Clinical trial NCT04407013: Enhanced Supportive Care for Advanced Cancer Patients: Evaluation of Standardized Care Pathway
Official title: Enhanced Supportive Care for Advanced Cancer Patients: Evaluation of Standardized Care Pathway
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Advanced Cancer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2020-05-29
Enrollment: 780
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* patients with cognitive or psychiatric issue

Primary outcomes:
measure: Symptom measured by the ESAS (Edmonton Symptom Assessment Scale + 5 additional symptoms)
timeFrame: 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)
measure: Coping measured by brief COPE
timeFrame: at the visit for cycle 5 of chemotherapy (at average 3 month)
measure: Quality of life measured by the EORTC QLQ C-30
timeFrame: at the visit for cycle 5 of chemotherapy (at average 3 month)
Secondary outcomes:
measure: Depression measured by the HADS (Hospital Anxiety and Depression Scale) : research participation
timeFrame: at the visit for cycle 5 of chemotherapy (at average 3 month)
measure: Depression measured by the HADS (Hospital Anxiety and Depression Scale) : research participation
timeFrame: at 6 month
measure: Depression measured by the HADS (Hospital Anxiety and Depression Scale) : caregiver
timeFrame: at the visit for cycle 5 of chemotherapy (at average 3 month)
measure: Depression measured by the HADS (Hospital Anxiety and Depression Scale) : caregiver
timeFrame: at 6 month
measure: Self-efficacy measured by the Cancer Behavior Inventory 3.0
timeFrame: at the visit for cycle 5 of chemotherapy (at average 3 month)
measure: Self-efficacy measured by the Cancer Behavior Inventory 3.0
timeFrame: at 6 month
measure: Survival
timeFrame: at 6 month
measure: Survival
timeFrame: at 12 month
measure: Symptom measured by the ESAS (Edmonton Symptom Assessment Scale+5 additional symptoms)
timeFrame: at 6 month
measure: Coping measured by brief COPE
timeFrame: at 6 month
measure: Quality of life measured by the EORTC QLQ C-30
timeFrame: at 6 month
measure: Symptom change measured by the ESAS (Edmonton Symptom Assessment Scale + 5 additional symptoms): from baseline to 3 month
timeFrame: At baseline, at the beginning of Cycle 2, Cycle 3, Cycle 4, Cycle 5 (each cycle is from 2 weeks to 4 weeks depending on chemotherapy regimen)(at average 3 month)
measure: Depression change measured by the HADS (Hospital Anxiety and Depression Scale): from baseline to 3 month
timeFrame: At baseline, at the beginning of Cycle 2, Cycle 3, Cycle 4, Cycle 5 (each cycle is from 2 weeks to 4 weeks depending on chemotherapy regimen)(at average 3 month)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University
Study officials:
References: