An interventional study of Home-based care in Malignant Neoplasm, Home Care Services and Quality of LIfe, sponsored by Seoul National University Hospital. Recruiting at 6 sites in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2022-12-05.
Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Supportive care
To test the effects of home-based care on unplanned hospitalization within 6 months among advanced cancer patients with decreased performance status. Home-based care includes education for patients and their family caregivers, home visits by specialized home-based medical staff, and regular status check-ups.
This study is a cluster, non-randomized controlled trial to test the effects of home-based care on unplanned hospitalization in 6 months among advanced cancer patients with decreased performance status. Home-based care includes education for patients and their family caregivers, home visits by specialized home-based medical staff, and regular status check-up. We are recruiting the study participants from 6 institutions, aiming for 396 cancer patients.
Participants for the intervention group will be recruited from Seoul National University Hospital, Chung-ang University Hospital, and Dongguk University Ilsan Hospital. Participants for the control group will be recruited from Kyung Hee University Medical Center, CHA Bundang Medical Center, and Seoul National University Bundang Hospital.
9,610 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.
This study's planned enrollment of 396 is above the median of 50 across 7,429 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Seoul National University Hospital is the lead sponsor of 1,897 studies on the registry; 273 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Both the patient and their family caregiver must meet the criteria to be considered for this research.
Patient
A person who meets one of the following conditions
Family Caregiver
A family* member of the patient
* Family: refers to the patient's spouse (including a common-law partner), descendants and their spouses up to the second degree, siblings and their spouses, and relatives and their spouses up to the eighth degree.
A person who meets one of the following conditions:
Exclusion Criteria:
If either the patient or the family caregiver meets any one of these criteria, they are excluded from the study.
Patient
A person residing outside the range that can be visited by the respective medical institution (the conditions for distance are to be specified by each medical institution)*
* This condition is not applicable for the control group.
Family Caregiver
Patients enrolled in the intervention cluster (institution) are given specialized home-based medical care based on a specialized home-based medical team approach.
Other: Home-based care
Patients enrolled in the control cluster (institution) are only given the educational materials. Except for the home-based care intervention, usual care for advanced cancer patients was not restricted for these patients.
Home-based medical care is based on a specialized home-based medical team approach, including following: 1. Specialized Home-Based Medical Team Approach 2. Initial Assessment and Education 3. Initial Home Visits and Education 4. Multidisciplinary Team Meeting 5. Regular Assessment After the Initial Visit
Unplanned hospitalization
1. admission to the enrolled hospital to treat unexpected symptoms or medical conditions (not including planned admission for chemotherapy or admission for planned surgery or intervention) 2. admission to a hospital other than the enrolled hospital 3. admission to a nursing hospital for a duration of less than 4 weeks.
Time frame: within 6 months following enrollment
Patient medical utilization
The total number of hospital utilization, including hospitalization, emergency room visit, and clinic visits
Time frame: within 6 months following enrollment
Hospitalization
the number of hospitalization
Time frame: within 6 months following enrollment
ER visits
the number of emergency room visits
Time frame: within 6 months following enrollment
Healthcare use
the number of healthcare use for severe diseases
Time frame: within 6 months following enrollment
Patient end-of-life care: ICU admission
ICU admission one month before death
Time frame: within 1 month before death
Patient end-of-life care: ventilator treatment
Mechanical ventilator apply one month before death
Time frame: within 1 month before death
Patient end-of-life care: an advance directive
Completion of advance medical directives within 1 month before death
Time frame: within 1 month before death
Quality of life of patient - ESAS
Modified Edmonton Symptom Assessment System (ESAS) of patient
Time frame: within 6 months following enrollment
Quality of life of patient - EQ-5D
Euro-Quality of Life-5 Dimension (EQ-5D) of patient
Time frame: within 6 months following enrollment
Depressive symptom of patient
Patient Health Questionnaire-9 (PHQ-9) of patient
Time frame: within 6 months following enrollment
Satisfaction with services (patient)
Satisfaction of the study participant (patient) with the service in this study, evaluated by questionnaire
Time frame: within 6 months following enrollment
Quality of life of family caregiver
Euro-Quality of Life-5 Dimension (EQ-5D) of family caregiver
Time frame: within 6 months following enrollment
Care burden of family caregiver
The Korean version of Caregiver Reaction Assessment (CRA-K) of family caregiver
Time frame: within 6 months following enrollment
Depressive symptom of family caregiver
Patient Health Questionnaire-9 (PHQ-9) of family caregiver
Time frame: within 6 months following enrollment
Caring competency of family caregiver
Caring competency of family caregiver, measured by questionnaire
Time frame: within 6 months following enrollment
Satisfaction with services (family caregiver)
Satisfaction of the study participant (family caregiver) with the service in this study, evaluated by questionnaire
Time frame: within 6 months following enrollment
Expenses
medical expenses, care expenses
Time frame: within 6 months following enrollment
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Seoul National University Hospital →