Clinical trial · Interventional
Comparing Distress Screening + Consultation With Enhanced Usual Care for Caregivers of Cancer Patients
The Impact of Caregiver Distress Screening, Targeted Referral and Consultation on MSK Caregiver, Patient and Health System Outcomes
NCT03856086CI-TRIAL-00097217completedN/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 will help the researchers find out whether the S+C approach is better, the same as, or worse than EUC.
Conditions
Conditions (1)
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 Caregivers | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Baseline questionnaire | Behavioral | — | UNRESOLVED |
| CSS-CG | Behavioral | — | UNRESOLVED |
| FACT-GP | Behavioral | — | UNRESOLVED |
| HADS | Behavioral | — | UNRESOLVED |
| NCCN Problem List | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Enhanced usual care (EUC)
- description
- ICs randomized to EUC following baseline questionnaire completion will be given instructions (Appendix I) on how to access or create an account to access the myMSK online portal IC Resources page (https://my.mskcc.org/login). If the caregiver does not wish to enroll in MyMSK, the research study staff will send them an email with sample referral material ( Appendix D. The IC Resources page includes links to extant MSK educational materials for ICs (e.g., "A Guide for Caregivers" \[47\]), contact information for psychosocial services (e.g., Caregivers Clinic in the MSK Counseling Center), and external resources (e.g., educational materials and services through the CSC, American Cancer Society, and others) (Appendix D,).
- interventionNames
- Behavioral: Baseline questionnaire
- Behavioral: NCCN Problem List
- Behavioral: FACT-GP
- Behavioral: HADS
- type
- EXPERIMENTAL
- label
- CancerSupportSource-CG screening plus consultation (S+C)
- description
- ICs randomized to S+C will complete the web-based CSS-CG (Appendix C) using a tablet immediately following baseline study measures. In case of technical issues, ICs may complete Appendix C with the guidance of a member of the research study team. The CSS-CG asks ICs to rate their level of concern for 33 different possible problems: if a need is rated as low (i.e., "A little" or less concern), after each problem is rated ICs will be prompted to request pertinent educational materials if they are interested. If a need is endorsed (i.e., "Moderate" or greater concern), ICs are asked through the web-based electronic platform (https://mskcc.mycarereport.com) whether they would like educational materials and/or to speak with someone about that need (i.e., receive a referral).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Self-identified caregiver to a patient receiving surgery at JRSC OR self-identified caregiver to a patient at various inpatient surgical floors (i.e., M4, M7, M8) at the Main Hospital OR self-identified caregiver to a patient at the BMT clinic. * English fluency: Self-report by subject identifying English as the preferred language for healthcare, and self-reported degree of fluency as speaking English "Very well." * 18 years old or older as per self report * Agree to fulfill responsibilities as an IC during the perioperative phases as per self report Exclusion Criteria: * Cognitive difficulties that preclude participation in the intervention or accurate assessment in the judgment of the PI * Medical illness that is of sufficient severity to preclude further participation in the study. * Presenting to JRSC as the IC for a patient undergoing a prophylactic procedure
References
Publications (1)
- DERIVEDApplebaum AJ, Schofield E, Kastrinos A, Gebert R, Behrens M, Loschiavo M, Shaffer KM, Levine M, Dannaoui A, Bellantoni C, Miller MF, Zaleta AK. A randomized controlled trial of a distress screening, consultation, and targeted referral system for family caregivers in oncologic care. Psychooncology. 2024 Feb;33(2):e6301. doi: 10.1002/pon.6301. PMID 38363002