Weill Medical College of Cornell University
New York, 10065, United States
NCT Number: NCT02747160
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).
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Notify Me65 year and older
All sexes
Interventional
Not applicable
New York, 10065, United States
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Post-intervention (6-8 weeks after baseline)
Attrition rates
Time frame: Post-intervention (6-8 weeks after baseline)
Likert scale ratings of perceived helpfulness and readability of the intervention
Time frame: Post-intervention (6-8 weeks after baseline)
Sum of number of intervention exercises completed with number of sessions completed by patients and caregivers
Time frame: Baseline (1-2 weeks after enrollment) and Post-intervention (6-8 weeks after baseline)
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)
Distress Thermometer
Time frame: Baseline (1-2 weeks after enrollment) and Post-intervention (6-8 weeks after baseline)
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)
Depression sub-scale of the Hospital Anxiety and Depression Scale
Memorial Sloan Kettering Cancer Center
Other
Evaluation of an Anxiety Intervention for Older Adults With Cancer and Informal Caregivers of Older Adults With Cancer
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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