Central Catheters Used for Chemotherapy in Women With Breast Cancer

Study Overview
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Brief Summary
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The overall aim of this study is to evaluate two different central venous lines, PICC-lines (PICC) and subcutaneous venous access ports (SVAP) used for chemotherapy in women with breast cancer. The study will compare complications, material wear of the catheters used, patients'- and health care professionals' experiences, and costs. The study will give knowledge about which central venous access that is the most advantageous regarding adjuvant chemotherapy for women with breast cancer in the aspects of safety, quality of care, and quality of life.

Detailed Description
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N=250 women between 18 and 70 years of age with invasive breast cancer who are allocated to adjuvant or neo adjuvant chemotherapy during 18 weeks at the Department of Oncology at Karolinska University Hospital , Stockholm Sweden are eligible to participate in the present study. Exclusion criteria are cognitive dysfunction and/or inability to understand Swedish. Before participation an informed consent will be collected. The patients will be randomized to receive a PICC or a SVAP. Complications will be registered as well as the treatments. Bacterial cultures will be taken at removal of PICC/SVAP. The used PICC/SVAP will be transported to the Royal Institute of Technology (KTH) and subjected to material analyses. Comparison with reference materials from the in-vitro study and with new reference catheters will be performed. Patient assessments with questionnaire concerning HRQL, illness perception, body imaging, life style and sleep disturbance will be collected at baseline and at the last chemotherapy session. Interviews with the patients about life situations will be conducted half through the chemotherapy treatment period.In- and out-patients costs, i.e. medication, materials, costs related to the care of the PICC/SVAP, costs for complications, additional costs for the patients regarding the treatment, etc., will be monitored and registered. In- and out-patient costs will also be monitored. Data from medical records concerning treatments for complications will also be taken into consideration.

Official Title
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Evaluation of Central Venous Catheters Used for Chemotherapy in Women With Breast Cancer - An Interdisciplinary Randomized Controlled Study of Complications, Material Wear, Staff- and Patient Perspectives, and Health Economy.

Conditions
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Catheter Related Complications

Intervention / Treatment
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* Drug: FEC75 (or EC90) x 6
* Drug: FEC100 + Taxotere (EC90 + Taxotere) 3+3
* Drug: Paclitaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adjuvant or neo adjuvant chemotherapy, speak Swedish Exclusion Criteria: cognitive dysfunction and/or inability to understand Swedish, recurrent breast cancer

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PICC-Line<br>Women allocated to PICC-line when receiving chemotherapy | Drug: FEC75 (or EC90) x 6<br>* Type of Chemotherapy<br>Drug: FEC100 + Taxotere (EC90 + Taxotere) 3+3<br>* Type of Chemotherapy<br>Drug: Paclitaxel<br>* Type of Chemotherapy<br>|
| Experimental: Subcutaneous Venous Access Port (SVAP)<br>Women allocated to SVAP when receiving chemotherapy | Drug: FEC75 (or EC90) x 6<br>* Type of Chemotherapy<br>Drug: FEC100 + Taxotere (EC90 + Taxotere) 3+3<br>* Type of Chemotherapy<br>Drug: Paclitaxel<br>* Type of Chemotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | all complications during the chemotherapy treatment period are registered | Through study completion up to 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire EQ-5D | Health related quality of life is measured with scores and a scale using EQ-5D. | At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements) | 
| Questionnaire EORT-QLQ 30 | To measure Health related quality of life for patients with cancer the questionnaire EORT-QLQ 30 (Scores) is used. | At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements) | 
| Questionnaire EORT-QLQ BR32 | The Questionnaire EORT-QLQ BR32 (Scores) is used to measure Health related quality of life for patients with breast cancer | At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements) | 
| Questionnaire Insomnia Symptom Score | To measure Sleep disturbance the questionnaire Insomnia Symptom Score (Scores) is used. | At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements) | 
| Body Esteem Scale (BES) | The participants Body image is measured by Questionnaire: Body Esteem Scale (BES) (Scores) | At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements) | 
| Enriched Social Support Instrument (ESSI) | The participants social support is measured with the questionnaire: Enriched Social Support Instrument (ESSI) (Scores) | At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements) | 
| Brief-Illness Perception Questionnaire (B-IPQ) | Illness Perception is measured with the questionnaire: Brief-Illness Perception Questionnaire (B-IPQ) (scores) | At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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picc-line, central venous access port, catheter related complications, Infections, thrombosis, Material degradation, Health economic costs, Bio-material, Health related quality of life