Home-based care for advanced cancer patients
SupporTive Care At Home Research (STAHR): a Cluster Non-randomized Controlled Trial for Patients With Advanced Cancer
NA · Seoul National University Hospital · NCT05636384
This study is testing if home-based care can help advanced cancer patients avoid unexpected hospital visits over six months.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 396 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Seoul National University Hospital (other) |
| Locations | 6 sites (Goyang-si, Gyeonggi-do and 5 other locations) |
| Trial ID | NCT05636384 on ClinicalTrials.gov |
What this trial studies
This study tests the effects of home-based care on reducing unplanned hospitalizations within six months for advanced cancer patients with decreased performance status. The intervention includes education for patients and their family caregivers, home visits by specialized medical staff, and regular health check-ups. Participants will be recruited from six institutions, with a total of 396 cancer patients targeted for the study. The trial is designed as a cluster, non-randomized controlled trial.
Who should consider this trial
Good fit: Ideal candidates include advanced-stage solid cancer patients with decreased performance status who wish to receive care at home.
Not a fit: Patients with early-stage cancer or those who do not have a family caregiver residing at home may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce unplanned hospitalizations and improve the quality of life for advanced cancer patients.
How similar studies have performed: Other studies have shown promising results with home-based care approaches for similar patient populations, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Goyang-si, Gyeonggi-do and 5 other locations
- Dongguk University Medical Center — Goyang-si, Gyeonggi-do, South Korea (RECRUITING)
- Bundang CHA Hospital — Seongnam-si, Gyeonggi-do, South Korea (RECRUITING)
- Seoul National University Bundang Hospital — Seongnam-si, Gyeonggi-do, South Korea (RECRUITING)
- Seoul National University Hospital — Seoul, South Korea (RECRUITING)
- Chung-Ang University Hosptial — Seoul, South Korea (RECRUITING)
- Kyung Hee University Hospital — Seoul, South Korea (RECRUITING)
Study contacts
- Principal investigator: Belong Cho, MD, MPH, PhD — Seoul National University Hospital
- Study coordinator: Ga-Young Lee
- Email: yoyo4284@snu.ac.kr
- Phone: 82-10-6527-3066
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Malignant Neoplasm, Home Care Services, Quality of LIfe, Unplanned Hospitalization