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

Not Applicable

Completed

• Conditions: Activities of Daily Living; Everyday Activities; Cancer; Quality of Life; Palliative Care
• Interventions: Other: The Cancer Home Life Intervention

• Registration Number: NCT02356627
• Lead Sponsor: University of Southern Denmark

Brief Summary

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.

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 Timeline

• Study First Submitted: 2015-01-31
• Study Start: 2015-02-01
• Study First Submitted QC: 2015-02-02
• Study First Posted: 2015-02-05
• Primary Completion: 2016-10-31
• Study Completion: 2017-03-31
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-09
• Last Update Posted: 2017-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 242

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The Cancer Home Life Intervention	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

Primary Outcome Measures

Name	Time	Method
Activity of Daily Living (ADL) motor ability as measured by the Assessment of Motor and Process Skills (AMPS)	3 months	Observed quality of Activity of Daily Living (ADL) motor ability

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Odense University Hospital; 🇩🇰 Odense, Denmark

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark