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



Status:Active, not recruiting
Conditions:Anxiety, Depression
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:65 - Any
Updated:8/3/2018
Start Date:June 2016
End Date:April 2019

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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).

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
We found this trial at
1
site
445 E 69th St
New York, New York 10021
(212) 746-1067
Phone: 212-746-3185
Weill Medical College of Cornell University Founded in 1898, and affiliated with what is now...
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from
New York, NY
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