Anxiety, Depression, Quality of Life
Conditions
Keywords
Cancer, Anxiety, Cognitive behavior therapy, Elderly, Caregivers, 18-542
Brief summary
This study is being done to test the effects of Managing Anxiety from Cancer (MAC) therapy on anxiety compared to usual care, in patients and their caregivers. MAC is different from usual care because it uses a plan for managing anxiety that has been shown to work in previous studies. MAC has designed this plan for people 65 years of age and older. MAC also includes the primary caregiver which has been shown to help patients manage their anxiety.
Interventions
BEHAVIORALManaging Anxiety from Cancer (MAC)
The intervention consists of seven telephone-administered sessions. Session topics include psychoeducation on anxiety, behavioral strategies for managing anxiety, cognitive restructuring, communication skills training, acceptance techniques, problem-solving strategies, and planning for future anxiety. Session content is tailored for older adults and caregivers of older adults with cancer.
Sponsors
Weill Medical College of Cornell University
National Institute on Aging (NIA)
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Patient-caregiver dyads will be randomly assigned to the intervention or a usual care control condition.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
PATIENTS: * Age 65 or older * Confirmed diagnosis of breast, lymphoma, genitourinary, thoracic, gynecological or gastrointestinal cancer, currently on active treatment or within six months of completion of treatment * As determined by the patient's primary oncologist and/or study staff, physically and cognitively able to complete study procedures * English fluent (as per self-reported fluency of very well)\*\* * In the judgment of the investigators and/or consenting professional, able to perform informed consent * Has a primary informal caregiver (as defined by an unpaid individual who provides the patient with emotional, physical, and/or practical support) who is willing and able to participate in the study * As part of the patient-caregiver dyad, at least one member reports elevated anxiety as defined by a score of 8 or greater on the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS) * As per self-report, residency in New York or ability to complete sessions in New York * Able to communicate over the phone for sessions * Willingness to be audio-recorded for assessments and, if applicable, study sessions CAREGIVERS: * Age 21 or older * In the judgment of the investigators and/or consenting professional, able to perform informed consent * As part of the patient-caregiver dyad, at least one member reports elevated anxiety as defined by a score of 8 or greater on the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS) * English fluent (as per self-reported fluency of very well)\*\* * Is a primary informal caregiver (as defined by an unpaid individual who provides the patient with emotional, physical, and/or practical support) for an MSK patient * As per self-report, residency in New York or ability to complete sessions in New York * Able to communicate over the phone for sessions * Willingness to be audio-recorded for assessments and, if applicable, study sessions
Exclusion criteria
PATIENTS: * Endorsing active suicidal ideation on the item, In light of your current circumstances, have you ever had thoughts of killing yourself? * As per oncologist or self-report, too weak or cognitively impaired to participate in the intervention and complete the assessments * Per self-report/screening measures, has received cognitive-behavioral therapy since cancer diagnosis * As per medical record or self-report, currently being treated for schizophrenia, substance use or dependence, and/or bi-polar disorder * Anxiety due solely to a medical procedure as determined by a patient-report item on the screening questionnaire CAREGIVERS: * Endorsing active suicidal ideation on the item, In light of your current circumstances, have you ever had thoughts of killing yourself? * Per self-report/screening measures, has received cognitive-behavioral therapy since patients cancer diagnosis * As per self-report, currently being treated for schizophrenia, substance use or dependence, and/or bi-polar disorder * If female, currently pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety sub-scale of the Hospital Anxiety and Depression Scale | Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline) | Change in anxiety from baseline to follow-up |
| Hamilton Anxiety Rating Scale | Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline) | Change in anxiety from baseline to follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Assessment of Cancer Therapy-General: Emotional Quality of Life Sub-Scale (patients only) | Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline) | Change in health-related quality of life |
| Depression sub-scale of the Hospital Anxiety and Depression Scale | Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline) | Change in depression from baseline to follow-up |
| Montgomery-Asberg Depression Scale | Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline) | Change in depression from baseline to follow-up |
| Caregiver Quality of Life-Cancer (caregivers only) | Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline) | Change in health-related quality of life |
| Distress Thermometer | Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline) | Change in distress from baseline to follow-up |
Countries
United States
Outcome results
None listed