Cancer
Conditions
Brief summary
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.
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, 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.
Interventions
BEHAVIORALOne-on-one support/educational sessions
One-on-one support/educational sessions with the caregiver during radiation treatments (note - intervention sessions 2 \& 3 delivered by phone during COVID-19 and remained an option after the pandemic).
BEHAVIORALTelephone booster contact
Telephone booster contact 2 weeks post-treatment.
Sponsors
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Masking description
Research Assistant (RA) will be blind to which group CG is assigned.
Intervention model description
Patient and family caregiver dyads are enrolled in this 2-group, prospective, randomized controlled design to test the effect of a caregiver intervention during radiation therapy. The study enrolled a total of 484 participants(242 dyads)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(for patients): * 18 years of age or older. * Diagnosis of stage I, II, III cancers of the rectum and anus, stage I, II, III, IVa esophagus; stage II-III NSCLC (excluding those receiving SBRT due to short treatment course); and stage I - IV A/B head/neck (tongue, gum, oral cavity, nasopharynx, oropharynx, hypopharynx, parotid, or larynx). Stage IV A/B will be allowed for HNC and stage IVa for esophagus as the intent of therapy is curative. * Has an identified family CG who is willing to participate. Inclusion Criteria (for CGs): * 18 years of age or older * Family member or friend of an adult patient described above * 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CG Anxiety at 20 Weeks Post-treatment | 20 weeks post treatment | Difference in CG anxiety between the intervention and control groups at 20 weeks post-radiation treatment. CG anxiety will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form 7a. This 7-item questionnaire assesses self-reported fear, worry, anxiety, tension, nervousness, and restlessness in the family caregiver over the last 7 days. This outcome will be reporting the average T-score for anxiety as measured by the PROMIS scale. Raw scores range from 7 to 35. Each participant's raw score on the scale will be converted to a standardized T-score that has a mean of 50 and a standard deviation of 10. A higher T-score represents greater anxiety. For example, a T-score of 60 is one standard deviation worse anxiety than average. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CG Anxiety at Baseline | Baseline | CG anxiety will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form 7a. This 7-item questionnaire assesses self-reported fear, worry, anxiety, tension, nervousness, and restlessness in the family caregiver over the last 7 days. This outcome will be reporting the average T-score for anxiety as measured by the PROMIS scale. Raw scores range from 7 to 35. Each participant's raw score on the scale will be converted to a standardized T-score that has a mean of 50 and a standard deviation of 10. A higher T-score represents greater anxiety. For example, a T-score of 60 is one standard deviation worse anxiety than average. |
| CG Anxiety at the End of Radiation Treatment | At end of treatment, average of seven weeks | Difference in CG anxiety between the intervention and control groups at the end of radiation treatment CG anxiety will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form 7a. This 7-item questionnaire assesses self-reported fear, worry, anxiety, tension, nervousness, and restlessness in the family caregiver over the last 7 days. This outcome will be reporting the average T-score for anxiety as measured by the PROMIS scale. Raw scores range from 7 to 35. Each participant's raw score on the scale will be converted to a standardized T-score that has a mean of 50 and a standard deviation of 10. A higher T-score represents greater anxiety. For example, a T-score of 60 is one standard deviation worse anxiety than average. |
| CG Anxiety at 4 Weeks Post Treatment | 4 weeks post treatment | CG anxiety between the intervention and control groups at 4 weeks post treatment. CG anxiety will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form 7a. This 7-item questionnaire assesses self-reported fear, worry, anxiety, tension, nervousness, and restlessness in the family caregiver over the last 7 days. This outcome will be reporting the average T-score for anxiety as measured by the PROMIS scale. Raw scores range from 7 to 35. Each participant's raw score on the scale will be converted to a standardized T-score that has a mean of 50 and a standard deviation of 10. A higher T-score represents greater anxiety. For example, a T-score of 60 is one standard deviation worse anxiety than average. |
| CG Depression | at baseline, at end of treatment (average of seven weeks), and at 4 and 20 weeks post treatment | CG depression will be measured with the PROMIS Depression Short Form 8b. This 8-item questionnaire assesses caregiver self-reported negative mood (sadness, guilt), views of self (worthlessness), and social cognition (loneliness), as well as decreased positive affect and engagement. It assesses depression over the last 7 days. This outcome will be reporting the average T-score for depression as measured by the PROMIS scale. Raw scores range from 8 to 40. Each participant's raw score on the scale will be converted to a standardized T-score that has a mean of 50 and a standard deviation of 10. A higher T-score represents greater depression. For example, a T-score of 60 is one standard deviation worse depression than average. |
| CG Health-related Quality of Life (HRQOL) as Measured by PROMIS Global Health Scale - Global Mental Health Domain | at baseline, at end of treatment (average of seven weeks), and at 4 and 20 weeks post treatment | The PROMIS Global Health Scale will be scored as two separate domains - Global Physical Health and Global Mental Health. These domains are not combined for a total score. Raw scores range from 4 to 20. Each participant's raw score on the scale will be converted to a standardized T-score that has a mean of 50 and a standard deviation of 10. A higher T-score represents better health (Global Physical Health or Global Mental Health) than the general population. For example, a T-score of 60 is one standard deviation better health than average |
| CG HRQOL as Measured by PROMIS Global Health Scale - Global Physical Health | Baseline, end of treatment, 4 weeks and 20 weeks post treatment | The PROMIS Global Health Scale will be scored as two separate domains - Global Physical Health and Global Mental Health. These domains are not combined for a total score. Raw scores range from 4 to 20. Each participant's raw score on the scale will be converted to a standardized T-score that has a mean of 50 and a standard deviation of 10. A higher T-score represents better health (Global Physical Health or Global Mental Health) than the general population. For example, a T-score of 60 is one standard deviation better health than average |
| CG Fatigue | at baseline, at end of treatment (average of seven weeks), and at 4 and 20 weeks post treatment | CG fatigue will be measured with the PROMIS Fatigue Short Form 7a, a 7-item questionnaire that evaluates the self-reported experience of fatigue (frequency, duration, intensity) and the impact of fatigue on daily activities. It assesses fatigue over the last 7 days. This outcome will be reporting the average T-score for fatigue. Raw scores range from 7 to 35. Each participant's raw score on the scale will be converted to a standardized T-score that has a mean of 50 and a standard deviation of 10. A higher T-score represents greater fatigue. For example, a T-score of 60 is one standard deviation worse fatigue than average. |
| Participant HRQOL (Cancer Patient) as Measured by FACT-G | at baseline, at end of treatment (average of seven weeks), and at 4 and 20 weeks post treatment | Participant HRQOL will be measured using the disease-specific versions of FACT-G that include common subscales (physical, social, emotional, and functional well-being) plus cancer-specific questions. The effect of the intervention on HRQOL across diagnoses will be analyzed using the common subscales. The symptom experience with each diagnostic group will be described using the cancer-specific subscale. Participants rate their response to each item on a 5-point Likert-type scale. After reverse-scoring negatively worded questions, items are summed. Higher scores indicate better quality of life. The FACT - Colorectal (FACT-C, Version 4) is a 37-item questionnaire that measures self-reported HRQOL in patients with colorectal cancer over the last 7 days. |
| Interrupted Treatment | End of radiation treatment, average of seven weeks | Interrupted Radiation Treatment Course, defined as the total number of missed treatment days due to patient or caregiver reasons, will be determined from the patient's radiation therapy treatment record. Number of days of each episode of absence from treatment will also be recorded. |
| Healthcare Utilization for Participants, as Measured by Number of Hospital Admissions | 20 weeks post treatment | Healthcare utilization was measured by number of hospital admissions during the entire study period. These were assessed via review of the patient's medical record at T4 (end of study). |
| Healthcare Utilization for Participants, as Measured by Number of Emergency Room Visits | 20 weeks post treatment | Healthcare utilization was measured by number of emergency room visits during the entire study period. These were assessed via review of the patient's medical record at T4 (end of study). |
| Healthcare Utilization for Participants, as Measured by Number of Visits for IV Hydration | 20 weeks post treatment | Healthcare utilization was measured by number of visits for IV hydration during the entire study period. These were assessed via review of the patient's medical record at T4 (end of study). |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSusan Mazanec, PhD, RN
Case Western Reserve University, Case Comprehensive Cancer Center, University Hospitals Cleveland Medical Center
Participant flow
Pre-assignment details
Family caregiver and cancer participant dyads are enrolled in this 2-group, prospective, randomized controlled design to test the effect of a caregiver intervention during radiation therapy. The study enrolled a total of 242 dyads=484 participants
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized 20-29 | 8 Participants |
| Age, Customized 30-39 | 18 Participants |
| Age, Customized 40-49 | 40 Participants |
| Age, Customized 50-59 | 134 Participants |
| Age, Customized 60-69 | 153 Participants |
| Age, Customized 70-79 | 104 Participants |
| Age, Customized 80-89 | 21 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 93 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 23 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 83 Participants |
| Race/Ethnicity, Customized Hispanic | 1 Participants |
| Race/Ethnicity, Customized More than one race | 2 Participants |
| Race/Ethnicity, Customized White | 387 Participants |
| Sex: Female, Male Female | 43 Participants |
| Sex: Female, Male Male | 211 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 117 | 9 / 117 | 0 / 125 | 9 / 125 |
| other Total, other adverse events | 0 / 117 | 0 / 117 | 0 / 125 | 0 / 125 |
| serious Total, serious adverse events | 0 / 117 | 0 / 117 | 0 / 125 | 0 / 125 |
Outcome results
None listed