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| Name | Class |
|---|---|
| Weill Medical College of Cornell University | OTHER |
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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).
This study is a single arm pre-post evaluation of a six-session telephone-administered cognitive-behavioral therapy (CBT) intervention for anxiety in older adults with cancer and their primary informal (unpaid) caregiver. The primary purposes of this study are to evaluate the feasibility of the intervention and study procedures, acceptability of the intervention to older adults with cancer and their primary informal caregiver, and patient and caregiver adherence to the intervention. The secondary purpose is to examine changes in patient and caregiver anxiety, depression, distress, and quality of life pre to post intervention to determine whether the intervention has a clinically significant impact on these outcomes. Anxiety is the primary outcome; depression, distress, and quality of life are secondary outcomes. Patients will be 65 years of age or older and will be recruited from the myeloma, lung, lymphoma, gynecologic, and gastrointestinal cancer clinics at a single institution. Study measures will be administered by telephone prior to initiating the intervention (pre-intervention) and following intervention completion (post-intervention).
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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 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Managing Anxiety from Cancer (MAC) | Behavioral | The intervention consists of six telephone-administered sessions. Session topics include psychoeducation on anxiety, behavioral strategies for managing anxiety, cognitive restructuring, communication skills training, acceptance techniques (patient only), problem-solving strategies (caregiver only), and planning for future anxiety. Session content is tailored for older adults and caregivers of older adults with cancer. |
| Measure | Description | Time Frame |
|---|---|---|
| Intervention feasibility | Attrition rates | Post-intervention (6-8 weeks after baseline) |
| Intervention acceptability | Likert scale ratings of perceived helpfulness and readability of the intervention | Post-intervention (6-8 weeks after baseline) |
| Patient/caregiver adherence | Sum of number of intervention exercises completed with number of sessions completed by patients and caregivers | Post-intervention (6-8 weeks after baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in anxiety from baseline to post-intervention | Anxiety sub-scale of the Hospital Anxiety and Depression Scale | Baseline (1-2 weeks after enrollment) and Post-intervention (6-8 weeks after baseline) |
| Change in distress from baseline to post-intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kelly M Trevino, PhD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Medical College of Cornell University | New York | New York | 10065 | United States |
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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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|
Distress Thermometer |
| Baseline (1-2 weeks after enrollment) and Post-intervention (6-8 weeks after baseline) |
| Emotional health-related quality of life | Functional Assessment of Cancer Therapy-General: Emotional Quality of Life Sub-Scale; Caregiver Quality of Life-Cancer | Baseline (1-2 weeks after enrollment) and Post-intervention (6-8 weeks after baseline) |
| Change in depression from baseline to post-intervention | Depression sub-scale of the Hospital Anxiety and Depression Scale | Baseline (1-2 weeks after enrollment) and Post-intervention (6-8 weeks after baseline) |