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

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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Quality of Life; Anxiety
• Intervention / Treatment: Behavioral: Managing Anxiety from Cancer (MAC)

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Managing Anxiety from Cancer (MAC); 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); 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.
No Intervention: Usual Care; 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?

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)

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: National Institute on Aging (NIA); Weill Medical College of Cornell University
• Investigators: Principal Investigator: Kelly Trevino, PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2019
• Primary Completion (Actual): October 27, 2025
• Study Completion (Actual): October 27, 2025

Study Registration Dates

• First Submitted: May 23, 2017
• First Submitted That Met QC Criteria: May 25, 2017
• First Posted (Actual): May 30, 2017

Study Record Updates

• Last Update Posted (Estimated): October 29, 2025
• Last Update Submitted That Met QC Criteria: October 27, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Elderly; Cancer; Anxiety; Cognitive behavior therapy; Caregivers; 18-542
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Behavior; Neoplasms; Anxiety Disorders; Depression
• Other Study ID Numbers: 18-542; 5K23AG048632 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No