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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Completed

Conditions: Quality of Life; Depression; Anxiety

Treatments: Behavioral: Managing Anxiety from Cancer (MAC)

Study type: Interventional

Funder types: Other

Identifiers

NCT02747160

19-280

Details and patient eligibility

About

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).

Full 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).

Enrollment: 50 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Managing Anxiety from Cancer (MAC)

Experimental group

Description:

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.

Treatment:

Behavioral: Managing Anxiety from Cancer (MAC)