Clinical trial NCT03881137: Improved Function and Quality of Life for Older Patients Receiving Radiotherapy, Part II
Official title: Improving Function and Quality of Life for Older Cancer Patients Receiving Radiotherapy, a Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Radiotherapy
Older Patients
Keywords: older
cancer
radiotherapy
geriatric assessment
quality of life
physical function
Lead sponsor: Sykehuset Innlandet HF
Sponsor class: OTHER
Collaborators: name: Trondheim University Hospital
name: Norwegian University of Science and Technology
name: Trondheim Kommune
name: Oslo University Hospital
name: University of Oslo
name: Oslo Metropolitan University
First posted: 2019-03-19
Enrollment: 178
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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:

1. assess the potential short- and long-term effect of the intervention on global QoL and physical functioning for older cancer patients receiving RT
2. assess the feasibility of the intervention

   1. at the patient level (recruitment, compliance and adherence)
   2. at the organizational level (structures facilitating or impeding implementation and collaboration across sectors and between professionals)
3. 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.

Eligibility criteria: 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)

Primary outcomes:
measure: physical function
timeFrame: 8 weeks following termination of radiotherapy (RT)
Secondary outcomes:
measure: physical function
timeFrame: trend during follow-up from inclusion to one year after termination of radiotherapy
measure: global health
timeFrame: 8 weeks after radiotherapy and trend during follow-up from inclusion to one year after radiotherapy
measure: Health related quality of life (HRQoL)
timeFrame: 8 weeks after radiotherapy and trend during follow-up from inclusion to one year after radiotherapy
measure: mobility
timeFrame: 8 weeks after radiotherapy and trend during follow-up from inclusion up to 16 weeks after radiotherapy
measure: grip strength
timeFrame: 8 weeks after radiotherapy and trend during follow-up from inclusion up to 16 weeks after radiotherapy
measure: the incremental cost-effectiveness ratio (ICER)
timeFrame: 8 weeks after radiotherapy and during follow-up (up to 52 weeks after after radiotherapy)
measure: Use of health care services
timeFrame: From inclusion through overall follow-up (up to 52 weeks after radiotherapy)
Other outcomes:
measure: mobility
timeFrame: 8 weeks after radiotherapy and trend during follow-up up to 16 weeks after radiotherapy)
measure: balance
timeFrame: 8 weeks after radiotherapy and trend during follow-up up from inclusion to 16 weeks after radiotherapy
measure: symptom occurence
timeFrame: 8 weeks after radiotherapy and trend during follow-up from inclusion to one year after radiotherapy
measure: Body mass index (BMI)
timeFrame: From baseline throughout follow-up up to 52 weeks after RT
measure: appetite loss (AL)
timeFrame: 8 weeks after radiotherapy and trend during follow-up from inclusion to one year after radiotherapy
measure: emotional functioning (EF)
timeFrame: 8 weeks after radiotherapy and trend during follow-up from inclusion to one year after radiotherapy
Locations:
city: Gjøvik
country: Norway
facility: Innlandet Hospital Trust
city: Trondheim
country: Norway
facility: St Olav Hospital, Trondheim University Hospital
Study officials:
affiliation: Sykehuset Innlandet HF
name: Marit S Jordhøy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.