The Cancer Home Life Intervention Study. A Randomised, Controlled Multicentre Trial and a Health Economic Evaluation
NCT ID: NCT02356627
Last Updated: 2017-05-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
242 participants
INTERVENTIONAL
2015-02-01
2017-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Family and Coping Oriented Palliative Homecare Nursing Aimed at Advanced Cancer Patients
NCT01444157
Hospital-based Home Care for Children With Cancer
NCT01538706
Evaluating Quality and Cost of (Partial) Oncological Home-Hospitalization
NCT03668275
Home Parenteral Nutrition in Cancer Patients
NCT01152879
A Multi-center Investigation of Family Health.
NCT06433349
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
The Cancer Home Life Intervention
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
The Cancer Home Life Intervention
Adaptive interventions aiming at compensating for functional limitations.
Control
Usual care from hospital and municipality
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
The Cancer Home Life Intervention
Adaptive interventions aiming at compensating for functional limitations.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Live in a nursing home or a hospice
* Considered incapable of complying with the trial
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Southern Denmark
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Åse Brandt
External lecturer
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Karen la Cour, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Southern Denmark
Åse Brandt, PhD
Role: PRINCIPAL_INVESTIGATOR
The National Bord of Social Services
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Aarhus University Hospital
Aarhus, , Denmark
Odense University Hospital
Odense, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Oestergaard LG, la Cour K, Lindahl-Jacobsen LE, Brandt A, Pilegaard MS. The Cost-Effectiveness of the Cancer Home-Life Intervention: An Economic Evaluation Alongside a Randomized Clinical Trial with a Six-Month Time Frame. J Palliat Med. 2025 Sep 16. doi: 10.1177/10966218251374527. Online ahead of print.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AKT
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.