Caregivers

Researchers are studying Chinese American family caregivers of people with moderate or advanced dementia who face difficult decisions about feeding options when persistent eating problems develop. The study evaluates a culturally adapted decision aid called the Chinese version of Making Choices Feeding Options for Patients with Dementia Decision Aid (CMCFODA) to help caregivers make informed choices about feeding methods. This research aims to improve decision-making by addressing cultural factors, lack of advance directives, and limited knowledge about the risks and benefits of tube feeding in dementia care. Participants are randomly assigned to one of two groups. One group receives usual care, which includes information from healthcare providers, and will get the electronic decision aid after data collection. The other group receives both electronic and paper versions of the CMCFODA decision aid along with personalized decision coaching within two weeks via secure video conferencing. This intervention is designed to support caregivers in making feeding-related decisions for their family members with dementia. During the study, researchers collect data at the start, one month, and three months later to measure decision conflict, knowledge about feeding options and dementia, and expectations of tube feeding. Other assessments include communication frequency with family and healthcare providers, feeding option preferences, and the feasibility and acceptability of the decision aid and coaching. Participants will be monitored throughout these periods to evaluate outcomes and support caregiver decision-making over time.

Young adults aged 25 to 39 who have cancer face unique challenges in coping, and their partners who provide care may feel burdened and less confident in their caregiving roles. Researchers are evaluating a brief psychotherapy intervention designed to improve how these young adults and their caregiving partners cope with cancer and maintain their relationships. This pilot study aims to test whether this intervention is feasible and acceptable in this specific group, providing important information for future larger studies. The intervention involves eight weekly virtual psychotherapy sessions lasting 45 to 60 minutes, delivered to young adults with cancer and their self-identified partners together. It is based on cognitive-behavioral therapy and couples-focused therapy principles tailored for young adults. A trained mental health practitioner will guide the sessions, which include teaching, practical exercises, and home practice. The study includes 10 young adults with cancer and their caregiving partners, totaling 20 participants. Participants will complete surveys before starting the intervention and again after finishing the eight sessions to measure feasibility and acceptability over approximately 14 weeks. They will also be invited to take part in optional interviews to share their experiences. This study is sponsored by Massachusetts General Hospital and does not include a control group or blinding. The total duration of involvement for participants is about three and a half months.

Researchers are evaluating a 12-week home-based mobile health (mHealth) intervention called the Shining Star study, aimed at improving adherence to the 24-Hour Movement Guidelines among preschool-aged children (3-4 years old) who currently meet zero or one of the guidelines for physical activity, screen time, and sleep. The trial seeks to determine if the intervention increases the number of children meeting all three guidelines and if the program is feasible for parents to implement. This randomized controlled trial compares an intervention group using the app to a waitlist control group. Participants in the intervention group will use the Shining Star mobile app, which delivers weekly lessons and behavior-related goals through concise messages, gamification features, behavior trackers, and a parent forum. The control group will receive no intervention during the initial 12 weeks but will complete the same assessments as the intervention group. After 12 weeks, control group participants will gain access to the app and resources. Physical activity and sleep will be tracked with accelerometers, and parents will complete questionnaires. Children's physical activity, sedentary behavior, and sleep patterns will be assessed at baseline, 6 weeks, and 12 weeks using accelerometers. Parents will provide feedback on their child's movement behaviors, development, and app usability through questionnaires and weekly surveys. Additional measures include motor skills tests, cognition assessments, behavioral problems, executive function, and BMI. Data will be securely stored and analyzed to evaluate the intervention's impact and app feasibility over the 12-week period.

Researchers are investigating how cancer affects the health and well-being of both patients and their families throughout the cancer journey. This study focuses on family health, needs, perceived support, quality of life, self-efficacy, depression, stress, and resilience among patients with breast, prostate, colorectal cancer, or lymphoma and their caregivers. The goal is to identify families who are particularly burdened or vulnerable and understand the factors contributing to their vulnerability. Participants include 240 patients and their appointed adult caregivers recruited from six Danish hospital departments. The study uses a mixed-methods approach, combining a longitudinal survey and family interviews. Patients and caregivers complete questionnaires at baseline, 3, 6, 12, and 18 months, assessing various aspects such as family health, support, quality of life, self-efficacy, depression, distress, and resilience. A subset of families participates in interviews at 3 and 12 months to explore their experiences and needs more deeply. During the study, participants will fill out validated questionnaires including the Family Health Scale, ICE Family Perceived Support Questionnaires, EQ-5D-5L, General Self-Efficacy Scale, Patient Health Questionnaire-9, Distress Thermometer, and Connor-Davidson Resilience Scale. The interviews will be conducted in person, at home, or online, lasting about one hour. Researchers will analyze the data to better understand family dynamics and identify vulnerable families, monitoring family health outcomes over a one-year period.

This research aims to evaluate whether the mother-daughter intervention called "Conmigo" can increase physical activity levels in Latina preadolescent girls aged 8 to 11. The study targets families from lower-income and less-acculturated backgrounds, addressing the decline in physical activity during adolescence. It also explores how individual factors like mothers' activity levels and family communication influence changes in physical activity over time. The trial compares two 10-week programs delivered at 18 elementary schools: a physical activity promotion intervention and an attention-control program focused on healthy eating. Both are led by YMCA staff and involve weekly 2-hour sessions where mothers and daughters participate together. The physical activity group engages in discussions, goal-setting, and group exercise, while the control group focuses on dietary behavior strategies. Participants will be assessed using devices that measure physical activity at enrollment, 3, 9, and 15 months. Mothers and daughters attend weekly sessions, and researchers will evaluate changes in physical activity, mother-daughter communication, parenting practices, and dietary intake. The study includes long-term follow-up and qualitative interviews to understand how the program works and its potential for broader use.

This research focuses on caregivers in the Bronx who are experiencing increased psychological distress due to the COVID-19 pandemic and related social challenges. It aims to evaluate how the CARE program and the Valera Health app can reduce this distress, improve access to healthcare, and support vulnerable caregivers, including those of children with psychiatric or autoimmune conditions and frontline healthcare workers. The study is a randomized controlled trial designed to assess these interventions' effects on caregiver stress, mood, anxiety, and healthcare engagement. Participants will be randomly assigned to one of three groups: the CARE program alone, the Valera Health app alone, or a combination of both. The CARE program involves 12 weekly one-hour group sessions lasting 12 weeks, while the Valera Health app offers parent education materials and connection to their child's treatment team. Smartphones and internet connectivity will be provided if needed to support participation. During the 24-week study period, caregivers will complete surveys at enrollment, 6 weeks, 12 weeks, and 24 weeks to measure perceived stress, reflective functioning, mood, anxiety, suicidality, and healthcare access. The study also explores how providing technology affects outcomes and uses machine learning to analyze various personal and social factors. The trial includes follow-ups and ongoing monitoring to understand the interventions' impact over time.

This research aims to evaluate the feasibility of a parent-child yoga intervention designed to reduce attention deficits in children aged 4 to 6 years with congenital heart disease (CHD). Children with CHD often face neurodevelopmental challenges, including a higher risk of attention deficit hyperactivity disorder (ADHD). This study is a preliminary step before conducting a larger randomized controlled trial (RCT) to test the effectiveness of this intervention in improving attention and long-term academic and psychosocial outcomes for these children and their families. The study is a single-blind, two-center, two-arm randomized feasibility trial involving 24 parent-child pairs. Participants will be randomly assigned in a 2:1 ratio to either an 8-week parent-child yoga program plus standard clinical care or standard clinical care alone with a waitlist option for yoga after the study. The yoga sessions last 45 minutes each week and include active and calming parts embedded in stories suitable for the child's developmental level. Parents and children will also be encouraged to practice 5-minute at-home exercises three times a week throughout the 8-week period and continue up to a 6-month follow-up. Participants will undergo three neurodevelopmental assessments: before the intervention, immediately after, and six months later. The study will monitor recruitment, dropout, and adherence rates; acceptability of randomization; variation in yoga delivery; and data completeness. These measurements will help determine the feasibility of the procedures and inform the sample size for the future full-scale RCT. Overall participation spans about eight months including the intervention and follow-up periods.

This research aims to compare the well-being of caregivers of patients undergoing autologous hematopoietic stem cell transplant by evaluating different care settings after transplant. The study focuses on measuring caregiver strain using the Caregiver Strain Index and other quality of life and mental health assessments. It is a randomized Phase 2 trial sponsored by Duke University, involving adult patients and their caregivers. Participants are assigned to one of three groups: home care where transplant aftercare is provided in the patient's home, hospital care with aftercare in the hospital, and clinic care with outpatient clinic aftercare. The study evaluates the impact of these care models on caregiver outcomes over various timeframes, including 14 days for the primary outcome and up to one year for secondary outcomes. The trial also includes monitoring of patient survival, infection rates, hospital admissions, and treatment-related effects. Participants will engage in assessments such as caregiver strain questionnaires, time diaries, self-efficacy scales, fatigue and mental health measures, quality of life surveys, and physical function tests. Data collection occurs at multiple timepoints up to one year, including tracking of costs and health resource use. Researchers will also evaluate biological samples like fecal and skin microbiome changes. Safety and treatment effects are monitored throughout with follow-ups extending to one year post-transplant.

This research aims to explore the effects and feasibility of a group-based Acceptance and Commitment Therapy (ACT) program for families of individuals with special health care needs. Parenting children with special needs can be stressful and impact caregivers' mental health, while individuals with special needs may struggle with the mismatch between their requirements and typical practices around them. The study focuses on promoting psychological flexibility, which supports value-guided living despite distressing thoughts or feelings. Participants will receive Acceptance and Commitment Therapy, a well-established behavioral psychotherapy adapted for families of individuals with special health care needs. The intervention is delivered in a group format tailored to these families. This pilot study evaluates how this therapy influences psychological flexibility and wellbeing over a six-week treatment period. During the study, participants will be assessed at baseline and at two, four, and six weeks into treatment. Researchers will measure changes in psychological flexibility, psychological inflexibility, psychological wellbeing, and parenting stress using standardized inventories and scales. Child behavior and participants' satisfaction and personal experiences with the program will also be evaluated. The study includes follow-up assessments within six weeks after completing treatment to understand the intervention's impact.

Researchers are evaluating the safety and effectiveness of a liposomal mitoxantrone combination regimen in treating relapsed and refractory solid tumors in children, adolescents, and young adults aged 6 to 24 years. This prospective, single-arm, multicenter clinical study aims to improve the objective response rate compared to historical data and to assess related side effects. The study focuses on specific tumor types including bone and soft tissue tumors and neuroblastoma among others. Participants will receive a treatment regimen combining mitoxantrone liposome, capecitabine, and anlotinib over 4 to 6 cycles, each lasting 21 days. Capecitabine is given twice daily on days 1 to 14, while anlotinib dosage is adjusted based on body weight and administered for 14 days per cycle. Those showing partial response or better may receive additional local treatments such as surgery or radiotherapy. During the study, participants will have regular checkups and tests to monitor tumor status, blood parameters, and other relevant health indicators. The main measurement is the objective response rate after up to 6 treatment cycles. Other outcomes include disease control rate, progression-free survival, overall survival, and safety monitoring for up to one year after treatment. The total observation period includes follow-up assessments to evaluate lasting effects and adverse events.