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

Not Applicable

Completed

Brief Summary: 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: 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).

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Managing Anxiety from Cancer (MAC)	Managing Anxiety from Cancer (MAC)	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.

Primary Outcome Measures

Name	Time	Method
Intervention feasibility	Post-intervention (6-8 weeks after baseline)	Attrition rates
Intervention acceptability	Post-intervention (6-8 weeks after baseline)	Likert scale ratings of perceived helpfulness and readability of the intervention
Patient/caregiver adherence	Post-intervention (6-8 weeks after baseline)	Sum of number of intervention exercises completed with number of sessions completed by patients and caregivers

Secondary Outcome Measures

Name	Time	Method
Emotional health-related quality of life	Baseline (1-2 weeks after enrollment) and Post-intervention (6-8 weeks after baseline)	Functional Assessment of Cancer Therapy-General: Emotional Quality of Life Sub-Scale; Caregiver Quality of Life-Cancer
Change in depression from baseline to post-intervention	Baseline (1-2 weeks after enrollment) and Post-intervention (6-8 weeks after baseline)	Depression sub-scale of the Hospital Anxiety and Depression Scale
Change in anxiety from baseline to post-intervention	Baseline (1-2 weeks after enrollment) and Post-intervention (6-8 weeks after baseline)	Anxiety sub-scale of the Hospital Anxiety and Depression Scale
Change in distress from baseline to post-intervention	Baseline (1-2 weeks after enrollment) and Post-intervention (6-8 weeks after baseline)	Distress Thermometer

Locations (1): Weill Medical College of Cornell University
🇺🇸
New York, New York, United States