CancerNCT03881137
Improved Function and Quality of Life for Older Patients Receiving Radiotherapy, Part II
A study testing Geriatric assessment with management in people with Cancer and Radiotherapy, run by Sykehuset Innlandet HF at 2 sites in Norway.
Trial summary
This cluster randomized controlled pilot study is designed to test the feasibility, and potential effect of a multicomponent, community-based intervention aiming to improve quality of life (QoL) and function for older patients receiving radiotherapy (RT), and thereby reduce the needs for professional help. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cancer, Radiotherapy, Older Patients
- What is being tested?
- Geriatric assessment with management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 2 sitesNorway
- Study dates
- 8 May 2019to 10 Jun 2022
- 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
Who may be able to join
- ≥65 years of age
- confirmed cancer diagnosis (histology/cytology)
- living in one of the participating municipalities in the catchment area of Innlandet Hospital Trust or in the municipality of Trondheim
- referred for palliative or curative RT
- fluency in Norwegian, orally and in writing
- ability to fill in self-report questionnaires
- provide written informed consent
Who cannot join
- severely ill with a life expectancy < 3months
- referred to receive one fraction of RT only (one day treatment)
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Innlandet Hospital Trust
Gjøvik
St Olav Hospital, Trondheim University Hospital
Trondheim
About this study
Official title: Improving Function and Quality of Life for Older Cancer Patients Receiving Radiotherapy, a Randomized Controlled Pilot Study
This cluster randomized controlled pilot study is designed to test the feasibility, and potential effect of a multicomponent, community-based intervention aiming to improve quality of life (QoL) and function for older patients receiving radiotherapy (RT), and thereby reduce the needs for professional help. The intervention will be based on geriatric assessment and management (GAM), i.e. systematic assessment and management of physical, mental and functional problems frequently occurring in the elderly. It will target individual patients according to needs and be carried out in collaboration between hospital and community services from start of RT until 8 weeks post-treatment.
Read the detailed description
Background:
Older cancer patients (> 65 years) represent the majority of the cancer population, and their number grows due to an aging population. These patients often present with a multiplicity of problems. They frequently suffer from physical- or mental health comorbidities, and are often frail with impairment in mobility, daily life functioning and cognition. When diagnosed with cancer and in need of therapy, they are at substantial risk of complications and functional decline.
Geriatric assessment with management (GAM) has documented success in improving outcomes in older patients with other diseases than cancer. Thus, GAM is strongly recommended as an approach to optimize treatment and care for older cancer patients. Evidence for the potential benefits is still scarce and in particular for older patients receiving radiotherapy.
Although GAM has been proven successful in other contexts, there is no universally accepted recipe for how such an intervention should be performed and implemented. To be feasible and efficient, adjustments according to patient population, health care organization and available resources are necessary. The present study will be conducted to provide the evidence needed for a subsequent definitive evaluation of a GAM intervention for older patients receiving radiotherapy in a larger RTC, aiming at improving quality of life (QoL) and function, and thereby reduce the burden for the patients, their families and the society.
The detailed objectives are to:
- assess the potential short- and long-term effect of the intervention on global QoL and physical functioning for older cancer patients receiving RT
- assess the feasibility of the intervention
- at the patient level (recruitment, compliance and adherence)
- at the organizational level (structures facilitating or impeding implementation and collaboration across sectors and between professionals)
- study the use of health care services and related costs in the intervention and control group
Methods:
The study emerges from Innlandet Hospital Trust and will be conducted in cooperation with Trondheim University Hospital, and 30 municipalities in the catchment area of Innlandet Hospital Trust, and Trondheim Municipality. The intervention is developed by an interdisciplinary, experienced research group in close collaboration with user representatives, hospital- and primary health care professionals. It is based on experience, results and preliminary results from foregoing studies by our study group (including NCT03071640 and NCT01742442) and focus group interviews with health professionals.
The design is cluster-randomized, randomizing municipalities and city districts. Patients will be recruited at the radiotherapy units at Innlandet Hospital Trust (primary study center) and Trondheim University Hospital (second study center). Anticipated number of participants from the two hospitals is 102 patients and 60 patients, respectively.
Eligible, consenting patients will be included by the start of radiotherapy (RT), and enter the control or intervention groups in accordance with the assignment of the municipality or city district in which they reside. They will be followed with study specific assessments for one year after end of RT, and for survival for five years.
Assessments:
By the time of inclusion, demographic and medical characteristics (including cancer diagnosis, stage of disease, former and ongoing tumor treatment, ECOG performance status, RT treatment aim (palliative or curative), and comorbidity. Detailed information about the RT schedule will be registered by the end of RT.
Patient reported outcomes (EORTC QLQ-C30 and EQ-5D-5L) will be assessed at baseline, by the end of RT, and thereafter 4, 8, 16, 32 and 52 weeks after RT. Physical performance tests, i.e. Short Physical Performance Battery (SPPB), Timed Up and Go (TUG), grip strength and one-legged balance test, will be applied at baseline and 8 and 16 weeks after the end of RT. Cognitive function will be tested at baseline using the MiniCog.
To evaluate the cost-effectiveness of the intervention in comparison to control (standard care), detailed information on the patients' use of health care services (home based and institutional care) will be registered throughout the intervention period and during follow-up (one year, week 52).
Feasibility will be assessed by a process evaluation, aiming to identify facilitators and barriers for a successful implementation, using mixed methodology. Measures recommended for each patient's intervention plan will be consecutively registered, as will patients' compliance and adherence through weekly contact with the coordinating nurse (log notes). Further data will include interviews with patients and providers. Questionnaires to involved primary health care nurses and other relevant professionals will also be applied.
- Conditions
- Cancer, Radiotherapy, Older Patients
- Being tested
- Geriatric assessment with management
- Keywords
- older, cancer, radiotherapy, geriatric assessment, quality of life, physical function
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geriatric assessment with managementOther
A multicomponent intervention, carried out in cooperation between hospital and community services, based on a geriatric assessment (GA) followed by individually adapted measures targeting identified needs.
The GA and the start of the intervention will be handled by a PhD student (geriatrician) or project cancer nurse at start of RT. Pre-planned guidelines will be followed. Contribution from relevant hospital professionals will be sought according to needs. Then the intervention will be offered in the primary health care taking advantage of existing services, e.g. home care, rehabilitation services, exercise groups etc. A community-based coordinating nurse will follow the patients with weekly contacts throughout RT and to end of intervention 8 weeks post-RT. To ensure that each patient's intervention is properly adjusted to changing needs, repeated clinical assessments will be performed by the end of RT and 4 weeks post-RT.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Geriatric assessment with management Receives: Other: Geriatric assessment with management |
| Control | No intervention | Patients receiving supportive care and follow up according to routine practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
physical function
physical function as assessed by patient report using the EORTC QLQ-C30 questionnaire. The analysis will assess the difference between control and intervention groups in physical function measured by the EORTC QLQ-C30 questionnaire at 8 weeks after baseline. Longitudinal analysis of covariance will be performed by estimating a linear mixed model with fixed effects for baseline values, time and interaction between time and group variable. The model will include random effects for patients nested within study cluster.
Measured: 8 weeks following termination of radiotherapy (RT)
Secondary outcomes (7)
physical function
physical function as assessed by patient report using the physical function scale from the EORTC QLQ-C30. The scale ranges from 0 (worse) to 100 (best)
Measured: trend during follow-up from inclusion to one year after termination of radiotherapy
global health
assessed by the EORTC QLQ-C30 questionnaire's global health/quality of life (QoL) sub-scale (question 29 and 30). The scale ranges from 0 (worse) to 100 (best)
Measured: 8 weeks after radiotherapy and trend during follow-up from inclusion to one year after radiotherapy
Health related quality of life (HRQoL)
assessed by the EQ-5D-5L index values
Measured: 8 weeks after radiotherapy and trend during follow-up from inclusion to one year after radiotherapy
mobility
assessed by the short physical performance battery (SPPB)
Measured: 8 weeks after radiotherapy and trend during follow-up from inclusion up to 16 weeks after radiotherapy
grip strength
assessed by dynamometer
Measured: 8 weeks after radiotherapy and trend during follow-up from inclusion up to 16 weeks after radiotherapy
the incremental cost-effectiveness ratio (ICER)
We will calculate the intervention cost based on a micro-costing approach. Cost-effectiveness of the intervention will be evaluated by calculating the incremental cost-effectiveness ratio (ICER) that is the difference in mean costs divided by the difference in mean Quality Adjusted Life Years (QALYs). We calculate QALYs by an area under the curve approach under the assumption of piecewise linear change in EQ-5D-5L-index values over time. Missing data will be imputed by multiple imputation and the uncertainty of the ICER will be assessed by performing sensitivity analysis including application of bootstrapping techniques.
Measured: 8 weeks after radiotherapy and during follow-up (up to 52 weeks after after radiotherapy)
Use of health care services
use of health care services (hospital in- and outpatient services and municipality services in terms of home care, nursing home care and use of other services such as general practitioner, physiotherapist, occupational therapists, and rehabilitation programs)
Measured: From inclusion through overall follow-up (up to 52 weeks after radiotherapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start8 May 2019
- Primary completion25 Jul 2021
- Study completion10 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CancerStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The present study is a controlled cluster-randomized pilot study. Cluster-randomization is chosen to avoid contamination of the control group. Before patient recruitment commences, a selection of 32 municipalities and city districts (= clusters) will be stratified into blocks in accordance with number of inhabitants. The selection will include city districts, large and smaller municipalities to ensure sample size and representativity. Clusters within each block will be randomly assigned to intervention or control by using a computer-generated code, 1:1, i.e. 16 in each group Eligible, consenting patients from municipalities/city districts randomized to control will enter the control group. Eligible, consenting patients from municipalities randomized to intervention will enter the intervention group
- Masking
- None (open label)
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sykehuset Innlandet HF
- Sponsor type
- University, hospital or other
- Collaborators
- Trondheim University Hospital, Norwegian University of Science and Technology, Trondheim Kommune, Oslo University Hospital, University of Oslo, Oslo Metropolitan University
- Responsible party
- Sponsor
- Investigators
- Marit S Jordhøy, PhD, Principal investigator, Sykehuset Innlandet HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03881137
- Sponsor's protocol ID
- SI0303150406
- Status last verified
- Nov 2022
- First submitted
- 13 Mar 2019
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: According to Norwegian Data Protection regulations, sharing of individual participants data is not accepted unless purpose and involved researchers are explicitly stated and approved by the participants (informed consent form) and approved by The Ethical Review Board.
Publications
Royset I, Saltvedt I, Rostoft S, Gronberg BH, Kirkevold O, Oldervoll L, Bye A, Benth JS, Bergh S, Melby L, Halsteinli V, Dohl O, Rostad T, Eriksen GF, Sollid MIV, Rolfson D, Slaaen M. Geriatric assessment with management for older patients with cancer receiving radiotherapy. Protocol of a Norwegian cluster-randomised controlled pilot study. J Geriatr Oncol. 2022 Apr;13(3):363-373. doi: 10.1016/j.jgo.2021.11.001. Epub 2021 Nov 12.
PubMed 34776384Royset IM, Saltvedt I, Sollid MIV, Kirkevold O, Gronberg BH, Eriksen GF, Rolfson D, Rostoft S, Slaaen M. Primary care implementation of a cross-sector geriatric assessment with management intervention for older patients undergoing radiotherapy. Eur J Oncol Nurs. 2026 Sep 4;84:103314. doi: 10.1016/j.ejon.2026.103314. Online ahead of print.
PubMed 42721749Sollid MIV, Melby L, Slaaen M, Eilertsen G, Royset IM, Kirkevold O. Experiences With an Intervention Based on Geriatric Assessment With Management: A Qualitative Study. Nurs Open. 2025 Apr;12(4):e70220. doi: 10.1002/nop2.70220.
PubMed 40223637Slaaen M, Royset IM, Saltvedt I, Gronberg BH, Halsteinli V, Dohl O, Vossius C, Kirkevold O, Bergh S, Rostoft S, Oldervoll L, Bye A, Melby L, Rosstad T, Eriksen GF, Sollid MIV, Rolfson D, Saltyte Benth J. Geriatric assessment with management for older patients with cancer receiving radiotherapy: a cluster-randomised controlled pilot study. BMC Med. 2024 Jun 10;22(1):232. doi: 10.1186/s12916-024-03446-4.
PubMed 38853251
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Function and Quality of Life for Older Cancer Patients Receiving Radiotherapy, a Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT03881137
- Acronym / sponsor ID
- SI0303150406
- Conditions
- Cancer, Radiotherapy, Older Patients
- Keywords
- older, cancer, radiotherapy, geriatric assessment, quality of life, physical function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Sykehuset Innlandet HFUniversity, hospital or other
- Collaborators
- Trondheim University Hospital, Norwegian University of Science and Technology, Trondheim Kommune, Oslo University Hospital, University of Oslo, Oslo Metropolitan University
- Study start
- 8 May 2019 (actual)
- Primary completion
- 25 Jul 2021 (actual)
- Study completion
- 10 Jun 2022 (actual)
- First posted
- 19 Mar 2019 (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.
This cluster randomized controlled pilot study is designed to test the feasibility, and potential effect of a multicomponent, community-based intervention aiming to improve quality of life (QoL) and function for older patients receiving radiotherapy (RT), and thereby reduce the needs for professional help. The intervention will be based on geriatric assessment and management (GAM), i.e. systematic assessment and management of physical, mental and functional problems frequently occurring in the elderly. It will target individual patients according to needs and be carried out in collaboration between hospital and community services from start of RT until 8 weeks post-treatment.
Detailed description
Background:
Older cancer patients (> 65 years) represent the majority of the cancer population, and their number grows due to an aging population. These patients often present with a multiplicity of problems. They frequently suffer from physical- or mental health comorbidities, and are often frail with impairment in mobility, daily life functioning and cognition. When diagnosed with cancer and in need of therapy, they are at substantial risk of complications and functional decline.
Geriatric assessment with management (GAM) has documented success in improving outcomes in older patients with other diseases than cancer. Thus, GAM is strongly recommended as an approach to optimize treatment and care for older cancer patients. Evidence for the potential benefits is still scarce and in particular for older patients receiving radiotherapy.
Although GAM has been proven successful in other contexts, there is no universally accepted recipe for how such an intervention should be performed and implemented. To be feasible and efficient, adjustments according to patient population, health care organization and available resources are necessary. The present study will be conducted to provide the evidence needed for a subsequent definitive evaluation of a GAM intervention for older patients receiving radiotherapy in a larger RTC, aiming at improving quality of life (QoL) and function, and thereby reduce the burden for the patients, their families and the society.
The detailed objectives are to:
- assess the potential short- and long-term effect of the intervention on global QoL and physical functioning for older cancer patients receiving RT
- assess the feasibility of the intervention
- at the patient level (recruitment, compliance and adherence)
- at the organizational level (structures facilitating or impeding implementation and collaboration across sectors and between professionals)
- study the use of health care services and related costs in the intervention and control group
Methods:
The study emerges from Innlandet Hospital Trust and will be conducted in cooperation with Trondheim University Hospital, and 30 municipalities in the catchment area of Innlandet Hospital Trust, and Trondheim Municipality. The intervention is developed by an interdisciplinary, experienced research group in close collaboration with user representatives, hospital- and primary health care professionals. It is based on experience, results and preliminary results from foregoing studies by our study group (including NCT03071640 and NCT01742442) and focus group interviews with health professionals.
The design is cluster-randomized, randomizing municipalities and city districts. Patients will be recruited at the radiotherapy units at Innlandet Hospital Trust (primary study center) and Trondheim University Hospital (second study center). Anticipated number of participants from the two hospitals is 102 patients and 60 patients, respectively.
Eligible, consenting patients will be included by the start of radiotherapy (RT), and enter the control or intervention groups in accordance with the assignment of the municipality or city district in which they reside. They will be followed with study specific assessments for one year after end of RT, and for survival for five years.
Assessments:
By the time of inclusion, demographic and medical characteristics (including cancer diagnosis, stage of disease, former and ongoing tumor treatment, ECOG performance status, RT treatment aim (palliative or curative), and comorbidity. Detailed information about the RT schedule will be registered by the end of RT.
Patient reported outcomes (EORTC QLQ-C30 and EQ-5D-5L) will be assessed at baseline, by the end of RT, and thereafter 4, 8, 16, 32 and 52 weeks after RT. Physical performance tests, i.e. Short Physical Performance Battery (SPPB), Timed Up and Go (TUG), grip strength and one-legged balance test, will be applied at baseline and 8 and 16 weeks after the end of RT. Cognitive function will be tested at baseline using the MiniCog.
To evaluate the cost-effectiveness of the intervention in comparison to control (standard care), detailed information on the patients' use of health care services (home based and institutional care) will be registered throughout the intervention period and during follow-up (one year, week 52).
Feasibility will be assessed by a process evaluation, aiming to identify facilitators and barriers for a successful implementation, using mixed methodology. Measures recommended for each patient's intervention plan will be consecutively registered, as will patients' compliance and adherence through weekly contact with the coordinating nurse (log notes). Further data will include interviews with patients and providers. Questionnaires to involved primary health care nurses and other relevant professionals will also be applied.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The present study is a controlled cluster-randomized pilot study. Cluster-randomization is chosen to avoid contamination of the control group. Before patient recruitment commences, a selection of 32 municipalities and city districts (= clusters) will be stratified into blocks in accordance with number of inhabitants. The selection will include city districts, large and smaller municipalities to ensure sample size and representativity. Clusters within each block will be randomly assigned to intervention or control by using a computer-generated code, 1:1, i.e. 16 in each group Eligible, consenting patients from municipalities/city districts randomized to control will enter the control group. Eligible, consenting patients from municipalities randomized to intervention will enter the intervention group
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Geriatric assessment with managementGeriatric assessment with management |
| Control | No intervention | –Patients receiving supportive care and follow up according to routine practice |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- ≥65 years of age
- confirmed cancer diagnosis (histology/cytology)
- living in one of the participating municipalities in the catchment area of Innlandet Hospital Trust or in the municipality of Trondheim
- referred for palliative or curative RT
- fluency in Norwegian, orally and in writing
Key exclusion criteria (2 listed)
- severely ill with a life expectancy < 3months
- referred to receive one fraction of RT only (one day treatment)
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 assessment with managementA multicomponent intervention, carried out in cooperation between hospital and community services, based on a geriatric assessment (GA) followed by individually adapted measures targeting identified needs. The GA and the start of the intervention will be handled by a PhD student (geriatrician) or project cancer nurse at start of RT. Pre-planned guidelines will be followed. Contribution from relevant hospital professionals will be sought according to needs. Then the intervention will be offered in the primary health care taking advantage of existing services, e.g. home care, rehabilitation services, exercise groups etc. A community-based coordinating nurse will follow the patients with weekly contacts throughout RT and to end of intervention 8 weeks post-RT. To ensure that each patient's intervention is properly adjusted to changing needs, repeated clinical assessments will be performed by the end of RT and 4 weeks post-RT. | Other | Intervention |
Primary outcome
physical function
Time frame: 8 weeks following termination of radiotherapy (RT)
physical function as assessed by patient report using the EORTC QLQ-C30 questionnaire. The analysis will assess the difference between control and intervention groups in physical function measured by the EORTC QLQ-C30 questionnaire at 8 weeks after baseline. Longitudinal analysis of covariance will be performed by estimating a linear mixed model with fixed effects for baseline values, time and interaction between time and group variable. The model will include random effects for patients nested within study cluster.
7 secondary outcomes
physical function
Time frame: trend during follow-up from inclusion to one year after termination of radiotherapy
global health
Time frame: 8 weeks after radiotherapy and trend during follow-up from inclusion to one year after radiotherapy
Health related quality of life (HRQoL)
Time frame: 8 weeks after radiotherapy and trend during follow-up from inclusion to one year after radiotherapy
mobility
Time frame: 8 weeks after radiotherapy and trend during follow-up from inclusion up to 16 weeks after radiotherapy
grip strength
Time frame: 8 weeks after radiotherapy and trend during follow-up from inclusion up to 16 weeks after radiotherapy
the incremental cost-effectiveness ratio (ICER)
Time frame: 8 weeks after radiotherapy and during follow-up (up to 52 weeks after after radiotherapy)
Use of health care services
Time frame: From inclusion through overall follow-up (up to 52 weeks after radiotherapy)
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 9 Nov 2022.
- Background: PubMed 34776384Royset I, Saltvedt I, Rostoft S, Gronberg BH, Kirkevold O, Oldervoll L, Bye A, Benth JS, Bergh S, Melby L, Halsteinli V, Dohl O, Rostad T, Eriksen GF, Sollid MIV, Rolfson D, Slaaen M. Geriatric assessment with management for older patients with cancer receiving radiotherapy. Protocol of a Norwegian cluster-randomised controlled pilot study. J Geriatr Oncol. 2022 Apr;13(3):363-373. doi: 10.1016/j.jgo.2021.11.001. Epub 2021 Nov 12.
- Derived from this study: PubMed 42721749Royset IM, Saltvedt I, Sollid MIV, Kirkevold O, Gronberg BH, Eriksen GF, Rolfson D, Rostoft S, Slaaen M. Primary care implementation of a cross-sector geriatric assessment with management intervention for older patients undergoing radiotherapy. Eur J Oncol Nurs. 2026 Sep 4;84:103314. doi: 10.1016/j.ejon.2026.103314. Online ahead of print.
- Derived from this study: PubMed 40223637Sollid MIV, Melby L, Slaaen M, Eilertsen G, Royset IM, Kirkevold O. Experiences With an Intervention Based on Geriatric Assessment With Management: A Qualitative Study. Nurs Open. 2025 Apr;12(4):e70220. doi: 10.1002/nop2.70220.
- Derived from this study: PubMed 38853251Slaaen M, Royset IM, Saltvedt I, Gronberg BH, Halsteinli V, Dohl O, Vossius C, Kirkevold O, Bergh S, Rostoft S, Oldervoll L, Bye A, Melby L, Rosstad T, Eriksen GF, Sollid MIV, Rolfson D, Saltyte Benth J. Geriatric assessment with management for older patients with cancer receiving radiotherapy: a cluster-randomised controlled pilot study. BMC Med. 2024 Jun 10;22(1):232. doi: 10.1186/s12916-024-03446-4.
- Røyset et al. Protocolpaper, JGO 2022 Apr;13(3):363-373. doi: 10.1016/j.jgo.2021.11.001.Link provided by the sponsor.
- Individual participant dataSharing planned: No. According to Norwegian Data Protection regulations, sharing of individual participants data is not accepted unless purpose and involved researchers are explicitly stated and approved by the participants (informed consent form) and approved by The Ethical Review Board.
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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.
Marit S Jordhøy, PhD principal investigator
Sykehuset Innlandet HF
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Geriatric assessment with management in people with Cancer and Radiotherapy, run by Sykehuset Innlandet HF at 2 sites in Norway.
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 7 inclusion and 2 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 9 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. 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?
physical function (time frame: 8 weeks following termination of radiotherapy (RT)). 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 NCT03881137, which also lists 4 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 9 Nov 2022.