Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06204328
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-12
First Post:
2023-12-28
Brief Title:
Combined Effects of mHealth Psychoeducational and Benson Relaxation Technique Among Female Informal Caregivers of Cancer Patients in Bangladesh
Sponsor:
Hiroshima University
Organization:
Hiroshima University
Study Overview
Official Title:
The Prevalence of Caregiving Burden With Influencing Factors and Effect of mHealth Psychoeducational and Benson Relaxation Technique Among Female Informal Caregivers of Cancer Patients in Bangladesh
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background Cancer is a global health concern that places a substantial burden not only on patients but also on their informal caregivers often family members or close friends without formal medical training Numerous studies show that caregivers face significant burdens which impact their physical social and psychological well-being Female caregivers often subjected to cultural expectations face heightened challenges contributing to higher levels of burden and emotional distress However the combined effectiveness of Benson relaxation techniques and mHealth psychoeducational interventions on female informal caregivers of cancer patients remains relatively unexplored
Objective This study aims to investigate the combined effectiveness of the mHealth psychoeducational intervention and Benson relaxation techniques to reducing caregiving burden as well as anxiety and depression and to assess the impact on the quality of life among female informal caregivers of cancer patients in Bangladesh
Methods A randomized control trial study will be conducted at the Khwaja Yunus Ali Medical College and Hospital in Enayetpur Sirajganj Bangladesh Computer-generated simple random sampling technique will be used to select study participants The study period will be from April 2024 to September 2024 Data will be collected through face-to-face interviews employing validated tools such as Zarit Burden Interview Hospital Anxiety Depression Scale and Bangla WHOQOL-BREF
The intervention group will receive a combined intervention using self-determination theory symptom management maintaining and enhancing relationships problem-solving stress and coping self-care and effective communication and Benson relaxation techniques through recorded videos phone calls and SMS reminders over six months The control group will receive only usual care
The study ensures ethical practices obtains informed consent and prioritizes data safety and confidentiality Results will be analyzed using statistical methods which will provide valuable information for healthcare professionals policymakers and researchers in the field of cancer caregiving
Objective This study aims to investigate the combined effectiveness of the mHealth psychoeducational intervention and Benson relaxation techniques to reducing caregiving burden as well as anxiety and depression and to assess the impact on the quality of life among female informal caregivers of cancer patients in Bangladesh
Methods A randomized control trial study will be conducted at the Khwaja Yunus Ali Medical College and Hospital in Enayetpur Sirajganj Bangladesh Computer-generated simple random sampling technique will be used to select study participants The study period will be from April 2024 to September 2024 Data will be collected through face-to-face interviews employing validated tools such as Zarit Burden Interview Hospital Anxiety Depression Scale and Bangla WHOQOL-BREF
The intervention group will receive a combined intervention using self-determination theory symptom management maintaining and enhancing relationships problem-solving stress and coping self-care and effective communication and Benson relaxation techniques through recorded videos phone calls and SMS reminders over six months The control group will receive only usual care
The study ensures ethical practices obtains informed consent and prioritizes data safety and confidentiality Results will be analyzed using statistical methods which will provide valuable information for healthcare professionals policymakers and researchers in the field of cancer caregiving
Detailed Description:
Chronic and non-communicable diseases represent major challenges of the twenty-first century leading to severe consequences and societal issues for patients and communities across the globe Cancer is a significant public health concern worldwide Each year cancer claims the lives of over 50 million people globally with a particularly significant observation that 80 of these deaths occur in low- and middle-income countries Cancer is impacting not only the patients but also their families and caregivers Informal caregivers who are often family members or close friends play a crucial role in providing support and assistance to cancer patients These caregivers usually have no knowledgeable medical training The role of these caregivers is crucial throughout the entire disease trajectory of cancer patients starting from the moment of diagnosis until the end stages of the illness In the context of cancer caregivers often face significant challenges related to the patients treatment symptom management and fulfilling daily care needs Caring for cancer patients can result in increased levels of caregiving burden anxiety depression and reduced quality of life which they encounter throughout their caregiving journey
The prevalence of caregiving burden among caregivers of cancer patients is significant and well-established A study published in India reported that 925 of caregivers experienced mild to severe levels of burden Furthermore a systematic review published in Cancer Nursing indicated that between 37 and 100 of family caregivers reported feeling a certain level of caregiver burden in various studies Caregiving burden is negatively correlated with depression and anxiety A systematic review highlighted that among the population of cancer caregivers the prevalence of depression and anxiety was found to be 42 and 47 respectively This study indicated that nearly half of the caregivers experienced severe levels of depression 46 and anxiety 53 In addition the demands of caregiving can result in physical emotional and social limitations leading to a reduced overall quality of life Previous studies reported that the burden of caregiving has a negative impact on the quality of life among caregivers of cancer patients In Iran another study discovered that as the quality of life among caregivers increased there was a corresponding decrease in caregiver burden
Over the past few years there has been a growing interest in utilizing digital health technology particularly mobile health mHealth As defined by the World Health Organization mHealth is a term used for medical and public health practice supported by mobile devices such as mobile phones patient monitoring devices Personal Digital Assistants PDAs and other wireless devices The mHealth involves various communication channels such as short messaging service SMS phone calls online platforms social networks and emails to provide interventions mHealth psychoeducational interventions can provide caregivers with accessible information self-care tools and resources specific to their caregiving journey which can improve their knowledge skills and self-efficacy ultimately enhancing their capacity to manage caregiving responsibilities and their own well-being A previous study published in the JMIR Mental Health journal showed the effectiveness of mHealth psychological interventions as a viable treatment approach for caregivers who experience high levels of stress or burden In parallel relaxation techniques are one of the non-pharmacological methods used to relieve mental health problems in various patients and their caregivers Various relaxation techniques exist and among them Bensons relaxation technique BRT is considered one of the most effective low-cost and straightforward methods of intervention These techniques include mindfulness exercises that specifically treat a variety of mental and emotional symptoms such as burden anxiety pain depression mood swings and self-esteem problems Previous studies have demonstrated the effectiveness of the BRT in reducing caregiving burden anxiety and depression among various populations including caregivers
In Bangladesh 13-15 million cancer patients which is added 02 million every year Female caregivers play a vital role in providing personal support to patients As a cultural expectation women are generally expected to perform caregiving activities while also maintaining household responsibilities and familial commitments which places an additional burden on them Females in Bangladesh experience the most disadvantage and vulnerability for a multitude of reasons Research has shown that female caregivers experience higher levels of burden and emotional distress than male caregivers which has a substantial influence on life quality However the unique cultural context gender inequalities and social norms of Bangladesh might provide additional difficulties for these caregivers It is essential to create effective interventions and support systems to alleviate their burden and improve their mental health and overall quality of life To our knowledge there is a significant knowledge gap while there is growing evidence supporting the effectiveness of BRT and mHealth psychoeducational interventions separately their combined impact on female informal caregivers of cancer patients remains relatively unexplored This research protocol outlines a randomized controlled trial aimed at evaluating the effectiveness of combining the mHealth psychoeducational intervention and BRT in reducing these negative effects
The results of this study are expected that the combination of mHealth psychoeducational and BRT will be effective in reducing caregiver burden increasing psychological well-being and improving overall quality of life
The prevalence of caregiving burden among caregivers of cancer patients is significant and well-established A study published in India reported that 925 of caregivers experienced mild to severe levels of burden Furthermore a systematic review published in Cancer Nursing indicated that between 37 and 100 of family caregivers reported feeling a certain level of caregiver burden in various studies Caregiving burden is negatively correlated with depression and anxiety A systematic review highlighted that among the population of cancer caregivers the prevalence of depression and anxiety was found to be 42 and 47 respectively This study indicated that nearly half of the caregivers experienced severe levels of depression 46 and anxiety 53 In addition the demands of caregiving can result in physical emotional and social limitations leading to a reduced overall quality of life Previous studies reported that the burden of caregiving has a negative impact on the quality of life among caregivers of cancer patients In Iran another study discovered that as the quality of life among caregivers increased there was a corresponding decrease in caregiver burden
Over the past few years there has been a growing interest in utilizing digital health technology particularly mobile health mHealth As defined by the World Health Organization mHealth is a term used for medical and public health practice supported by mobile devices such as mobile phones patient monitoring devices Personal Digital Assistants PDAs and other wireless devices The mHealth involves various communication channels such as short messaging service SMS phone calls online platforms social networks and emails to provide interventions mHealth psychoeducational interventions can provide caregivers with accessible information self-care tools and resources specific to their caregiving journey which can improve their knowledge skills and self-efficacy ultimately enhancing their capacity to manage caregiving responsibilities and their own well-being A previous study published in the JMIR Mental Health journal showed the effectiveness of mHealth psychological interventions as a viable treatment approach for caregivers who experience high levels of stress or burden In parallel relaxation techniques are one of the non-pharmacological methods used to relieve mental health problems in various patients and their caregivers Various relaxation techniques exist and among them Bensons relaxation technique BRT is considered one of the most effective low-cost and straightforward methods of intervention These techniques include mindfulness exercises that specifically treat a variety of mental and emotional symptoms such as burden anxiety pain depression mood swings and self-esteem problems Previous studies have demonstrated the effectiveness of the BRT in reducing caregiving burden anxiety and depression among various populations including caregivers
In Bangladesh 13-15 million cancer patients which is added 02 million every year Female caregivers play a vital role in providing personal support to patients As a cultural expectation women are generally expected to perform caregiving activities while also maintaining household responsibilities and familial commitments which places an additional burden on them Females in Bangladesh experience the most disadvantage and vulnerability for a multitude of reasons Research has shown that female caregivers experience higher levels of burden and emotional distress than male caregivers which has a substantial influence on life quality However the unique cultural context gender inequalities and social norms of Bangladesh might provide additional difficulties for these caregivers It is essential to create effective interventions and support systems to alleviate their burden and improve their mental health and overall quality of life To our knowledge there is a significant knowledge gap while there is growing evidence supporting the effectiveness of BRT and mHealth psychoeducational interventions separately their combined impact on female informal caregivers of cancer patients remains relatively unexplored This research protocol outlines a randomized controlled trial aimed at evaluating the effectiveness of combining the mHealth psychoeducational intervention and BRT in reducing these negative effects
The results of this study are expected that the combination of mHealth psychoeducational and BRT will be effective in reducing caregiver burden increasing psychological well-being and improving overall quality of life
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None