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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02747160
• Other study ID #: 19-280
• Status: Completed
• Phase: N/A
• Start date: June 2016
• Est. completion date: July 2, 2020

Study information

• Verified date: October 2020
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2, 2020
• Est. primary completion date: July 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Quality of Life

Intervention

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.

Locations

Country	Name	City	State
United States	Weill Medical College of Cornell University	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intervention feasibility	Attrition rates	Post-intervention (6-8 weeks after baseline)
Primary	Intervention acceptability	Likert scale ratings of perceived helpfulness and readability of the intervention	Post-intervention (6-8 weeks after baseline)
Primary	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	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)
Secondary	Change in distress from baseline to post-intervention	Distress Thermometer	Baseline (1-2 weeks after enrollment) and Post-intervention (6-8 weeks after baseline)
Secondary	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)
Secondary	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)