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NCT Number: NCT05636384

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

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Key information

Conditions

Malignant Neoplasm Home Care Services Neoplasms Quality of Life Unplanned Hospitalization

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dongguk University Medical Center, Goyang-si, Gyeonggi-do, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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
  • A person who wants the patient to stay at home
  • A person who can communicate easily with medical staff
  • 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.

  • 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

Treatment and study plan

Home-based care

Other

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

Primary outcomes

  1. Unplanned hospitalization

    Time frame: within 6 months following enrollment

    • 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.

Secondary outcomes

  1. Patient medical utilization

    Time frame: within 6 months following enrollment

    The total number of hospital utilization, including hospitalization, emergency room visit, and clinic visits

  2. Hospitalization

    Time frame: within 6 months following enrollment

    the number of hospitalization

  3. ER visits

    Time frame: within 6 months following enrollment

    the number of emergency room visits

  4. Healthcare use

    Time frame: within 6 months following enrollment

    the number of healthcare use for severe diseases

  5. Patient end-of-life care: ICU admission

    Time frame: within 1 month before death

    ICU admission one month before death

  6. Patient end-of-life care: ventilator treatment

    Time frame: within 1 month before death

    Mechanical ventilator apply one month before death

  7. Patient end-of-life care: an advance directive

    Time frame: within 1 month before death

    Completion of advance medical directives within 1 month before death

  8. Quality of life of patient - ESAS

    Time frame: within 6 months following enrollment

    Modified Edmonton Symptom Assessment System (ESAS) of patient

  9. Quality of life of patient - EQ-5D

    Time frame: within 6 months following enrollment

    Euro-Quality of Life-5 Dimension (EQ-5D) of patient

  10. Depressive symptom of patient

    Time frame: within 6 months following enrollment

    Patient Health Questionnaire-9 (PHQ-9) of patient

  11. Satisfaction with services (patient)

    Time frame: within 6 months following enrollment

    Satisfaction of the study participant (patient) with the service in this study, evaluated by questionnaire

  12. Quality of life of family caregiver

    Time frame: within 6 months following enrollment

    Euro-Quality of Life-5 Dimension (EQ-5D) of family caregiver

  13. Care burden of family caregiver

    Time frame: within 6 months following enrollment

    The Korean version of Caregiver Reaction Assessment (CRA-K) of family caregiver

  14. Depressive symptom of family caregiver

    Time frame: within 6 months following enrollment

    Patient Health Questionnaire-9 (PHQ-9) of family caregiver

  15. Caring competency of family caregiver

    Time frame: within 6 months following enrollment

    Caring competency of family caregiver, measured by questionnaire

  16. Satisfaction with services (family caregiver)

    Time frame: within 6 months following enrollment

    Satisfaction of the study participant (family caregiver) with the service in this study, evaluated by questionnaire

  17. Expenses

    Time frame: within 6 months following enrollment

    medical expenses, care expenses

Study contacts

Contact information is provided by the study sponsor or research team.

Ga-Young Lee

CONTACT

[email protected]

82-10-6527-3066

So-Hee Kim

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Bundang CHA Hospital
  • Chung-Ang University Hospital
  • DongGuk University
  • Kyung Hee University Hospital
  • Seoul National University Bundang Hospital

Registry information

Official study title

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

Acronym: HOMECARE

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Dec 5, 2022
Registry last updated
Dec 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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