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.
Overview
- Phase
- Not Applicable
- Intervention
- FEC75 (or EC90) x 6
- Conditions
- Catheter Related Complications
- Sponsor
- Swedish Red Cross University College
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- Complications
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Gunilla Bjorling
Professor
Swedish Red Cross University College
Eligibility Criteria
Inclusion Criteria
- •adjuvant or neo adjuvant chemotherapy,
- •speak Swedish
Exclusion Criteria
- •cognitive dysfunction
- •and/or inability to understand Swedish,
- •recurrent breast cancer
Arms & Interventions
PICC-Line
Women allocated to PICC-line when receiving chemotherapy
Intervention: FEC75 (or EC90) x 6
PICC-Line
Women allocated to PICC-line when receiving chemotherapy
Intervention: FEC100 + Taxotere (EC90 + Taxotere) 3+3
PICC-Line
Women allocated to PICC-line when receiving chemotherapy
Intervention: Paclitaxel
Subcutaneous Venous Access Port (SVAP)
Women allocated to SVAP when receiving chemotherapy
Intervention: FEC75 (or EC90) x 6
Subcutaneous Venous Access Port (SVAP)
Women allocated to SVAP when receiving chemotherapy
Intervention: FEC100 + Taxotere (EC90 + Taxotere) 3+3
Subcutaneous Venous Access Port (SVAP)
Women allocated to SVAP when receiving chemotherapy
Intervention: Paclitaxel
Outcomes
Primary Outcomes
Complications
Time Frame: Through study completion up to 18 weeks
all complications during the chemotherapy treatment period are registered
Secondary Outcomes
- Questionnaire EQ-5D(At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements))
- Questionnaire EORT-QLQ 30(At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements))
- Questionnaire EORT-QLQ BR32(At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements))
- Questionnaire Insomnia Symptom Score(At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements))
- Body Esteem Scale (BES)(At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements))
- Enriched Social Support Instrument (ESSI)(At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements))
- Brief-Illness Perception Questionnaire (B-IPQ)(At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements))