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

Not Applicable

Recruiting

• Conditions: Malignant Neoplasm; Home Care Services; Quality of LIfe; Unplanned Hospitalization
• Interventions: Other: Home-based care

• Registration Number: NCT05636384
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study Start: 2022-07-25
• Study First Submitted: 2022-10-17
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-23
• Last Update Submitted: 2022-11-23
• Study First Posted: 2022-12-05
• Last Update Posted: 2022-12-05
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 396

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Home-based care	Patients enrolled in the intervention cluster (institution) are given specialized home-based medical care based on a specialized home-based medical team approach.

Primary Outcome Measures

Name	Time	Method
Unplanned hospitalization	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.

Secondary Outcome Measures

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

Trial Locations

Locations (6)

Dongguk University Medical Center; 🇰🇷 Goyang-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

Bundang CHA Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Kyung Hee University Hospital; 🇰🇷 Seoul, Korea, Republic of