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

NCT ID: NCT02747160

Last Updated: 2020-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2020-07-02

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).

Conditions

Anxiety; Depression; Quality of Life

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Managing Anxiety from Cancer (MAC)

Intervention Type: 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.

Interventions

Managing Anxiety from Cancer (MAC)

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kelly M Trevino, PhD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Weill Medical College of Cornell University

New York, New York, United States

Countries

United States

Other Identifiers

19-280

Identifier Type: -

Identifier Source: org_study_id