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

University of Southern Denmark (SDU)

Status: Completed

Conditions: Quality of Life; Cancer; Activities of Daily Living; Palliative Care; Everyday Activities

Treatments: Other: The Cancer Home Life Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02356627

AKT

Details and patient eligibility

About

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.

Full 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).

Enrollment: 242 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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242 participants in 2 patient groups

The Cancer Home Life Intervention

Experimental group

Description:

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

Treatment:

Other: The Cancer Home Life Intervention

Control

No Intervention group

Description:

Usual care from hospital and municipality