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Completed

NCT Number: NCT04324346

Central Catheters Used for Chemotherapy in Women With Breast Cancer

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.

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Key information

Conditions

Catheter Related Complications Cardiovascular Diseases Embolism and Thrombosis Infections Thrombosis Vascular Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Onkologiska kliniken, Karolinska University Hospital, Danderyd Hospital

Stockholm, 18288, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adjuvant or neo adjuvant chemotherapy,
  • speak Swedish

Exclusion criteria

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

Treatment and study plan

FEC75 (or EC90) x 6

Drug

Type of Chemotherapy

FEC100 + Taxotere (EC90 + Taxotere) 3+3

Drug

Type of Chemotherapy

paclitaxel

Drug

Type of Chemotherapy

Primary outcomes

  1. Complications

    Time frame: Through study completion up to 18 weeks

    all complications during the chemotherapy treatment period are registered

Secondary outcomes

  1. Questionnaire EQ-5D

    Time frame: 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.

  2. Questionnaire EORT-QLQ 30

    Time frame: 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.

  3. Questionnaire EORT-QLQ BR32

    Time frame: 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

  4. Questionnaire Insomnia Symptom Score

    Time frame: 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.

  5. Body Esteem Scale (BES)

    Time frame: 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)

  6. Enriched Social Support Instrument (ESSI)

    Time frame: 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)

  7. Brief-Illness Perception Questionnaire (B-IPQ)

    Time frame: 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 outcomes

  1. Morphological material degradation

    Time frame: 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

  2. Health Economy related to HRQL

    Time frame: 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

  3. Health Economy related to PICC and SVAP

    Time frame: 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

  4. Lived experience of complications

    Time frame: weekly, through study completion up to 18 weeks

    Structured diary filled by the participants regarding VAS, Visual Analog Scale

  5. Lived experience of management of complications

    Time frame: weekly, through study completion up to 18 weeks

    Structured study specific diary filled by the participants regarding time management of device and complications.

Sponsors and collaborators

Lead sponsor

Swedish Red Cross University College

Other

Collaborators

  • KTH Royal Institute of Technology
  • Karolinska Institutet
  • Karolinska University Hospital
  • Norwegian University of Science and Technology
  • Stockholm South General Hospital

Registry information

Official study 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.

Acronym: PICC&PAC

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Mar 27, 2020
Registry last updated
Mar 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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