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NCT Number: NCT04066153

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

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.

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Key information

Conditions

Cancer Cardiovascular Diseases Digestive System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Heart Failure Kidney Diseases Liver Diseases Lung Diseases Male Urogenital Diseases Neoplasms Nervous System Diseases Neurologic Disorder Physical Disorder Pulmonary Disease Quality of Life Respiratory Tract Diseases Side Effect Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rigshospitalet

Copenhagen, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Unmet physical functioning needs

    Time frame: At baseline

    The Three-Levels-of-Needs Questionnaire (3LNQ)

Secondary outcomes

  1. Lower body physical function

    Time frame: At baseline

    30 seconds Sit-To-Stand test

  2. Hand grip strength

    Time frame: At baseline

    Maximum strength test by handgrip dynamometer

  3. Walking endurance

    Time frame: At baseline

    Six Minute Walking Test

  4. Health-related quality of life

    Time frame: At baseline

    EORTC QLQ-C30

  5. Overall distress

    Time frame: At baseline

    Distress thermometer

  6. Psychological distress

    Time frame: At baseline

    Hospital Anxiety and Depression Scale (HADS)

  7. Sleep quality

    Time frame: At beseline

    Pittsburgh Sleep Quality Index (PSQI)

  8. Level of fatigue

    Time frame: At baseline

    Functional Assessment of Cancer Therapy - Fatigue (FACT-F) 13 item fatigue subscale

  9. Patients self-perception of performance in everyday living

    Time frame: At baseline

    The Canadian Occupational Performance Measure (COPM)

  10. Physical activity level

    Time frame: At baseline

    International Physical Activity Questionnaire (IPAQ) short form

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 26, 2019
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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