Clinical trial · Interventional
Anxiety With Cancer in the Elderly (ACE): A Cognitive-behavioral Intervention
Evaluation of an Anxiety Intervention for Older Adults With Cancer and Informal Caregivers of Older Adults With Cancer
- 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 examine the feasibility and acceptability of and patient adherence to a telephone-administered cognitive-behavioral therapy intervention for anxiety in older adults (65 years and older) with cancer and their primary informal caregiver. This study will also examine whether the intervention has a clinically significant impact on patient anxiety (primary outcome) and depression, distress, and quality of life (secondary outcomes).
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 |
|---|---|---|---|
| Anxiety | — | UNRESOLVED | — |
| Depression | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Managing Anxiety from Cancer (MAC) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Managing Anxiety from Cancer (MAC)
- description
- Older adults with cancer and their primary informal caregiver will receive a six-session cognitive-behavior therapy intervention administered over the telephone by a trained study interventionist. The intervention is administered weekly and each session is 45-50 minutes in length. Patients and caregivers will receive the intervention independently and from separate therapists.
- interventionNames
- Behavioral: Managing Anxiety from Cancer (MAC)
Primary outcomes (3)
- measure
- Intervention feasibility
- timeFrame
- Post-intervention (6-8 weeks after baseline)
- description
- Attrition rates
- measure
- Intervention acceptability
- timeFrame
- Post-intervention (6-8 weeks after baseline)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient age 65 years or older 2. Diagnosis of cancer 3. Patient and/or caregiver score of 8 or higher on the anxiety subscale of the Hospital Anxiety and Depression Scale 4. A primary informal caregiver who is willing and able to participate 5. Patient and caregiver are able to communicate over the telephone 6. Caregiver is age 21 years or older. Exclusion Criteria: 1. Patient or caregiver is not fluent in English 2. Patient or caregiver is too weak or cognitively impaired to participate in the intervention 3. Patient or caregiver has received CBT since the patient's cancer diagnosis 4. Patient or caregiver has an active major psychiatric condition such as schizophrenia 5. Patient only experiences anxiety in the context of a specific medical procedure 6. Patient or caregiver endorses active suicidal ideation
References
Publications (0)
Data not yet available