NCT02356627

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
242

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2015

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2015

Completed
1 day until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2017

Completed
Last Updated

May 10, 2017

Status Verified

May 1, 2017

Enrollment Period

1.7 years

First QC Date

January 31, 2015

Last Update Submit

May 9, 2017

Conditions

Activities of Daily LivingEveryday ActivitiesPalliative CareCancerQuality of Life

Keywords

Occupational therapyAdaptive interventionHome-basedAssistive TechnologyHome modificationClinical effectivenessCost-effectivenessCost-utility

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Individually Prioritised Problems Assessment (IPPA)

    6 weeks and 3 months

  • Everyday activity pattern captured by a One Day Diary

    3 months

  • Impact on Participation and Autonomy Questionnaire (IPAQ)

    6 weeks and 3 months

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

    6 weeks and 3 months

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

    6 weeks, 3 months, and 6 months

Study Arms (2)

The Cancer Home Life Intervention

EXPERIMENTAL

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

Other: The Cancer Home Life Intervention

Control

NO INTERVENTION

Usual care from hospital and municipality

Interventions

The Cancer Home Life InterventionOTHER

Adaptive interventions aiming at compensating for functional limitations.

The Cancer Home Life Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (13)

  • 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.

    BACKGROUND

  • 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.

    PMID: 23042603BACKGROUND

  • 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.

    PMID: 19939309BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 24225013BACKGROUND

  • 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.

    PMID: 20875178BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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 Dec;28(12):1620-1628. doi: 10.1177/10966218251374527. Epub 2025 Sep 16.

    PMID: 40955537DERIVED

  • 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.

    PMID: 32611224DERIVED

  • 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.

    PMID: 29299957DERIVED

  • 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.

    PMID: 26801394DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Karen la Cour, PhD

    University of Southern Denmark

    PRINCIPAL INVESTIGATOR

  • Åse Brandt, PhD

    The National Bord of Social Services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
External lecturer

Study Record Dates

First Submitted

January 31, 2015

First Posted

February 5, 2015

Study Start

February 1, 2015

Primary Completion

October 31, 2016

Study Completion

March 31, 2017

Last Updated

May 10, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

DK(2)