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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04407013
Recruitment Status : Not yet recruiting
First Posted : May 29, 2020
Last Update Posted : May 29, 2020
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:

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. 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 3 month, 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.


Condition or disease Intervention/treatment Phase
Advanced Cancer Other: Enhanced supportive care based on standardized care pathway Other: Control group with usual care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 780 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Enhanced Supportive Care for Advanced Cancer Patients: Evaluation of Standardized Care Pathway
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : February 2024

Arm Intervention/treatment
Experimental: A
Experimental group with application of the standardized care pathways and symptom management education
Other: 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 over 3 months, according to the standardized care pathway.

B
Control group with usual care
Other: Control group with usual care
Control group will receive usual care




Primary Outcome Measures :
  1. Symptom measured by the ESAS (Edmonton Symptom Assessment Scale) [ Time Frame: at Baseline (before start of chemotherapy) ]
  2. Symptom measured by the ESAS (Edmonton Symptom Assessment Scale) [ Time Frame: At the beginning of Cycle 2 (each cycle is from 2 weeks to 4 weeks depending on chemotherapy regimen) ]
  3. Symptom measured by the ESAS (Edmonton Symptom Assessment Scale) [ Time Frame: At the beginning of Cycle 3 (each cycle is from 2 weeks to 4 weeks depending on chemotherapy regimen) ]
  4. Symptom measured by the ESAS (Edmonton Symptom Assessment Scale) [ Time Frame: At the beginning of Cycle 4 (each cycle is from 2 weeks to 4 weeks depending on chemotherapy regimen) ]
  5. Symptom measured by the ESAS (Edmonton Symptom Assessment Scale) [ Time Frame: at 3 month ]
  6. Symptom measured by the ESAS (Edmonton Symptom Assessment Scale) [ Time Frame: at 6 month ]
  7. Coping measured by brief COPE [ Time Frame: Baseline (at enrollment) ]
  8. Coping measured by brief COPE [ Time Frame: at 3 month ]
  9. Coping measured by brief COPE [ Time Frame: at 6 month ]
  10. Quality of life measured by the EORTC QLQ C-30 [ Time Frame: Baseline (at enrollment) ]
  11. Quality of life measured by the EORTC QLQ C-30 [ Time Frame: at 3 month ]
  12. Quality of life measured by the EORTC QLQ C-30 [ Time Frame: at 6 month ]

Secondary Outcome Measures :
  1. Depression measured by the HADS (Hospital Anxiety and Depression Scale) : research participation [ Time Frame: at Baseline (before start of chemotherapy) ]
  2. Depression measured by the HADS (Hospital Anxiety and Depression Scale) : research participation [ Time Frame: At the beginning of Cycle 2 (each cycle is from 2 weeks to 4 weeks depending on chemotherapy regimen) ]
  3. Depression measured by the HADS (Hospital Anxiety and Depression Scale) : research participation [ Time Frame: At the beginning of Cycle 3 (each cycle is from 2 weeks to 4 weeks depending on chemotherapy regimen) ]
  4. Depression measured by the HADS (Hospital Anxiety and Depression Scale) : research participation [ Time Frame: At the beginning of Cycle 4 (each cycle is from 2 weeks to 4 weeks depending on chemotherapy regimen) ]
  5. Depression measured by the HADS (Hospital Anxiety and Depression Scale) : research participation [ Time Frame: at 3 month ]
  6. Depression measured by the HADS (Hospital Anxiety and Depression Scale) : research participation [ Time Frame: at 6 month ]
  7. Depression measured by the HADS (Hospital Anxiety and Depression Scale) : caregiver [ Time Frame: at Baseline (before start of chemotherapy) ]
  8. Depression measured by the HADS (Hospital Anxiety and Depression Scale) : caregiver [ Time Frame: at 3 month ]
  9. Depression measured by the HADS (Hospital Anxiety and Depression Scale) : caregiver [ Time Frame: at 6 month ]
  10. Self-efficacy measured by the Cancer Behavior Inventory 3.0 [ Time Frame: at Baseline (before start of chemotherapy) ]
  11. Self-efficacy measured by the Cancer Behavior Inventory 3.0 [ Time Frame: at 3 month ]
  12. Self-efficacy measured by the Cancer Behavior Inventory 3.0 [ Time Frame: at 6 month ]
  13. Survival [ Time Frame: at 6 month ]
  14. Survival [ Time Frame: at 12 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • patients with cognitive or psychiatric issue

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04407013


Contacts
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Contact: Jiyeon Lee, Ph.D 82-2-2228-3255 jiyeonest@yuhs.ac

Locations
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Korea, Republic of
Yonsei University
Seoul, Korea, Republic of
Contact: Jiyeon Lee, Ph.D    82-2-2228-3255    jiyeonest@yuhs.ac   
Sponsors and Collaborators
Yonsei University
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT04407013    
Other Study ID Numbers: 4-2020-0304
First Posted: May 29, 2020    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms