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

Quality of LIfe Clinical Trial

— HOMECARE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05636384
• Other study ID #: HC21C0115-1
• Status: Recruiting
• Phase: N/A
• Start date: July 25, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: November 2022
• Source: Seoul National University Hospital
• Contact: Ga-Young Lee
• Phone: 82-10-6527-3066
• Email: yoyo4284[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 396
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malignant Neoplasm
• Neoplasms
• Quality of LIfe

Intervention

Other:
• Home-based care
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

Locations

Country	Name	City	State
Korea, Republic of	Dongguk University Medical Center	Goyang-si	Gyeonggi-do
Korea, Republic of	Bundang CHA Hospital	Seongnam-si	Gyeonggi-do
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do
Korea, Republic of	Chung-Ang University Hosptial	Seoul
Korea, Republic of	Kyung Hee University Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (6)

Lead Sponsor	Collaborator
Seoul National University Hospital	Bundang CHA Hospital, Chung-Ang University Hosptial, Chung-Ang University College of Medicine, DongGuk University, Kyung Hee University Hospital, Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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