Clinical trial NCT04324346: Central Catheters Used for Chemotherapy in Women With Breast Cancer
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Catheter Related Complications
Keywords: picc-line
central venous access port
catheter related complications
Infections
thrombosis
Material degradation
Health economic costs
Bio-material
Health related quality of life
Lead sponsor: Swedish Red Cross University College
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
name: KTH Royal Institute of Technology
name: Karolinska University Hospital
name: Stockholm South General Hospital
name: Norwegian University of Science and Technology
First posted: 2020-03-27
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: Inclusion Criteria:

* adjuvant or neo adjuvant chemotherapy,
* speak Swedish

Exclusion Criteria:

* cognitive dysfunction
* and/or inability to understand Swedish,
* recurrent breast cancer

Primary outcomes:
measure: Complications
timeFrame: Through study completion up to 18 weeks
Secondary outcomes:
measure: Questionnaire EQ-5D
timeFrame: At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements)
measure: Questionnaire EORT-QLQ 30
timeFrame: At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements)
measure: Questionnaire EORT-QLQ BR32
timeFrame: At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements)
measure: Questionnaire Insomnia Symptom Score
timeFrame: At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements)
measure: Body Esteem Scale (BES)
timeFrame: At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements)
measure: Enriched Social Support Instrument (ESSI)
timeFrame: At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements)
measure: Brief-Illness Perception Questionnaire (B-IPQ)
timeFrame: At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements)
Other outcomes:
measure: Morphological material degradation
timeFrame: After study completion up to 18 weeks
measure: Health Economy related to HRQL
timeFrame: At baseline, 9 weeks and at study completion 18 weeks (3 measurements)
measure: Health Economy related to PICC and SVAP
timeFrame: Retrospective data assessment after study completion 18 weeks
measure: Lived experience of complications
timeFrame: weekly, through study completion up to 18 weeks
measure: Lived experience of management of complications
timeFrame: weekly, through study completion up to 18 weeks
Locations:
city: Stockholm
country: Sweden
facility: Onkologiska kliniken, Karolinska University Hospital, Danderyd Hospital
Study officials:
affiliation: The Swedish Red Cross University College
name: Gunilla Björling, PhD
role: STUDY_CHAIR
References: