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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Behavioral: CareSTEPS

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.

• Study Type: Interventional
• Enrollment (Actual): 317
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CareSTEPS; 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; Caregivers receive a workbook and 6 one-hour telephone sessions with a trained interventionist.
No Intervention: Usual Medical Care (UMC); 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	8 weeks
Caregiver Anxiety	PROMS Anxiety Short form	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caregiver Depression	PROMIS Depression Short Form	6 months
Caregiver burden	Zarit Burden Interview	8 weeks and 6 months
Patient emotional quality of life	PROMIS Depression and Anxiety Short Forms	8 weeks and 6 months
Caregiver Anxiety	PROMIS Anxiety Short Form	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient physical quality of life	MD Anderson Symptom Inventory (MDASI-LC)	8 weeks and 6 months
Caregiver Self-care behaviors	Self-Management Behaviors (based on Lorig, 1996) Self-care (based on Schulz, 1999)	8 weeks and 6 months
Caregiver Satisfaction with Care	FAMCARE Scale	8 weeks and 6 months
Caregiver physical quality of life	Physical summary scale of the Short Form 12 (SF12)	8 weeks and 6 months

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Hoda Badr, PhD, Baylor College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2014
• Primary Completion (Actual): June 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: April 7, 2015
• First Submitted That Met QC Criteria: April 10, 2015
• First Posted (Estimated): April 13, 2015

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: caregivers; psychosocial intervention; self-care; advanced lung cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: H-38998; R01CA187143 (U.S. NIH Grant/Contract)