Clinical trial NCT05636384: SupporTive Care At Home Research for Patients With Advanced Cancer (STAHR-cancer)
Official title: SupporTive Care At Home Research (STAHR): a Cluster Non-randomized Controlled Trial for Patients With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Malignant Neoplasm
Home Care Services
Quality of LIfe
Unplanned Hospitalization
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: DongGuk University
name: Kyung Hee University Hospital
name: Bundang CHA Hospital
name: Seoul National University Bundang Hospital
First posted: 2022-12-05
Enrollment: 396
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A cluster, non-randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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

Primary outcomes:
measure: Unplanned hospitalization
timeFrame: within 6 months following enrollment
Secondary outcomes:
measure: Patient medical utilization
timeFrame: within 6 months following enrollment
measure: Hospitalization
timeFrame: within 6 months following enrollment
measure: ER visits
timeFrame: within 6 months following enrollment
measure: Healthcare use
timeFrame: within 6 months following enrollment
measure: Patient end-of-life care: ICU admission
timeFrame: within 1 month before death
measure: Patient end-of-life care: ventilator treatment
timeFrame: within 1 month before death
measure: Patient end-of-life care: an advance directive
timeFrame: within 1 month before death
measure: Quality of life of patient - ESAS
timeFrame: within 6 months following enrollment
measure: Quality of life of patient - EQ-5D
timeFrame: within 6 months following enrollment
measure: Depressive symptom of patient
timeFrame: within 6 months following enrollment
measure: Satisfaction with services (patient)
timeFrame: within 6 months following enrollment
measure: Quality of life of family caregiver
timeFrame: within 6 months following enrollment
measure: Care burden of family caregiver
timeFrame: within 6 months following enrollment
measure: Depressive symptom of family caregiver
timeFrame: within 6 months following enrollment
measure: Caring competency of family caregiver
timeFrame: within 6 months following enrollment
measure: Satisfaction with services (family caregiver)
timeFrame: within 6 months following enrollment
measure: Expenses
timeFrame: within 6 months following enrollment
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: Dongguk University Medical Center
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Bundang CHA Hospital
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hosptial
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Belong Cho, MD, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References: