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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02414672
• Other study ID #: H-38998
• Secondary ID: R01CA187143
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: December 2020

Study information

• Verified date: April 2024
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 317
• Est. completion date: December 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Behavioral:
• CareSTEPS
Caregivers receive a workbook and 6 one-hour telephone sessions with a trained interventionist.

Locations

Country	Name	City	State
United States	Baylor College of Medicine	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient physical quality of life	MD Anderson Symptom Inventory (MDASI-LC)	8 weeks and 6 months
Other	Caregiver Self-care behaviors	Self-Management Behaviors (based on Lorig, 1996) Self-care (based on Schulz, 1999)	8 weeks and 6 months
Other	Caregiver Satisfaction with Care	FAMCARE Scale	8 weeks and 6 months
Other	Caregiver physical quality of life	Physical summary scale of the Short Form 12 (SF12)	8 weeks and 6 months
Primary	Caregiver Depression	PROMIS Depression Short Form	8 weeks
Primary	Caregiver Anxiety	PROMS Anxiety Short form	8 weeks
Secondary	Caregiver burden	Zarit Burden Interview	8 weeks and 6 months
Secondary	Patient emotional quality of life	PROMIS Depression and Anxiety Short Forms	8 weeks and 6 months
Secondary	Caregiver Depression	PROMIS Depression Short Form	6 months
Secondary	Caregiver Anxiety	PROMIS Anxiety Short Form	6 months