- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06498193
Cancer-related Fatigue Among Patients Receiving Home-based Palliative Care
July 7, 2024 updated by: Pei-Hung Liao, National Taipei University of Nursing and Health Sciences
A Comparative Study of Cancer-related Fatigue Among Patients Receiving Home-based Palliative Care and Hospice-shared Care
Cancer-related fatigue, which significantly impacts the quality of life, is prevalent among patients with terminal cancer.
The experiences of fatigue, its associated needs, and the strategies for managing it are closely linked to the individual uniqueness, cultural background, and resource availability of terminal cancer patients.
Study Overview
Status
Active, not recruiting
Detailed Description
Fatigue is defined as any perceived or actual physical or mental tiredness that adversely affects the quality of life [7,8].
The multifaceted nature of fatigue means it manifests in various forms, including physical cognitive, and emotional.
Fatigue may involve chronic exhaustion and reduced mobility that cannot be relieved by rest [9,10].
CRF is associated with cancer progression and treatment, presenting it as a painful, persistent, and subjective sensation involving physical, emotional, and cognitive tiredness or exhaustion.
CRF disproportionately affects physical activities and impairs executive functions in daily life [10,11].
Factors contributing to CRF include cancer itself, treatment side effects, psychological factors such as personality traits (e.g., levels of optimism, anxiety, or depression), comorbid physical conditions, iatrogenic comorbidities, and lifestyle factors (e.g., physical activity levels) [10-12].
From the perspective of individual patients, fatigue frequently coexists with symptom clusters, such as insomnia, low mood or depression, or pain, collectively resulting in reduced daily functioning and diminished quality of life [13].
Various non-pharmaceutical interventions have demonstrated effectiveness in addressing CRF, including physical activity, mind-body approaches, and psychosocial interventions [9,14,15].
Therefore, this study aims to investigate the level of fatigue among terminal cancer patients receiving home-based hospice care, hospital-based hospice care, and hospice-shared care.
The anticipated results may facilitate the enhancement of CRF management strategies
Study Type
Observational
Enrollment (Actual)
120
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
-
-
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Taipei, Taiwan
- National Taipei University of Nursing and Health Science
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-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Terminal cancer patients receiving hospital-based, hospice-shared, or home-based hospice care under the supervision of a teaching hospital in Taipei, Taiwan, were recruited through convenience sampling
Description
Inclusion Criteria:
- (i) patients aged 20 years and above proficient in Mandarin and/or Taiwanese and willing to participate in the study; (ii) patients deemed ineligible for curative treatments by oncologists or cancer-related specialists; (iii) patients with an Eastern Cooperative Oncology Group Scale (ECOG) score of 2 or above suitable for hospice care; and (iv) patients who signed a letter of intent for hospice care,
Exclusion Criteria:
- preference on their National Health Insurance card, or signed a letter of intent for do-not-resuscitate. Patients deemed too frail
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 |
|---|---|---|
|
comparing CRF scores at baseline with those after one week,
Time Frame: 1 week
|
The BFI survey was utilized to promptly assess CRF severity and its impact on daily functioning.
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
January 1, 2024
Primary Completion (Estimated)
September 1, 2024
Study Completion (Estimated)
September 30, 2024
Study Registration Dates
First Submitted
July 7, 2024
First Submitted That Met QC Criteria
July 7, 2024
First Posted (Actual)
July 12, 2024
Study Record Updates
Last Update Posted (Actual)
July 12, 2024
Last Update Submitted That Met QC Criteria
July 7, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 108A-07
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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.