The Cancer Home Life Intervention Study. A Randomised, Controlled Multicentre Trial and a Health Economic Evaluation

May 9, 2017 updated by: Åse Brandt, University of Southern Denmark

The Cancer Home Life Intervention Study Protocol: Effectiveness on Everyday Activities and Quality of Life in People With Advanced Cancer Living at Home. A Randomised, Controlled Multicentre Trial and a Health Economic Evaluation

The purpose of this study is to examine the effectiveness and cost-effectiveness of the Cancer Home Life Intervention compared to usual care on performance of and participation in everyday activities and quality of life in people with advanced cancer living at home.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The sample size is based on the primary outcome measure: the mean Activty of Daily Living (ADL) motor ability 1.04 logits (SD 0.727) as measured by the Assessment of Motor and Process Skills (AMPS). A significance level of 0.05 would provide 80% power to detect a between-group difference of 0.3 logits requiring a sample size of N=184. An expected drop-out rate of 32% at 3 months follow-up means that 272 patients with advanced cancer must be included in the study from three hospitals.

Multiple imputation will be used to estimate a plausible value for missing data of participants that are lost to follow-up due to other reasons than death. This does not, however, apply to the primary outcome data where no estimations will be computed.

For normally distributed ratio data the intervention group will be compared with the control group using multiple linear regression analysis of mean changes from baseline. Logistic regression analysis will be used for ordinal data. Adjustments for hospital and for baseline values will be made. A modified intention-to-treat analysis will be applied. Subgroup analyses to identifiy groups that especially benefit from the intervetnion will be performed.

The cost-effectiveness analysis wil be performed with ADL motor ability as the clinical parameter, and the cost-utility analysis will be based on the calculation of Quality Adjusted Life Years (QALY). The Incremental Cost-effectiveness Ratio (ICER) will be calculated and the results summarised in a cost-effectiveness acceptability curve (CEAC).

Study Type

Interventional

Enrollment (Actual)

242

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Aarhus University Hospital
      • Odense, Denmark, 5000
        • Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ≥18 years old
  • Diagnosed with cancer
  • Evaluated incurable by responsible oncologist in respective out-patient unit
  • Functional level 1-2 on the WHO performance scale
  • Live within a radius of maximum 60 km from AUH or NH or on the island of Funen
  • Live in a private home or in sheltered living
  • Know sufficient Danish to fill out questionnaires and participate in interviews.

Exclusion Criteria:

  • Cognitive impairment preventing the participants from participating in a structured interview
  • Live in a nursing home or a hospice
  • Considered incapable of complying with the trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The Cancer Home Life Intervention

One or more of the following:

  • prioritisation of resources and everyday activities
  • adaptation of activities
  • adaptation of posture and seating positioning
  • provision of assistive devices
  • modification of the physical home environment And usual care from hospital and municipality
Other: The Cancer Home Life Intervention
Adaptive interventions aiming at compensating for functional limitations.
No Intervention: Control
Usual care from hospital and municipality

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Activity of Daily Living (ADL) motor ability as measured by the Assessment of Motor and Process Skills (AMPS)
Time Frame: 3 months
Observed quality of Activity of Daily Living (ADL) motor ability
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Individually Prioritised Problems Assessment (IPPA)
Time Frame: 6 weeks and 3 months
Everyday activities that the participant has problems with and prioritise to have solved
6 weeks and 3 months
Everyday activity pattern captured by a One Day Diary
Time Frame: 3 months
The participant records every ½ hour what he/she does, where, is together with, how he/she feels mentally and physically
3 months
Impact on Participation and Autonomy Questionnaire (IPAQ)
Time Frame: 6 weeks and 3 months
Autonomy and participation is assessed regarding autonomy indoors, family roles, and social life and relationships
6 weeks and 3 months
The European Organization for Research Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C-30)
Time Frame: 6 weeks and 3 months
Cancer specific health-related quality of life
6 weeks and 3 months
EuroQol 5-dimensions 5 levels (EQ-5D-5L)
Time Frame: 6 weeks, 3 months, and 6 months
Health-related quality of life
6 weeks, 3 months, and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern Denmark

Investigators

  • Principal Investigator: Karen la Cour, PhD, University of Southern Denmark
  • Principal Investigator: Åse Brandt, PhD, The National Bord of Social Services

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2015

Primary Completion (Actual)

October 31, 2016

Study Completion (Actual)

March 31, 2017

Study Registration Dates

First Submitted

January 31, 2015

First Submitted That Met QC Criteria

February 2, 2015

First Posted (Estimate)

February 5, 2015

Study Record Updates

Last Update Posted (Actual)

May 10, 2017

Last Update Submitted That Met QC Criteria

May 9, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AKT (Other Grant/Funding Number: UKRI)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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