Short summary

The objective of this study is to examine the effectiveness and cost-effectiveness of the Home Life Intervention compared to usual care on everyday activities and quality of life in people with advanced cancer living at home. The study is part of a larger research project "Aktivitet, kræft og livskvalitet i eget hjem" (the Cancer Home Life Project).

The study is a randomised, controlled multicentre trial (RCT). A health economic evaluation will be performed alongside the RCT. Two hundred and seventy two persons with advanced cancer are enrolled from Odense University Hospital (OUH), Aarhus University Hospital (AUH) and Næstved Hospital (NH).

Rationale

A growing number of people live longer with advanced cancer and are to a larger extent expected to manage their daily life at home. However, research shows that people with advanced cancer often have difficulties managing and performing everyday activities and many do not receive the help they need. Most likely, this situation has a significant, negative bearing on these persons' quality of life. There is accordingly a need for interventions that can help people with advanced cancer to manage their everyday activities. Yet, the current research in the field is sparse and research into the effect of activity-oriented interventions is needed. The Cancer Home Life Project has, in a cross-sectional study, identified needs and problems encountered by people with advanced cancer at home. The results have been used to develop the Home Life Intervention, which aims to enable the target group to master everyday activities at home by employing adaptive strategies. In order to get knowledge about the effectiveness of the Home Life Intervention, an evaluation of it is required. Moreover, in order to be able to decide whether the intervention is cost-effective, it needs to undergo an economic evaluation.

Description of the cohort

The participants are enrolled from Odense University Hospital (OUH), Aarhus University Hospital (AUH) and Næstved Hospital (NH) with an equal number from each hospital. Participants who fulfil the following inclusion criteria will be enrolled in the study:

Inclusion criteria:                          

·        18 years or older

·        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 at home or in sheltered living

·        Know sufficient Danish to fill out questionnaires and participate in interviews

Exclusion criteria:

·        Cognitive impairments preventing the participants from participating in a structured interview

·        Live in a nursing home or a hospice

·        Considered incapable of complying with the trial

Data and biological material

Baseline T1: Data will be collected by means of a study specific questionnaire which includes the following:

-        Demography

-        Health

-        Health expenditures

-        EuroQol 5-dimensions (EQ-5D)

-        European Organization for Research Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C-30)

-        Activities of Daily Living-Questionnaire (ADL-Q)

-        Impact on Participation and Autonomy questionnaire (IPA-DK)

Furthermore, a one day diary is sent out before a home visit, where the Assessment of Motor and Process Skills (AMPS) and Individually Prioritised Problems Assessment (IPPA) are applied. 

Six weeks follow-up T2: Data will be collected by means of the study specific questionnaire. Demographic data are only collected at baseline.

Three months follow-up T3: Data will be collected by means of the study specific questionnaire sent out before a home visit, where the AMPS and IPPA again are applied.

Six months follow-up T4: Data will be collected by means of the study specific questionnaire.

Register data:

Clinical data: Primary cancer diagnosis and dissemination of cancer will be extracted from the medical records.

Costs in the secondary health care sector: The costs of secondary health care use and the associated DRG rates will be extracted from the National Patient Registry (NPR).

Costs in the primary healthcare sector: Data on the use of primary health care including contacts to general practitioners, medical specialist and physiotherapist will be extracted from The Danish National Health Service Register for Primary Care (NHSR).

Productivity costs: This will be calculated using data on the number of weeks of sick leave obtained from the Danish Register for Evaluation of Marginalization (DREAM).

Average gross salaries: We will use age- and gender-matched average gross salaries from Statistics Denmark.

Collaborating researchers and departments

Research Initiative for Activity Studies and Occupational Therapy, Department of Public Health, University of Southern Denmark

• Project Leader Karen la Cour, MSc, PhD
• Senior Researcher Åse Brandt, MSc, PhD
• Research Assistant Marc Sampredo Pilegaard, MHSc
• Project Coordinator Line Lindahl-Jacobsen, Postdoc, MSc, PhD

Department of Physiotherapy and Occupational Therapy, Århus University Hospital

• Research Therapist Lisa Gregersen Østergaard, Postdoc, MHSc, PhD

Publications associated with the project

Effectiveness of the "Cancer Home-Life Intervention" on everyday activities and quality of life in people with advanced cancer living at home: a randomised controlled trial and an economic evaluation / Brandt, Å, Pilegaard, MS, Oestergaard, LG, Lindahl-Jacobsen, L, Sørensen, J, Johnsen, AT, la Cour, K; BMC Palliative Care, 2016, 15:10.