This trial studies how well CareSTEPS works in improving quality of life in caregivers and participants with stage IIIB-IV non-small cell lung cancer or extensive stage small cell lung cancer. CareSTEPS may be useful in helping patients and caregivers manage and cope with the physical, social, and emotional consequences of lung cancer and its treatment.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02414672.
PRIMARY OBJECTIVES:
I. To determine the impact of the intervention on caregiver self-care behaviors, physical and emotional quality of life (QOL), and satisfaction with care.
SECONDARY OBJECTIVES:
I. Examine the effects of the intervention on the Self Determination Theory (SDT) constructs of competence, autonomy, and relatedness.
II. Test whether caregiver competence, autonomy and relatedness mediate the effects of the intervention on caregiver outcomes as hypothesized.
III. Explore whether sociodemographic (e.g., age, gender), medical (e.g., disease stage, treatment, comorbidities), and relationship factors (e.g., whether the caregiver is a spouse/partner or other family member) moderate the effects of the intervention on SDT constructs.
IV. Explore the effects of the intervention on patient physical and emotional QOL, palliative care utilization, and satisfaction with care.
OUTLINE: Participants are randomized into 1 of 2 groups.
GROUP I: Participants receive an informational binder including 6 modules that contains tips and information about things that they can do at home to take care of themselves while caring for a loved one with cancer, manage physical symptoms at home, and coordinate care. Caregivers also receive telephone calls from the study counselor for 45-60 minutes every week to check in and review the program materials.
GROUP II: Participants receive usual care.
After completion of study, participants are followed up at 8 weeks and 6 months.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationBaylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Principal InvestigatorHoda Badr