NCT04885439

NextSteps Intervention for Advanced Cancer Patients and Caregivers

NextSteps: A Supportive Care Program For Advanced Cancer Patients and Their Caregivers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 242 (actual)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study seeks to test the efficacy of a psychosocial intervention to empower advanced cancer patients and their caregivers and improve their quality of life (QOL). The program, called NextSTEPS, provides skills training in six domains that are central to patient and caregiver QOL: self-care, stress management, symptom management, effective communication, problem-solving, and social support.

Detailed description

In this study, 200 advanced cancer patients who are within one month of treatment initiation (baseline) and their caregivers will complete baseline surveys and be randomized to NextSTEPS or a usual medical care (UMC) condition. In addition to UMC, patients and caregivers in the NextSTEPS condition will each receive an intervention manual and six weekly 45-minute telephone counseling sessions with a trained interventionist. Patients and caregivers in both the NextSTEPS and UMC conditions will complete follow-up surveys at 8 weeks (primary endpoint), and 4 and 6 months post-baseline (secondary endpoints). The specific aims are to: 1. Determine the impact of NextSTEPS on patient physical and emotional QOL, palliative care utilization, and satisfaction with care relative to UMC. We hypothesize that at 8 weeks (2 months), and 4 and 6 months, patients in NextSTEPS will have less symptom burden, less emotional distress, greater palliative care utilization, and greater satisfaction with care relative to patients in UMC. 2. Determine the impact of NextSTEPS on caregiver self-care, physical and emotional QOL, and satisfaction with care. We hypothesize that at 8 weeks, and 4 and 6 months, caregivers in NextSTEPS will report more self-care, better physical QOL, less emotional distress, and greater satisfaction with care relative to caregivers in UMC. Secondary/exploratory aims and hypotheses are to: Examine the effects of the NextSTEPS intervention on Self Determination Theory (SDT) constructs. We hypothesize that NextSTEPS will enhance patient and caregiver competence, autonomy, and relatedness. Test whether the SDT constructs of competence, autonomy and relatedness mediate the effects of NextSTEPS on patient/caregiver outcomes as hypothesized. Explore whether sociodemographic (e.g., age, gender), medical (e.g., disease stage, comorbidities), and relationship factors (e.g., whether the caregiver is a spouse/partner or other family member) moderate the effects of NextSTEPS on patient/caregiver competence, autonomy, and relatedness. NextSTEPS fills an important service gap by providing education, skills training, and support to advanced cancer patients and their caregivers shortly after diagnosis. Home-based telephone delivery will facilitate dissemination and outreach. By empowering families with the skills they need to coordinate care and meet the challenges of advanced cancer together, NextSTEPS holds great promise for improving patient and caregiver QOL, and the quality of palliative and supportive care in cancer.

Conditions

• Lung Cancer
• Gastrointestinal Cancer

Interventions

Type	Name	Description
BEHAVIORAL	NextSteps	Intervention sessions are delivered by a Masters level trained interventionist. During sessions, the interventionist will: conduct the weekly symptom screen, review content, answer questions, ensure skills mastery through homework review, and work with participants to develop action plans and identify/overcome barriers to self-care/caregiving. Patients and caregivers will receive individual calls from the interventionist for sessions 1, 2, and 3, and participate together for sessions 4, 5, and 6 via speakerphone.

Timeline

• Start date: 2015-07-01
• Primary completion: 2020-12-01
• Completion: 2021-06-30
• First posted: 2021-05-13
• Last updated: 2024-04-22

Locations

1 site across 1 country: United States