An interventional study of NextSteps in Lung Cancer and Gastrointestinal Cancer, sponsored by Baylor College of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-22.
Sponsored by Baylor College of Medicine · Not applicable, Interventional, and Supportive care
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.
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:
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.
779 studies on the registry are indexed under Gastrointestinal Neoplasms; 231 are open to participants now.
This study's enrollment of 242 is above the median of 60 across 569 interventional studies indexed under Gastrointestinal Neoplasms.
Browse Gastrointestinal Neoplasms studies →Baylor College of Medicine is the lead sponsor of 734 studies on the registry; 110 are open to participants now.
Of its 83 completed or terminated interventional studies of FDA-regulated products, 44 (53%) have results posted.
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Exclusion Criteria:
Patients and caregivers will each receive their own tailored manual and six weekly 45-minute telephone calls that correspond to the manual, delivered by a Masters level trained interventionist.
Behavioral: NextSteps
UMC consists of standard oncologic care for the patient from the point of diagnosis of advanced cancer.
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.
Patient and Caregiver Depression
Patient Reported Outcomes Measurement Information System Depression 6 item Short form
Time frame: 2 months
Patient and Caregiver Anxiety
Patient Reported Outcomes Measurement Information System Anxiety 6 item Short form
Time frame: 2 months
Patient and Caregiver Satisfaction with Care
20-item Family Satisfaction with Care (FAMCARE) scale
Time frame: 2 months, 4 months, and 6 months
Patient Symptom Burden
M D Anderson Symptom Inventory
Time frame: 2 months, 4 months, and 6 months
Patient and Caregiver Depression
Patient Reported Outcomes Measurement Information System Depression 6 item Short form
Time frame: 4 and 6 months
Patient and Caregiver Anxiety
Patient Reported Outcomes Measurement Information System Anxiety 6 item Short form
Time frame: 4 and 6 months
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Baylor College of Medicine