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| ID | Type | Description | Link |
|---|---|---|---|
| 5K23AG048632 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Weill Medical College of Cornell University | OTHER |
| National Institute on Aging (NIA) | NIH |
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This study is being done to test the effects of Managing Anxiety from Cancer (MAC) therapy on anxiety compared to usual care, in patients and their caregivers. MAC is different from usual care because it uses a plan for managing anxiety that has been shown to work in previous studies. MAC has designed this plan for people 65 years of age and older. MAC also includes the primary caregiver which has been shown to help patients manage their anxiety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Managing Anxiety from Cancer (MAC) | Experimental | Older adults with cancer and their primary informal caregiver will receive a seven-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. |
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| Usual Care | No Intervention | Older adults with cancer and their primary informal caregiver will receive standard care provided by their medical team. These participants will not receive any intervention from the research team. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Managing Anxiety from Cancer (MAC) | Behavioral | The intervention consists of seven telephone-administered sessions. Session topics include psychoeducation on anxiety, behavioral strategies for managing anxiety, cognitive restructuring, communication skills training, acceptance techniques, problem-solving strategies, and planning for future anxiety. Session content is tailored for older adults and caregivers of older adults with cancer. |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety sub-scale of the Hospital Anxiety and Depression Scale | Change in anxiety from baseline to follow-up | Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline) |
| Hamilton Anxiety Rating Scale | Change in anxiety from baseline to follow-up | Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Depression sub-scale of the Hospital Anxiety and Depression Scale | Change in depression from baseline to follow-up | Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline) |
| Distress Thermometer |
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Inclusion Criteria:
PATIENTS:
CAREGIVERS:
Exclusion Criteria:
PATIENTS:
CAREGIVERS:
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| Name | Affiliation | Role |
|---|---|---|
| Kelly Trevino, PhD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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Patient-caregiver dyads will be randomly assigned to the intervention or a usual care control condition.
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Change in distress from baseline to follow-up
| Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline) |
| Functional Assessment of Cancer Therapy-General: Emotional Quality of Life Sub-Scale (patients only) | Change in health-related quality of life | Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline) |
| Caregiver Quality of Life-Cancer (caregivers only) | Change in health-related quality of life | Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline) |
| Montgomery-Asberg Depression Scale | Change in depression from baseline to follow-up | Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline) |