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

Memorial Sloan Kettering Cancer Center50 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Anxiety Depression Quality of Life

Interventions

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.

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Weill Medical College of Cornell University

New York, New York, United States

Outcomes

Primary Outcomes

Intervention feasibility

Attrition rates

Time frame: Post-intervention (6-8 weeks after baseline)

Intervention acceptability

Likert scale ratings of perceived helpfulness and readability of the intervention

Time frame: 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

Time frame: Post-intervention (6-8 weeks after baseline)

Secondary Outcomes

Change in anxiety from baseline to post-intervention

Anxiety sub-scale of the Hospital Anxiety and Depression Scale

Time frame: Baseline (1-2 weeks after enrollment) and Post-intervention (6-8 weeks after baseline)

Change in distress from baseline to post-intervention

Distress Thermometer

Time frame: 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

Time frame: 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

Time frame: Baseline (1-2 weeks after enrollment) and Post-intervention (6-8 weeks after baseline)

Data from ClinicalTrials.gov

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