Central Catheters Used for Chemotherapy in Women With Breast Cancer

Catheter Related Complications Clinical Trial

— PICC&PAC  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04324346
• Other study ID #: RKH2014.1
• Status: Completed
• Phase: N/A
• Start date: April 1, 2016
• Est. completion date: February 1, 2021

Study information

• Verified date: March 2021
• Source: Swedish Red Cross University College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: February 1, 2021
• Est. primary completion date: February 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• adjuvant or neo adjuvant chemotherapy,

• speak Swedish

Exclusion Criteria:

• cognitive dysfunction

• and/or inability to understand Swedish,

• recurrent breast cancer

Related Conditions & MeSH terms

• Catheter Related Complications

Intervention

Drug:
• FEC75 (or EC90) x 6
Type of Chemotherapy
• FEC100 + Taxotere (EC90 + Taxotere) 3+3
Type of Chemotherapy
• Paclitaxel
Type of Chemotherapy

Locations

Country	Name	City	State
Sweden	Onkologiska kliniken, Karolinska University Hospital, Danderyd Hospital	Stockholm

Sponsors (6)

Lead Sponsor	Collaborator
Swedish Red Cross University College	Karolinska Institutet, Karolinska University Hospital, KTH Royal Institute of Technology, Norwegian University of Science and Technology, Stockholm South General Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Morphological material degradation	Morphological surface changes of PICC and SVAP after clinical use.; End-ponits: • Material degradation of PICC/SVAP measured with Scanning Electronic Microscopy	After study completion up to 18 weeks
Other	Health Economy related to HRQL	Questionnaire EQ-5D (scores transformed to Qaly) In- and out-patient costs for PICC/SVAP	At baseline, 9 weeks and at study completion 18 weeks (3 measurements)
Other	Health Economy related to PICC and SVAP	Device costs, maintenance costs (including complication cost), operation costs, staff costs retrieved from medical and economical records	Retrospective data assessment after study completion 18 weeks
Other	Lived experience of complications	Structured diary filled by the participants regarding VAS, Visual Analog Scale	weekly, through study completion up to 18 weeks
Other	Lived experience of management of complications	Structured study specific diary filled by the participants regarding time management of device and complications.	weekly, through study completion up to 18 weeks
Primary	Complications	all complications during the chemotherapy treatment period are registered	Through study completion up to 18 weeks
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)