HRQOL (Health Related Quality of Life)Early Phase 1NCT01432197
Occupational Therapy for Cancer Patients: a Randomised, Controlled Study
A Early Phase 1 study testing ADL intervention in people with HRQOL (Health Related Quality of Life), run by University of Southern Denmark at 1 site in Denmark.
Trial summary
The aim of this study is to investigate the effect of occupational therapy, in shape of activities of daily living, for cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HRQOL (Health Related Quality of Life)
- What is being tested?
- ADL intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2010to Jun 2011
- Phase
- Early Phase 1
- 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
- Cancer patients
- Disability comparable with a performance status of 10 to 70 on Karnofsky Performance Status Scale
- Able to read and understand Danish
Who cannot join
- Referred to occupational therapy before study start
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Research Unit of General Practice, IST, University of Southern Denmark
Odense, 5000
About this study
Official title: Occupational Therapy for Cancer Patients: A Randomised Controlled Study
The aim of this study is to investigate the effect of occupational therapy, in shape of activities of daily living, for cancer patients.
Read the detailed description
Background
Cancer patients often experience serious dysfunctions leading to problems with activities of daily living (ADL) and reduced quality of life. Occupational therapy is believed to be effective in handling many of the problems with ADL experienced by patients with cancer, but the evidence is sparse.
Aim
The purpose of this study is to analyse the effects of an occupational therapy intervention targeting cancer patients.
Outcome measures are the patients self-reported quality of life and the patients ability to perform ADL.
Methods
Randomised controlled trial with 288 patients with cancer treated at Naestved hospital in Denmark. Occupational therapy intervention programme for the intervention group (N=144) and standard treatment and care for the controls (N=144).
A systematic review including studies of ADL intervention for cancer patients will be carried out. Feasibility of the recruitment and the intervention will be analysed and published.
The patients need for occupational therapy will be analysed using baseline information from the randomised controlled trial.
The effects of the intervention will be analysed using patient validated questionnaires including EORTC QLQ-C30 and the ADL taxonomy questionnaire.
- Conditions
- HRQOL (Health Related Quality of Life)
- Being tested
- ADL intervention
- Keywords
- HRQOL, Occupational therapy, ADL intervention, Cancer patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADL interventionOther
- ADL training, 2) home modifications, 3) delivery and supervision in adaptive equipments, and 4) instruction in self-training programs.
| Study group | Role | What they receive |
|---|---|---|
| Occupational therapy intervention | Experimental | Intervention group: Standard treatment and care added with an ADL intervention program: 1) ADL training, 2) home modifications, 3) delivery and supervision in adaptive equipments, and 4) instruction in self-training programs.
Control group: Standard treatment and care. No occupational therapy intervention. Receives: Other: ADL intervention |
| Standard treatment and care | No intervention | Control group: Standard treatment and care. No occupational therapy intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health related quality of life
Measured: 15 months
Secondary outcomes (1)
Ability to perform activities of daily living
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2011 (estimated)
- Study startMar 2010
- Primary completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HRQOL (Health Related Quality of Life)Studies 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Naestved Hospital
- Responsible party
- Principal investigator, Line Lindahl, University of Southern Denmark
- Investigators
- Dorte Gilsaa Hansen, Ph.D, M.D., Principal investigator, Research Unit of General Practice, IST, University of Southern DenmarkKaren la Cour, Ph.D, OT, MSc, Principal investigator, Health, Man and Society, IST, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01432197
- Sponsor's protocol ID
- RCT Occup Cancer
- Status last verified
- Sep 2011
- First submitted
- 8 Sep 2011
- Last updated
- 12 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occupational Therapy for Cancer Patients: A Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT01432197
- Acronym / sponsor ID
- RCT Occup Cancer
- Conditions
- HRQOL (Health Related Quality of Life)
- Keywords
- HRQOL, Occupational therapy, ADL intervention, Cancer patients
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Naestved Hospital
- Study start
- Mar 2010
- Primary completion
- Jun 2011 (actual)
- First posted
- 12 Sep 2011 (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 aim of this study is to investigate the effect of occupational therapy, in shape of activities of daily living, for cancer patients.
Detailed description
Background
Cancer patients often experience serious dysfunctions leading to problems with activities of daily living (ADL) and reduced quality of life. Occupational therapy is believed to be effective in handling many of the problems with ADL experienced by patients with cancer, but the evidence is sparse.
Aim
The purpose of this study is to analyse the effects of an occupational therapy intervention targeting cancer patients.
Outcome measures are the patients self-reported quality of life and the patients ability to perform ADL.
Methods
Randomised controlled trial with 288 patients with cancer treated at Naestved hospital in Denmark. Occupational therapy intervention programme for the intervention group (N=144) and standard treatment and care for the controls (N=144).
A systematic review including studies of ADL intervention for cancer patients will be carried out. Feasibility of the recruitment and the intervention will be analysed and published.
The patients need for occupational therapy will be analysed using baseline information from the randomised controlled trial.
The effects of the intervention will be analysed using patient validated questionnaires including EORTC QLQ-C30 and the ADL taxonomy questionnaire.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Occupational therapy intervention | Experimental | Other: ADL interventionIntervention group: Standard treatment and care added with an ADL intervention program: 1) ADL training, 2) home modifications, 3) delivery and supervision in adaptive equipments, and 4) instruction in self-training programs. Control group: Standard treatment and care. No occupational therapy intervention. |
| Standard treatment and care | No intervention | –Control group: Standard treatment and care. No occupational therapy intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Cancer patients
- Disability comparable with a performance status of 10 to 70 on Karnofsky Performance Status Scale
- Able to read and understand Danish
Key exclusion criteria (1 listed)
- Referred to occupational therapy before study start
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 |
|---|---|---|
| ADL intervention1) ADL training, 2) home modifications, 3) delivery and supervision in adaptive equipments, and 4) instruction in self-training programs. | Other | Occupational therapy intervention |
Primary outcome
Health related quality of life
Time frame: 15 months
1 secondary outcome
Ability to perform activities of daily living
Time frame: 15 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 12 Sep 2011.
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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.
Dorte Gilsaa Hansen, Ph.D, M.D. principal investigator
Research Unit of General Practice, IST, University of Southern Denmark
Karen la Cour, Ph.D, OT, MSc principal investigator
Health, Man and Society, IST, University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing ADL intervention in people with HRQOL (Health Related Quality of Life), run by University of Southern Denmark at 1 site 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 3 inclusion and 1 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 12 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Health related quality of life (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Sep 2011.