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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Malignant Neoplasm; Home Care Services; Quality of LIfe; Unplanned Hospitalization
• Intervention / Treatment: Other: Home-based care

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 Type: Interventional
• Enrollment (Anticipated): 396
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ga-Young Lee; Phone Number: 82-10-6527-3066; Email: yoyo4284@snu.ac.kr
• Study Contact Backup: Name: So-Hee Kim; Email: sh6487@snu.ac.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Recruiting
    • Seoul National University Hospital
    • Contact: Ga-Young Lee; Phone Number: 82-10-6527-3066; Email: yoyo4284@snu.ac.kr
  • Seoul, Korea, Republic of
    • Recruiting
    • Kyung Hee University Hospital
    • Contact: Sun Kyung Baek, MD
  • Seoul, Korea, Republic of
    • Recruiting
    • Chung-Ang University Hosptial
    • Contact: In Gyu Hwang, MD
  • Gyeonggi-do
    • Goyang-si, Gyeonggi-do, Korea, Republic of
      • Recruiting
      • Dongguk University Medical Center
      • Contact: Do yeun Kim, MD
    • Seongnam-si, Gyeonggi-do, Korea, Republic of
      • Recruiting
      • Bundang CHA Hospital
      • Contact: Beodeul Kang, MD
    • Seongnam-si, Gyeonggi-do, Korea, Republic of
      • Recruiting
      • Seoul National University Bundang Hospital
      • Contact: Yu Jung Kim, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Patients enrolled in the intervention cluster (institution) are given specialized home-based medical care based on a specialized home-based medical team approach.	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
No Intervention: Control; Patients enrolled in the control cluster (institution) are only given the educational materials. Except for the home-based care intervention, usual care for advanced cancer patients was not restricted for these patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Seoul National University Bundang Hospital; Chung-Ang University Hosptial, Chung-Ang University College of Medicine; Bundang CHA Hospital; DongGuk University; Kyung Hee University Hospital
• Investigators: Principal Investigator: Belong Cho, MD, MPH, PhD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2022
• Primary Completion (Anticipated): December 31, 2026
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: October 17, 2022
• First Submitted That Met QC Criteria: November 23, 2022
• First Posted (Actual): December 5, 2022

Study Record Updates

• Last Update Posted (Actual): December 5, 2022
• Last Update Submitted That Met QC Criteria: November 23, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: HC21C0115-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No