CancerNCT04066153
Patient Reported Unmet Needs for Function and Supportive Occupational- and Physiotherapy Rehabilitation Interventions
An observational study of Cancer and Kidney Diseases, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Purpose: To determine unmet functional needs in patients referred to the Palliative Care Unit at Rigshospitalet, Copenhagen University Hospital will be asked to fill out self reported questionnaires regarding problem intensity, problem burden and felt needs, physical functioning, emotional functioning, fatigue, sleep… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Kidney Diseases, Heart Failure
- How many people
- 43 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Aug 2019to 8 Nov 2019
- Phase
- Observational
- 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
Study population: All adult patients (≥ 18 years) referred to the Palliative Care Unit at Copenhagen University Hospital, Rigshospitalet will be considered eligible for inclusion. Patients will be cancer and non-cancer patients, some will receive in-hospital treatment at the hospital and others outpatient treatment.
Who may be able to join
- All adult patients (≥ 18 years) referred to the Palliative Care Unit at Copenhagen University Hospital, Rigshospitalet.
Who cannot join
- Inability to read and understand Danish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Reported Unmet Needs for Function and Supportive Occupational- and Physiotherapy Rehabilitation Interventions in a Palliative Care Setting
Purpose: To determine unmet functional needs in patients referred to the Palliative Care Unit at Rigshospitalet, Copenhagen University Hospital will be asked to fill out self reported questionnaires regarding problem intensity, problem burden and felt needs, physical functioning, emotional functioning, fatigue, sleep, distress. Furthermore patients physical function will be evaluated.
Read the detailed description
Physical functioning is found to be an important predictor for survival and physical ability 'to do what one wants' affects quality of life in cancer patients in palliative care and their spouses. Despite this, physical functioning is reported as a neglected dimension in palliative care quality of life outcome measures, and advanced cancer patients report that they do not receive the help they need. The vast majority of patients with advanced cancer described unmet palliative care needs, and with the most frequently reported problems being; fatigue (73%), limitations doing physical activities (65%), limitations in work and daily activities (58%), worry (58%), difficulties with sexuality (54%), pain (52%) and problems with concentration (43%). Furthermore, limitations in physical functioning and physical activity is a leading cause of distress and psychological problems a rehabilitative approach in palliative care integrated in the interdisciplinary interventions to the patients must be maintained throughout the entire illness trajectory from diagnosis through treatment, rehabilitation and palliative care to address such problems.
However, prevalence of patient unmet needs and reported physical functioning and performance is reported to differentiate largely between palliative units.
In order to address the functional needs of patients receiving specialist palliative care studies of their specific needs are required. Therefore, the aim of this study is to investigate the patient reported unmet needs for function and supportive occupational- and physiotherapy rehabilitation interventions in the palliative unit at Copenhagen University Hospital, Rigshospitalet. Furthermore, we aim to investigate if observations, additional disease-specific patient reported outcomes and assessment of physical function and performance can support the unmet needs.
- Conditions
- Cancer, Kidney Diseases, Heart Failure, Neurologic Disorder, Liver Diseases, Pulmonary Disease
- Keywords
- Palliative care, Physical functioning, Unmet needs
- Medical subject headings
- Neoplasms, Kidney Diseases, Heart Failure, Nervous System Diseases, Liver Diseases, Lung Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Unmet physical functioning needs
The Three-Levels-of-Needs Questionnaire (3LNQ)
Measured: At baseline
Secondary outcomes (10)
Lower body physical function
30 seconds Sit-To-Stand test
Measured: At baseline
Hand grip strength
Maximum strength test by handgrip dynamometer
Measured: At baseline
Walking endurance
Six Minute Walking Test
Measured: At baseline
Health-related quality of life
EORTC QLQ-C30
Measured: At baseline
Overall distress
Distress thermometer
Measured: At baseline
Psychological distress
Hospital Anxiety and Depression Scale (HADS)
Measured: At baseline
Sleep quality
Pittsburgh Sleep Quality Index (PSQI)
Measured: At beseline
Level of fatigue
Functional Assessment of Cancer Therapy - Fatigue (FACT-F) 13 item fatigue subscale
Measured: At baseline
Patients self-perception of performance in everyday living
The Canadian Occupational Performance Measure (COPM)
Measured: At baseline
Physical activity level
International Physical Activity Questionnaire (IPAQ) short form
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start20 Aug 2019
- Primary completion8 Nov 2019
- Study completion8 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Christensen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Jan Christensen, Principal investigator, Department of Occupational- and Physiotherapy, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04066153
- Sponsor's protocol ID
- 2018-418 6670
- Status last verified
- Apr 2025
- First submitted
- 21 Aug 2019
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Reported Unmet Needs for Function and Supportive Occupational- and Physiotherapy Rehabilitation Interventions in a Palliative Care Setting
- ClinicalTrials.gov ID
- NCT04066153
- Acronym / sponsor ID
- 2018-418 6670
- Conditions
- Cancer, Kidney Diseases, Heart Failure, Neurologic Disorder, Liver Diseases, Pulmonary Disease
- Keywords
- Palliative care, Physical functioning, Unmet needs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 20 Aug 2019 (actual)
- Primary completion
- 8 Nov 2019 (actual)
- Study completion
- 8 Nov 2019 (actual)
- First posted
- 26 Aug 2019 (actual)
- 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.
Purpose: To determine unmet functional needs in patients referred to the Palliative Care Unit at Rigshospitalet, Copenhagen University Hospital will be asked to fill out self reported questionnaires regarding problem intensity, problem burden and felt needs, physical functioning, emotional functioning, fatigue, sleep, distress. Furthermore patients physical function will be evaluated.
Detailed description
Physical functioning is found to be an important predictor for survival and physical ability 'to do what one wants' affects quality of life in cancer patients in palliative care and their spouses. Despite this, physical functioning is reported as a neglected dimension in palliative care quality of life outcome measures, and advanced cancer patients report that they do not receive the help they need. The vast majority of patients with advanced cancer described unmet palliative care needs, and with the most frequently reported problems being; fatigue (73%), limitations doing physical activities (65%), limitations in work and daily activities (58%), worry (58%), difficulties with sexuality (54%), pain (52%) and problems with concentration (43%). Furthermore, limitations in physical functioning and physical activity is a leading cause of distress and psychological problems a rehabilitative approach in palliative care integrated in the interdisciplinary interventions to the patients must be maintained throughout the entire illness trajectory from diagnosis through treatment, rehabilitation and palliative care to address such problems.
However, prevalence of patient unmet needs and reported physical functioning and performance is reported to differentiate largely between palliative units.
In order to address the functional needs of patients receiving specialist palliative care studies of their specific needs are required. Therefore, the aim of this study is to investigate the patient reported unmet needs for function and supportive occupational- and physiotherapy rehabilitation interventions in the palliative unit at Copenhagen University Hospital, Rigshospitalet. Furthermore, we aim to investigate if observations, additional disease-specific patient reported outcomes and assessment of physical function and performance can support the unmet needs.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients (≥ 18 years) referred to the Palliative Care Unit at Copenhagen University Hospital, Rigshospitalet will be considered eligible for inclusion. Patients will be cancer and non-cancer patients, some will receive in-hospital treatment at the hospital and others outpatient treatment.
Key inclusion criteria (1 listed)
- All adult patients (≥ 18 years) referred to the Palliative Care Unit at Copenhagen University Hospital, Rigshospitalet.
Key exclusion criteria (1 listed)
- Inability to read and understand Danish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Unmet physical functioning needs
Time frame: At baseline
The Three-Levels-of-Needs Questionnaire (3LNQ)
10 secondary outcomes
Lower body physical function
Time frame: At baseline
Hand grip strength
Time frame: At baseline
Walking endurance
Time frame: At baseline
Health-related quality of life
Time frame: At baseline
Overall distress
Time frame: At baseline
Psychological distress
Time frame: At baseline
Sleep quality
Time frame: At beseline
Level of fatigue
Time frame: At baseline
Patients self-perception of performance in everyday living
Time frame: At baseline
Physical activity level
Time frame: At baseline
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 6 Apr 2025.
- Related InfoLink provided by the sponsor.
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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.
Jan Christensen principal investigator
Department of Occupational- and Physiotherapy, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Kidney Diseases, run by Copenhagen University Hospital, Rigshospitalet 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 1 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 6 Apr 2025. 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.
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?
Unmet physical functioning needs (time frame: At baseline). 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 6 Apr 2025.