Activities of Daily LivingNCT02356627
The Cancer Home Life Intervention Study. A Randomised, Controlled Multicentre Trial and a Health Economic Evaluation
A study testing The Cancer Home Life Intervention in people with Activities of Daily Living and Everyday Activities, run by University of Southern Denmark at 2 sites in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Activities of Daily Living, Everyday Activities, Palliative Care
- What is being tested?
- The Cancer Home Life Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Feb 2015to 31 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Aarhus University Hospital
Aarhus, 8000
Odense University Hospital
Odense, 5000
About this study
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
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.
Read the 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).
- Being tested
- The Cancer Home Life Intervention
- Keywords
- Occupational therapy, Adaptive intervention, Home-based, Assistive Technology, Home modification, Clinical effectiveness, Cost-effectiveness, Cost-utility
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Cancer Home Life InterventionOther
Adaptive interventions aiming at compensating for functional limitations.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: The Cancer Home Life Intervention |
| Control | No intervention | Usual care from hospital and municipality |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (5)
Individually Prioritised Problems Assessment (IPPA)
Everyday activities that the participant has problems with and prioritise to have solved
Measured: 6 weeks and 3 months
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
Measured: 3 months
Impact on Participation and Autonomy Questionnaire (IPAQ)
Autonomy and participation is assessed regarding autonomy indoors, family roles, and social life and relationships
Measured: 6 weeks and 3 months
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
Measured: 6 weeks and 3 months
EuroQol 5-dimensions 5 levels (EQ-5D-5L)
Health-related quality of life
Measured: 6 weeks, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2015 (estimated)
- Study start1 Feb 2015
- Primary completion31 Oct 2016
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Activities of Daily LivingStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Åse Brandt, University of Southern Denmark
- Investigators
- Karen la Cour, PhD, Principal investigator, University of Southern DenmarkÅse Brandt, PhD, Principal investigator, The National Bord of Social Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02356627
- Sponsor's protocol ID
- AKT
- Status last verified
- May 2017
- First submitted
- 31 Jan 2015
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 23042603la 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.
PubMed 19939309la 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.
PubMed 24225013Sviden 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.
PubMed 20875178Vendrusculo 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 Dec;28(12):1620-1628. doi: 10.1177/10966218251374527. Epub 2025 Sep 16.
PubMed 40955537la 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.
PubMed 32611224Pilegaard 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.
PubMed 29299957Brandt 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.
PubMed 26801394
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02356627
- Acronym / sponsor ID
- AKT
- Keywords
- Occupational therapy, Adaptive intervention, Home-based, Assistive Technology, Home modification, Clinical effectiveness, Cost-effectiveness, Cost-utility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- 1 Feb 2015 (actual)
- Primary completion
- 31 Oct 2016 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 5 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Cancer Home Life Intervention | Experimental | Other: The Cancer Home Life InterventionOne 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 |
| Control | No intervention | –Usual care from hospital and municipality |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Cancer Home Life InterventionAdaptive interventions aiming at compensating for functional limitations. | Other | The Cancer Home Life Intervention |
Primary outcome
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
5 secondary outcomes
Individually Prioritised Problems Assessment (IPPA)
Time frame: 6 weeks and 3 months
Everyday activity pattern captured by a One Day Diary
Time frame: 3 months
Impact on Participation and Autonomy Questionnaire (IPAQ)
Time frame: 6 weeks and 3 months
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
EuroQol 5-dimensions 5 levels (EQ-5D-5L)
Time frame: 6 weeks, 3 months, and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
- BackgroundBrandt 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: PubMed 23042603Johnsen 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.
- Background: PubMed 19939309la 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.
- Backgroundla 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.
- BackgroundLindahl-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: PubMed 24225013Rabow 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.
- Background: PubMed 20875178Sviden 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.
- BackgroundVendrusculo 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.
- BackgroundWæhrens 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.
- Derived from this study: PubMed 40955537Oestergaard 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.
- Derived from this study: PubMed 32611224la 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.
- Derived from this study: PubMed 29299957Pilegaard 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.
- Individual participant dataSharing planned: No
Related trials for Activities of Daily Living
RecruitingObservational study
Impact of Vestibular Function on Deaf Infants' Activities of Daily Living
Vestibular Dysfunction, Hearing Loss
RecruitingObservational study
Effects of Obesity on Physical Abilities and Daily Living Activities in Elderly Adults
Obesity, Sarcopenic Obesity
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Recruiting
Evaluation of the PPAL
Age Problems
RecruitingObservational study
Physical Impairments in Premature Ventricular Complex
Premature Ventricular Complexes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen la Cour, PhD principal investigator
University of Southern Denmark
Åse Brandt, PhD principal investigator
The National Bord of Social Services
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Cancer Home Life Intervention in people with Activities of Daily Living and Everyday Activities, run by University of Southern Denmark at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Activity of Daily Living (ADL) motor ability as measured by the Assessment of Motor and Process Skills (AMPS) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02356627, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2017.