Anxiety With Cancer in the Elderly (ACE): A Cognitive-behavioral Intervention

Study Overview
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Brief Summary
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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).

Detailed Description
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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).

Official Title
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Evaluation of an Anxiety Intervention for Older Adults With Cancer and Informal Caregivers of Older Adults With Cancer

Conditions
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Anxiety, Depression, Quality of Life

Intervention / Treatment
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* Behavioral: Managing Anxiety from Cancer (MAC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient age 65 years or older Diagnosis of cancer Patient and/or caregiver score of 8 or higher on the anxiety subscale of the Hospital Anxiety and Depression Scale A primary informal caregiver who is willing and able to participate Patient and caregiver are able to communicate over the telephone Caregiver is age 21 years or older. Exclusion Criteria: Patient or caregiver is not fluent in English Patient or caregiver is too weak or cognitively impaired to participate in the intervention Patient or caregiver has received CBT since the patient's cancer diagnosis Patient or caregiver has an active major psychiatric condition such as schizophrenia Patient only experiences anxiety in the context of a specific medical procedure Patient or caregiver endorses active suicidal ideation

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Managing Anxiety from Cancer (MAC)<br>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. | Behavioral: Managing Anxiety from Cancer (MAC)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Anxiety, Cognitive behavior therapy, Elderly, Caregivers