Clinical trial NCT04066153: Patient Reported Unmet Needs for Function and Supportive Occupational- and Physiotherapy Rehabilitation Interventions
Official title: Patient Reported Unmet Needs for Function and Supportive Occupational- and Physiotherapy Rehabilitation Interventions in a Palliative Care Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Kidney Diseases
Heart Failure
Neurologic Disorder
Liver Diseases
Pulmonary Disease
Side Effect
Quality of Life
Physical Disorder
Keywords: Palliative care
Physical functioning
Unmet needs
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2019-08-26
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

Brief 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, 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.

Eligibility criteria: 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

Primary outcomes:
measure: Unmet physical functioning needs
timeFrame: At baseline
Secondary outcomes:
measure: Lower body physical function
timeFrame: At baseline
measure: Hand grip strength
timeFrame: At baseline
measure: Walking endurance
timeFrame: At baseline
measure: Health-related quality of life
timeFrame: At baseline
measure: Overall distress
timeFrame: At baseline
measure: Psychological distress
timeFrame: At baseline
measure: Sleep quality
timeFrame: At beseline
measure: Level of fatigue
timeFrame: At baseline
measure: Patients self-perception of performance in everyday living
timeFrame: At baseline
measure: Physical activity level
timeFrame: At baseline
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Department of Occupational- and Physiotherapy, Rigshospitalet
name: Jan Christensen
role: PRINCIPAL_INVESTIGATOR
References: