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

Sponsor

Swedish Red Cross University College (Other)

Overall Status

Completed

CT.gov ID

NCT04324346

Collaborator

Karolinska Institutet (Other), KTH Royal Institute of Technology (Other), Karolinska University Hospital (Other), Stockholm South General Hospital (Other), Norwegian University of Science and Technology (Other)

250

Enrollment

Location

Arms

58.1

Actual Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Catheter Related Complications	Drug: FEC75 (or EC90) x 6 Drug: FEC100 + Taxotere (EC90 + Taxotere) 3+3 Drug: Paclitaxel	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

250 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

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.

Actual Study Start Date :

Apr 1, 2016

Actual Primary Completion Date :

Feb 1, 2021

Actual Study Completion Date :

Feb 1, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Complications [Through study completion up to 18 weeks]
all complications during the chemotherapy treatment period are registered

Secondary Outcome Measures

Questionnaire EQ-5D [At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements)]
Health related quality of life is measured with scores and a scale using EQ-5D.
Questionnaire EORT-QLQ 30 [At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements)]
To measure Health related quality of life for patients with cancer the questionnaire EORT-QLQ 30 (Scores) is used.
Questionnaire EORT-QLQ BR32 [At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements)]
The Questionnaire EORT-QLQ BR32 (Scores) is used to measure Health related quality of life for patients with breast cancer
Questionnaire Insomnia Symptom Score [At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements)]
To measure Sleep disturbance the questionnaire Insomnia Symptom Score (Scores) is used.
Body Esteem Scale (BES) [At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements)]
The participants Body image is measured by Questionnaire: Body Esteem Scale (BES) (Scores)
Enriched Social Support Instrument (ESSI) [At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements)]
The participants social support is measured with the questionnaire: Enriched Social Support Instrument (ESSI) (Scores)
Brief-Illness Perception Questionnaire (B-IPQ) [At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements)]
Illness Perception is measured with the questionnaire: Brief-Illness Perception Questionnaire (B-IPQ) (scores)

Other Outcome Measures

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