Clinical trial · Interventional
Integrating Family Caregiver Support Into Cancer Clinical Trials
Feasibility and Acceptability of Integrating Family Caregiver Support Into Cancer Clinical Trials
NCT03069287CI-TRIAL-00065632withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of funding and resources
Summary
Brief summary (as posted)
The aim of this study is to assess the effects of integrating family caregiver support into cancer clinical trials on the well-being of the caregiver, the care-recipient and on the cancer clinical trial system.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Caregivers | — | UNRESOLVED | — |
| Clinical Trials | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Benjamin Rose Institute (BRI) Care Consultation™ Program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patient-caregiver dyads
- description
- Dyads will include family caregivers and patients with a diagnosis of cancer who agreed to participate in a therapeutic clinical trial.
- interventionNames
- Behavioral: Benjamin Rose Institute (BRI) Care Consultation™ Program
Primary outcomes (2)
- measure
- Absolute change in the Caregiver Reaction Assessment (CRA) score
- timeFrame
- 1 year
- description
- Caregiver Reaction Assessment (CRA) will be used to measure caregiver burden. The instrument was designed as a questionnaire with Likert-type responses ranging from strongly agree (1) to strongly disagree. The 24 items form 5 distinct unidimensional subscales that include: family burden (lack of family support; 5 items), financial burden (struggle with bills; 3 items), health burden (caregivers' health decline; 4 items), schedule burden (disruption of daily tasks; 5 items), and caregiving esteem (7 items), a positive subscale that measures enjoyment and importance of caregiving. A higher score on the caregiver's esteem subscale indicates a more positive effect of caregiving while higher scores on the other subscales indicate greater negative effects of caregiving in those domains
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * dyad must be at least 18 years of age, * patient is enrolled or expressed intent to enroll in a therapeutic cancer clinical trial * caregiver is a self-identified primary caregiver, * able to speak, read, and understand English, * willing to participate in completion of surveys, and * co-residence
References
Publications (2)
- BACKGROUNDSaria MG, Courchesne N, Evangelista L, Carter J, MacManus DA, Gorman MK, Nyamathi AM, Phillips LR, Piccioni D, Kesari S, Maliski S. Cognitive dysfunction in patients with brain metastases: influences on caregiver resilience and coping. Support Care Cancer. 2017 Apr;25(4):1247-1256. doi: 10.1007/s00520-016-3517-3. Epub 2016 Dec 5. PMID 27921222
- BACKGROUNDSaria MG, Nyamathi A, Phillips LR, Stanton AL, Evangelista L, Kesari S, Maliski S. The Hidden Morbidity of Cancer: Burden in Caregivers of Patients with Brain Metastases. Nurs Clin North Am. 2017 Mar;52(1):159-178. doi: 10.1016/j.cnur.2016.10.002. PMID 28189161