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

Cancer Clinical Trial

Official title:

Patient Reported Unmet Needs for Function and Supportive Occupational- and Physiotherapy Rehabilitation Interventions in a Palliative Care Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04066153
• Other study ID #: 2018-418 6670
• Status: Completed
• Start date: August 20, 2019
• Est. completion date: November 8, 2019

Study information

• Verified date: March 2020
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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, distress. Furthermore patients physical function will be evaluated.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: November 8, 2019
• Est. primary completion date: November 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Disease
• Heart Failure
• Kidney Diseases
• Liver Diseases
• Nervous System Diseases
• Neurologic Disorder
• Physical Disorder
• Pulmonary Disease
• Quality of Life
• Side Effect

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unmet physical functioning needs	The Three-Levels-of-Needs Questionnaire (3LNQ)	At baseline
Secondary	Lower body physical function	30 seconds Sit-To-Stand test	At baseline
Secondary	Hand grip strength	Maximum strength test by handgrip dynamometer	At baseline
Secondary	Walking endurance	Six Minute Walking Test	At baseline
Secondary	Health-related quality of life	EORTC QLQ-C30	At baseline
Secondary	Overall distress	Distress thermometer	At baseline
Secondary	Psychological distress	Hospital Anxiety and Depression Scale (HADS)	At baseline
Secondary	Sleep quality	Pittsburgh Sleep Quality Index (PSQI)	At beseline
Secondary	Level of fatigue	Functional Assessment of Cancer Therapy - Fatigue (FACT-F) 13 item fatigue subscale	At baseline
Secondary	Patients self-perception of performance in everyday living	The Canadian Occupational Performance Measure (COPM)	At baseline
Secondary	Physical activity level	International Physical Activity Questionnaire (IPAQ) short form	At baseline