Chemotherapy EffectNCT03753542
Effect of Nurse-led Education on Parent's Anxiety and Depression on Managing Side Effects of Chemotherapy
A study testing Multimedia education, booklet Providence and tele-nursing follow-up in people with Chemotherapy Effect, run by Nomi Waqas Gul at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Chemotherapy Effect
- What is being tested?
- Multimedia education, booklet Providence and tele-nursing follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 6 Sep 2018to 15 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Parents along with their Children younger than 18 years of age Note: (Here Child age was taken as Inclusion criteria for Parents, because child age is evident for impact on Parents Psychology, in local study no association of Parents age was evident)
- Parents along with their children newly diagnosed with cancer in last three weeks
- Parents along with their children schedule to receive first time chemotherapy in the outpatient department
Who cannot join
- Parents along with their children refused to participate
- Parents along with their children already receiving interventions like multimedia education, booklet providence and telephonic follow up for chemotherapy and side effect management
- Parents taking medicine for their anxiety and depression. (e.g. Anxiolytics/ Antidepressant)
- Parents showing uneasiness and discomfort during educational session.
Trial locations and contacts
1 site in 1 country.
About this study
ABSTRACT
Background:
Read more
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
Read the 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.
- Conditions
- Chemotherapy Effect
- Being tested
- Multimedia education, booklet Providence and tele-nursing follow-up
- Keywords
- chemotherapy, side effects, parents, anxiety, depression
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimedia education, booklet Providence and tele-nursing follow-upOther
Multimedia education, booklet and weekly tele-nursing follow-up is about chemotherapy and side effects management
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The Intervention group will received multimedia education, booklet and weekly tele-nursing follow-up about chemotherapy and side effects management Receives: Other: Multimedia education, booklet Providence and tele-nursing follow-up |
| Control | No intervention | The Control group will receive routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression, Anxiety and Stress Scale - 21 (DASS-21)
DASS-21 is comprised of questionnaires for three separate scales measuring Depression, Anxiety and Stress. The depression scale is scored by summing the responses of each question, multiplying by 2 and then scoring on a scale ranging from a minimum of 0 to a maximum of 28+, with higher scores indicating greater severity. The anxiety scale is scored by summing the responses of each question, multiplying by 2 and then scoring on a scale ranging from a minimum of 0 to a maximum of 20+, with higher scores indicating greater severity. The stress scale is scored by summing the responses of each question, multiplying by 2 and then scoring on a scale ranging from a minimum of 0 to a maximum of 37+, with higher scores indicating greater severity
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start6 Sep 2018
- Primary completion30 Dec 2018
- Study completion15 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy EffectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nomi Waqas Gul
- Sponsor type
- University, hospital or other
- Collaborators
- Indus Hospital and Health Network
- Responsible party
- Sponsor-investigator, Nomi Waqas Gul, Dow University of Health Sciences
- Investigators
- Dr. Mehwish HUSSAIN, PhD (Statistics), Study chair, Assistant Professor, DUHS, KarachiDr. SHAMVIL ASHRAF, MBBS, DCH, MCPS, FCPS, MRCP, Study chair, Indus Hospital KarachiMr. Hakim Shah, MSN, Study chair, Associate Professor Institute of Nursing Dow University of Health Sciences Karachi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03753542
- Sponsor's protocol ID
- Enr # 12/2015/912
- Status last verified
- Jul 2022
- First submitted
- 16 Nov 2018
- Last updated
- 28 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan
Publications
Bhurgri Y, Bhurgri A, Nishter S, Ahmed A, Usman A, Pervez S, Ahmed R, Kayani N, Riaz A, Bhurgri H, Bashir I, Hassan SH. Pakistan--country profile of cancer and cancer control 1995-2004. J Pak Med Assoc. 2006 Mar;56(3):124-30. No abstract available.
PubMed 16696512Ashraf MS. Pediatric oncology in Pakistan. J Pediatr Hematol Oncol. 2012 Mar;34 Suppl 1:S23-5. doi: 10.1097/MPH.0b013e318249abf9.
PubMed 22357147CCHK. Children cancer Hospital karachi. 2017 [cited 2017; Available from: http://ccfpakistan.org/.
Klein CA. Cancer. The metastasis cascade. Science. 2008 Sep 26;321(5897):1785-7. doi: 10.1126/science.1164853. No abstract available.
PubMed 18818347Mansoor, S. and S. Jehangir, Anxiety, depression in patient receving chemotherapy for solid tumors. Pak Armed Forces Med. J, 2015. 65(1): p. 89-93.
Iqbal A, Siddiqui KS. Depression among parents of children with acute lymphoblastic leukemia. J Ayub Med Coll Abbottabad. 2002 Apr-Jun;14(2):6-9.
PubMed 12238347Borsellino M, Young MM. Anticipatory coping: taking control of hair loss. Clin J Oncol Nurs. 2011 Jun;15(3):311-5. doi: 10.1188/11.CJON.311-315.
PubMed 21624866Graca Pereira M, Figueiredo AP, Fincham FD. Anxiety, depression, traumatic stress and quality of life in colorectal cancer after different treatments: A study with Portuguese patients and their partners. Eur J Oncol Nurs. 2012 Jul;16(3):227-32. doi: 10.1016/j.ejon.2011.06.006. Epub 2011 Jul 23.
PubMed 21783416Pouresmail, Z., S. Sharafi, and M. Razi, The Role of Evidence Based Nursing in Prevention of Gastrointestinal Side Effects of Chemotherapy in Children with Cancer. International Journal of Pediatrics, 2014. 2(2.1): p. 48-48
Mohammed, H.A., Impact of proposed nursing rehabilitation program on self management of selected side effects of chemotherapy for elderly patints with gastrointestinal cancer. CU Theses, 2012.
Munir F, Burrows J, Yarker J, Kalawsky K, Bains M. Women's perceptions of chemotherapy-induced cognitive side affects on work ability: a focus group study. J Clin Nurs. 2010 May;19(9-10):1362-70. doi: 10.1111/j.1365-2702.2009.03006.x.
PubMed 20500346Garcia S. The effects of education on anxiety levels in patients receiving chemotherapy for the first time: an integrative review. Clin J Oncol Nurs. 2014 Oct;18(5):516-21. doi: 10.1188/14.CJON.18-05AP.
PubMed 25164233Hoon LS, Chi Sally CW, Hong-Gu H. Effect of psychosocial interventions on outcomes of patients with colorectal cancer: a review of the literature. Eur J Oncol Nurs. 2013 Dec;17(6):883-91. doi: 10.1016/j.ejon.2013.05.001. Epub 2013 Jun 4.
PubMed 23759360Lerdkiattikorn, P., et al., Quality of life among stage III colon cancer patients receiving oral and intravenous chemotherapy regimens in Thailand. Mahidol University Journal of Pharmaceutical Sciences, 2012. 39: p. 41-3.
Kutlu, R., et al., Kanserli hastalarda depresyon ve yaşam kalitesini etkileyen faktörler. Selçuk Üniv Tıp Derg, 2011. 27(3): p. 149-153
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nurse-led Education on Parent's Anxiety and Depression on Managing Side Effects of Chemotherapy
- ClinicalTrials.gov ID
- NCT03753542
- Acronym / sponsor ID
- Enr # 12/2015/912
- Conditions
- Chemotherapy Effect
- Keywords
- chemotherapy, side effects, parents, anxiety, depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Nomi Waqas GulUniversity, hospital or other
- Collaborators
- Indus Hospital and Health Network
- Study start
- 6 Sep 2018 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 15 Jun 2019 (actual)
- First posted
- 27 Nov 2018 (actual)
- Results
- Posted 28 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Multimedia education, booklet Providence and tele-nursing follow-upThe Intervention group will received multimedia education, booklet and weekly tele-nursing follow-up about chemotherapy and side effects management |
| Control | No intervention | –The Control group will receive routine care |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Parents along with their Children younger than 18 years of age Note: (Here Child age was taken as Inclusion criteria for Parents, because child age is evident for impact on Parents Psychology, in local study no association of Parents age was evident)
- Parents along with their children newly diagnosed with cancer in last three weeks
- Parents along with their children schedule to receive first time chemotherapy in the outpatient department
Key exclusion criteria (4 listed)
- Parents along with their children refused to participate
- Parents along with their children already receiving interventions like multimedia education, booklet providence and telephonic follow up for chemotherapy and side effect management
- Parents taking medicine for their anxiety and depression. (e.g. Anxiolytics/ Antidepressant)
- Parents showing uneasiness and discomfort during educational session.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimedia education, booklet Providence and tele-nursing follow-upMultimedia education, booklet and weekly tele-nursing follow-up is about chemotherapy and side effects management | Other | Intervention |
Primary outcome
Depression, Anxiety and Stress Scale - 21 (DASS-21)
Time frame: up to 4 weeks
DASS-21 is comprised of questionnaires for three separate scales measuring Depression, Anxiety and Stress. The depression scale is scored by summing the responses of each question, multiplying by 2 and then scoring on a scale ranging from a minimum of 0 to a maximum of 28+, with higher scores indicating greater severity. The anxiety scale is scored by summing the responses of each question, multiplying by 2 and then scoring on a scale ranging from a minimum of 0 to a maximum of 20+, with higher scores indicating greater severity. The stress scale is scored by summing the responses of each question, multiplying by 2 and then scoring on a scale ranging from a minimum of 0 to a maximum of 37+, with higher scores indicating greater severity
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16696512Bhurgri Y, Bhurgri A, Nishter S, Ahmed A, Usman A, Pervez S, Ahmed R, Kayani N, Riaz A, Bhurgri H, Bashir I, Hassan SH. Pakistan--country profile of cancer and cancer control 1995-2004. J Pak Med Assoc. 2006 Mar;56(3):124-30. No abstract available.
- Background: PubMed 22357147Ashraf MS. Pediatric oncology in Pakistan. J Pediatr Hematol Oncol. 2012 Mar;34 Suppl 1:S23-5. doi: 10.1097/MPH.0b013e318249abf9.
- BackgroundCCHK. Children cancer Hospital karachi. 2017 [cited 2017; Available from: http://ccfpakistan.org/.
- Background: PubMed 18818347Klein CA. Cancer. The metastasis cascade. Science. 2008 Sep 26;321(5897):1785-7. doi: 10.1126/science.1164853. No abstract available.
- BackgroundMansoor, S. and S. Jehangir, Anxiety, depression in patient receving chemotherapy for solid tumors. Pak Armed Forces Med. J, 2015. 65(1): p. 89-93.
- Background: PubMed 12238347Iqbal A, Siddiqui KS. Depression among parents of children with acute lymphoblastic leukemia. J Ayub Med Coll Abbottabad. 2002 Apr-Jun;14(2):6-9.
- Background: PubMed 21624866Borsellino M, Young MM. Anticipatory coping: taking control of hair loss. Clin J Oncol Nurs. 2011 Jun;15(3):311-5. doi: 10.1188/11.CJON.311-315.
- Background: PubMed 21783416Graca Pereira M, Figueiredo AP, Fincham FD. Anxiety, depression, traumatic stress and quality of life in colorectal cancer after different treatments: A study with Portuguese patients and their partners. Eur J Oncol Nurs. 2012 Jul;16(3):227-32. doi: 10.1016/j.ejon.2011.06.006. Epub 2011 Jul 23.
- BackgroundPouresmail, Z., S. Sharafi, and M. Razi, The Role of Evidence Based Nursing in Prevention of Gastrointestinal Side Effects of Chemotherapy in Children with Cancer. International Journal of Pediatrics, 2014. 2(2.1): p. 48-48
- BackgroundMohammed, H.A., Impact of proposed nursing rehabilitation program on self management of selected side effects of chemotherapy for elderly patints with gastrointestinal cancer. CU Theses, 2012.
- Background: PubMed 20500346Munir F, Burrows J, Yarker J, Kalawsky K, Bains M. Women's perceptions of chemotherapy-induced cognitive side affects on work ability: a focus group study. J Clin Nurs. 2010 May;19(9-10):1362-70. doi: 10.1111/j.1365-2702.2009.03006.x.
- Background: PubMed 25164233Garcia S. The effects of education on anxiety levels in patients receiving chemotherapy for the first time: an integrative review. Clin J Oncol Nurs. 2014 Oct;18(5):516-21. doi: 10.1188/14.CJON.18-05AP.
- Individual participant dataSharing planned: No. No plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Mehwish HUSSAIN, PhD (Statistics) study chair
Assistant Professor, DUHS, Karachi
Dr. SHAMVIL ASHRAF, MBBS, DCH, MCPS, FCPS, MRCP study chair
Indus Hospital Karachi
Mr. Hakim Shah, MSN study chair
Associate Professor Institute of Nursing Dow University of Health Sciences Karachi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimedia education, booklet Providence and tele-nursing follow-up in people with Chemotherapy Effect, run by Nomi Waqas Gul at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression, Anxiety and Stress Scale - 21 (DASS-21) (time frame: up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03753542, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2022.