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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Activities of Daily Living, Everyday Activities, Palliative Care, Cancer, Quality of Life

Intervention / Treatment
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* Other: The Cancer Home Life Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The Cancer Home Life Intervention<br>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<br>* Adaptive interventions aiming at compensating for functional limitations.<br>|
| No Intervention: Control<br>Usual care from hospital and municipality | |

What is the study measuring?
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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) | 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) | 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 | 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) | 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) | Cancer specific health-related quality of life | 6 weeks and 3 months | 
| EuroQol 5-dimensions 5 levels (EQ-5D-5L) | Health-related quality of life | 6 weeks, 3 months, and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Occupational therapy, Adaptive intervention, Home-based, Assistive Technology, Home modification, Clinical effectiveness, Cost-effectiveness, Cost-utility