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Completed

NCT Number: NCT02356627

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aarhus University Hospital, Aarhus, Denmark

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The Cancer Home Life Intervention

Other

Adaptive interventions aiming at compensating for functional limitations.

Primary outcomes

  1. Activity of Daily Living (ADL) motor ability as measured by the Assessment of Motor and Process Skills (AMPS)

    Time frame: 3 months

    Observed quality of Activity of Daily Living (ADL) motor ability

Secondary outcomes

  1. Individually Prioritised Problems Assessment (IPPA)

    Time frame: 6 weeks and 3 months

    Everyday activities that the participant has problems with and prioritise to have solved

  2. Everyday activity pattern captured by a One Day Diary

    Time frame: 3 months

    The participant records every ½ hour what he/she does, where, is together with, how he/she feels mentally and physically

  3. Impact on Participation and Autonomy Questionnaire (IPAQ)

    Time frame: 6 weeks and 3 months

    Autonomy and participation is assessed regarding autonomy indoors, family roles, and social life and relationships

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

    Time frame: 6 weeks and 3 months

    Cancer specific health-related quality of life

  5. EuroQol 5-dimensions 5 levels (EQ-5D-5L)

    Time frame: 6 weeks, 3 months, and 6 months

    Health-related quality of life

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Feb 5, 2015
Registry last updated
May 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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