Effect of Nurse-led Education on Parent's Anxiety and Depression on Managing Side Effects of Chemotherapy

• ClinicalTrials.gov Identifier: NCT03753542
• Recruitment Status: Unknown
• First Posted: November 27, 2018
• Last Update Posted: February 11, 2019
• Sponsor: Nomi Waqas Gul
• Collaborator: Indus Hospital and Health Network
• Information provided by (Responsible Party): Nomi Waqas Gul, Dow University of Health Sciences

Study Description

Brief Summary:

ABSTRACT

Background:

Today, a wide range of pediatric cancers is treated by chemotherapy. More than 21 side effects of chemotherapy have been identified. Among those nausea; vomiting, infection and anemia are most common. The adverse effects are normally managed by the parents at home. Ineffective coping and lack of knowledge about chemotherapy side effect management leads parents stress. Contemporary research evidence that Nurse-led education, booklet providence and follow up about chemotherapy and side effect management, help to decrease parents anxiety and depression.

Objectives:

To measure the effect of nurse-led multimedia education, booklet providence and telephonic follow up about chemotherapy and side effects management on parents anxiety and depression of children receiving chemotherapy for the first time.

Methodology:

A randomized control trial will be conducted in the department of chemotherapy at Indus Children Cancer Hospital Karachi from March 2018 to August 2018 on parents of children below 18 years of age undergoing chemotherapy for the first time. Total 100 parents will be randomly divided into Intervention group (n=50) and Control Group (n=50). The Intervention group will received multimedia education, booklet and weekly tele-nursing follow-up about chemotherapy and side effects management. The Control group will receive routine care. Parent's anxiety and depression will be identified by using DASS-21 and generalized estimating estimation will be used to analyzed the data.

Keywords:

Nurse-led, Multimedia education, Booklet, telephonic follow-up, chemotherapy, side effects, parents, anxiety, depression, children, cancer

Condition or disease	Intervention/treatment	Phase
Chemotherapy Effect	Other: Multimedia education, booklet Providence and tele-nursing follow-up	Not Applicable

Detailed Description:

INTRODUCTION Background Children Cancer in Pakistan: Millions of people are affected by cancer worldwide. Cancer is one of the major health problems in Pakistan . About 8,000 children below 18 year were diagnosed with cancer annually. Most children diagnosed in advance stage . In Pakistan 31% children had leukemia, 20% had Lymphoma, 08 % had sarcoma, 8 % had bone tumor, 7% had brain tumor, 6 % had retinoblastoma, 5 % had wilms tumor, 4% had germ cell tumor, 4 % had neuroblastoma and the other had 7 % .Cancer affects family emotionally and physically.

Chemotherapy and side effect: Millions of people are also facing difficulties due to chemotherapy worldwide. If the patient will not prepare for chemotherapy treatment properly he/she can face problem in future .Chemotherapy is the common method of treatment. The common side effects of chemotherapy are diarrhea, nausea and vomiting, hair loss, neuropathy, weight loss, dysphagia, oral ulcer, fatigue, dyspnea, constipation, insomnia and cognitive impairment, also affects quality of life, economic conditions, emotions and social wellbeing. Before starting chemotherapy treatment the patient should receive written information about diagnoses, treatment goal, chemotherapy duration, side effects of drugs, the material should design at the level of patient knowledge.

Cancer vs anxiety depression: The anxiety is due to unawareness about chemotherapy side effect. 47% victims of patient have anxiety due to cancer . The power to control disease can be lost due to anxiety .Side effect of chemotherapy management required self-care and it is can be effect due to depression. Anxiety and depression has an association with cancer, chemotherapy related fatigue, lack of education about chemotherapy side effect management and long term exposure of children in hospital . Cancer treatment required nursing intervention to reduce anxiety and depression . Anxiety leads to delay chemotherapy treatment and prognoses.

Evidences of Multimedia education to reduce Anxiety and depression: It is the main responsibility of Oncology nurse to educate patient about the management of side effect of chemotherapy but mostly patient received written material only. The recommended practice to reduce anxiety of patient is to educate about side effect of chemotherapy. The patient should be education both for short term management and long-term management. Education about side effect helps to decrease anxiety. The effect of multimedia education to reduce anxiety is evident in mammography, MRI, ECT, cardiac surgeries, gynecological laparotomy, laparoscopic cystectomy, hemodialysis, teeth removal and peptic ulcer disease. Nursing intervention through education helps to reduce anxiety and stress , after chemotherapy, promote side effect management, decrease complications and increase psychological wellbeing. Many resource centers for patient education on cancer are available on internet about chemotherapy and side effect to increase the psychosocial health. The resources can be utilized as a part of continuous nursing education.

Anxiety and depression in Pakistan: Anxiety and depression is more common in Pakistan due to lack of infrastructure for mental health services.

Aim of the study: The main aim of this study is to find the effect of nurse let chemotherapy education on parent's anxiety as in children case parents are the key role for securing among children cancer. The study will help to examine the effect of psycho-education about chemotherapy and side effect management on parent's anxiety and depression at Indus children cancer Hospital, Karachi Pakistan.

Literature Review

International Findings:

European study found that 20 minutes of video education is more effective with verbal and written education . A randomize control trial was done by Williams and Schreier (2005), on RCT(N=71), the experimental group (n-38) received audiotaped 20 minutes of education on management of fatigue, sleep disturbance and anxiety along with standard care and the control group (n=33) received verbal instruction and written material. The anxiety level was measured at 1 month and 2 months. Larger number of patient (n=16) in control group reported anxiety as compared to experimental group (n=10) significantly (p=0.001). Similar result were found from the study of Malone (2007) that education helps to reduce anxiety. Another study mentioned that familiarity with environment of chemotherapy is necessary as it also impact on anxiety. Almost 50% cases diagnosed with cancer reported the symptoms of anxiety. According to NCCN guideline, the anxiety management related to chemotherapy and side effect management is the primary responsibility of oncology team including oncology nurse . Study from USA mentioned that, the caregiver of children diagnosed with cancer have 44% greater stress as compared to 24% parents of healthy children . Another study mentioned that 98% participant were satisfied with chemotherapy educational experience, 100 % participants mentioned that educational environment is supportive, 81% feel that quality of life can be improved through education . Another study mentioned, 87.6% participant were satisfied with chemotherapy education, 87.5 % agree that it helps to reduce anxiety, 93.3% participant felt that it will be effective if given first time before chemotherapy, 86.6% participant was satisfied for 30 minutes of education timing before chemotherapy treatment. 85.7% participant report that quite room environment is effective for chemotherapy education .In another study mentioned that, 84% patient report that educational class was help to reduce anxiety and 64.7% participant disagree for education in group . A randomize control trail was conducted in Greenville and founded that 23% participant in control group report anxiety after 1 month of treatment as compared to 14% in interventional group significantly . Written information before chemotherapy should be provided to patient, the information should include chemotherapy and side effect, future plan, and follow-up . Many studies had mentioned that that psycho-education is effective to reduce anxiety during chemotherapy management.

Local findings:

A study from Rawalpindi reported that 10-25% participant reported anxiety and depression during chemotherapy and 16% have anxiety and 27% have depression . Another study mentioned that myeloid leukemia is commonly diagnosed in younger age but mostly reported in chronic phase . A study from Lahore mentioned that 56% parents have depression, higher in mothers specially those who are low educated and had poor socio-economical class. A study from Karachi mentioned caregiver stress related to cancer patient s, 17% mild, 34% moderate and 49 % severe stress. It was also conclude that caregiver stress for cancer patient had significant association with caregiver age, relationship with child , female gender and longer duration of care.

Statement of Problem Children cannot look after themselves. Parents are the primary caregiver of children. If they initially feel anxiety and depression, it will be difficult for them to manage chemotherapy and side effects. Education about chemotherapy is neglected due to heavy workload and other responsibilities. More than 50% of individual newly diagnosed with cancer have unknown anxiety related to chemotherapy and their side effect . Those who do not receive chemotherapy education prior to treatment face difficulties in later life . The side effects of chemotherapy like vomiting, nausea, loss of appetite and fatigue were managed through self-care . After an intensive literature review it was found that no study was conducted in Pakistan focusing effect of nurse-led multimedia education and telephonic follow up, on chemotherapy side effects management for parent's anxiety and depression.

Rationale of Study Pediatric cancer is the leading cause of children mortality and morbidity in Pakistan. More than 8,000 children under 18 year of age were diagnosed with cancer in a year. Cancer treatment were managed by the parents specially mother. Evidences showed lack of knowledge about chemotherapy and dissatisfaction of the information about what they have received, leads uncertainty, apprehension and delay continuation with chemotherapy treatment. Many organization developed booklet for patient education about chemotherapy and side effect management. They also have provided online resources. The patient read information at their own efforts. Multimedia education and Tele- nursing follow up was found cost effective method to reduce family anxiety in many countries . Parent's anxiety and depression leads poor management of cancer treatment for their child. Literature evidence that Nurse led psycho-education through multimedia education telephonic follows up is cost effective method to reduce anxiety and depression related to treatment process. According to senior oncologist Pakistan, Parents are anxious not only about Chemo side-effect but also about disease itself. Most parents have same knowledge of side effects of chemotherapy because of their experiences with friend's relatives who have undergo to course treatment. Secondly, side effect is mentioned at first counseling session by primarily oncologist.

Objectives To measure the effect of nurse-led multimedia education, booklet providence and telephonic follow up about chemotherapy and side effects management on parent's anxiety and depression of children receiving chemotherapy for the first time.

Operational Definitions Nurse-Led: Any intervention given by the nurses under professional guidelines. Multimedia education: Education given by using PowerPoint presentation or by using multimedia projector.

Telephonic Follow up: The continuation of educational process by using Tele-communication.

Chemotherapy side effect: The adverse effects of chemotherapy other than therapeutic effect.

Parent's anxiety and depression: Feelings of concern, uneasiness, nervousness and sadness of parents related to child, diagnosed with cancer and undergoing for chemotherapy first time.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 2 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: The sample size calculated was 30 samples per group. After adjusting error in non-response of data collection 50 samples will be drown from each group. Total 100 caregivers along with their children will be selected.
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Effect of Nurse-led Education on Parent's Anxiety and Depression on Managing Side Effects of Chemotherapy
• Actual Study Start Date: September 6, 2018
• Actual Primary Completion Date: December 30, 2018
• Estimated Study Completion Date: March 30, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention; The Intervention group will received multimedia education, booklet and weekly tele-nursing follow-up about chemotherapy and side effects management	Other: Multimedia education, booklet Providence and tele-nursing follow-up; Multimedia education, booklet and weekly tele-nursing follow-up is about chemotherapy and side effects management
No Intervention: Control; The Control group will receive routine care

Outcome Measures

Primary Outcome Measures :

1. Depression, Anxiety and Stress Scale - 21 (DASS-21) [ Time Frame: up to 4 weeks ]
   Depression (D) and anxiety (A) and stress(S) will be outcome variable. They will be identified by using DASS-21 Scale. The use of DASS-21 Scale is evident in Pakistan . There are 21 questions in this scale equally divided in to three parts having seven questions for Depression, Anxiety and stress respectively. Each question have four level of measurement 0,1, 2 and 3, represent past week experiences. 0 means not applicable to person, 1 means applicable to some degree or sometime, 2 means applicable to considerable degree or good part of time, 3 means applicable to person very much or most of the time. Each question is separate for Stress(s), Anxiety (a) and Depression (d).

Eligibility Criteria

• Ages Eligible for Study: up to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

1. Parents along with their children younger than 18 years of age
2. Parents along with their children newly diagnosed with cancer in last three weeks
3. Parents along with their children schedule to receive first time chemotherapy in the outpatient department

Exclusion Criteria:

1. Parents along with their children refused to participate
2. Parents along with their children already receiving interventions like multimedia education, booklet providence and telephonic follow up for chemotherapy and side effect management
3. Parents taking medicine for their anxiety and depression. (e.g. Anxiolytics/ Antidepressant)
4. Parents showing uneasiness and discomfort during educational session.

Contacts and Locations

Locations

Pakistan

Indus Children Cancer Hospital Karachi

Karachi, Sindh, Pakistan

Sponsors and Collaborators

Nomi Waqas Gul

Indus Hospital and Health Network

Investigators

• Study Chair: Dr. Mehwish HUSSAIN, PhD (Statistics); Senior Lecturer, DUHS, Karachi
• Study Chair: Dr. SHAMVIL ASHRAF, MBBS, DCH, MCPS, FCPS, MRCP; Indus Hospital Karachi
• Study Chair: Mr. Hakim Shah, MSN; Associate Professor Institute of Nursing Dow University of Health Sciences Karachi

More Information

Publications:

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• Responsible Party: Nomi Waqas Gul, Principal Investigator, Dow University of Health Sciences
• ClinicalTrials.gov Identifier: NCT03753542
• Other Study ID Numbers: Enr # 12/2015/912
• First Posted: November 27, 2018
• Last Update Posted: February 11, 2019
• Last Verified: February 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: No plan

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nomi Waqas Gul, Dow University of Health Sciences:

chemotherapy, side effects, parents, anxiety, depression

Additional relevant MeSH terms:

Depression; Behavioral Symptoms