Trial Title:
SupporTive Care At Home Research for Patients With Advanced Cancer (STAHR-cancer)
NCT ID:
NCT05636384
Condition:
Malignant Neoplasm
Home Care Services
Quality of LIfe
Unplanned Hospitalization
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
A cluster, non-randomized controlled trial
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Home-based care
Description:
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
Arm group label:
Intervention
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.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
Both the patient and their family caregiver must meet the criteria to be considered for
this research.
1. Patient
1. 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
2. A person who meets one of the following conditions
1. Has been evaluated as having ECOG performance status 2
2. Has been evaluated as having ECOG performance status 1 and is over 70
years of age
3. A person who wishes to stay at home
4. A person whose family caregiver resides at home
5. A person who wishes to participate in the research
2. Family Caregiver
1. 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.
2. A person who meets one of the following conditions:
1. Lives with the patient (patient's household member)
2. Does not live with the patient, but visits the patient's home more than
three times a week
3. A person who wants the patient to stay at home
4. A person who can communicate easily with medical staff
5. 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.
1. Patient
1. A person who cannot speak, hear, or read Korean
2. A person who is judged by a medical doctor to be unable to take part in this
research due to extremely poor health
3. 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.
4. A person who has used hospital- or home-type hospice and palliative care
services
5. A person who is under the age of 19
2. Family Caregiver
1. A person who cannot speak, hear, or read Korean
2. A person who is judged by a medical doctor to be unable to take part in this
research due to extremely poor health
3. A person under the age of 19
Gender:
All
Minimum age:
19 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Dongguk University Medical Center
Address:
City:
Goyang-si
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Do yeun Kim, MD
Facility:
Name:
Bundang CHA Hospital
Address:
City:
Seongnam-si
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Beodeul Kang, MD
Facility:
Name:
Seoul National University Bundang Hospital
Address:
City:
Seongnam-si
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Yu Jung Kim, MD
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Ga-Young Lee
Phone:
82-10-6527-3066
Email:
yoyo4284@snu.ac.kr
Facility:
Name:
Chung-Ang University Hosptial
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
In Gyu Hwang, MD
Facility:
Name:
Kyung Hee University Hospital
Address:
City:
Seoul
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Sun Kyung Baek, MD
Start date:
July 25, 2022
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Seoul National University Hospital
Agency class:
Other
Collaborator:
Agency:
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Agency class:
Other
Collaborator:
Agency:
DongGuk University
Agency class:
Other
Collaborator:
Agency:
Kyung Hee University Hospital
Agency class:
Other
Collaborator:
Agency:
Bundang CHA Hospital
Agency class:
Other
Collaborator:
Agency:
Seoul National University Bundang Hospital
Agency class:
Other
Source:
Seoul National University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05636384
