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

Sponsor
Yonsei University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04407013
Collaborator
(none)
780
1
2
43.3
18

Study Details

Study Description

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 (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.

Condition or Disease Intervention/Treatment Phase
  • Other: Enhanced supportive care based on standardized care pathway
  • Other: Control group with usual care
N/A

Study Design

Study Type:
Interventional
Anticipated 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
Actual Study Start Date :
Jun 23, 2020
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

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, according to the standardized care pathway.

Other: B

Control group with usual care (symptom monitoring only)

Other: Control group with usual care
Control group will receive usual care (symptom monitoring only)

Outcome Measures

Primary Outcome Measures

  1. Symptom measured by the ESAS (Edmonton Symptom Assessment Scale) [at Baseline (before start of chemotherapy)]

  2. Symptom measured by the ESAS (Edmonton Symptom Assessment Scale) [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) [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) [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) [at the visit for cycle 5 (each cycle is from 2 weeks to 4 weeks depending on chemotherapy regimen) of chemotherapy (at average 3 month)]

  6. Symptom measured by the ESAS (Edmonton Symptom Assessment Scale) [at 6 month]

  7. Coping measured by brief COPE [Baseline (at enrollment)]

  8. Coping measured by brief COPE [at the visit for cycle 5 of chemotherapy (at average 3 month)]

  9. Coping measured by brief COPE [at 6 month]

  10. Quality of life measured by the EORTC QLQ C-30 [Baseline (at enrollment)]

  11. Quality of life measured by the EORTC QLQ C-30 [at the visit for cycle 5 of chemotherapy (at average 3 month)]

  12. Quality of life measured by the EORTC QLQ C-30 [at 6 month]

Secondary Outcome Measures

  1. Depression measured by the HADS (Hospital Anxiety and Depression Scale) : research participation [at Baseline (before start of chemotherapy)]

  2. Depression measured by the HADS (Hospital Anxiety and Depression Scale) : research participation [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 [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 [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 [at the visit for cycle 5 of chemotherapy (at average 3 month)]

  6. Depression measured by the HADS (Hospital Anxiety and Depression Scale) : research participation [at 6 month]

  7. Depression measured by the HADS (Hospital Anxiety and Depression Scale) : caregiver [at Baseline (before start of chemotherapy)]

  8. Depression measured by the HADS (Hospital Anxiety and Depression Scale) : caregiver [at the visit for cycle 5 of chemotherapy (at average 3 month)]

  9. Depression measured by the HADS (Hospital Anxiety and Depression Scale) : caregiver [at 6 month]

  10. Self-efficacy measured by the Cancer Behavior Inventory 3.0 [at Baseline (before start of chemotherapy)]

  11. Self-efficacy measured by the Cancer Behavior Inventory 3.0 [at the visit for cycle 5 of chemotherapy (at average 3 month)]

  12. Self-efficacy measured by the Cancer Behavior Inventory 3.0 [at 6 month]

  13. Survival [at 6 month]

  14. Survival [at 12 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • adult (age >=19 years old),

  • cancer patients and their family

  • ECOG =<2

Exclusion Criteria:
  • patients with cognitive or psychiatric issue

Contacts and Locations

Locations

Site City State Country Postal Code
1 Yonsei University Seoul Korea, Republic of

Sponsors and Collaborators

  • Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yonsei University
ClinicalTrials.gov Identifier:
NCT04407013
Other Study ID Numbers:
  • 4-2020-0304
First Posted:
May 29, 2020
Last Update Posted:
Jul 21, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 21, 2021