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

Evaluation of an Anxiety Intervention for Older Adults With Cancer and Informal Caregivers of Older Adults With Cancer

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).

Study Overview

• Status: Completed
• Conditions: Depression; Quality of Life; Anxiety
• Intervention / Treatment: Behavioral: Managing Anxiety from Cancer (MAC)

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).

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Weill Medical College of Cornell University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: 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.

Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention feasibility	Attrition rates	Post-intervention (6-8 weeks after baseline)
Intervention acceptability	Likert scale ratings of perceived helpfulness and readability of the intervention	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	Post-intervention (6-8 weeks after baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in anxiety from baseline to post-intervention	Anxiety sub-scale of the Hospital Anxiety and Depression Scale	Baseline (1-2 weeks after enrollment) and Post-intervention (6-8 weeks after baseline)
Change in distress from baseline to post-intervention	Distress Thermometer	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	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	Baseline (1-2 weeks after enrollment) and Post-intervention (6-8 weeks after baseline)

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Kelly M Trevino, PhD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2016
• Primary Completion (ACTUAL): July 2, 2020
• Study Completion (ACTUAL): July 2, 2020

Study Registration Dates

• First Submitted: April 12, 2016
• First Submitted That Met QC Criteria: April 18, 2016
• First Posted (ESTIMATE): April 21, 2016

Study Record Updates

• Last Update Posted (ACTUAL): October 14, 2020
• Last Update Submitted That Met QC Criteria: October 9, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Elderly; Cancer; Anxiety; Cognitive behavior therapy; Caregivers
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 19-280

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO