to Investigate the Level of Fatigue Among Terminal Cancer Patients Receiving Home-based Hospice CareNCT06498193
Cancer-related Fatigue Among Patients Receiving Home-based Palliative Care
An observational study of to Investigate the Level of Fatigue Among Terminal Cancer Patients Receiving Home-based Hospice Care, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- to Investigate the Level of Fatigue Among Terminal Cancer Patients Receiving Home-based Hospice Care
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2024to 30 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- (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,
Who cannot join
- preference on their National Health Insurance card, or signed a letter of intent for do-not-resuscitate. Patients deemed too frail
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- to Investigate the Level of Fatigue Among Terminal Cancer Patients Receiving Home-based Hospice Care
- Keywords
- hospice care; cancer-related fatigue; Eastern Cooperative Oncology Group Scale
What is being measured
The primary outcome is the main question the study is designed to answer.
comparing CRF scores at baseline with those after one week,
The BFI survey was utilized to promptly assess CRF severity and its impact on daily functioning.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start1 Jan 2024
- Primary completion1 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for to Investigate the Level of Fatigue Among Terminal Cancer Patients Receiving Home-based Hospice CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pei-Hung Liao, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06498193
- Sponsor's protocol ID
- 108A-07
- Status last verified
- Jul 2024
- First submitted
- 7 Jul 2024
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Cancer-related Fatigue Among Patients Receiving Home-based Palliative Care and Hospice-shared Care
- ClinicalTrials.gov ID
- NCT06498193
- Acronym / sponsor ID
- 108A-07
- Conditions
- to Investigate the Level of Fatigue Among Terminal Cancer Patients Receiving Home-based Hospice Care
- Keywords
- hospice care; cancer-related fatigue; Eastern Cooperative Oncology Group Scale
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (actual)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 12 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- (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,
Key exclusion criteria (1 listed)
- preference on their National Health Insurance card, or signed a letter of intent for do-not-resuscitate. Patients deemed too frail
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of to Investigate the Level of Fatigue Among Terminal Cancer Patients Receiving Home-based Hospice Care, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparing CRF scores at baseline with those after one week, (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024.