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

Memorial Sloan Kettering Cancer Center1 site in 1 country26 target enrollmentJanuary 23, 2019

ConditionsAnxiety Depression Quality of Life

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Anxiety
Sponsor: Memorial Sloan Kettering Cancer Center
Enrollment: 26
Locations: 1
Primary Endpoint: Anxiety sub-scale of the Hospital Anxiety and Depression Scale
Status: Completed
Last Updated: 6 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 23, 2019

End Date

October 27, 2025

Last Updated

6 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Memorial Sloan Kettering Cancer Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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

Outcomes

Primary Outcomes

Anxiety sub-scale of the Hospital Anxiety and Depression Scale

Time Frame: 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

Time Frame: Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline)

Change in anxiety from baseline to follow-up

Secondary Outcomes

Distress Thermometer(Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline))
Caregiver Quality of Life-Cancer (caregivers only)(Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline))
Montgomery-Asberg Depression Scale(Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline))
Depression sub-scale of the Hospital Anxiety and Depression Scale(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)(Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline))