Managing Anxiety From Cancer (MAC): Testing an Intervention for Anxiety in Older Adults With Cancer and Their Caregivers

Study Overview
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Brief Summary
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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.

Official Title
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Managing Anxiety From Cancer (MAC): A Pilot Randomized Controlled Trial of a Psychological Intervention for Anxiety in Older Adults With Cancer and Their Caregivers

Conditions
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Anxiety, Depression, Quality of Life

Intervention / Treatment
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* Behavioral: Managing Anxiety from Cancer (MAC)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patient-caregiver dyads will be randomly assigned to the intervention or a usual care control condition.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Managing Anxiety from Cancer (MAC)<br>Older adults with cancer and their primary informal caregiver will receive a seven-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)<br>* 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.<br>|
| No Intervention: Usual Care<br>Older adults with cancer and their primary informal caregiver will receive standard care provided by their medical team. These participants will not receive any intervention from the research team. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety sub-scale of the Hospital Anxiety and Depression Scale | Change in anxiety from baseline to follow-up | Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline) | 
| Hamilton Anxiety Rating Scale | Change in anxiety from baseline to follow-up | Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression sub-scale of the Hospital Anxiety and Depression Scale | Change in depression from baseline to follow-up | Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline) | 
| Distress Thermometer | Change in distress from baseline to follow-up | Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline) | 
| Functional Assessment of Cancer Therapy-General: Emotional Quality of Life Sub-Scale (patients only) | Change in health-related quality of life | Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline) | 
| Caregiver Quality of Life-Cancer (caregivers only) | Change in health-related quality of life | Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline) | 
| Montgomery-Asberg Depression Scale | Change in depression from baseline to follow-up | Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Anxiety, Cognitive behavior therapy, Elderly, Caregivers, 18-542