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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02356627
• Other study ID #: AKT
• Status: Completed
• Phase: N/A
• First received: January 31, 2015
• Last updated: May 9, 2017
• Start date: February 1, 2015
• Est. completion date: March 31, 2017

Study information

• Verified date: May 2017
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: March 31, 2017
• Est. primary completion date: October 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Activities of Daily Living
• Cancer
• Everyday Activities
• Palliative Care
• Quality of Life

Intervention

Other:
• The Cancer Home Life Intervention
Adaptive interventions aiming at compensating for functional limitations.

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus
Denmark	Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (9)

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. — View 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. — View 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.

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. Review. — View Citation

Svidén 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. — View 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.

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Activity of Daily Living (ADL) motor ability as measured by the Assessment of Motor and Process Skills (AMPS)	Observed quality of Activity of Daily Living (ADL) motor ability	3 months
Secondary	Individually Prioritised Problems Assessment (IPPA)	Everyday activities that the participant has problems with and prioritise to have solved	6 weeks and 3 months
Secondary	Everyday activity pattern captured by a One Day Diary	The participant records every ½ hour what he/she does, where, is together with, how he/she feels mentally and physically	3 months
Secondary	Impact on Participation and Autonomy Questionnaire (IPAQ)	Autonomy and participation is assessed regarding autonomy indoors, family roles, and social life and relationships	6 weeks and 3 months
Secondary	The European Organization for Research Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C-30)	Cancer specific health-related quality of life	6 weeks and 3 months
Secondary	EuroQol 5-dimensions 5 levels (EQ-5D-5L)	Health-related quality of life	6 weeks, 3 months, and 6 months