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

Seoul National University

Status: Enrolling

Conditions: Malignant Neoplasm; Quality of LIfe; Unplanned Hospitalization; Home Care Services

Treatments: Other: Home-based care

Study type: Interventional

Funder types: Other

Identifiers

NCT05636384

HC21C0115-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 396 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

396 participants in 2 patient groups

Intervention

Experimental group

Description:

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

Treatment:

Other: Home-based care

Control

No Intervention group

Description:

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.