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

NCT05636384 | Recruiting

• 1 other identifier: HC21C0115-1
• Study Type: interventional
• Target: 396
• Locations: 1 country
• Sites: 6

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Unplanned hospitalization

  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.

  within 6 months following enrollment

Secondary Outcomes (17)

• Patient medical utilization

  within 6 months following enrollment

• Hospitalization

  within 6 months following enrollment

• ER visits

  within 6 months following enrollment

• Healthcare use

  within 6 months following enrollment

• Patient end-of-life care: ICU admission

  within 1 month before death

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

Home-based care OTHER

Home-based medical care is based on a specialized home-based medical team approach, including following: 1. Specialized Home-Based Medical Team Approach 2. Initial Assessment and Education 3. Initial Home Visits and Education 4. Multidisciplinary Team Meeting 5. Regular Assessment After the Initial Visit

Intervention

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both the patient and their family caregiver must meet the criteria to be considered for this research.
• Patient
• 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
• A person who meets one of the following conditions
• Has been evaluated as having ECOG performance status 2
• Has been evaluated as having ECOG performance status 1 and is over 70 years of age
• A person who wishes to stay at home
• A person whose family caregiver resides at home
• A person who wishes to participate in the research
• Family Caregiver
• 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.
• A person who meets one of the following conditions:
• Lives with the patient (patient's household member)
• Does not live with the patient, but visits the patient's home more than three times a week

You may not qualify if:

• If either the patient or the family caregiver meets any one of these criteria, they are excluded from the study.
• Patient
• A person who cannot speak, hear, or read Korean
• A person who is judged by a medical doctor to be unable to take part in this research due to extremely poor health
• 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.
• A person who has used hospital- or home-type hospice and palliative care services
• A person who is under the age of 19
• Family Caregiver
• A person who cannot speak, hear, or read Korean
• A person who is judged by a medical doctor to be unable to take part in this research due to extremely poor health
• A person under the age of 19

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Chung-Ang University Hosptial, Chung-Ang University College of Medicine: collaborator
• DongGuk University: collaborator
• Kyung Hee University Hospital: collaborator
• Bundang CHA Hospital: collaborator
• Seoul National University Bundang Hospital: collaborator

Study Sites (6)

Dongguk University Medical Center

Goyang-si, Gyeonggi-do, South Korea

RECRUITING

Bundang CHA Hospital

Seongnam-si, Gyeonggi-do, South Korea

RECRUITING

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

RECRUITING

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Chung-Ang University Hosptial

Seoul, South Korea

RECRUITING

Kyung Hee University Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Home Care Services, Hospital-Based

Intervention Hierarchy (Ancestors)

Home Care Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Belong Cho, MD, MPH, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ga-Young Lee

CONTACT

82-10-6527-3066; yoyo4284@snu.ac.kr

So-Hee Kim

CONTACT

sh6487@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A cluster, non-randomized controlled trial

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: December 5, 2022
• Study Start: July 25, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 5, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (6)