http://doi.org/10.33698/NRF0266 -Pramod Kumar, Rupinder Kaur, Sukhpal Kaur, Amita Trehan, Rakesh Kapoor

ABSTRACT:

Background: Patients undergoing chemotherapy are at risk of developing neutropenia. This may lead to life-threatening infections leading to sepsis, and death. Specic guidelines and protocol can guide nurses and caregivers for early interventions and timely management to minimize complications and possibly improve outcome in these patients. Objective: To develop a protocol for nurses and caregivers related to prevention, early detection and management of chemotherapy induced neutropenic complications. Methodology and results: Methodological study design was used to develop the protocol. The preliminary draft was prepared after reviewing relevant literature and assessment of current practices of the nurses and caregivers regarding prevention, early detection and management of chemotherapy induced neutropenic complications. Group discussions were conducted with the nurses working in the oncology units. Delphi rounds amongst the experts were carried out to validate the protocol. A try out was conducted to know feasibility of protocol. A checklist to be used for the evaluation of the protocol was also developed. Nurses and caregivers were taught as per the developed protocol. Content Validity Index (CVI) of protocol and checklist was 100%. Overall Cronbach’s alpha value was 0.859. A pilot study was conducted and the protocol was found to be feasible in terms of understanding, clarity and easy implementation. Conclusion: The present study has provided set of valid and reliable written guidelines for the for nurses and caregivers related to prevention, early detection and management of chemotherapy induced neutropenic complications

Key words: Chemotherapy induced neutropenia; Caregivers; Nurses; Protocol

Corresponding author:

Dr Sukhpal Kaur Lecturer,

National Institute of Nursing Education, PGIMER, Chandigarh

Introduction:

Hematologic cancers comprise an aggregate of several different cancers, such as leukemia, lymphoma, retinoblastoma, Ewing’s sarcoma etc. Cancer in children and adolescents is biologically different from cancer in adults.1It is estimated that about 148000 cancers occurred during 2008 in children aged 0–14 years in less- developed regions.2 In India cancer is the 9th common cause for the deaths among children between 5 to 14 years of age.3 Hematologic cancers affect the body’s blood, bone marrow, and lymphatic system, leaving these patients more susceptible to infections.4 Newly diagnosed patient with cancer receive aggressive chemotherapy treatment and are closely monitored in the hospital. Treatment-related complications including fever, pain, nausea and vomiting, oral mucositis, alopecia, anorexia and respiratory distress. These complications may bring the patient to the emergency department before his or her next scheduled clinic appointment.5,6

Patients undergoing chemotherapy are at risk of developing neutropenia. This may lead to life-threatening infections leading to sepsis, and death.7,8 Severe neutropenia and febrile neutropenia (FN) are major causes of morbidity, treatment interruptions and dose reductions in patients undergoing chemotherapy.9 In  addition  to  clinical i m p a c t , t h e e c o n o m i c i m p a c t o f neutropenia is considerable.10 As the rates of hospitalization for febrile neutropenia are extremely high as well as the durations of such hospitalization are long. This consequently puts a signicant economic burden on the healthcare system. 1 1 Preventing infections including FN is thus extremely important for a successful chemotherapy outcome. Nurses play an important role in the prevention, detection and management of neutropenia, as well as provision of information to patients for ensuring better compliance.12

Nurses should recognize patients at risk for developing neutropenia and monitor patients who already have it for early diagnosis and early initiation of interventions to improve patient care as well as QoL in patients.13 It is also vital that n u r s e s u n d e r s t a n d t h e p h y s i c a l , psychological and cost implications to enable them to support patients. Nurses can help families to engage in caring, lend support to family’s integrity during the chemotherapy induced neutropenic (CIN) experience, although the benets of which may not be evident to the nurse immediately, but the long-term gains are signicant.14 There may be a need for improvement in a number of areas of oncology care, including; communication between patients and healthcare professionals as patients need to receive understandable and timely information; links to information for healthcare professionals; provision of effective prophylaxis against neutropenia. Among all, patient education is considered the most crucial for neutropenia management.12

Health care members should be well prepared and equipped to identify, prioritize, and develop strategies for treatment while getting patients involved in making decisions about treatment because compliance with therapy may be poor if patients do not perceive that treatments are leading to improvements.13Development of a protocol should be based on clinical guidelines and need based assessment of nurses, caregivers and patients. The protocol can assist nurses and caregivers in making decisions about appropriate and effective care for the patients. Hence the need was felt to prepare such kind of protocol.

Objective of the study:

To develop a protocol for nurses and caregivers related to prevention, early detection and management of CIN complications.

Methodology:

A methodological research approach was adopted to develop the protocol. The study was conducted in tertiary care center. Annually around 1000 new cancer patients are registered in different units. Ethical permission was obtained from Institute Ethics Committee. The study was conducted during July to Sept. 2018.The protocol development was carried out in three phases.

Phase-I: Preparation Phase:

The preparation phase included review of literature, assessment of current practices, and group discussion with nurses and caregivers.

Step 1: Review of Literature:

An extensive review of relevant literature was carried out on the recent evidences and latest  practices  regarding p r e v e n t i o n , e a r l y d e t e c t i o n a n d management of chemotherapy induced neutropenic complications. Latest available literature was reviewed related to standard nursing practices, using oncology books, national and international journals, manuals and web search of literature including both electronic data as well as printed material.

Step 2: Assessment of Current Practices:

Assessment of current practices of nurses and caregivers was done by using an observation checklist regarding oral care, hand washing, intravenous line care and sitz b a t h a m o n g p a t i e n t s r e c e i v i n g chemotherapy. Nurse’s practices were observed in all the duty shifts. Caregiver’s practices were observed at time of chemotherapy administration. Hand washing, oral care, sitz bath, and intravenous line care practice were unsatisfactory (95%) among nurses and caregivers.

Step 3: Focus Group Discussion:

Two FGDs were organized among nurses working  in  oncology  units  and c a r e g i v e r s o f p a t i e n t s r e c e i v i n g chemotherapy. The FGDs explored various issues pertaining to  prevention,  early d e t e c t i o n a n d m a n a g e m e n t o f chemotherapy induced neutropenic complications. Principle of redundancy was followed. Total 10 nurses, 10 patients and 10 caregivers with 3-4 in each group from respective oncology units were involved to seek their suggestions and assess problems faced by them.

Step 4: Preparation of preliminary draft of protocol:

The preliminary draft of protocol and an observation checklist to assess the implementation of protocol were prepared u s i n g r e l e v a n t l i t e r a t u r e s e a r c h ; incorporating the results of assessments of current practices and valuable suggestions from nurses gathered in FGDs. The protocol included childhood cancer: An introduction, neutrophils and its role in chemotherapy, signs and symptoms of infection, granulocyte colony-stimulating factors, guidelines to reduce the risk of infection, hand washing, oral care, intravenous line care, sitz bath , guidelines about food and beverages, guidelines for the patient’s room environment, guidelines for taking strict measures when neutrophil count are very less, and discharge instructions.

Phase II- Validation phase:

The protocol was validated using Delphi technique. Selected Delphi experts were invited to participate in various rounds of Delphi. A Delphi panel of 13 members from eld of oncology, nursing education and nursing practices was formulated. The rounds were repeated until the agreement amongst experts s t abilized 100 % consensus. They were requested to check each item by keeping in mind that the items listed in the protocol were relevant to subjects and were easily understandable and meaningful for the users.

Modifications made in preliminary draft after Delphi rounds

Delphi round I:

Majority of Delphi members gave suggestions to make protocol in the form of booklet for CIN complications.

Item added:

Guidelines regarding food  and b e v e r a g e f o r c h i l d r e n r e c e i v i n g

l ike hand washing with discharge instructions for caregivers.

A) Item added:

Monitor patients laboratory values, complications with grades.

The second draft of protocol in the form of booklet had the following contents

  1. Childhood cancer: An introduction (for nurses and caregivers)
  2. N e u t r o p h i l s a n d i t s r o l e i n chemotherapy (for nurses)
  3. Signs and symptoms of infection (for nurses)
  4. Granulocyte colony-stimulating factors (for nurses)
  5. Guidelines to reduce the risk of infection (for nurses and caregivers)· Hand washing, oral care (for both nurses & caregivers), intravenous line care (for nurses), sitz bath (for caregivers)
  6. Guidelines about food and beverages (for nurses and caregivers)
  7. Guidelines for the patient’s  room e n v i r o n m e n t ( f o r n u r s e s a n d caregivers)
  8. Guidelines for taking strict measures when neutrophil count are very less chemotherapy and discharge instructions

Delphi round II:

< 500 / mm 3

caregivers)

( for both nurses &

In the second Delphi round, protocol was developed in the form of booklet per the suggestions given by the Delphi members of Delphi round 1. They have suggested to club some nursing activities

  1. Discharge instructions (for both nurses & caregivers)

Delphi round III:

In third Delphi round no new suggestions was given by Delphi members. All the Delphi members were agreed with the content matter of protocol and checklist to implement protocol. They suggested that protocol in the form of booklet as well as checklist were ready to be given to the study participant. Hence the nal draft of protocol for prevention, early detection and management of chemotherapy induced neutropenic complications And checklist for implementing checklist was prepared on the suggestions of Delphi members and in consultation with guide and co-guides. Content validity index of protocol and checklist was one for each item.

Phase III: Testing feasibility of the protocol by pilot study:

First try out in the form of pilot study was conducted on 10 nurses, 10 patients and 10 caregivers in month of July 2018 to check the feasibility of the developed protocol and checklist. Permission for conducting pilot study was taken from Head, Department of Oncology and informed written consent was taken from the participants (nurses, patients and caregivers). Study participants who were available and fulll inclusion criteria (nurses working  in oncology  units, c a r e g i v e r s o f p a t i e n t s r e c e i v i n g chemotherapy) during given time period were taken up for the pilot study. The protocol was found feasible and complete during pilot study. Nurses and caregivers were trained according to the protocol. A total of 10 lectures with hands on training, group discussion and doubt clearance session on topics related to early detection, p r e v e n t i o n a n d m a n a g e m e n t o f chemotherapy induced neutropenic complications according to protocol were delivered by principal investigators.

Nurses and caregivers were given demonstrations of hand washing, oral care, intravenous line care and sitz bath in the oncology units and return demonstrations were taken to ensure that they were working as per the protocol. Nurses and caregivers were observed while providing care to the patents using an observational checklist. The language of protocol and checklistwas understandable to the study participants. They were able to perform All the procedures demonstrated to them. It was feasible to apply the checklist to check implementation of checklist.

Reliability of the checklist:

Total 10 study participants were enrolled. 10 nurses, 10 patients and 10 caregivers in month of August 2018 to check the reliability of the developed checklist. Informed written consent was taken from the participants (nurses, patients and caregivers). Study participants who were available and fulll inclusion criteria (nurses working in  oncology  units, c a r e g i v e r s o f p a t i e n t s r e c e i v i n g chemotherapy) during given time period were taken up for the pilot studyNurses and caregivers were trained according to the protocol. A total of 10 lectures with hands on training, group discussion and doubt clearance session on topics related to early detection, prevention and management of chemotherapy induced neutropenic complications according to protocol were delivered by principal investigators.

Nurses and caregivers were given demonstrations of hand washing, oral care, intravenous line care and sitz bath in the oncology units and return demonstrations were taken to ensure that they were working as per the protocol. Nurses and caregivers were observed while providing care to the patents using an observational checklist. Test and re-test method was used to check the reliability of the checklists. Crohnbach’s alpha was used to nd out the internal consistency reliability of the checklist to implement protocol  on  early  detection, p r e v e n t i o n a n d m a n a g e m e n t o f chemotherapy induced neutropenic complications.

Table 1 to 6 depicts the items analysis of the checklists. The total score coefcient alpha ranges from 0.80 to 0.87 which depicts the internal consistency reliability of each item of the practices regarding care of CIN complications was good. Three times checklists was implemented on study participants to check the reliability. The output was useful to identify the importance of each item for the scale reliability estimate.

For item no.3 in hand washing practice of nurses i.e. turns on water, wet hands and wrist thoroughly under running water Cronbach’s alpha increased to 0.852, on deletion of item. Similarly for item no 7 of sitz bath procedure i.e. allows the patient to sit for 20 minutes and then assist with drying crohnbach’s alpha increased to 0.852 on deletion of item. Delphi panelist were asked about the deletion of these two items. All the Delphi panelists suggested keeping these items in the nal protocol as these items are important. Hence all the items of checklist were retained.

 

Table 1: Cronbach’s alpha of each items of the checklist on hand washing practice by nurses

Sr.

No.

Steps of nursing practice Scale Mean if Item

Deleted

Corrected Item-Total

Correlation

Cronbach’s Alpha Item

Deleted

1. Inspects surface of hands for breaks/cuts, cover lesions 25.40 .448 .859
2. Removes wristwatch, jewellery and fold long uniform sleeves 25.25 .294 .856
3. Turns on water, wet hands and wrist thoroughly under running

water

25.23 .360 .852
4. Applies a small amount of soap or antiseptic 25.30 .350 .850
5. Scurbs hands using plenty of lather and friction for at least 20 to 30

seconds, using 9 steps of hand washing.

25.25 .294 .856
6. Left palm over the right dorsum and right palm over the left dorsum 25.30 .350 .850
7. Palm to palm finger interlaced 25.31 .325 .852
8. Back of fingers to opposing palm with finger interlocked 25.18 .418 .844
9. Rotate left thumb with right hand and vice versa 25.20 .253 .852
10. Rubs left hand finger tip over the right palm and repeat wise versa 25.18 .418 .844
11. Rotate each wrist with opposite hands 25.30 .350 .850
12. Rinsing the hands under running water 25.31 .325 .852
13. Drying the hands 25.20 .253 .852
14. Turns off water using paper towel or with help of elbow 25.18 .418 .844
15. Discards used paper towel appropriately 25.30 .350 .850

 

Table 2: Cronbach’s alpha of each items of the checklist on oral care practice by nurses

 

Sr.No. Steps of nursing practice Scale Mean if Item

Deleted

Corrected Item-Total Correlation Cronbach’s Alpha Item Deleted
1. Explains of the procedure to caregivers 25.18 .208 .844
2. Arranges articles near the bedside and

provide the comfortable position

25.30 .482 .854
3. Washes hands with soap and water and

place a small towel on chest encircling neck

25.20 .253 .848
4. Instructs the patients to open the mouth and

examine the oral mucosa under the light of a torch

25.18 .208 .844
5. Takes enough quantity of toothpaste as per age of the patient’s on the toothbrush and brush the teeth as follows:

i. Holds the brush against the teeth with

bristles at 45-degree angle.

25.23 .429 .850
6. ii. Moves the bristles up and down gently in

short strokes

25.20 .253 .848
7. iii. Cleans the biting surfaces by moving the brush back and forth over them in short

strokes

25.26 .362 .852
8. Brushes the tongue gently with a toothbrush 25.31 .482 .855
9. Hands over the patient cup of water to rinse the mouth and place the kidney tray under

the mouth

25.20 .253 .848
10. Repeats the preceding steps until the mouth

is free of foods particles

25.18 .208 .844
11. Removes the kidney tray and help the

patient to wipe the mouth

25.25 .218 .853
12. Applies emollient to the lips if required 25.20 .253 .848
13. Washes the hands and replaces the article

appropriately

25.18 .208 .848
14. Documents the procedure in nursing notes 25.31 .482 .855

 

Table 3: Cronbach’s alpha of each items of the checklist on IV line care practice by nurses

 

Sr.No. Steps of nursing practice Scale Mean if Item

Deleted

Corrected Item-Total Correlation Cronbach’s Alpha Item Deleted
1. Explains the procedure to

patients/caregivers

25.20 .362 .844
2. Gathers all the articles at bed side of

patients

25.18 .208 .842
3. Washes hands and follow aseptic

technique throughout the procedure

25.46 .446 .860
4. Assesses the intravenous line for patency, erythema, tenderness, pain,

swelling, dressing integrity and position

25.20 .362 .844
5. Removes the previous dressing and

discard it

25.30 .375 .853
6. Compares the IV site with the opposite

limb to look for signs of swelling

25.21 .294 .848
7. Cleans the skin around the IV line with

chlorhexidine solution

25.30 .375 .853
8. Allows area to dry then apply a new

dressing

25.20 .362 .844
9. Uses 0.9 % normal saline for a ush of

the intravenous line

25.40 .448 .866
10. Documents the date of dressing change

and the physical condition of the site in the patient’s treatment le

25.20 .362 .844
11. Washes hands after the procedure 25.40 .448 .866
12. Disposes all the waste in appropriate

biomedical waste bin

25.18 .208 .840

 

 Table 4: Cronbach’s alpha of each items of the checklist on hand washing practice by caregivers

 

Sr.No. Steps of caregivers practice Scale Mean if Item

Deleted

Corrected Item-Total Correlation Cronbach’s Alpha Item Deleted
1. Removes wristwatch, jewellery and fold

long sleeves.

25.40 .208 .866
2. Turns on   water, wet hands and wrist

thoroughly under running water

25.25 .362 .855
3. Applies a small amount of soap or

antiseptic

25.23 .294 .844
4. Scurbs hands using plenty of lather and friction for at least 20 to 30 seconds, using 9 steps of hand washing:

Palm to palm

25.54 .449 .868
5. Left palm over the right dorsum and

right palm over the left dorsum

25.32 .356 .859
6. Palm to palm finger interlaced. 25.30 .375 .856
7. Back of fingers to opposing palm with

finger interlocked

25.31 .424 .857
8. Rotate left thumb with right hand and

vice versa

25.18 .334 .840
9. Rubs left hand finger tip over the

right palm and repeat wise versa

25.20 .390 .842
10. Rotate each wrist with opposite

hands

25.18 .334 .840
11. Rinsing the hands under running

water

25.30 .375 .856
12. Drying the hands 25.31 .424 .857
13. Turns off water using paper towel or help

of elbow

25.20 .390 .842
14. Discards used paper towel appropriately 25.18 .334 .840

 

 Table 5: Cronbach’s alpha of each items of the checklist on oral care practice by caregivers

 

Sr.No. Steps of caregivers practice Scale Mean if Item

Deleted

Corrected Item-Total

Correlation

Cronbach’s Alpha Item

Deleted

1. Arranges articles near the bedside of the patients and provide the comfortable

position.

25.18 .210 .842
2. Washes hands with soap and water and

place a small towel on chest encircling neck.

25.30 .294 .850
3. Instructs the patients to open the mouth as per their age and examine the oral

mucosa under the light of a torch.

25.28 .412 .848
4. Takes enough quantity of toothpaste as per age of the patient’s on the toothbrush and brush the teeth as follows:

i. Holds the brush against the teeth with

bristles at 45-degree angle.

25.18 .210 0.842
5. ii. Moves the bristles up and down gently

in short strokes.

25.23 .362 .845
6. iii. Cleans the biting surfaces by moving the brush back and forth over them in

short strokes.

25.23 .362 .845
7. Brushes the tongue gently with a

toothbrush.

25.28 .375 .848
8. Hands over the patient cup of wate r to rinse the mouth thoroughly and hold the

kidney tray to help in rinsing the mouth.

25.31 .390 .852
9. Repeats the preceding steps until the

mouth is free of foods particles.

25.20 .399 .843
10. Removes the kidney tray and help the

patient wipe to the mouth.

25.18 .210 .842
11. Applies emollient to the lips if required. 25.30 .294 .850
12. Washes the hands and replaces the article

appropriately

25.20 .399 .843

 

 Table 6 : Cronbach’s alpha of each items of the checklist on sitz bath practice by caregivers

 

Sr.No. Steps of caregivers practice Scale Mean if Item

Deleted

Corrected Item-Total

Correlation

Cronbach’s Alpha Item

Deleted

1. Assembles all articles near the patient’s

bed side and wash hands

25.31 .218 .853
2. Adds 3-4 tablespoon of betadine solution

in 10-15 litre of water and mix it

25.20 .208 .848
3. Fills the basin with warm water at the

temperature of 105 -1100 F

25.18 .346 .844
4. Assists the patient to sit in the sitz bath

basin/tub

25.30 .394 .852
5. Places the towel on the patient’s thigh

and cover the shoulders with a sheet

25.30 .394 .852
6. Does not leave the patients unattended

during the procedure

25.31 .218 .853
7. Allows the patient to sit for 20 minutes

and then assist with drying

25.30 .394 .852
8. Assists the patient back to bed and

instruct to stay in bed for 20 minutes

25.21 .294 .850
9. Cleans and replace all the articles 25.20 .294 .848
10. Washes hands 25.50 .468 .866

Table 7: Overall reliability statistics of the checklist

 

Reliability Statistics
Cronbach’s alpha Cronbach’s alpha based on Standardized Items No. of Items
0.859 0.823 77

 

Table 7 depicts the Reliability statistics of the checklist. Cronbach’ s alpha coefcient was 0.859 which indicate the internal consistency and reliability of the newly developed checklists (ideally Crohnbach’s alpha coefcient should be equal or above 0.70)

Results:

Three Delphi rounds were conducted and found that protocol in the form of booklet was feasible for prevention, early detection and management of CIN complications among patients receiving chemotherapy along with valid and reliable checklist. Ready to use booklet was used to draw protocol and was made available in all units of oncology.

Discussion:

The quality and consistency of clinical care can be improved by the readily availability of clear evidence-based guidelines. Clinical nursing protocols may enhance nursing efciency by working independently. Protocol contains a comprehensive, up-to-date review of the disease process and provides the rationale for each nursing action. The nursing protocols also represent an important educational resource for nurses as well as caregivers. The aim of current study was to develop a protocol to help nurses and caregivers to minimize chemotherapy induced neutropenic complications among patients receiving chemotherapy and checklist to implement protocol. These patients are at higher risk of developing complications like fever, pain, nausea and vomiting, oral mucositis, alopecia, anorexia and respiratory distress4,5. So, it is important to have specic guidelines for such patients in order to reduce the complications.

D e v e l o p m e n t o f t h e n u r s i n g intervention protocol was done in two phases. Preparation phase was started with an extensive review of relevant literature by using various national/international oncology journals and books besides using electronic data from reputed e-sources like pub-med, Cochrane library. The ndings of the current practices assessment were quite in favor of developing a nursing intervention protocol for early detection, prevention and management CIN complications as many important aspects of nursing care were either missing or were not followed properly. The second phase was for validation of protocol content. Delphi technique was used to establish the validity of the protocol. Total three Delphi rounds were conducted with experts from the department of medical oncology, nursing education and nursing practices. After consulting the guide and co-guides to generate the nal draft of protocol for CIN c o m p l i c a t i o n s a n d c h e c k l i s t f o r implementing it. Three Delphi rounds were conducted to reach nal consensus.

The classical original cronbach’s alpha is used to assess internal consistency and reliability of the tool as reliability is best appreciated as a measure of the consistency of recorded observation. cronbach’s alpha coefcient for the checklist was found to be 0.859. Ideally, cronbach’s alpha coefcient value should be > 0.70 or above. Except two all items were internally consistent and contributing to the total reliability of the checklists. The results were discussed with Delphi panelists. All members were in the favor of keeping all the items because they were equally important in the protocol in spite of the low correlation indicated in the individual item score. A Similar study by Bijarania et al on the development of a checklist to implement protocol for assessment of nurse’s practice while performing drugs administration, the cronbach’s alpha has been shown to be 0.87 and 0.84.14 Devi et al on a study to develop a checklist to implement standard operational protocol for nurses on central line care in intensive care units has documented the checklist reliability established by cronabch’s alpha as 0.75.15 A Similar study by Kumar M et al on the development of checklist for implementing protocol on nursing management of post- operative cerebral aneurysm patients, the cronbach’s alpha has been shown to be 0.85 and 0.82.16

The practice standards are not only desirable but are necessary for the healthy growth of nursing profession and for the professional dignity and identity. CIN complications are known side effects of chemotherapy drugs, however theses side effects should be minimized with effective nursing care. The use of nursing protocols has been proven benecial for nurses, caregivers, and patients. Nurses are empowered to make decisions and initiate changes in patient care. It is recommended to use this protocol for early detection, prevention and management of CIN complications. The checklist can be used by n u r s e s u p e r v i s o r s t o a s s e s s t h e implementation of protocol.

Conclusion:

The nursing care  protocol for p r e v e n t i o n , e a r l y d e t e c t i o n a n d management of CIN complications among patients receiving chemotherapy in oncology units was found to be valid in its content with potential applicability along w i t h r e l i a b l e c h e c k l i s t f o r i t s implementation. Nursing care during and after chemotherapy is very important aspect of the outcome. A nursing protocol can improve nursing practices by applying evidence-based guidelines and can possibly minimize CIN complications.

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