Clinical trial NCT02356627: The Cancer Home Life Intervention Study. A Randomised, Controlled Multicentre Trial and a Health Economic Evaluation
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Activities of Daily Living
Everyday Activities
Palliative Care
Cancer
Quality of Life
Keywords: Occupational therapy
Adaptive intervention
Home-based
Assistive Technology
Home modification
Clinical effectiveness
Cost-effectiveness
Cost-utility
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2015-02-05
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Activity of Daily Living (ADL) motor ability as measured by the Assessment of Motor and Process Skills (AMPS)
timeFrame: 3 months
Secondary outcomes:
measure: Individually Prioritised Problems Assessment (IPPA)
timeFrame: 6 weeks and 3 months
measure: Everyday activity pattern captured by a One Day Diary
timeFrame: 3 months
measure: Impact on Participation and Autonomy Questionnaire (IPAQ)
timeFrame: 6 weeks and 3 months
measure: The European Organization for Research Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C-30)
timeFrame: 6 weeks and 3 months
measure: EuroQol 5-dimensions 5 levels (EQ-5D-5L)
timeFrame: 6 weeks, 3 months, and 6 months
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: University of Southern Denmark
name: Karen la Cour, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The National Bord of Social Services
name: Åse Brandt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brandt Å, la Cour K, Wæhrens. Activity problems important to people with advanced cancer living at home. Oral session presented at: 16th International Congress of the World Federation of Occupational Therapists.; June 18-21; Yokohama, Japan; 2014.
citation: Johnsen AT, Petersen MA, Pedersen L, Houmann LJ, Groenvold M. Do advanced cancer patients in Denmark receive the help they need? A nationally representative survey of the need related to 12 frequent symptoms/problems. Psychooncology. 2013 Aug;22(8):1724-30. doi: 10.1002/pon.3204. Epub 2012 Oct 8.
citation: la Cour K, Johannessen H, Josephsson S. Activity and meaning making in the everyday lives of people with advanced cancer. Palliat Support Care. 2009 Dec;7(4):469-79. doi: 10.1017/S1478951509990472.
citation: la Cour K, Nordell K, Josephsson S. Everyday lives of people with advanced cancer: Activity, time, location, and experience. OTJR Occup Part Health 2009 December;29(4):154-162.
citation: Lindahl-Jacobsen L. Occupational therapy for cancer patients - a randomised, controlled study [PhD thesis]. Research Unit of General Practice, Institute of Public Health: University of Southern Denmark; 2014.
citation: Rabow M, Kvale E, Barbour L, Cassel JB, Cohen S, Jackson V, Luhrs C, Nguyen V, Rinaldi S, Stevens D, Spragens L, Weissman D. Moving upstream: a review of the evidence of the impact of outpatient palliative care. J Palliat Med. 2013 Dec;16(12):1540-9. doi: 10.1089/jpm.2013.0153. Epub 2013 Nov 13.
citation: Sviden GA, Tham K, Borell L. Involvement in everyday life for people with a life threatening illness. Palliat Support Care. 2010 Sep;8(3):345-52. doi: 10.1017/S1478951510000143.
citation: Vendrusculo Fangel LM, Sanches Panobianco M, Martins Kebbe L, de Almeida AM, de OG. Qualify of life and daily activities performance after breast cancer treatment. ACTA PAUL ENFERMAGEM 2013 February;26(1):93-100.
citation: Wæhrens E, la Cour K, Brandt Å. The quality of ADL task performance based on self-report and observation in people living at home with cancer. Poster presented at: 16th International Congress of the World Federation of Occupational Therapists.; June 18-21; Yokohama, Japan; 2014.
citation: la Cour K, Gregersen Oestergaard L, Brandt A, Offersen SMH, Lindahl-Jacobsen L, Cutchin M, Pilegaard MS. Process evaluation of the Cancer Home-Life Intervention: What can we learn from it for future intervention studies? Palliat Med. 2020 Dec;34(10):1425-1435. doi: 10.1177/0269216320939227. Epub 2020 Jul 2.
citation: Pilegaard MS, la Cour K, Gregersen Oestergaard L, Johnsen AT, Lindahl-Jacobsen L, Hojris I, Brandt A. The 'Cancer Home-Life Intervention': A randomised controlled trial evaluating the efficacy of an occupational therapy-based intervention in people with advanced cancer. Palliat Med. 2018 Apr;32(4):744-756. doi: 10.1177/0269216317747199. Epub 2018 Jan 4.
citation: Brandt A, Pilegaard MS, Oestergaard LG, Lindahl-Jacobsen L, Sorensen J, Johnsen AT, la Cour K. 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. BMC Palliat Care. 2016 Jan 22;15:10. doi: 10.1186/s12904-016-0084-9.