Clinical trial NCT03168971: Managing Anxiety From Cancer (MAC): Testing an Intervention for Anxiety in Older Adults With Cancer and Their Caregivers
Official title: Managing Anxiety From Cancer (MAC): A Pilot Randomized Controlled Trial of a Psychological Intervention for Anxiety in Older Adults With Cancer and Their Caregivers
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Anxiety
Depression
Quality of Life
Keywords: Cancer
Anxiety
Cognitive behavior therapy
Elderly
Caregivers
18-542
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Weill Medical College of Cornell University
name: National Institute on Aging (NIA)
First posted: 2017-05-30
Enrollment: 26
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patient-caregiver dyads will be randomly assigned to the intervention or a usual care control condition.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 patient"s cancer diagnosis
* As per self-report, currently being treated for schizophrenia, substance use or dependence, and/or bi-polar disorder
* If female, currently pregnant

Primary outcomes:
measure: Anxiety sub-scale of the Hospital Anxiety and Depression Scale
timeFrame: Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline)
measure: Hamilton Anxiety Rating Scale
timeFrame: Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline)
Secondary outcomes:
measure: Depression sub-scale of the Hospital Anxiety and Depression Scale
timeFrame: Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline)
measure: Distress Thermometer
timeFrame: Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline)
measure: Functional Assessment of Cancer Therapy-General: Emotional Quality of Life Sub-Scale (patients only)
timeFrame: Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline)
measure: Caregiver Quality of Life-Cancer (caregivers only)
timeFrame: Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline)
measure: Montgomery-Asberg Depression Scale
timeFrame: Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline)
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Kelly Trevino, PhD
role: PRINCIPAL_INVESTIGATOR
References: