Clinical trial NCT02414672: CareSTEPS: A Supportive Care Program for the Caregivers of Advanced Lung Cancer Patients
Official title: CareSTEPS: A Supportive Care Program for the Caregivers of Advanced Lung Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: psychosocial intervention
advanced lung cancer
caregivers
self-care
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-04-13
Enrollment: 317
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_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.

Eligibility criteria: 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

Primary outcomes:
measure: Caregiver Depression
timeFrame: 8 weeks
measure: Caregiver Anxiety
timeFrame: 8 weeks
Secondary outcomes:
measure: Caregiver burden
timeFrame: 8 weeks and 6 months
measure: Patient emotional quality of life
timeFrame: 8 weeks and 6 months
measure: Caregiver Depression
timeFrame: 6 months
measure: Caregiver Anxiety
timeFrame: 6 months
Other outcomes:
measure: Patient physical quality of life
timeFrame: 8 weeks and 6 months
measure: Caregiver Self-care behaviors
timeFrame: 8 weeks and 6 months
measure: Caregiver Satisfaction with Care
timeFrame: 8 weeks and 6 months
measure: Caregiver physical quality of life
timeFrame: 8 weeks and 6 months
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Hoda Badr, PhD
role: PRINCIPAL_INVESTIGATOR
References: