Study design
This was a quasi-experimental study that the intervention was evaluated before and after study with a control group.
Study setting
This study was carried out on recruited patients with gynecologic cancer or breast cancer who were receiving chemotherapy in the GYN Department and Breast Department of a teaching tertiary specialized hospital with 800 beds in Shanghai.
Study population
A convenience sample of 130 patients who had confirmed gynecologic cancer or breast cancer finished the final study. The patients receiving chemotherapy without radiotherapy were recruited from October 2017 to March 2019; then the patients were randomly and evenly divided into the experimental group (n=65) and the control group (n=65) (Figure 1). Patients were eligible to participate if they met the inclusion criteria: ①age≥18 years, ②patients who were inserted, maintained and removed catheters in our hospital, ③patients who were finished the whole cycles of chemotherapy, ④patients who were provided informed consent and were willing to participate in this study, and ⑤mandarin speaking. The exclusion criteria: ① patients who were allergic to PICC, ②patients who were inserted PICC repeatedly, ③patients who had a history of mental illness, and ④patients who could not understand the contents or independently complete the questionnaire.
Sample size
According to the literature [4,5], the rate of PICC related complications in cancer patients was around 40%, and this study expected it to drop to 15% after the intervention. According to the formula
using 80% power, alpha=0.05, Z0.05/2=1.96 and Z0.10=1.282,p1 was the incidence of the control group while p2 was the incidence of the experimental group,a sample size of 65 participants in each group was required. Accounting for a 10% loss to follow-up, 70 participants were required in each group.
Randomisation
Participants were randomly assigned to experimental group or control group according to odd or even number from random number table in a sealed envelope. The participants who met the inclusion and exclusion criteria were given a sealed envelope according to the order of diagnosis. The consecutive envelope was based on the order of the random number table, and the odd or even number tickets were put in the envelope. The patients who got the odd number ticket entered the experimental group, while those who got the even number entered the control group.
Interventions
Continuous nursing intervention group
A PICC continuous nursing intervention group was established in this study. Two doctors, and eight nurses who obtained the qualification certificate of PICC specialist nurse from Shanghai Nursing Committee, participated in the group. The specialist nurses were required to receive unified PICC related knowledge and practice training, including establishment of PICC patient assessment files, humanistic care in nursing extension services, observation and judgment criteria of PICC complications, and management of WeChat, etc.
Procedure
Both the experimental and control groups completed the pre-test questionnaires and researchers finished the patients’ health records through the hospital network system, including general information, disease-related information, catheterization information, etc. During this study period, a routine intervention was conducted in the control group. The patients were placed with PICC by the continuous nursing group, and were educated the precautions after the placement. The patients were given immediate guidance according to their indwelling condition during the weekly catheter maintenance.
The patients of experimental group accepted Orem’s theory-based intervention. Firstly, the researcher assessed the patients’ needs and identified the universal and health deviation self-care requisites. Then, the researcher gave the intervention program of five sessions based on Orem’s supportive educational nursing system. The content and time of intervention program were as follows:
- Face to face education: (i) A PICC specialist nurse of continuous nursing intervention group (hereinafter as “a PICC specialist nurse”) explained the catheterization methods, advantages and purposes to improve the cognitive level of PICC catheterization before indwelling. (ii) And after indwelling, a PICC specialist nurse established patient health assessment files through the hospital network system, guided patients one-on-one, and demonstrated early functional exercise, explained the purpose, method, time, frequency arrangement and requirements of health follow-up during the intermission of chemotherapy with PICC to improve the patients' trust in nursing, relieve anxiety and fear of catheterization, and lay the foundation for later self-care activity. (iii) PICC continuing care health education manuals were sent to the patients, and a PICC specialist nurse explained basic knowledge of PICC, catheter maintenance knowledge, causes of complications and risk factors, to help patients understand their own unhealthy behaviors and the risk of complications caused by factors at discharge.
- WeChat platform: Within one month after catheterization, patients experienced a transition from passive acceptance to active learning. WeChat platform for PICC continuous nursing was built weekly for one month to push the self-care knowledge and skills to guide patients the catheter related self-care precautions and to identify the abnormal conditions related to PICC in daily life. The forms included videos, illustrated popular science essays, pictures, etc.
- Telephone visits: Supervise patients’ implementation of self-care behavior, including understanding the related knowledge of catheter maintenance, daily activities, local skin condition of puncture point, whether the catheter is damaged or displaced, etc, judge the maintenance of PICC, answer the questions and encourage patients to actively participate in self-care activities weekly for one month.
- PICC salon: Within one month after catheterization, invite patients who have no complications to share self-care experiences, to improve patients' confidence in keeping healthy behaviors. Invite patients’ family members to participate in PICC salon, guide them to give support and care to patients so that patients have the confidence to adhere to self-care.
- Specialty clinic: Assess patients' difficulties in establishing health behaviors and help them solve existing or potential problems with PICCs when patients come to hospital for catheter maintenance weekly until extubation.
Instruments
Socio-demographic information and clinical characteristics
A standardized proforma questionnaire was applied to investigate the patients’ socio‐demographic information, including age, education level, marital status and income. The clinical characteristics, including diagnosis, vein, puncture site and chemotherapeutic regimens and cycles, etc were obtained from electronic patients’ health records.
Self-care agency
Self-care agency was assessed through using the Exercise of Self-care Agency (ESCA) Scale. This self-administered instrument was developed by Kearney and Fleischer based on Orem’s self-care theory [15]. The scale has 43 items, which consists of four dimensions, including self-concept, motivation, knowledge and information seeking, and passivity. Each item is rated on a 5-point Likert scale. The total score of ESCA ranges from 0-172. The scale was translated into Chinese in the year 2000, and the Chinese version showed good validity and in the Chinese populations in Taiwan Province of China [16]. In this study, the content validity index (CVI) of the scale was 1.00, and Cronbach’α coefficients was 0.811.
Complications and adverse events
PICC related complications and adverse events include phlebitis, catheter-related bloodstream infection (CRBSI), thrombosis, rash, bleeding at the puncture site, breakage or damage of the external part of PICC, PICC exfoliation, and unplanned extubation.
Data collection
Data were collected at two time points, including the baseline with socio-demographic information and clinical characteristics, and the ESCA scale (before intervention, within 24 hr of indwelling PICC, T0). The Orem’s theory-based continuous nursing intervention lasts for a long time, and the self-care ability of patients may be affected. The second point we collected the ESCA scale, complications and adverse events rates (after the end of chemotherapy and extubation, T1).
Statistical analysis
We used IBM SPSS statistics version 20.0 software to analyze the data. Values were expressed as frequencies, percentages, means and SDs. We employed the independent- and paired samples t-tests to compare the study groups in terms of self-care ability. Moreover, the Chi square test was to compare the complications and adverse events rates between two groups. The level of significance was set at below 0.05.