Results Summary
What was the research about?
After having a stem cell transplant to treat cancer, patients often need help from a full-time caregiver at home. Support from a caregiver is important to a patient’s recovery. But being a caregiver can be stressful. Stress management programs for caregivers may improve their well-being. Having a caregiver who is less stressed may also improve patients’ quality of life.
The research team created a stress management program for caregivers of patients who received a stem cell transplant. The team wanted to see if the program helped caregivers and the patients they cared for. Caregivers in the program talked to a social worker about coping with stress and getting help from others when they felt stressed. The team compared people in the program with people getting usual support. Usual support included services such as support groups that hospitals offer as well as educational materials.
What were the results?
Caregivers in the program reported feeling less distressed and depressed compared with caregivers with usual support. There were no differences between caregivers in the two groups in other signs of well-being.
There were no differences in quality of life between patients with caregivers in the program and patients with caregivers getting usual support.
Who was in the study?
The study included 155 patients with cancer who had stem cell transplants and their caregivers. Patients received care from a hospital or a health center in Denver, Colorado. Of the caregivers, 83 percent were white, 6 percent were another race, and 4 percent were multiracial. Also, 7 percent were Hispanic. The average caregiver age was 54, and 80 percent were women.
What did the research team do?
This study put caregivers into one of two groups by chance. The first group was in the stress management program. The second group had usual support.
Caregivers in the program had 8 to 10 sessions with a social worker in the three months after the patients’ transplants. About 15 percent of sessions were by telephone or video chat. The rest were in-person sessions.
The research team followed up with patients and caregivers at six weeks, three months, and six months after the patients’ transplants. Caregivers answered questions about depression, anxiety, stress, and burden. They also gave blood and hair samples to test for signs of stress. Patients took surveys about quality of life.
A community advisory board gave input during the study. The board included six former patients and their caregivers and two members of a community support group.
What were the limits of the study?
This study took place in the Denver area. Most caregivers were white women in their 50s. Results may have been different for caregivers from other backgrounds or who live in other places. Results also may have been different for patients with other cancers or who didn’t have stem cell transplants.
Future research could look at ways to further lower caregiver stress and include patients and caregivers with different backgrounds.
How can people use the results?
Hospitals can look at these results when deciding on ways to help lower caregivers’ stress.
Professional Abstract
Objective
To examine if a stress management program for caregivers of patients with cancer who received stem cell transplants improves patient quality of life and reduces caregiver distress compared with usual support for caregivers
Study Design
| Design Elements | Description |
|---|---|
| Design | Randomized controlled trial, intent-to-treat analysis |
| Population | 155 patients with cancer receiving allogeneic hematopoietic stem cell transplants and their caregivers |
| Interventions/ Comparators |
|
| Outcomes |
Primary: patient quality of life (measured as general, functional, social, emotional, and physical well-being), caregiver distress (measured as a composite of depression, anxiety, and stress) Secondary: caregiver-reported depression, anxiety, stress, and burden; caregiver biomarkers of stress |
| Timeframe | 6-month follow-up for primary outcomes |
In this randomized controlled trial, the research team assigned the caregivers of patients with cancer who had undergone stem cell transplants to either a stress management program called Psychoeducation, Paced Respiration, and Relaxation (PEPRR-2.0) or to usual support. Usual support included access to the hospital’s psychosocial resources, such as psychologists and support groups, as well as educational materials.
The study included 155 patient-caregiver dyads receiving care at a hospital and a medical center in the Denver, Colorado, area. Of the caregivers, 83% were white, 6% were another race, and 4% were multiracial; also, 7% were Hispanic. The mean caregiver age was 54, and 80% were female.
In the stress management program, caregivers attended 8 to 10 one-hour individual sessions with a social worker during the three months after the patients’ transplants. Sessions covered coping skills; social support; and identification of distorted thinking or thinking that is based more on emotions and worries than on facts. About 15% of sessions occurred via telephone or video conference; the rest were in-person. The research team assessed the patients and caregivers at six weeks, three months, and six months after the patients’ transplants.
A community advisory board provided input throughout the study. The board consisted of six former patients and their caregivers and two members of a community support group.
Results
Caregivers in the stress management program showed decreased distress (p=0.007) and depression (p=0.05) from baseline to six months compared with caregivers who received usual support. The research team did not find significant differences between the two groups in caregiver anxiety, stress, burden, or biomarkers of stress.
Patients with caregivers in the stress management program did not show greater improvement in quality of life than patients whose caregivers received usual support.
Limitations
The study took place in the Denver area. Results may differ in other locations. Most caregivers were white women in their 50s, and most patients were white men in their 50s. All patients were receiving a specific cancer treatment with caregiving requirements. Results may not apply to other groups of caregivers or patients.
Conclusions and Relevance
Clinicians and hospital administrators can use these findings when considering how to support caregivers of patients with cancer receiving stem cell transplants.
Future Research Needs
Future research could examine other stress management programs for caregivers or examine the performance of this stress management program with patients who have a wider variety of healthcare needs and characteristics.
Final Research Report
View this project's final research report.
Journal Citations
Results of This Project
Related Journal Citations
Peer-Review Summary
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
Peer reviewers commented, and the researchers made changes or provided responses. The comments and responses included the following:
- Reviewers asked whether researchers met key statistical assumptions given the large number of patients and caregivers who did not complete outcomes assessments at six months. The researchers explained that they had to close recruitment to meet study time limits, and they assumed data were missing at random because the drop-out rates were similar to the researchers’ previous experiences with this population.
- Reviewers criticized enrollment criteria that excluded those who did not speak and read English and were unwilling to use a smartphone. The researchers explained that they did not exclude any participants for refusing to use a smartphone. Researchers also explained that they excluded fewer than 16 percent of potential participants from the study because of a language barrier. More common barriers involved clinical issues. Ultimately, the demographics of those recruited for the study matched those for stem cell transplant recipients nationally.
- Given past studies that found benefits to caregivers who received support, reviewers suggested that randomly assigning some participants to treatment as usual may no longer be ethically acceptable. The researchers agreed and explained that although the control group did not receive one-on-one counseling sessions, the group received the same written materials as those in the intervention group. Based on reviewers’ suggestions, the researchers changed the name of this comparison condition to enhanced treatment as usual.
- Reviewers wondered whether the patient outcome measures used were well chosen. The researchers said that in retrospect they would have used a different measure for patient quality of life, one that was more sensitive to psychological effects. But once the researchers registered the clinical trial publicly, restrictions prevented them from changing the primary outcome measure. The researchers emphasized the limitations of the patient outcome measure in their report, and they plan to complete exploratory analyses of the measure’s subscales to determine if there are other effects of caregiver distress.
- Reviewers asked whether a conceptual model could be used to guide interpretation of the findings and better support the concept of caregiver distress affecting patient quality of life, as well as a post-hoc conceptual model for ongoing analyses. The researchers added a conceptual model to the revision but did not feel it was appropriate to develop a post-hoc conceptual model since they were still going through extensive exploratory analyses.