This mixed-methods feasibility trial includes one experimental arm in which all participants receive the powered mobility intervention following a structured therapist training. Trained physical and occupational therapists participate in one to two days of in-person training to learn how to implement the intervention with children with cerebral palsy (GMFCS IV-V) and their caregivers in early childhood settings. Following training, therapists identify eligible child-caregiver dyads from their caseloads and conduct twelve biweekly home-based intervention sessions over six months. Each session focuses on mobility opportunities, caregiver coaching, and integration of powered mobility into daily routines using the Permobil Explorer Mini device. All sessions are video recorded for fidelity monitoring and qualitative analysis.

Therapists participate in a structured, evidence-based training on implementing powered mobility interventions for children with cerebral palsy (GMFCS IV-V) in early childhood settings. Training consists of one to two days of in-person sessions focused on knowledge transfer, therapist confidence, self-efficacy, and use of caregiver coaching and routines-based strategies. The training is co-designed with a community advisory board of administrators, therapists, and caregivers to ensure contextual relevance and feasibility.

Therapist Training on Powered Mobility Implementation

Following therapist training, participating therapists deliver a six-month powered mobility intervention to children with cerebral palsy (GMFCS IV-V) and their caregivers. Therapists conduct twelve biweekly home-based sessions focused on providing mobility opportunities, caregiver coaching, and integration of powered mobility into daily routines. The intervention uses the Permobil Explorer Mini device to facilitate self-initiated mobility. All sessions are audio-video recorded for fidelity monitoring and qualitative analysis.

Powered Mobility Intervention for Child-Caregiver Dyads

Rikkie Schley, M.S. CCC-SLP

Ashleigh Walters

Bethany M Sloane, PT, DPT, PhD

This arm will enroll patient and caregiver participants receiving evidence-based therapy as part of the protocol.

Participants will complete:

* 6-16 sessions of therapy 1x/week. Sessions are virtual or in-person at the Massachusetts General Hospital Cancer Center.
* Surveys and questionnaires pre- and post-treatment.

At the discretion of the therapist and the supervising therapist, the participant may receive up to 4 booster sessions after completion of the specific treatment protocol.

The intervention will mirror clinical care in psycho-oncology in which the therapist, collaboratively with their supervisor, will choose specific components of the following evidence-based treatments to administer based on the clinical presentation of the patient or caregiver and referring problem.

* Cognitive Behavioral Therapy (CBT)
* Acceptance Commitment Therapy (ACT)
* Mindfulness-Based Cognitive Therapy (MBCT)
* Mindfulness-Based Stress Reduction (MBSR)
* Meaning-Centered Psychotherapy (MCP)
* Cognitive Behavioral Therapy for Insomnia (CBT-I)
* CBT for pain
* CBT for fatigue
* CBT for nausea

Individualized Evidence-Based Therapy in Cancer (Patients and Caregivers)

This arm will enroll therapist participants as part of the protocol. Therapists participants will enroll in the study and receive training in delivering evidence-based therapy to patients in the cancer center. Therapists will complete pre and post-measures of therapist self-efficacy and competence, as well as a semi-structured exit interview.

Enrolled therapist participants will receive training in evidence-based therapies and deliver therapy to patient and caregiver participants.

Training in Individualized Evidence-Based Therapy in Cancer (Therapists)

Jamie Jacobs, Ph.D

This arm with serve as the control arm and receive the current standard of care, which is no caregiver training to conduct mid-upper arm circumference screenings and monthly clinic-based follow-up appointments for 3 months with a final visit at 6 months post enrollment.

This arm will include caregiver screening with a mid-upper arm circumference tape at home weekly. Caregivers will be trained to screen their child for malnutrition relapse using mid-upper arm circumference tapes and requested to bring their child back to the clinic when relapse is detected. Additionally, this arm will receive the standard of care, which includes a monthly follow-up schedule for the first 3 months post enrollment and a final follow-up at 6 months.

Caregivers enrolled in the trial who are assigned to the two experimental arms, will be provided mid-upper arm circumference tapes and trained on how to screen their child for malnutrition relapse and asked to bring their child back to the clinic if relapse is detected.

Training caregivers to screen children for malnutrition relapse

This arm will include caregiver screening with a mid-upper arm circumference tape at home weekly. Caregivers will be trained to screen their child for malnutrition relapse using mid-upper arm circumference tapes and requested to bring their child back to the clinic when relapse is detected. Additionally, this arm will receive a reduced follow-up schedule at the clinic, which will include one planned visit at 3 months post enrollment and a final follow-up visit at 6 months.

Caregivers in one of the caregiver mid-upper arm circumference screening arms, will be asked to adhere to a reduced follow-up clinic visit schedule for when they bring their child to the clinic for planned visits. The standard of care includes monthly visits for the first 3 months post recovery, but those randomized to the reduced follow-up schedule arm, will not bring their child to the clinic for planned visits 1 month and 2 months after baseline.

Reduced follow-up schedule

Ali Sie, MD, PHD

Mamadou Bountogo, MD, PHD

Complex care psychoeducation training intervention for family caregivers

Learning Skills Together is a 6-week psychoeducational intervention developed to improve caregivers' confidence when completing complex care tasks (e.g., using a gait belt). Participants are asked to attend six 1.5-hour Zoom-delivered group discussion sessions once per week, which cover topics such as how to communicate with someone who is living with dementia, medication management, and home safety. Participants are also provided with a workbook that accompanies each lesson, and includes short readings, videos, additional resources, as well as weekly practice and reflection exercises.

Learning Skills Together Intervention

Healthy living intervention for family caregivers

Participants in the Caregiver Healthy Living Intervention will participate in a 6-week educational intervention to help improve caregiver health behaviors (e.g., getting enough sleep). Participants are asked to attend six 1.5-hour Zoom-delivered group discussion sessions once per week, which cover topics such as how to eat a healthy diet, getting enough physical activity, and taking care of mental health. Participants are also provided a workbook that includes short readings and additional resources.

Caregiver Healthy Living Intervention

Kylie Meyer, PhD

The BTS-C is an online sleep health education program that is located on a mobile application. The BTS-C utilizes asynchronous avatar-based interactive learning and educational content and videos that are tailored to the caregivers' goals and expectations, paired with targeting messages for change surrounding principles of sleep health practices. The modules will be completed over the course of 6 weeks.

The BTS-C includes 6 educational modules on different topics related to sleep health: principles of healthy sleep practices include sleep routines, the sleep environment, considerations for screen time, timing of sleep and activities surrounding sleep, expectations for healthy sleep and sleep duration. Caregivers will also receive a combination of tailored messages or prompts to explore progress, identify strategies for change, and goal setting.

Bedtime Stories Sleep Health Education Program for Caregivers (BTS-C)

Grace Y Wang

Arm Type: Experimental Relatives of chemotherapy patients received a structured training program covering self-efficacy, nutrition, and stress management. The training was delivered in group sessions supported by educational materials.

A structured educational intervention designed for caregivers of cancer patients undergoing chemotherapy, delivered in 30-45 minute sessions to groups of 4-5 participants. The program includes modules on self-efficacy, stress management, healthy lifestyle behaviors, interpersonal relationships, and nutrition based on the Mediterranean diet. Content covers evidence-based strategies for improving family health, psychological well-being, and dietary adherence. Sessions are conducted by a certified practitioner with 480 hours of family counseling training in a university hospital's medical oncology unit seminar room. The intervention aims to reduce caregiver burden, enhance psychological well-being, improve adherence to the Mediterranean diet, and promote family health, as assessed by the Family Health Scale (ASÖ), Mediterranean Diet Adherence Scale (MEDAS), and Psychological Well-Being Scale (PİO) at baseline (t0), post-intervention (t1), and 6 weeks follow-up (t2).

Structured Education Program for Caregivers of Chemotherapy Patients

Relatives of chemotherapy patients received standard care without additional structured training.

Participants received an 8-week online nutrition education program. Individuals with Down syndrome attended weekly sessions (\~15 minutes) focusing on understanding food groups, adopting healthy eating principles, reducing sugary/packaged foods, increasing daily physical activity, and emphasizing adequate daily water intake. Caregivers received four modules (\~30 minutes each) covering healthy eating principles, food groups, physical activity, common comorbidities and metabolic changes in Down syndrome, and key considerations in nutrition therapy. Sessions were delivered via live video conferencing with slide-based materials shared during sessions and sent afterward via online messaging.

An 8-week online nutrition education program delivered via live video conferencing with slide-based materials shared during sessions and sent afterward to caregivers.

Caregiver-Involved Nutrition Education

Patient level: training on how to use a blood pressure (BP) monitor and online patient portal (ex. MyChart), receive reminders to take their BP at home, receive educational messages, and access to language-concordant educational materials.

Clinic level: training on standardized workflows and EHR tools, audit and feedback

Patients will be taught how to use a BP monitor, along with the accompanying mobile app to view their readings.

BP monitor use training and app training

Patients will receive training on how to use an online patient portal. If they are not yet enrolled in an online patient portal and would like to be, they will also be enrolled into one.

Online patient portal enrollment and training

Patients will receive reminders via SMS to take their blood pressure.

SMS reminders to take blood pressure

One-time training with action planning, access to website with language concordant patient education, and educational text messages

Education about self-management of hypertension

Patient level: In addition to the Low-Intensity Arm strategies, patients will be asked to attend four educational group sessions with other trial patients. Patients will also be asked to involve support persons in their hypertension management. The educational messages that patients receive will also explicitly encourage involvement of a support person.

Clinic level: training on standardized workflows and EHR tools, audit and feedback

Educational text messages about behavioral changes that explicitly encourage seeking support from a support person

Educational text messages that encourage seeking support from a support person

Patients will be asked to involve a caregiver or support person for all activities above, including patient portal proxy access.

Involvement of caregiver or support person

Patients will be asked to attend in-person or online group education classes on hypertension management

Group classes

Participants randomized to the intervention group will be assigned a CHW/P who will provide support for up to 6 months after randomization. CHW/Ps will attend the initial oncology visit when possible, review and explain the treatment plan, assist with scheduling and logistics (e.g., transportation, language services), complete a social needs assessment, connect patients to social support services, and offer peer support connections. CHW/Ps will maintain regular contact with patients, at least every other week for the first 3 months, and be available by phone as needed for an additional 3 months. They will also alert the clinical team if the patient expresses unresolved concerns or questions.

A Community Health Worker/Patient Navigator provides care coordination, social needs assessment, assistance accessing services, logistical support, and ongoing contact for up to 6 months following randomization.

CHW/P Navigator Support

Participants in the control group will receive a printed or digital list of local social service resources, including websites and phone numbers, but will not receive CHW/P support or navigation services.

Participants receive a printed or digital list of local social service resources, including websites and phone numbers for enrollment and access to services.

치료사를 위한 전동 이동 장치 활용 교육, 아동-보호자 쌍을 위한 전동 이동 장치 중재

암 환자 및 보호자를 위한 개별 맞춤형 근거 기반 치료, 암 환자를 위한 개별 맞춤형 근거 기반 치료 교육(치료사)

영양실조 재발을 위한 어린이 검진을 위한 보호자 교육, 후속 조치 일정 단축

함께 배우는 기술 훈련 프로그램, 보호자 건강 생활 프로그램

보호자를 위한 취침 이야기 수면 건강 교육 프로그램(BTS-C)

항암화학요법 환자 보호자를 위한 체계적 교육 프로그램

보호자 참여형 영양 교육

라인 환자 포털 등록 및 교육, 혈압 측정 알림 문자 메시지, 고혈압 자가 관리 교육, 보호자의 도움을 구하도록 권장하는 교육용 문자 메시지, 간병인 또는 보호자 참여, 그룹 수업

지역사회 보건 종사자/보호자 내비게이터 지원, 사회복지 서비스 자원 목록