SupporTive Care At Home Research for Patients With Advanced Cancer (STAHR-cancer)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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SupporTive Care At Home Research (STAHR): a Cluster Non-randomized Controlled Trial for Patients With Advanced Cancer

Conditions
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Malignant Neoplasm, Home Care Services, Quality of LIfe, Unplanned Hospitalization

Intervention / Treatment
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* Other: Home-based care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Both the patient and their family caregiver must meet the criteria to be considered for this research. Patient A person who has an advanced-stage solid cancer diagnosis (ICD-10 code C00-C70); A person who is receiving or planning to receive cancer treatment A person who meets one of the following conditions Has been evaluated as having ECOG performance status 2 Has been evaluated as having ECOG performance status 1 and is over 70 years of age A person who wishes to stay at home A person whose family caregiver resides at home A person who wishes to participate in the research 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: Lives with the patient (patient's household member) Does not live with the patient, but visits the patient's home more than three times a week A person who wants the patient to stay at home A person who can communicate easily with medical staff A person who wishes to participate in the research 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 who cannot speak, hear, or read Korean A person who is judged by a medical doctor to be unable to take part in this research due to extremely poor health 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. A person who has used hospital- or home-type hospice and palliative care services A person who is under the age of 19 Family Caregiver A person who cannot speak, hear, or read Korean A person who is judged by a medical doctor to be unable to take part in this research due to extremely poor health A person under the age of 19

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A cluster, non-randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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<br>* Home-based medical care is based on a specialized home-based medical team approach, including following: Specialized Home-Based Medical Team Approach Initial Assessment and Education Initial Home Visits and Education Multidisciplinary Team Meeting Regular Assessment After the Initial Visit<br>|
| No Intervention: Control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unplanned hospitalization | 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) admission to a hospital other than the enrolled hospital admission to a nursing hospital for a duration of less than 4 weeks. | within 6 months following enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient medical utilization | The total number of hospital utilization, including hospitalization, emergency room visit, and clinic visits | within 6 months following enrollment | 
| Hospitalization | the number of hospitalization | within 6 months following enrollment | 
| ER visits | the number of emergency room visits | within 6 months following enrollment | 
| Healthcare use | the number of healthcare use for severe diseases | within 6 months following enrollment | 
| Patient end-of-life care: ICU admission | ICU admission one month before death | within 1 month before death | 
| Patient end-of-life care: ventilator treatment | Mechanical ventilator apply one month before death | within 1 month before death | 
| Patient end-of-life care: an advance directive | Completion of advance medical directives within 1 month before death | within 1 month before death | 
| Quality of life of patient - ESAS | Modified Edmonton Symptom Assessment System (ESAS) of patient | within 6 months following enrollment | 
| Quality of life of patient - EQ-5D | Euro-Quality of Life-5 Dimension (EQ-5D) of patient | within 6 months following enrollment | 
| Depressive symptom of patient | Patient Health Questionnaire-9 (PHQ-9) of patient | within 6 months following enrollment | 
| Satisfaction with services (patient) | Satisfaction of the study participant (patient) with the service in this study, evaluated by questionnaire | within 6 months following enrollment | 
| Quality of life of family caregiver | Euro-Quality of Life-5 Dimension (EQ-5D) of family caregiver | within 6 months following enrollment | 
| Care burden of family caregiver | The Korean version of Caregiver Reaction Assessment (CRA-K) of family caregiver | within 6 months following enrollment | 
| Depressive symptom of family caregiver | Patient Health Questionnaire-9 (PHQ-9) of family caregiver | within 6 months following enrollment | 
| Caring competency of family caregiver | Caring competency of family caregiver, measured by questionnaire | 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 | within 6 months following enrollment | 
| Expenses | medical expenses, care expenses | within 6 months following enrollment |