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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Activities of Daily Living
- Sponsor
- University of Southern Denmark
- Enrollment
- 242
- Locations
- 2
- Primary Endpoint
- Activity of Daily Living (ADL) motor ability as measured by the Assessment of Motor and Process Skills (AMPS)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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).
Investigators
Åse Brandt
External lecturer
University of Southern Denmark
Eligibility Criteria
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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Individually Prioritised Problems Assessment (IPPA)(6 weeks and 3 months)
- Everyday activity pattern captured by a One Day Diary(3 months)
- Impact on Participation and Autonomy Questionnaire (IPAQ)(6 weeks and 3 months)
- The European Organization for Research Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C-30)(6 weeks and 3 months)
- EuroQol 5-dimensions 5 levels (EQ-5D-5L)(6 weeks, 3 months, and 6 months)