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

NCT03881137 | Completed

• 1 other identifier: SI0303150406
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 2

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.

Conditions

Cancer; Radiotherapy; Older Patients

Keywords

older; cancer; radiotherapy; geriatric assessment; quality of life; physical function

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• physical function

  trend during follow-up from inclusion to one year after termination of radiotherapy

• global health

  8 weeks after radiotherapy and trend during follow-up from inclusion to one year after radiotherapy

• Health related quality of life (HRQoL)

  8 weeks after radiotherapy and trend during follow-up from inclusion to one year after radiotherapy

• mobility

  8 weeks after radiotherapy and trend during follow-up from inclusion up to 16 weeks after radiotherapy

• grip strength

  8 weeks after radiotherapy and trend during follow-up from inclusion up to 16 weeks after radiotherapy

Other Outcomes (6)

• mobility

  8 weeks after radiotherapy and trend during follow-up up to 16 weeks after radiotherapy)

• balance

  8 weeks after radiotherapy and trend during follow-up up from inclusion to 16 weeks after radiotherapy

• symptom occurence

  8 weeks after radiotherapy and trend during follow-up from inclusion to one year after radiotherapy

Study Arms (2)

Intervention

EXPERIMENTAL

Geriatric assessment with management

Other: Geriatric assessment with management

Control

NO INTERVENTION

Patients receiving supportive care and follow up according to routine practice

Interventions

Geriatric assessment with management OTHER

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.

Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• severely ill with a life expectancy \< 3months
• referred to receive one fraction of RT only (one day treatment)

Sponsors & Collaborators

• Sykehuset Innlandet HF: lead
• Trondheim University Hospital: collaborator
• Norwegian University of Science and Technology: collaborator
• Trondheim Kommune: collaborator
• Oslo University Hospital: collaborator
• University of Oslo: collaborator
• Oslo Metropolitan University: collaborator

Study Sites (2)

Innlandet Hospital Trust

Gjøvik, Norway

Location

St Olav Hospital, Trondheim University Hospital

Trondheim, Norway

Location

Related Publications (3)

• 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.

  PMID: 34776384 BACKGROUND

• Sollid 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.

  PMID: 40223637 DERIVED

• Slaaen 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.

  PMID: 38853251 DERIVED

Related Links

• Røyset et al. Protocolpaper, JGO 2022 Apr;13(3):363-373. doi: 10.1016/j.jgo.2021.11.001.

MeSH Terms

Conditions

Neoplasms

Interventions

Geriatric Assessment; Therapeutics

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Status; Demography; Population Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Marit S Jordhøy, PhD

  Sykehuset Innlandet HF

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: March 13, 2019
• First Posted: March 19, 2019
• Study Start: May 8, 2019
• Primary Completion: July 25, 2021
• Study Completion: June 10, 2022
• Last Updated: November 9, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)