Catheter Related Complications
Conditions
Keywords
picc-line, central venous access port, catheter related complications, Infections, thrombosis, Material degradation, Health economic costs, Bio-material, Health related quality of life
Brief summary
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
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.
Interventions
DRUGFEC75 (or EC90) x 6
Type of Chemotherapy
DRUGFEC100 + Taxotere (EC90 + Taxotere) 3+3
Type of Chemotherapy
DRUGPaclitaxel
Type of Chemotherapy
Sponsors
Karolinska Institutet
KTH Royal Institute of Technology
Karolinska University Hospital
Stockholm South General Hospital
Norwegian University of Science and Technology
Swedish Red Cross University College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* adjuvant or neo adjuvant chemotherapy, * speak Swedish
Exclusion criteria
* cognitive dysfunction * and/or inability to understand Swedish, * recurrent breast cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complications | Through study completion up to 18 weeks | all complications during the chemotherapy treatment period are registered |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Questionnaire EORT-QLQ 30 | At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements) | To measure Health related quality of life for patients with cancer the questionnaire EORT-QLQ 30 (Scores) is used. |
| Questionnaire EORT-QLQ BR32 | At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements) | The Questionnaire EORT-QLQ BR32 (Scores) is used to measure Health related quality of life for patients with breast cancer |
| Questionnaire Insomnia Symptom Score | At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements) | To measure Sleep disturbance the questionnaire Insomnia Symptom Score (Scores) is used. |
| Body Esteem Scale (BES) | At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements) | The participants Body image is measured by Questionnaire: Body Esteem Scale (BES) (Scores) |
| Enriched Social Support Instrument (ESSI) | At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements) | The participants social support is measured with the questionnaire: Enriched Social Support Instrument (ESSI) (Scores) |
| Brief-Illness Perception Questionnaire (B-IPQ) | At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements) | Illness Perception is measured with the questionnaire: Brief-Illness Perception Questionnaire (B-IPQ) (scores) |
| Questionnaire EQ-5D | At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements) | Health related quality of life is measured with scores and a scale using EQ-5D. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Health Economy related to HRQL | At baseline, 9 weeks and at study completion 18 weeks (3 measurements) | Questionnaire EQ-5D (scores transformed to Qaly) In- and out-patient costs for PICC/SVAP |
| Health Economy related to PICC and SVAP | Retrospective data assessment after study completion 18 weeks | Device costs, maintenance costs (including complication cost), operation costs, staff costs retrieved from medical and economical records |
| Lived experience of management of complications | weekly, through study completion up to 18 weeks | Structured study specific diary filled by the participants regarding time management of device and complications. |
| Morphological material degradation | After study completion up to 18 weeks | Morphological surface changes of PICC and SVAP after clinical use. End-ponits: • Material degradation of PICC/SVAP measured with Scanning Electronic Microscopy |
| Lived experience of complications | weekly, through study completion up to 18 weeks | Structured diary filled by the participants regarding VAS, Visual Analog Scale |
Countries
Sweden
Outcome results
None listed