Caregiver BurdenNCT06204328
Combined Effects of mHealth Psychoeducational and Benson Relaxation Technique Among Female Informal Caregivers of Cancer Patients in Bangladesh
A study testing Benson relaxation technique and mHealth psychoeducation in people with Caregiver Burden, run by Hiroshima University at 1 site in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Caregiver Burden
- What is being tested?
- Benson relaxation technique and mHealth psychoeducation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Oct 2024to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Who is facing caregiving burden in the baseline screening of the study.
- Female being 18 years of age or older.
- At least 6 months of providing care to a cancer-diagnosed patient.
Who cannot join
- Refusal to collaborate with ongoing study.
- Caregivers who receive financial compensation or are employed as formal caregivers.
- Extremely traumatic events that occur during the study (such as the death of loved ones or patients, separations, etc.) or caregivers undergoing treatment with psychotropic drugs will not be included in the study.
- Without smart mobile devices at home.
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
Khwaja Yunus Ali Medical College Hospital
Sirajganj, Rajshahi Division, 6751
About this study
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
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.
Read more
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.
Read the 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 patient's 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 92.5% 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 Benson's 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, 1.3-1.5 million cancer patients which is added 0.2 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.
- Conditions
- Caregiver Burden
- Being tested
- Benson relaxation technique and mHealth psychoeducation
- Keywords
- Cancer, Caregiver, Care Burden, mHealth Psychoeducation, Benson Relaxation Technique, Bangladesh
- Medical subject headings
- Caregiver Burden, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benson relaxation technique and mHealth psychoeducationOther
Benson relaxation technique \& mHealth psychoeducation (combined intervention) will receive: 6 months.
Benson relaxation technique: Definition, benefits, and instruction about the Benson relaxation technique will be provided through recorded video, and a nurse will guide individuals face-to-face after receiving training from a physiotherapist.
mHealth psychoeducation: There will be six sessions in a total of six months of intervention, and every session will be conducted at the beginning of each month. During each session, recorded videos based on the self-determination theory (symptom management, maintaining and enhancing relationships, problem-solving, stress and coping, self-care, and effective communication) will be provided face-to-face to the intervention group via smartphones, tablets, or handheld computers. As well as phone calls and SMS reminders will continue every week for follow-up and question and answer sessions.
| Study group | Role | What they receive |
|---|---|---|
| Benson relaxation technique and mHealth psychoeducation | Active comparator | Intervention Group will receive 6 months mHealth psychoeducation \& Benson Relaxation Technique Receives: Other: Benson relaxation technique and mHealth psychoeducation |
| Usual care | No intervention | The usual care group will follow established and common practices by healthcare providers in these settings. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes the caregiving burden among female informal caregivers of cancer patients in Bangladesh.
The primary outcome will be evaluated by the Zarit Burden Interview scale.
The Zarit Burden Interview scale consists of 22 items, and each item has a 5-point Likert scale ranging from 0 to 4, whereas higher scores represent higher burden.
Measured: Baseline, 3 months (midline), and 6 months (endline) of intervention
Secondary outcomes (2)
Changes in caregivers' anxiety and depression of cancer patients.
Evaluate by using the Hospital Anxiety and Depression Scale.
The Hospital Anxiety and Depression Scale comprises 14 items, divided into 7 questions for anxiety and another 7 questions for depression. Each item has a 4-point Likert scale, with a minimum value of 0 and a maximum value of 3. The higher score indicates high anxiety or depression.
Measured: Baseline, 3 months (midline), and 6 months (endline) of intervention
Measuring the changes in quality of life among caregivers of patients with cancer.
Evaluate by using World Health Organization Quality of Life: Brief Version Instrument
The World Health Organization Quality of Life Brief Version comprises 26 items rated on a 5-point Likert scale ranging from 1 to 5, with a lower score representing the least favorable outcome and a higher score representing the most favorable outcome.
Measured: Baseline, 3 months (midline), and 6 months (endline) of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start1 Oct 2024
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver BurdenStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hiroshima University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MD MARUFUR ROSHID, Hiroshima University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06204328
- Sponsor's protocol ID
- NUB/ DPH/EC 2023/ 26
- Status last verified
- Nov 2025
- First submitted
- 28 Dec 2023
- Last updated
- 26 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: When the data will be available and we will share the data according to the recommendations of the clinical trial registration and the requests of the journals.
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06204328
- Acronym / sponsor ID
- NUB/ DPH/EC 2023/ 26
- Conditions
- Caregiver Burden
- Keywords
- Cancer, Caregiver, Care Burden, mHealth Psychoeducation, Benson Relaxation Technique, Bangladesh
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Hiroshima UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 12 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 patient's 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 92.5% 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 Benson's 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, 1.3-1.5 million cancer patients which is added 0.2 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Benson relaxation technique and mHealth psychoeducation | Active comparator | Other: Benson relaxation technique and mHealth psychoeducationIntervention Group will receive 6 months mHealth psychoeducation \& Benson Relaxation Technique |
| Usual care | No intervention | –The usual care group will follow established and common practices by healthcare providers in these settings. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Who is facing caregiving burden in the baseline screening of the study.
- Female being 18 years of age or older.
- At least 6 months of providing care to a cancer-diagnosed patient.
Key exclusion criteria (4 listed)
- Refusal to collaborate with ongoing study.
- Caregivers who receive financial compensation or are employed as formal caregivers.
- Extremely traumatic events that occur during the study (such as the death of loved ones or patients, separations, etc.) or caregivers undergoing treatment with psychotropic drugs will not be included in the study.
- Without smart mobile devices at home.
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 |
|---|---|---|
| Benson relaxation technique and mHealth psychoeducationBenson relaxation technique \& mHealth psychoeducation (combined intervention) will receive: 6 months. Benson relaxation technique: Definition, benefits, and instruction about the Benson relaxation technique will be provided through recorded video, and a nurse will guide individuals face-to-face after receiving training from a physiotherapist. mHealth psychoeducation: There will be six sessions in a total of six months of intervention, and every session will be conducted at the beginning of each month. During each session, recorded videos based on the self-determination theory (symptom management, maintaining and enhancing relationships, problem-solving, stress and coping, self-care, and effective communication) will be provided face-to-face to the intervention group via smartphones, tablets, or handheld computers. As well as phone calls and SMS reminders will continue every week for follow-up and question and answer sessions. | Other | Benson relaxation technique and mHealth psychoeducation |
Primary outcome
Changes the caregiving burden among female informal caregivers of cancer patients in Bangladesh.
Time frame: Baseline, 3 months (midline), and 6 months (endline) of intervention
The primary outcome will be evaluated by the Zarit Burden Interview scale. The Zarit Burden Interview scale consists of 22 items, and each item has a 5-point Likert scale ranging from 0 to 4, whereas higher scores represent higher burden.
2 secondary outcomes
Changes in caregivers' anxiety and depression of cancer patients.
Time frame: Baseline, 3 months (midline), and 6 months (endline) of intervention
Measuring the changes in quality of life among caregivers of patients with cancer.
Time frame: Baseline, 3 months (midline), and 6 months (endline) of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Individual participant dataSharing planned: No. When the data will be available and we will share the data according to the recommendations of the clinical trial registration and the requests of the journals.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Benson relaxation technique and mHealth psychoeducation in people with Caregiver Burden, run by Hiroshima University at 1 site in Bangladesh.
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 26 Nov 2025. 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 Bangladesh. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes the caregiving burden among female informal caregivers of cancer patients in Bangladesh. (time frame: Baseline, 3 months (midline), and 6 months (endline) of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Nov 2025.