Improved Function and Quality of Life for Older Patients Receiving Radiotherapy, Part II

Study Overview
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Brief Summary
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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
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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.

Official Title
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Improving Function and Quality of Life for Older Cancer Patients Receiving Radiotherapy, a Randomized Controlled Pilot Study

Conditions
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Cancer, Radiotherapy, Older Patients

Intervention / Treatment
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* Other: Geriatric assessment with management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥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 Exclusion Criteria: severely ill with a life expectancy < 3months referred to receive one fraction of RT only (one day treatment)

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Geriatric assessment with management | Other: Geriatric assessment with management<br>* 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.<br>|
| No Intervention: Control<br>Patients receiving supportive care and follow up according to routine practice | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 8 weeks following termination of radiotherapy (RT) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 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 | 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) | 8 weeks after radiotherapy and trend during follow-up from inclusion up to 16 weeks after radiotherapy | 
| grip strength | assessed by dynamometer | 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. | 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) | From inclusion through overall follow-up (up to 52 weeks after radiotherapy) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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older, cancer, radiotherapy, geriatric assessment, quality of life, physical function