Clinical trial · Interventional
NextSteps Intervention for Advanced Cancer Patients and Caregivers
NextSteps: A Supportive Care Program For Advanced Cancer Patients and Their Caregivers
NCT04885439CI-TRIAL-00076333completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Cancer | Malignant Digestive System Neoplasm | ALIAS | 0.90 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NextSteps | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- NextSteps Intervention
- description
- 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.
- interventionNames
- Behavioral: NextSteps
- type
- NO_INTERVENTION
- label
- Usual Medical Care
- description
- UMC consists of standard oncologic care for the patient from the point of diagnosis of advanced cancer.
Primary outcomes (2)
- measure
- Patient and Caregiver Depression
- timeFrame
- 2 months
- description
- Patient Reported Outcomes Measurement Information System Depression 6 item Short form
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient has stage 3A, 3B, or 4 NSLC or extensive stage SCLC and is within one month of treatment initiation OR patient has Stage 4 GI cancer and is within one month of treatment initiation 2. 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 3. patient has stable brain metastases and no limitation on hepatic or renal function 4. patient has a spouse/partner other or close family member who he/she defines as the primary caregiver 5. patient and caregiver are age 18 years or older 6. patient and caregiver have the ability to read and understand English at a sixth grade level, as determined by ability to understand the consent form 7. patient and caregiver can provide informed consent Exclusion Criteria: 1. patient or caregiver is deaf or has significant hearing impairment and thus cannot use the telephone 2. patient is currently enrolled in hospice.
References
Publications (0)
Data not yet available
No reference posted for this study.