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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA187143 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CareSTEPS | Experimental | 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. |
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| Usual Medical Care (UMC) | No Intervention | Patients receive standard oncologic and generalist palliative care from their healthcare team. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CareSTEPS | Behavioral | Caregivers receive a workbook and 6 one-hour telephone sessions with a trained interventionist. |
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| Measure | Description | Time Frame |
|---|---|---|
| Caregiver Depression | PROMIS Depression Short Form | 8 weeks |
| Caregiver Anxiety | PROMS Anxiety Short form | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Caregiver burden | Zarit Burden Interview | 8 weeks and 6 months |
| Patient emotional quality of life | PROMIS Depression and Anxiety Short Forms |
| 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hoda Badr, PhD | Baylor College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39583146 | Derived | Rangel ML, Milbury K, Kayser K, Ripley RT, Kvale E, Badr H. Multisite Randomized Controlled Trial of CareSTEPS: A Supportive Care Intervention for the Family Caregivers of Patients With Advanced Lung Cancer. JTO Clin Res Rep. 2024 Oct 17;5(12):100736. doi: 10.1016/j.jtocrr.2024.100736. eCollection 2024 Dec. |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 8 weeks and 6 months |
| Caregiver Depression | PROMIS Depression Short Form | 6 months |
| Caregiver Anxiety | PROMIS Anxiety Short Form | 6 months |
| 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 |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |