Behaviors and Mental Disorders

All Conditions

Caregiver Burden

Quality of Life

Explore Factors related to Truth Telling in Primary Caregivers of Children Newly Diagnosed with Cancer

Chen-Ni Li

SHIANN-TARNG JOU, PhD

The purpose in this study was to investigate the current status, changes, correlation, and predictive factors of the truth telling, hope, care burden, and quality of life during treatment in primary caregivers of newly diagnosed children with cancer.

Background: Over the last 50 years, telling truth in adult with cancer was direct. However, studies of truth telling in newly diagnosed children with cancer were seldom. Explore the factors and experiences related to truth telling in primary caregivers of children newly diagnosis with cancer were seldom too. Therefore, we could not estimate the current status of truth telling in primary caregivers of newly diagnosed children with cancer.

Purpose: The purpose in this study was to investigate the current status, changes, correlation, and predictive factors of the truth telling, hope, care burden, and quality of life during treatment in primary caregivers of newly diagnosed children with cancer.

Method: Purposive sampling structured questionnaire, used longitudinal resistance, repeated measurements, correlational design. SAS 9.3 for Windows was used for data entry and analyze. By using the frequency, percentage, mean, and standard deviation to describe demographic information and current status of truth telling. By using the mean, standard deviation, maximum and minimum to analyze hope, care burden, and quality of life. Demographic information, medical information data, truth telling, Herth Hope Index, caregiver burden scale, and quality of life index were tested by Pearson correlation coefficients; the change and predictors about truth telling, Herth Hope Index, caregiver burden scale, and quality of life index were tested by Generalized estimating equation.

Limitation: Studying in one medical center in Taipei, it could not estimate the country's primary caregivers of newly diagnosed children with cancer in conclusions. Because of the limitation of the manpower, time and case numbers, study tracked only six month, could not be assessed the long-term change of the Herth Hope Index, caregiver burden scale, truth telling and quality of life in primary caregivers of newly diagnosed children with cancer.

Factors Related to Truth Telling in Primary Caregivers

Explore Factors Related to Truth Telling in Primary Caregivers of Children Newly Diagnosed With Cancer

The scores of primary caregivers' Herth Hope Index change from baseline at family meeting at 3 months, and at 6 months.

We use Herth Hope Index(HHI) to evaluate the hope that the primary caregivers' care their child during treatment.

There are twelve questions in the Herth Hope Index. The total score is from 12 to 48. Cronbach's α is .89. Retest is .80. Two weeks retest is .86.

The higher the score is, the greater the hope is.

The scores of primary caregivers' quality of life index change from baseline at family meeting at 3 months, and at 6 months.

We use quality of life index(Q.L.I) to evaluate the quality of life that the primary caregivers' care their child during treatment.

There are 66 questions in the quality of life index. The total score is from 66 to 264. Cronbach's α is .95. Two weeks retest is .87.

The primary caregivers' truth telling change from baseline at family meeting at 3 months, and at 6 months.

Asking the primary caregivers' about that if you tell your child that he/she got the cancer, if you tell your child that he/she the treatment in future, and if you tell your child that he/she the rate of survival.

The scores of primary caregivers' care burden change from baseline at family meeting at 3 months, and at 6 months.

We use Questionnaire of care burden to evaluate the care burde that the primary caregivers' care their child during treatment.

There are 20 questions in the quality of life index. The total score is from 0 to 60. Cronbach's α is .91.

The higher the score is, the heavier the care burden is.

National Taiwan University Hospital

Stress, Psychological

Behavioral Symptoms

Intervention Group will receive 6 months mHealth psychoeducation \& Benson Relaxation Technique

The usual care group will follow established and common practices by healthcare providers in these settings.

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.

Benson relaxation technique and mHealth psychoeducation

MD MARUFUR ROSHID

Md Moshiur Rahman, PhD

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.

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.

The computer-generated simple random sampling technique will be used to select the caregiving burden of study participants for both the intervention and control groups.

Combined Effects of mHealth Psychoeducational and Benson Relaxation Technique Among Female Informal Caregivers of Cancer Patients in Bangladesh

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

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.

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.

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Factors Related to Truth Telling in Primary Caregivers	NCT02214446	Primary Caregiv...		20 Years -	National Taiwan University Hospital
Factors Related to Truth Telling in Primary Caregivers	NCT02214446	Primary Caregiv...		20 Years -	National Taiwan University Hospital
Combined Effects of mHealth Psychoeducational and Benson Relaxation Technique Among Female Informal Caregivers of Cancer Patients in Bangladesh	NCT06204328	Caregiver Burde...	Benson relaxati...	18 Years -	Hiroshima University
Factors Related to Truth Telling in Primary Caregivers	NCT02214446	Primary Caregiv...		20 Years -	National Taiwan University Hospital

Spots Global Cancer Trial Database for care burden

Every month we try and update this database with for care burden cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for care burden

Every month we try and update this database with for care burden cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for care burden cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.