- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04066153
Patient Reported Unmet Needs for Function and Supportive Occupational- and Physiotherapy Rehabilitation Interventions
Patient Reported Unmet Needs for Function and Supportive Occupational- and Physiotherapy Rehabilitation Interventions in a Palliative Care Setting
Study Overview
Status
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Copenhagen, Denmark
- Rigshospitalet
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria :
All adult patients (≥ 18 years) referred to the Palliative Care Unit at Copenhagen University Hospital, Rigshospitalet.
Exclusion Criteria:
Inability to read and understand Danish
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Unmet physical functioning needs
Time Frame: At baseline
|
The Three-Levels-of-Needs Questionnaire (3LNQ)
|
At baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lower body physical function
Time Frame: At baseline
|
30 seconds Sit-To-Stand test
|
At baseline
|
|
Hand grip strength
Time Frame: At baseline
|
Maximum strength test by handgrip dynamometer
|
At baseline
|
|
Walking endurance
Time Frame: At baseline
|
Six Minute Walking Test
|
At baseline
|
|
Health-related quality of life
Time Frame: At baseline
|
EORTC QLQ-C30
|
At baseline
|
|
Overall distress
Time Frame: At baseline
|
Distress thermometer
|
At baseline
|
|
Psychological distress
Time Frame: At baseline
|
Hospital Anxiety and Depression Scale (HADS)
|
At baseline
|
|
Sleep quality
Time Frame: At beseline
|
Pittsburgh Sleep Quality Index (PSQI)
|
At beseline
|
|
Level of fatigue
Time Frame: At baseline
|
Functional Assessment of Cancer Therapy - Fatigue (FACT-F) 13 item fatigue subscale
|
At baseline
|
|
Patients self-perception of performance in everyday living
Time Frame: At baseline
|
The Canadian Occupational Performance Measure (COPM)
|
At baseline
|
|
Physical activity level
Time Frame: At baseline
|
International Physical Activity Questionnaire (IPAQ) short form
|
At baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jan Christensen, Department of Occupational- and Physiotherapy, Rigshospitalet
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-418 6670
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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