Malignant NeoplasmHOMECARENCT05636384
SupporTive Care At Home Research for Patients With Advanced Cancer (STAHR-cancer)
A study testing Home-based care in people with Malignant Neoplasm and Home Care Services, run by Seoul National University Hospital at 6 sites in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Malignant Neoplasm, Home Care Services, Quality of LIfe
- What is being tested?
- Home-based care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 396 participants
- Where
- 6 sitesSouth Korea
- Study dates
- 25 Jul 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
So-Hee Kim contact
6 sites in 1 country
South Korea6 sites, 6 recruiting
- Recruiting
Dongguk University Medical Center
Goyang-si, Gyeonggi-do
Do yeun Kim, MD
- Recruiting
Bundang CHA Hospital
Seongnam-si, Gyeonggi-do
Beodeul Kang, MD
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do
Yu Jung Kim, MD
- Recruiting
Seoul National University Hospital
Seoul, 03080
Ga-Young Lee, 82-10-6527-3066, yoyo4284@snu.ac.kr
- Recruiting
Chung-Ang University Hosptial
Seoul
In Gyu Hwang, MD
- Recruiting
Kyung Hee University Hospital
Seoul
Sun Kyung Baek, MD
About this study
Official title: SupporTive Care At Home Research (STAHR): a Cluster Non-randomized Controlled Trial for Patients With Advanced Cancer
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.
Read the detailed description
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.
- Being tested
- Home-based care
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based careOther
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients enrolled in the intervention cluster (institution) are given specialized home-based medical care based on a specialized home-based medical team approach. Receives: Other: Home-based care |
| Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 6 months following enrollment
Secondary outcomes (17)
Patient medical utilization
The total number of hospital utilization, including hospitalization, emergency room visit, and clinic visits
Measured: within 6 months following enrollment
Hospitalization
the number of hospitalization
Measured: within 6 months following enrollment
ER visits
the number of emergency room visits
Measured: within 6 months following enrollment
Healthcare use
the number of healthcare use for severe diseases
Measured: within 6 months following enrollment
Patient end-of-life care: ICU admission
ICU admission one month before death
Measured: within 1 month before death
Patient end-of-life care: ventilator treatment
Mechanical ventilator apply one month before death
Measured: within 1 month before death
Patient end-of-life care: an advance directive
Completion of advance medical directives within 1 month before death
Measured: within 1 month before death
Quality of life of patient - ESAS
Modified Edmonton Symptom Assessment System (ESAS) of patient
Measured: within 6 months following enrollment
Quality of life of patient - EQ-5D
Euro-Quality of Life-5 Dimension (EQ-5D) of patient
Measured: within 6 months following enrollment
Depressive symptom of patient
Patient Health Questionnaire-9 (PHQ-9) of patient
Measured: within 6 months following enrollment
Satisfaction with services (patient)
Satisfaction of the study participant (patient) with the service in this study, evaluated by questionnaire
Measured: within 6 months following enrollment
Quality of life of family caregiver
Euro-Quality of Life-5 Dimension (EQ-5D) of family caregiver
Measured: within 6 months following enrollment
Care burden of family caregiver
The Korean version of Caregiver Reaction Assessment (CRA-K) of family caregiver
Measured: within 6 months following enrollment
Depressive symptom of family caregiver
Patient Health Questionnaire-9 (PHQ-9) of family caregiver
Measured: within 6 months following enrollment
Caring competency of family caregiver
Caring competency of family caregiver, measured by questionnaire
Measured: 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
Measured: within 6 months following enrollment
Expenses
medical expenses, care expenses
Measured: within 6 months following enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start25 Jul 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant NeoplasmStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A cluster, non-randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 396 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chung-Ang University Hospital, DongGuk University, Kyung Hee University Hospital, Bundang CHA Hospital, Seoul National University Bundang Hospital
- Responsible party
- Principal investigator, BeLong Cho, Seoul National University Hospital
- Investigators
- Belong Cho, MD, MPH, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05636384
- Sponsor's protocol ID
- HC21C0115-1
- Acronym
- HOMECARE
- Status last verified
- Nov 2022
- First submitted
- 17 Oct 2022
- Last updated
- 5 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SupporTive Care At Home Research (STAHR): a Cluster Non-randomized Controlled Trial for Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT05636384
- Acronym / sponsor ID
- HOMECARE / HC21C0115-1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 396 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Chung-Ang University Hospital, DongGuk University, Kyung Hee University Hospital, Bundang CHA Hospital, Seoul National University Bundang Hospital
- Study start
- 25 Jul 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Dec 2022 (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.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A cluster, non-randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Home-based carePatients enrolled in the intervention cluster (institution) are given specialized home-based medical care based on a specialized home-based medical team approach. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Both the patient and their family caregiver must meet the criteria to be considered for this research.
- Patient
- Family Caregiver
Key exclusion criteria (12 listed)
- If either the patient or the family caregiver meets any one of these criteria, they are excluded from the study.
- Patient
- Family Caregiver
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based careHome-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 | Other | Intervention |
Primary outcome
Unplanned hospitalization
Time frame: within 6 months following enrollment
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.
17 secondary outcomes
Patient medical utilization
Time frame: within 6 months following enrollment
Hospitalization
Time frame: within 6 months following enrollment
ER visits
Time frame: within 6 months following enrollment
Healthcare use
Time frame: within 6 months following enrollment
Patient end-of-life care: ICU admission
Time frame: within 1 month before death
Patient end-of-life care: ventilator treatment
Time frame: within 1 month before death
Patient end-of-life care: an advance directive
Time frame: within 1 month before death
Quality of life of patient - ESAS
Time frame: within 6 months following enrollment
Quality of life of patient - EQ-5D
Time frame: within 6 months following enrollment
Depressive symptom of patient
Time frame: within 6 months following enrollment
Satisfaction with services (patient)
Time frame: within 6 months following enrollment
Quality of life of family caregiver
Time frame: within 6 months following enrollment
Care burden of family caregiver
Time frame: within 6 months following enrollment
Depressive symptom of family caregiver
Time frame: within 6 months following enrollment
Caring competency of family caregiver
Time frame: within 6 months following enrollment
Satisfaction with services (family caregiver)
Time frame: within 6 months following enrollment
Expenses
Time frame: within 6 months following enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2022.
- Individual participant dataSharing planned: No
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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.
So-Hee Kim contact
Belong Cho, MD, MPH, PhD principal investigator
Seoul National University Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based care in people with Malignant Neoplasm and Home Care Services, run by Seoul National University Hospital at 6 sites in South Korea.
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 18 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 5 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Korea. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ga-Young Lee (82-10-6527-3066, yoyo4284@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unplanned hospitalization (time frame: within 6 months following enrollment). 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 5 Dec 2022.