Clinical trial NCT02747160: Anxiety With Cancer in the Elderly (ACE): A Cognitive-behavioral Intervention
Official title: Evaluation of an Anxiety Intervention for Older Adults With Cancer and Informal Caregivers of Older Adults With Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Depression
Quality of Life
Keywords: Cancer
Anxiety
Cognitive behavior therapy
Elderly
Caregivers
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Weill Medical College of Cornell University
First posted: 2016-04-21
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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).

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

Primary outcomes:
measure: Intervention feasibility
timeFrame: Post-intervention (6-8 weeks after baseline)
measure: Intervention acceptability
timeFrame: Post-intervention (6-8 weeks after baseline)
measure: Patient/caregiver adherence
timeFrame: Post-intervention (6-8 weeks after baseline)
Secondary outcomes:
measure: Change in anxiety from baseline to post-intervention
timeFrame: Baseline (1-2 weeks after enrollment) and Post-intervention (6-8 weeks after baseline)
measure: Change in distress from baseline to post-intervention
timeFrame: Baseline (1-2 weeks after enrollment) and Post-intervention (6-8 weeks after baseline)
measure: Emotional health-related quality of life
timeFrame: Baseline (1-2 weeks after enrollment) and Post-intervention (6-8 weeks after baseline)
measure: Change in depression from baseline to post-intervention
timeFrame: Baseline (1-2 weeks after enrollment) and Post-intervention (6-8 weeks after baseline)
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Medical College of Cornell University
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Kelly M Trevino, PhD
role: PRINCIPAL_INVESTIGATOR
References: