Clinical trial · Interventional
A Study of Mental Health Care in People With Cancer
Mental Health Care Initiation Intervention for Older Adults With Cancer
NCT06037954CI-TRIAL-00117681recruitingN/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)
The purpose of this study is to look at mental health services for adults with depressed mood who were diagnosed with cancer at the age of 65 or older. This study will compare the usual approach for connecting older adults with depressed mood to mental health services with the Open Door for Cancer (OD-C) approach. We will find out if the OD-C approach is practical and useful for cancer patients who participate in the intervention and for providers who see or treat cancer patients.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 30-minute telephone or videoconference sessions | Other | — | UNRESOLVED |
| Interviews | Other | — | UNRESOLVED |
| Questionnaires | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Open Door for Cancer (OD-C)
- description
- OD-C includes five components delivered in three 30-minute telephone or videoconference visits over six weeks and one booster telephone call. All sessions are audio-recorded.
- interventionNames
- Other: 30-minute telephone or videoconference sessions
- type
- ACTIVE_COMPARATOR
- label
- Usual Care
- description
- Participants assigned to Usual Care (n=50) will receive standard care. MSK's current usual care for distress screening is that all patients are screened for distress when they initiate care at MSK. Additional distress screening is conducted based on the determination of the oncology team. In addition, patients are referred to social work, psychology, and/or psychiatry based on the judgment of the oncology team.
- interventionNames
- Other: Questionnaires
- Other: Interviews
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: Patients * Per medical record and/or self-report, diagnosed with breast, colorectal, lung, or prostate cancer at age 65 years or older * Per medical record and/or self-report, undergoing active cancer treatment (e.g., radiation, chemotherapy, immunotherapy, surgery) or within six months of completing treatment * Score of ≥5 on the Patient Health Questionnaire-9 (PHQ-9) * Per self-report, fluent in English\*\* \*\* Language verification: Prior to enrollment, patients will be asked the following two questions by a Clinical Research Coordinator (CRC) to verify English fluency necessary for participation in the study: 1. How well do you speak English? (must respond "very well" or "well" when given the choices of Very well, Well, Not well, Not at all, Don't know, or Refused) 2. What is your preferred language for healthcare? (must respond English) Providers * Per self-report, works in oncology, nursing, social work, psychology, or psychiatry * Per self-report, currently works in oncology at least 50% of the time * Per self-report, provided cancer care for at least three years at time of consent * Per self-report, fluent in English Exclusion Criteria: Patients * Severely cognitively impaired as demonstrated by Blessed Orientation Memory Concentration scores of ≥ 11 * Per research staff judgment and/or self-report, too ill or weak to complete study procedures * Per medical record and/or self-report, receiving hospice care at the time of enrollment * Per medical record and/or self-report, currently enrolled in mental health treatment Providers * N/A
References
Publications (0)
Data not yet available
No reference posted for this study.