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Principal Investigator: Susan Mazanec
Organization: CASE WESTERN RESERVE UNIVERSITY
Fiscal Year: 2024
Award: $440,890
Funding agency: National Cancer Institute
Project Summary/Abstract:
Patients with head and neck, lung, esophageal, rectal, and anal cancers typically undergo rigorous, intense,
combined-modality treatment (radiation, surgery, and/or chemotherapy) and experience high symptom burden,
functional impairment, and complex psychosocial issues. Positive treatment outcomes and avoidance of
complications are dependent largely on the adequacy of care provided by family members. However, family
caregivers (CGs) report feeling unprepared to assume the multiple, complex tasks of caregiving, including
tangible help with tracheostomy care, tube feedings, wound and colostomy care, pain management, and
ongoing emotional support. Despite being a critical extension of the oncology healthcare team, training of CGs
to manage symptoms, deal with communication issues with care recipients, and take care of their own physical
and emotional health, is not integrated into clinical practice. This study will measure the effect of a
psychoeducational and skills training intervention that incorporates structured simulation or experiential
learning to improve CG, patient, and healthcare utilization outcomes. Simulation is effective in training
healthcare professionals, but little is known about its effectiveness in training family CGs. The intervention is
designed for the period of active cancer treatment and the immediate transition to posttreatment survivorship, a
time when the CG and patient are most vulnerable. The specific aims of this 2-group, prospective, randomized
controlled trial are to: (1) evaluate the effect of a CG intervention, as compared to a control group, on CG
primary (anxiety) and secondary (depression, health-related quality of life [HRQOL], and fatigue) outcomes; (2)
measure the effect of the intervention on patient outcomes (HRQOL and interrupted treatment course) and
healthcare utilization outcomes (unplanned hospital admission, unplanned emergency room visits, and
unplanned use of intravenous fluids); (3) determine if CG self-efficacy mediates the effect of the intervention on
CG anxiety; (4) determine if patient illness factors, care demands, and patient and CG demographic factors
moderate the relationship between the intervention and CG outcomes; and (5) compare the costs of healthcare
utilization between the intervention and control groups. We will recruit 180 CGs from University Hospitals
Seidman Cancer Center at the Case Comprehensive Cancer Center. The intervention involves three in-person,
one-on-one sessions during radiation treatments, followed by a telephone contact 2 weeks posttreatment. Data
will be collected at baseline, at the end of radiation treatment, and 4 and 20 weeks postradiation treatment.
The analysis will consist of linear mixed model repeated measures, mediation and moderation tests, and
Poisson regression methods. The proposed project addresses National Cancer Institute's Division of Cancer
Control and Population Sciences mission of improving the delivery of care to individuals and family members
affected by cancer. The study findings will provide crucial information for translating the psychoeducational and
simulation methods used in this intervention to other CG populations and clinical settings.
Terms: <Active Learning><Address><Adverse Experience><Adverse event><Affect><After Care><After-Treatment><Aftercare><Anal><Anal Cancer><Anal Cancers><Anus><Anus Cancer><Anxiety><Cancer Center><Cancer Family><Cancer Treatment><Cancers><Care Givers><Care giver intervention><Caregiver instruction><Caregivers><Caring><Clinical><Colostomy><Colostomy Procedure><Combined Modality Therapy><Communication><Complex><Comprehensive Cancer Center><Control Groups><Cooperative Learning><DCCPS><Data><Decision Making><Dehydration><Demographic Factors><Distress><Division of Cancer Control and Population Sciences><ED visit><ER visit><Education><Education for Intervention><Educational Intervention><Educational aspects><Educational process of instructing><Effectiveness><Emergency care visit><Emergency department visit><Emergency hospital visit><Emergency room visit><Emotional><Emotional well being><Enteral Feeding><Esophageal Cancer><Esophagus><Esophagus Cancer><Event><Experiential Learning><Face><Family><Family Care Giver><Family Caregiver><Family member><Fatigue><Feeling><Feels well><Functional impairment><Goals><Head and Neck><Head and Neck Cancer><Head and Neck Carcinoma><Head and neck structure><Health><Health Care Professional><Health Care Systems><Health Care Team><Health Care Utilization><Health Professional><Healthcare Systems><Healthcare Team><Healthcare professional><Hospital Admission><Hospitalization><Hour><IV Fluid><Impairment><Individual><Instruction Intervention><Interruption><Intervention><Intervention Strategies><Intravenous Fluid><Lack of Energy><Lead><Location><Malignant Anal Neoplasm><Malignant Anal Tumor><Malignant Esophageal Neoplasm><Malignant Esophageal Tumor><Malignant Head and Neck Neoplasm><Malignant Neoplasm Therapy><Malignant Neoplasm Treatment><Malignant Neoplasms><Malignant Tumor><Malignant Tumor of the Anus><Malignant Tumor of the Esophagus><Malignant Tumor of the Lung><Malignant neoplasm of anus><Malignant neoplasm of esophagus><Malignant neoplasm of lung><Malnutrition><Measures><Mediating><Mediation><Medical Care Team><Mental Depression><Methods><Mission><Modality><Modeling><Multimodal Therapy><Multimodal Treatment><NCI Organization><NSCLC><NSCLC - Non-Small Cell Lung Cancer><National Cancer Institute><Negotiating><Negotiation><Non-Small Cell Lung Cancer><Non-Small-Cell Lung Carcinoma><Normal mental condition><Normal mental state><Normal psyche><Nutritional><Nutritional Deficiency><Oncology><Oncology Cancer><Operative Procedures><Operative Surgical Procedures><Outcome><Pain Control><Pain Therapy><Pain management><Patient Care><Patient Care Delivery><Patient outcome><Patient-Centered Outcomes><Patient-Focused Outcomes><Patients><Pb element><Persons><Phone><Play><Population><Preparation><Problem Solving><Process><Prognosis><Psychological Well Being><Psychosocial Influences><Psychosocial Issues><Pulmonary Cancer><Pulmonary malignant Neoplasm><QOC><Quality of Care><Radiation><Radiation therapy><Radiotherapeutics><Radiotherapy><Randomization trial><Randomized, Controlled Trials><Rectal Cancer><Rectal Carcinoma><Rectum><Reporting><Research><Role><Self Efficacy><Self Management><Sense of well-being><Skin><Structure><Surgical><Surgical Interventions><Surgical Procedure><Symptom Burden><Symptoms><Teaching><Techniques><Telephone><Testing><Time><Tracheostomy><Tracheostomy procedure><Training><Training Intervention><Translating><Treatment Side Effects><Treatment outcome><Treatment-related side effects><Undernutrition><University Hospitals><Well in self><anal squamous cell carcinoma><anti-cancer therapy><body water dehydration><cancer therapy><cancer-directed therapy><care delivery><care for patients><care giver education><care giver instruction><care giver training><care giving><care of patients><care receiver><care recipients><caregiver education><caregiver interventions><caregiver training><caregiving><caring for patients><chemotherapy><classroom environment><clinical practice><college atmosphere><collegial atmosphere><collegiate atmosphere><combination therapy><combined modality treatment><combined treatment><compare cost><cost comparison><depression><design><designing><dietary deficiency><education atmosphere><educational atmosphere><educational environment><emotional wellbeing><emotional wellness><enteric feeding><experience><faces><facial><family building><family management><feeding tube><feelings><gastric feeding><head/neck cancer><health care service use><health care service utilization><health related quality of life><health training><healthcare service use><healthcare service utilization><healthcare utilization><heavy metal Pb><heavy metal lead><improved><instructional intervention><intellectual atmosphere><intervention effect><interventional strategy><learning atmosphere><learning environment><lung cancer><malignancy><malignant head and neck tumor><malnourished><manage symptom><mental well-being><mental wellbeing><mental wellness><multi-modal therapy><multi-modal treatment><neoplasm/cancer><novel><nutrition deficiency><nutrition deficiency disorder><nutritional deficiency disorder><nutritious><oesophageal cancer><pain treatment><patient oriented outcomes><pilot test><point of care><post treatment><preparations><primary care giver><primary caregiver><prospective><psychoeducation><psychoeducational intervention><psychological distress><psychological wellbeing><psychological wellness><radiation treatment><randomized control trial><randomized trial><recruit><school atmosphere><school climate><self wellness><sense of wellbeing><simulation><skill acquisition><skill development><skills><skills training><social role><surgery><survivorship><symptom management><tissue wound><training atmosphere><treatment with radiation><tube feeding><university atmosphere><usual care arm><usual care control group><virtual><wound><wounding><wounds>