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

NCT ID: NCT04407013

Last Updated: 2022-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

780 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-23

Study Completion Date

2024-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Advanced Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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A

Experimental group with application of the standardized care pathways and symptom management education

Group Type EXPERIMENTAL

Enhanced supportive care based on standardized care pathway

Intervention Type OTHER

Enhanced supportive care based on standard care pathway is consisted of 1) symptom management (symptom assessment and according management) and 2) coping enhancement (nurse-led counseling). The enhanced supportive care will be provided 5 times, according to the standardized care pathway.

B

Control group with usual care (symptom monitoring only)

Group Type OTHER

Control group with usual care

Intervention Type OTHER

Control group will receive usual care (symptom monitoring only)

Interventions

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Enhanced supportive care based on standardized care pathway

Enhanced supportive care based on standard care pathway is consisted of 1) symptom management (symptom assessment and according management) and 2) coping enhancement (nurse-led counseling). The enhanced supportive care will be provided 5 times, according to the standardized care pathway.

Intervention Type OTHER

Control group with usual care

Control group will receive usual care (symptom monitoring only)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* patients with cognitive or psychiatric issue
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Yonsei University

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jiyeon Lee, Ph.D

Role: CONTACT

82-2-2228-3255

Facility Contacts

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Jiyeon Lee, Ph.D

Role: primary

82-2-2228-3255

References

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Choi YY, Hong B, Rha SY, Cho S, Lee HS, Lee J. The effect of nurse-led enhanced supportive care as an early primary palliative care approach for patients with advanced cancer: A randomized controlled trial. Int J Nurs Stud. 2025 Aug;168:105102. doi: 10.1016/j.ijnurstu.2025.105102. Epub 2025 May 1.

Reference Type DERIVED
PMID: 40378811 (View on PubMed)

Choi YY, Rha SY, Cho S, Lee HS, Hong B, Lee J. Enhanced supportive care for advanced cancer patients: study protocol for a randomized controlled trial. BMC Nurs. 2022 Dec 2;21(1):338. doi: 10.1186/s12912-022-01097-5.

Reference Type DERIVED
PMID: 36461000 (View on PubMed)

Other Identifiers

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4-2020-0304

Identifier Type: -

Identifier Source: org_study_id

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