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

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ClinicalTrials.gov Identifier: NCT03881137
Recruitment Status : Recruiting
First Posted : March 19, 2019
Last Update Posted : May 23, 2019
Sponsor:
Collaborators:
Trondheim University Hospital
Norwegian University of Science and Technology
Trondheim Kommune
Oslo University Hospital
University of Oslo
Oslo Metropolitan University
Information provided by (Responsible Party):
Sykehuset Innlandet HF

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.

Condition or disease Intervention/treatment Phase
Cancer Radiotherapy Older Patients Other: Geriatric assessment with management Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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

Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Improving Function and Quality of Life for Older Cancer Patients Receiving Radiotherapy, a Randomized Controlled Pilot Study
Actual Study Start Date : May 8, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
Experimental: Intervention
Geriatric assessment with management
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.


No Intervention: Control
Patients receiving supportive care and follow up according to routine practice



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. physical function [ Time Frame: trend during follow-up from inclusion to one year after termination of radiotherapy ]
    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)

  2. global health [ Time Frame: 8 weeks after radiotherapy and trend during follow-up from inclusion to one year after radiotherapy ]
    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)

  3. Health related quality of life (HRQoL) [ Time Frame: 8 weeks after radiotherapy and trend during follow-up from inclusion to one year after radiotherapy ]
    assessed by the EQ-5D-5L index values

  4. mobility [ Time Frame: 8 weeks after radiotherapy and trend during follow-up from inclusion up to 16 weeks after radiotherapy ]
    assessed by the short physical performance battery (SPPB)

  5. grip strength [ Time Frame: 8 weeks after radiotherapy and trend during follow-up from inclusion up to 16 weeks after radiotherapy ]
    assessed by dynamometer

  6. the incremental cost-effectiveness ratio (ICER) [ Time Frame: 8 weeks after radiotherapy and during follow-up (up to 52 weeks after after radiotherapy) ]
    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.

  7. Use of health care services [ Time Frame: From inclusion through overall follow-up (up to 52 weeks after radiotherapy) ]
    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)


Other Outcome Measures:
  1. mobility [ Time Frame: 8 weeks after radiotherapy and trend during follow-up up to 16 weeks after radiotherapy) ]
    assessed by the Timed Up and Go

  2. balance [ Time Frame: 8 weeks after radiotherapy and trend during follow-up up from inclusion to 16 weeks after radiotherapy ]
    registration of the time the patient is able to maintain balance on one leg

  3. symptom occurence [ Time Frame: 8 weeks after radiotherapy and trend during follow-up from inclusion to one year after radiotherapy ]
    measured by the EORTC QLQ-C30 questionnaire

  4. Body mass index (BMI) [ Time Frame: From baseline throughout follow-up up to 52 weeks after RT ]
    Body mass inndex assessed as weight (kg)/(height m2)

  5. appetite loss (AL) [ Time Frame: 8 weeks after radiotherapy and trend during follow-up from inclusion to one year after radiotherapy ]
    Assessed by the appetite loss subscale on the EORTC QLQ-C30 questionnaire. The scale ranges from 0 (best) to 100 (worse). To be noted is that for all symptom scales of the EORTC QLQ -C30, 0 indicates the best (no symptom), whereas 100 is the worse. This is opposite to the functioning scales such as physical function, global QoL and emotional function

  6. emotional functioning (EF) [ Time Frame: 8 weeks after radiotherapy and trend during follow-up from inclusion to one year after radiotherapy ]
    assessed by the emotional function subscale of theEORTC QLQ-C30 questionnaire. The scale ranges from 0 (worse) to 100 (best)



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03881137


Contacts
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Contact: Marit S Jordhøy, PhD 91857831 ext 47 marit.jordhoy@sykehuset-innlandet.no
Contact: Bergh Sverre, PhD 45679393 sverre.bergh@sykehuset-innlandet.no

Locations
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Norway
Innlandet Hospital Trust Recruiting
Gjøvik, Norway
Contact: Marit S Jordhøy, PhD    91857831 ext 47    marit.jordhoy@sykehuset-innlandet.no   
Contact: Sverre Bergh, PhD    45679393 ext 47    sverre.bergh@sykehuset-innlandet.no   
St Olav Hospital, Trondheim University Hospital Recruiting
Trondheim, Norway
Contact: Bjørn H Grønberg, PhD    42297878 ext 47    bjorn.h.gronberg@gmail.com   
Contact: Ingvild T Saltvedt, PhD    91752949 ext 47    ingvild.saltvedt@ntnu.no   
Sponsors and Collaborators
Sykehuset Innlandet HF
Trondheim University Hospital
Norwegian University of Science and Technology
Trondheim Kommune
Oslo University Hospital
University of Oslo
Oslo Metropolitan University
Investigators
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Principal Investigator: Marit S Jordhøy, PhD Sykehuset Innlandet HF
  Study Documents (Full-Text)

Documents provided by Sykehuset Innlandet HF:
Statistical Analysis Plan  [PDF] March 12, 2019


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Responsible Party: Sykehuset Innlandet HF
ClinicalTrials.gov Identifier: NCT03881137     History of Changes
Other Study ID Numbers: SI0303150406
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sykehuset Innlandet HF:
older
cancer
radiotherapy
geriatric assessment
quality of life
physical function