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

Study Overview
=================
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.

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

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Behavioral: CareSTEPS


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CareSTEPS<br>CareSTEPS provides skills training in six domains that are central to the caregiving role: self-care, stress management, symptom management, effective communication, problem-solving, and social support. | Behavioral: CareSTEPS<br>* Caregivers receive a workbook and 6 one-hour telephone sessions with a trained interventionist.<br>|
| No Intervention: Usual Medical Care (UMC)<br>Patients receive standard oncologic and generalist palliative care from their healthcare team. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caregiver Depression | PROMIS Depression Short Form | 6 months | 
| Caregiver Anxiety | PROMS Anxiety Short form | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caregiver burden | Zarit Burden Interview | 6 months | 
| Patient emotional quality of life | PROMIS Depression and Anxiety Short Forms | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
psychosocial intervention, advanced lung cancer, caregivers, self-care