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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
Onkologiska kliniken, Karolinska University Hospital, Danderyd Hospital
Stockholm, Sweden
Complications
all complications during the chemotherapy treatment period are registered
Time frame: Through study completion up to 18 weeks
Questionnaire EQ-5D
Health related quality of life is measured with scores and a scale using EQ-5D.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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)
Time frame: 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)
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NONE
Enrollment
250
Time frame: 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)
Time frame: At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements)