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

NCT03881137 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2022-11-09

No results posted yet for this study

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

Interventions

OTHER

Geriatric assessment with management

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.

Sponsors & Collaborators

  • Trondheim University Hospital

    collaborator OTHER

  • Norwegian University of Science and Technology

    collaborator OTHER

  • Trondheim Kommune

    collaborator OTHER

  • Oslo University Hospital

    collaborator OTHER

  • University of Oslo

    collaborator OTHER

  • Oslo Metropolitan University

    collaborator OTHER

  • Sykehuset Innlandet HF

    lead OTHER

Principal Investigators

  • Marit S Jordhøy, PhD · Sykehuset Innlandet HF

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-08
Primary Completion
2021-07-25
Completion
2022-06-10

Countries

  • Norway

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03881137 on ClinicalTrials.gov