persons Prescriptions (STOPP) criteria. Number of PIM will be registered for each patient
Measured: 3 months
Number of Potential Drug Interactions (PDI)
Using Stockley's Drug Interaction Database. Number of PDI will be registered for each patient
Measured: 3 months
Overall survival
Measured from Geriatric 8 screening to time of death
Measured: 12 months
Cancer specific survival
Measured from Geriatric 8 screening to time of death in patients with residual cancer
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start1 Nov 2020
- Primary completion1 Nov 2023
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by Odense 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
- Model description
- Randomized Clinical Trial with 2 randomized 1:1 parallel study groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 322 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark, Danish Cancer Society, Academy of Geriatric Cancer, Odense Patient Data Explorative Network, Region of Southern Denmark
- Responsible party
- Principal investigator, Ann-Kristine Weber Giger, Odense University Hospital
- Investigators
- Ann-Kristine W Giger, MD, Principal investigator, Department of Geriatric Medicine, Odense University Hospital, OdenseCecilia M Lund, MD, PhD, Study chair, Department of Medicine, Herlev and Gentofte University Hospital, CopenhagenPer Pfeiffer, MD, PhD, Study chair, Department of Clinical Oncology, Odense University Hospital, OdenseTrine L Jørgensen, MD, PhD, Study chair, Department of Clinical Oncology, Odense University Hospital, OdenseMarianne Ewertz, MD, DMSc, Study chair, Institute of Clinical Research, University of Southern Denmark, OdenseHenrik Ditzel, MD, DMSc, Study chair, Department og Geriatric Medicine, Odense University Hospital, OdenseJesper Ryg, MD, PhD, Study director, Department of Geriatric Medicine, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04686851
- Sponsor's protocol ID
- PROGNOSIS-RCT
- Other IDs
- R247-A14382, 20/ 17768
- Acronym
- PROGNOSIS-RCT
- Status last verified
- Dec 2023
- First submitted
- 26 Oct 2020
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Giger AW, Ditzel HM, Ditzel HJ, Ewertz M, Jorgensen TL, Pfeiffer P, Lund CM, Ryg J. Effects of comprehensive geriatric assessment-guided interventions on physical performance and quality of life in older patients with advanced cancer: A randomized controlled trial (PROGNOSIS-RCT). J Geriatr Oncol. 2024 Jan;15(1):101658. doi: 10.1016/j.jgo.2023.101658. Epub 2023 Nov 6.
PubMed 37939628Giger AW, Ditzel HM, Jorgensen TL, Ditzel HJ, Mohammadnejad A, Ewertz M, Pfeiffer P, Lund CM, Ryg J. Predictive value of geriatric oncology screening and geriatric assessment of older patients with cancer: A randomized clinical trial protocol (PROGNOSIS-RCT). J Geriatr Oncol. 2022 Jan;13(1):116-123. doi: 10.1016/j.jgo.2021.07.005. Epub 2021 Aug 4.
PubMed 34362713
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Geriatric Oncology Screening and Geriatric Assessment in Older Patients With Solid Cancers (PROGNOSIS-RCT)
- ClinicalTrials.gov ID
- NCT04686851
- Acronym / sponsor ID
- PROGNOSIS-RCT / PROGNOSIS-RCT
- Keywords
- Frailty, Aged, Neoplasms, Cancer Patients, Geriatric Screening, Geriatric 8, Geriatric Assessment, Randomized Clinical Trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 322 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- University of Southern Denmark, Danish Cancer Society, Academy of Geriatric Cancer, Odense Patient Data Explorative Network, Region of Southern Denmark
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 29 Dec 2020 (actual)
- 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 Randomized Clinical Trial examining the effects of Comprehensive Geriatric Assessment as an add on to oncologic treatment. Participants included are cancer patients found eligible for oncologic treatment, age 70 or more, and screened frail with the Geriatric 8 screening tool.
Detailed description
This study aims to examine the effects of Comprehensive Geriatric Assessment and interventions on prognosis in the older frail cancer patient in a Randomized Clinical Trial design.
Patients screened frail with the Geriatric 8 screening tool, aged 70 or more, and found eligible for oncologic treatment, will be included. We plan to enrol a total of 322 cancer patients for 12 months. Participants will be allocated randomly to either interventional or control group.
Participants in the interventional group will be offered a Comprehensive Geriatric Assessment and intervention at the start-up of cancer treatment. The Comprehensive Geriatric Assessment will be an add on to standardized cancer treatment offered at the Oncologic Outpatient Clinic at Odense University Hospital.
Comprehensive Geriatric Assessment will be performed by a team consisting of a doctor, nurse and physiotherapist. If needed, referral to a dietician or an occupational therapist for further evaluation will be made. The health issues are assessed using validated tests based on a Danish version of the Geriatric Core Dataset (G-CODE). Follow-up on Comprehensive Geriatric Assessment is scheduled for one month after initial evaluation.
The randomized groups will be compared with respect to primary and secondary endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Clinical Trial with 2 randomized 1:1 parallel study groups
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Comprehensive Geriatric Assessment and follow-upComprehensive Geriatric Assessment and follow-up as add on to standard oncologic care |
| Control | No intervention | –standard oncologic care according to national guidelines |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age ≥ 70 years
- Living in the region of Southern Denmark
- Newly diagnosed solid tumours assessed eligible for antineoplastic treatment
- Vulnerable or frail (G8 ≤ 14)
Key exclusion criteria (4 listed)
- Inability to speak or understand Danish
- Inability to give informed consent
- Already consulting geriatric outpatient clinic
- Already receiving active treatment for other coexisting solid tumours, haematologic cancers, or non-melanoma skin cancer or has received oncologic treatment the past year
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 Assessment and follow-upAll patients will receive standardized oncological treatment according to national guidelines. For patients randomized to the intervention arm, a full Comprehensive Geriatric Assessment (CGA) and corresponding interventions on identified health issues will be performed alongside oncologic treatment. The domains are assessed using validated tests based on a Danish version of the Geriatric Core Dataset (G-CODE). The domains are cognition, mood, comorbidity, functional status, physical status, polypharmacy, nutrition, fall risc and social support. The CGA will be performed by the PhD-student (geriatric resident) or a geriatrician together with geriatric nurses at the Department of Geriatric Medicine, OUH. Nutritional status and interventions are assessed by a dietician. A physical therapist will evaluate the physical performance as part of the CGA. Follow-up on initial treatment plan is scheduled to one month after baseline CGA. | Other | Intervention |
Primary outcome
physical function for patients receiving palliative oncologic treatment
Time frame: 3 months
measured by 30 seconds Chair Stand Test, number of repetitions in a 30 seconds time period.
unplanned hospital admissions for patients receiving adjuvant oncologic treatment
Time frame: 6 months
number of unplanned hospitalisations including admissions to Oncologic Department, Emergency Department and Medical Departments. Data will be retrieved trough review of electronic medical records.
14 secondary outcomes
Physical functional for patients receiving curative oncologic treatment
Time frame: 3 months
Physical functional for patients receiving curative oncologic treatment
Time frame: 6 months
Physical functional for patients receiving palliative oncologic treatment
Time frame: 6 months
number of unplanned hospital admissions for patients receiving palliative oncologic treatment
Time frame: 6 months
Health-related Quality of life
Time frame: 12 months
Health-related Quality of life
Time frame: 12 months follow-up
Elderly Functional Index Score (ELFI-score)
Time frame: 6 months
Number of patients who experience oncologic treatment toxicity
Time frame: 6 months
Number of patients with adherence to initial oncologic treatment plan
Time frame: 6 months
Degree of Polypharmacy (PP)
Time frame: 3 months
Number of potential Inappropriate Medications (PIM)
Time frame: 3 months
Number of Potential Drug Interactions (PDI)
Time frame: 3 months
Overall survival
Time frame: 12 months
Cancer specific survival
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Derived from this study: PubMed 37939628Giger AW, Ditzel HM, Ditzel HJ, Ewertz M, Jorgensen TL, Pfeiffer P, Lund CM, Ryg J. Effects of comprehensive geriatric assessment-guided interventions on physical performance and quality of life in older patients with advanced cancer: A randomized controlled trial (PROGNOSIS-RCT). J Geriatr Oncol. 2024 Jan;15(1):101658. doi: 10.1016/j.jgo.2023.101658. Epub 2023 Nov 6.
- Derived from this study: PubMed 34362713Giger AW, Ditzel HM, Jorgensen TL, Ditzel HJ, Mohammadnejad A, Ewertz M, Pfeiffer P, Lund CM, Ryg J. Predictive value of geriatric oncology screening and geriatric assessment of older patients with cancer: A randomized clinical trial protocol (PROGNOSIS-RCT). J Geriatr Oncol. 2022 Jan;13(1):116-123. doi: 10.1016/j.jgo.2021.07.005. Epub 2021 Aug 4.
- Individual participant dataSharing planned: Undecided
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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.
Ann-Kristine W Giger, MD principal investigator
Department of Geriatric Medicine, Odense University Hospital, Odense
Cecilia M Lund, MD, PhD study chair
Department of Medicine, Herlev and Gentofte University Hospital, Copenhagen
Per Pfeiffer, MD, PhD study chair
Department of Clinical Oncology, Odense University Hospital, Odense
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 and follow-up in people with Frailty and Cancer, run by Odense 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 4 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 13 Dec 2023. 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?
Contact Jesper Ryg, MD (60152610 ext. 0045, Jesper.Ryg@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
physical function for patients receiving palliative oncologic treatment (time frame: 3 months). The study lists 2 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 NCT04686851, which also lists 2 linked publications.
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 Dec 2023.