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CareSTEPS: A Supportive Care Program for the Caregivers of Advanced Lung Cancer Patients

CareSTEPS: A Supportive Care Program for the Caregivers of Advanced Lung Cancer Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02414672
Enrollment
317
Registered
2015-04-13
Start date
2014-11-30
Completion date
2020-12-31
Last updated
2024-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

psychosocial intervention, advanced lung cancer, caregivers, self-care

Brief summary

The CareSTEPS intervention fills an important service gap by providing education, skills training, and support to the caregivers of advanced lung cancer patients on active treatment. The home-based delivery format will facilitate future dissemination and outreach. By empowering families with the skills they need to provide care and meet the challenges of lung cancer, this intervention holds great promise for improving caregiver quality of life (QOL), patient QOL, and the quality of palliative and supportive care services offered to patients with advanced cancer and their families.

Detailed description

The profound symptom burden associated with advanced lung cancer (LC) makes caregiving a complex and burdensome task. Despite the input of outpatient palliative care services, LC families are often unprepared for caregiving, have low self-efficacy for managing symptoms at home, report high rates of physical and emotional distress, and receive very little skills training or psychosocial care. To date, the few psychosocial intervention trials targeting the caregivers of advanced cancer patients that have been conducted have mostly targeted the families of hospice patients, have not been well-integrated into routine palliative care, and have not addressed the specific needs of LC caregivers. Based on our published and recently completed pilot work in LC, the investigators have developed a psychosocial intervention called CareSTEPS (self-Care, Stress management, sympTom management, Effective communication, Problem-solving, and Social support). CareSTEPS is grounded by Self Determination Theory (SDT) which focuses on individuals' needs for developing autonomy (a sense of choice and volition), competence (self-efficacy), and relatedness (a sense of belonging and connection). It: 1) teaches skills to enhance caregiver competence for managing symptoms, practicing self-care, and coping with cancer; 2) supports caregiver autonomy by providing a clear rationale for recommendations and a variety of options to encourage choice and elaboration; and, 3) seeks to improve caregivers' sense of relatedness by teaching strategies for effective communication and soliciting/accepting social support. 200 LC patients will be enrolled within one month of treatment initiation (baseline) and their caregivers and randomize them to either a usual medical care (UMC) condition or the CareSTEPS intervention (caregivers receive a manual and six 45-minute weekly counseling sessions by telephone). The primary aim is to determine the impact of the CareSTEPS intervention on caregiver self-care behaviors, physical and emotional QOL, and satisfaction with care. Secondary aims are to: 1a) examine the effects of CareSTEPS on the SDT constructs of competence, autonomy, and relatedness; 1b) test whether caregiver competence, autonomy and relatedness mediate the effects of CareSTEPS on caregiver outcomes as hypothesized; 2) explore whether sociodemographic, medical, and relationship factors moderate the effects of the CareSTEPS intervention on SDT constructs; and, 3) explore the effects of CareSTEPS on patient QOL, palliative care utilization, and satisfaction with care. CareSTEPS fills an important service gap by providing education, skills training, and support to the caregivers of advanced LC patients who are on active treatment. The home-based delivery format will facilitate future dissemination and outreach. By empowering families with the skills they need to provide care and meet the challenges of LC, CareSTEPS holds great promise for improving caregiver QOL, patient QOL, and the quality of palliative/supportive care services for advanced cancer patients and their families.

Interventions

BEHAVIORALCareSTEPS

Caregivers receive a workbook and 6 one-hour telephone sessions with a trained interventionist.

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Baylor College of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patient has stage 3B or 4 NSLC or extensive stage SCLC and is within one month of treatment initiation * Patient is spending more than 50% of time out of bed on a daily basis, as measured by an ECOG Performance Status rating of level 0, 1, or 2 * Patient has a spouse/partner other or close family member who he/she defines as the primary caregiver * Patient and caregiver \> 18 years * Patient/caregiver has the ability to read and understand English at a sixth grade level, as determined by his/her ability to understand the consent form * Patient/caregiver can provide informed consent

Exclusion criteria

* Individuals with diminished mental capacity * Prisoners * Children * Pregnant Women * Fetuses

Design outcomes

Primary

MeasureTime frameDescription
Caregiver Depression8 weeksPROMIS Depression Short Form
Caregiver Anxiety8 weeksPROMS Anxiety Short form

Secondary

MeasureTime frameDescription
Patient emotional quality of life8 weeks and 6 monthsPROMIS Depression and Anxiety Short Forms
Caregiver burden8 weeks and 6 monthsZarit Burden Interview
Caregiver Depression6 monthsPROMIS Depression Short Form
Caregiver Anxiety6 monthsPROMIS Anxiety Short Form

Other

MeasureTime frameDescription
Caregiver Satisfaction with Care8 weeks and 6 monthsFAMCARE Scale
Caregiver physical quality of life8 weeks and 6 monthsPhysical summary scale of the Short Form 12 (SF12)
Caregiver Self-care behaviors8 weeks and 6 monthsSelf-Management Behaviors (based on Lorig, 1996) Self-care (based on Schulz, 1999)
Patient physical quality of life8 weeks and 6 monthsMD Anderson Symptom Inventory (MDASI-LC)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026