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Enhanced Supportive Care for Advanced Cancer Patients: Evaluation of Standardized Care Pathway

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Yonsei University

Status

Enrolling

Conditions

Advanced Cancer

Treatments

Other: Enhanced supportive care based on standardized care pathway
Other: Control group with usual care

Study type

Interventional

Funder types

Other

Identifiers

NCT04407013
4-2020-0304

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy of the standardized care pathway which provides enhanced supportive care for patients with advanced cancer.

A pilot study (single arm pre-post test) will be conducted to evaluate feasibility of applying standardized care pathway to provide enhanced supportive care. A Randomized Controlled Trial will be conducted by randomly allocating participants in a 1:1 ratio to intervention arm (receiving enhanced supportive care according to the standardized care pathway) or control arm (receiving usual care: symptom monitoring only). Participants in the intervention arm will receive enhanced supportive care consisted of symptom management and coping enhancement counseling for 5 times. Data from advanced cancer patients will be collected at baseline (before start of chemotherapy), during chemotherapy (intervention arm), at the visit for cycle 5 of chemotherapy, at 6 month, and at 12 month Data from caregivers will be collected at baseline, 3 month, and 6 month. Primary outcomes will be measured as advanced cancer patients' symptom, coping and quality of life.

Enrollment

780 estimated patients

Sex

All

Ages

19+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • adult (age >=19 years old),
  • cancer patients and their family
  • ECOG =<2

Exclusion criteria

  • patients with cognitive or psychiatric issue

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

780 participants in 2 patient groups

A
Experimental group
Description:
Experimental group with application of the standardized care pathways and symptom management education
Treatment:
Other: Enhanced supportive care based on standardized care pathway
B
Other group
Description:
Control group with usual care (symptom monitoring only)
Treatment:
Other: Control group with usual care

Trial contacts and locations

1

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Central trial contact

Jiyeon Lee, Ph.D

Data sourced from clinicaltrials.gov

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