Central Catheters Used for Chemotherapy in Women With Breast Cancer (PICC&PAC)

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.

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.

Study Overview

• Status: Completed
• Conditions: Catheter Related Complications
• Intervention / Treatment: Drug: FEC75 (or EC90) x 6; Drug: FEC100 + Taxotere (EC90 + Taxotere) 3+3; Drug: Paclitaxel

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.

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 18288
    • Onkologiska kliniken, Karolinska University Hospital, Danderyd Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• adjuvant or neo adjuvant chemotherapy,
• speak Swedish

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PICC-Line; Women allocated to PICC-line when receiving chemotherapy	Drug: FEC75 (or EC90) x 6; Type of Chemotherapy; Drug: FEC100 + Taxotere (EC90 + Taxotere) 3+3; Type of Chemotherapy; Drug: Paclitaxel; Type of Chemotherapy
EXPERIMENTAL: Subcutaneous Venous Access Port (SVAP); Women allocated to SVAP when receiving chemotherapy	Drug: FEC75 (or EC90) x 6; Type of Chemotherapy; Drug: FEC100 + Taxotere (EC90 + Taxotere) 3+3; Type of Chemotherapy; Drug: Paclitaxel; Type of Chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	all complications during the chemotherapy treatment period are registered	Through study completion up to 18 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)
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
Lived experience of complications	Structured diary filled by the participants regarding VAS, Visual Analog Scale	weekly, through study completion up to 18 weeks
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

Collaborators and Investigators

• Sponsor: Swedish Red Cross University College
• Collaborators: Karolinska University Hospital; Karolinska Institutet; Norwegian University of Science and Technology; Stockholm South General Hospital; KTH Royal Institute of Technology
• Investigators: Study Chair: Gunilla Björling, PhD, The Swedish Red Cross University College

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2016
• Primary Completion (ACTUAL): February 1, 2021
• Study Completion (ACTUAL): February 1, 2021

Study Registration Dates

• First Submitted: September 4, 2018
• First Submitted That Met QC Criteria: March 25, 2020
• First Posted (ACTUAL): March 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 18, 2021
• Last Update Submitted That Met QC Criteria: March 16, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Infections; thrombosis; Health related quality of life; central venous access port; picc-line; catheter related complications; Material degradation; Health economic costs; Bio-material
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Docetaxel; Paclitaxel
• Other Study ID Numbers: RKH2014.1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be available 36 months after study completion.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No