Comparison Between Initial Routine PICC and General IV Access in Terminally Ill Cancer Patients

Study Overview
=================
Brief Summary
-----------------
To establish the IV access strategy for terminally ill cancer patients, using comparisons of the safety, efficacy, and patient-perceived satisfaction between the initially routine PICC insertion group (routine PICC group) and general IV access group (optional PICC group).

Detailed Description
-----------------
Reliable intravenous (IV) access is an important issue in terminally ill cancer patients, however, they have limited or no peripheral venous access due to edema or long period of IV therapy. Thus, intravenous access has been provided by Central venous catheter (CVC). There are some options for applying CVC in cancer patients; subclavian venous catheter (SVC), chemo-port (CP), and the peripherally inserted central catheter (PICC). When considering the characteristics of terminally ill cancer patients, such as poor general condition and a limited period of survival, PICC could be a safe and effective method for intravenous access. There are two previous studies concerned about PICC study in terminally ill cancer patients. They showed that PICC might be overall safe and efficient in terminally ill cancer patients. However, these studies did not evaluate superiority of PICC insertion compared to no insertion and the appropriate time for PICC insertion due to limitation of their design, such as retrospective or single-arm observational study. Thus, strategies of PICC insertion for IV access in terminally ill cancer patients have not been determined until now. Considering the favorable results of PICC insertion in previous studies and limited survival time of terminally ill cancer patients, the investigator postulated that routine PICC insertion at the time of admission for terminal care would be effective for IV access. Thus, the investigator assumed that initially routine PICC insertion would be non-inferior in maintenance success rate / and complication rate compared to general IV access. In addition, it would be superior in patient-perceived satisfaction. The inveistigator will undertake a randomized phase II study to confirm the hypothesis.

Official Title
-----------------
Comparison of Safety, Efficacy, and Patient-perceived Satisfaction Between Initial Routine Peripherally Inserted Central Catheters Insertion and General Intravenous Access in Terminally Ill Cancer Patients: A Randomized Phase II Study

Conditions
-----------------
Peripherally Inserted Central Catheter, Intravenous Access

Intervention / Treatment
-----------------
* Device: peripherally inserted central catheter (PICC)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cancer patients with histologically or cytologically confirmed malignancy and fulfilled all of the following conditions Patients with expected survival time of 3 months or less due to a progressive disease without additional anticancer treatment. (However, palliative radiation treatment for symptom control is allowed.) Patients who need the IV access route continuously for hydration or medication. Age18 or older Signed and dated informed consent of document indicating that the patient (or legally acceptable representative) has been informed about all pertinent aspects of the trial prior to enrollment Exclusion Criteria: Patients who showed severe coagulopathy such as thrombocytopenia (Platelet count ≤ 20,000/mm2) or international normalized ratio (INR) prolongation (≥2.0 ) in spite of treatment Patients who have an evidence of current sepsis (bacteremia or fungemia) 'current' means bacteremia/fungemia without eradication on follow-up peripheral blood culture patients with persistent fever (bacteremia or fungemia cannot be ruled out) Patients who is impracticable to PICC insertion due to uncontrolled behavioral disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, Single institution, Open-label, Randomized, Phase 2
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Routine PICC group<br>PICC is initially routine insertion at the time of admission of hospice-palliative care unit | Device: peripherally inserted central catheter (PICC)<br>* comparisons of the safety, efficacy, and patient-perceived satisfaction between the initially routine PICC insertion group (routine PICC group) and general IV access group (general IV group)<br>|
| Active Comparator: General IV group<br>PICC is inserted if 3 or more times of IV insertion trial per day is required for IV access | Device: peripherally inserted central catheter (PICC)<br>* comparisons of the safety, efficacy, and patient-perceived satisfaction between the initially routine PICC insertion group (routine PICC group) and general IV access group (general IV group)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IV access maintenance success rate | rate of successful PICC maintenance until death or discharge/transfer | From date of enrollment until death or discharge/transfer, assess up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PICC related complication rate | rate of any complication which is related with PICC | From date of enrollment until death or discharge/transfer, assess up to 2 years | 
| PICC premature removal rate | rate of premature removal such as self-removal or CRBSI before death or discharge | From date of enrollment until date of PICC removal, assess up to 2 years | 
| PICC life span | median survival of PICC | From date of enrollment until death or discharge/transfer, assess up to 2 years | 
| patient perceived procedure-related distress | procedure-related distress during insertion of PICC | 5th day after procedure | 
| patient perceived comfort and convenience assessed by a newly developed question in this study | patient perceived comfort and convenience (How do participants feel comfort and convenience about the IV access? at 3th - 7th days after enrollment | 3th to 7th day after enrollment | 
| colonization of microbiology in PICC | Investigator evaluate the colonization of PICC using tip culture at the time of removal | at the time of PICC removal, assess up to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peripherally inserted central catheter, Terminally ill cancer patients, Palliative care