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
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.
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.
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