Patient Reported Unmet Needs for Function and Supportive Occupational- and Physiotherapy Rehabilitation Interventions

April 2, 2025 updated by: Jan Christensen, Rigshospitalet, Denmark

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.

Study Overview

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

Observational

Enrollment (Actual)

43

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Copenhagen, Denmark
        • Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jan Christensen, Department of Occupational- and Physiotherapy, Rigshospitalet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2019

Primary Completion (Actual)

November 8, 2019

Study Completion (Actual)

November 8, 2019

Study Registration Dates

First Submitted

August 21, 2019

First Submitted That Met QC Criteria

August 21, 2019

First Posted (Actual)

August 26, 2019

Study Record Updates

Last Update Posted (Actual)

April 6, 2025

Last Update Submitted That Met QC Criteria

April 2, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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