The purpose of this study is to learn whether an education and support program can help caregivers feel more confident in technical and communication skills needed to care for a person with cancer. Patients with cancer and their caregivers face many challenges. These include learning about cancer and its treatment, coping with symptoms from illness and treatment side effects, making adjustments to usual activities, and managing the emotional effects of having a serious illness. This study is testing whether different forms of education and support can help caregivers feel better prepared. To find out if education about caregiving and different kinds of support are effective, study personnel will compare approaches to help find ways to improve the services that are provided to caregivers during cancer treatment. About 180 patients and their caregivers at the Seidman Cancer Center will take part in this study. Participating in research is voluntary and this study is funded by the National Institute of Health.



Eligible Ages
Over 18 Years
Eligible Genders
Accepts Healthy Volunteers

Inclusion Criteria

(for patients): - Diagnosis of stage I, II, III cancers of the rectum, anus, and esophagus; stage III NSCLC; and stage I - IV A/B head/neck (tongue, gum, oral cavity, nasopharynx, oropharynx, hypopharynx, parotid, or larynx). - Receiving their first course of radiation therapy. - Has an identified family CG who is willing to participate. Inclusion Criteria (for CGs): - Family member or friend of an adult patient described above; and - Identified by the patient as his/her primary CG, who is providing daily assistance and/or emotional support.

Exclusion Criteria

  • Patients who do not have a caregiver will be excluded. - CGs of patients who are receiving hospice care will be excluded because of the patient's poor prognosis and multiple issues associated with end-of-life care. - CGs who are themselves undergoing active cancer treatment will be excluded (hormonal treatment allowed).

Study Design

Study Type
Intervention Model
Parallel Assignment
Intervention Model Description
Randomization will be done using the minimization stratified randomization technique (QMinim). Stratification variables will be CG gender, CG age, and patient cancer type.
Primary Purpose
Supportive Care
Single (Investigator)
Masking Description
Research Assistant (RA) will be blind to which group CG is assigned.

Arm Groups

ArmDescriptionAssigned Intervention
No Intervention
Control - Standard of Care
- All participants will be screened for health literacy using a 4-item Brief Health Literacy Screening Tool (BRIEF)
- All participants will be screened for health literacy using a 4-item Brief Health Literacy Screening Tool (BRIEF) - Three in-person, one-on-one teaching sessions with the caregiver during radiation treatments, followed by a telephone booster contact 2 weeks post-treatment.
  • Behavioral: One-on-one teaching sessions
    One-on-one teaching sessions with the caregiver during radiation treatments. (note - intervention sessions 2 & 3 delivered by phone during COVID-19)
  • Behavioral: Telephone booster contact
    Telephone booster contact 2 weeks post-treatment.

Recruiting Locations

MetroHealth Medical Center
Cleveland, Ohio 44109
Peter M Laye, MD

More Details

Case Comprehensive Cancer Center

Study Contact

Susan Mazanec, PhD

Detailed Description

This is a 2-group, prospective, randomized controlled design to test the effect of an intervention, as compared to a usual care control group, on family caregivers (CG) outcomes, patient outcomes, and healthcare utilization outcomes during treatment. The objectives of this study are to: - 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. - Measure the effect of the intervention, as compared to a control group, on patient outcomes (HRQOL and interrupted treatment course), and healthcare utilization outcomes (unplanned hospital admissions, unplanned emergency room visits, and unplanned use of intravenous [IV] fluids). - Determine if CG self-efficacy mediates the effect of the intervention on CG anxiety. - Determine if patient illness factors, care demands (hours per week spent caregiving), and patient and CG demographic factors moderate the relationship between the intervention and CG outcomes. - Compare the costs of healthcare utilization (unplanned hospital admission, unplanned emergency room visits, and unplanned use of IV fluids) between the intervention and control groups.


Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.