Clinical trial · Interventional
Collaborative Care Intervention for Cancer Caregivers
- 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)
The proposed randomized controlled trial will test the efficacy of a stepped collaborative care intervention, versus enhanced usual care arm, to reduce depression of cancer caregivers. Biobehavioral factors will include assessment of changes in health behaviors and biomarkers of inflammation. The investigators will also include measures metabolic abnormalities and clinical markers of CVD. The investigators expect few cardiac events during the study period. The investigators will also measure other health outcomes but CVD risk factors will be the focus of the study.
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 |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Depression | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| enhanced usual care | Behavioral | — | UNRESOLVED |
| stepped collaborative care | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Enhanced Usual Care
- description
- Referred to a therapist and/or psychiatrist in their home town depending on the type of treatment they prefer (e.g., behavioral and/or medication)
- interventionNames
- Behavioral: enhanced usual care
- type
- EXPERIMENTAL
- label
- stepped collaborative care
- description
- At least biweekly contact from a care coordinator by phone and face-to- face visits occurring approximately every 2 months during the patients outpatient visits or treatment, and 24/7 access to a website that was specifically designed during the pilot study for advanced cancer patients from socioeconomically disadvantaged backgrounds.
- interventionNames
- Behavioral: stepped collaborative care
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Patient: 1. Expected survival \< 2 years 2. Age \>21 years 3. Living with spouse or intimate partner Caregiver: 1. Age \>21 years 2. CES-D score \>=16 3. Living with a spouse or intimate partner with cancer Exclusion Criteria: * Patient: 1. Lack of fluency in written and spoken English 2. Cannot identify spouse or intimate partner 3. Evidence of thought disorder, suicidal ideation, hallucinations or delusions Caregiver: 1. Lack of fluency in written and spoken English 2. Taking corticosteroids or engaged in shift work 3. Evidence of thought disorder, suicidal ideation, hallucinations or delusions
References
Publications (0)
Data not yet available