Managing Anxiety From Cancer (MAC): Testing an Intervention for Anxiety in Older Adults With Cancer and Their Caregivers
2 other identifiers
interventional
26
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable anxiety
Started Jan 2019
Longer than P75 for not_applicable anxiety
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 23, 2017
CompletedFirst Posted
Study publicly available on registry
May 30, 2017
CompletedStudy Start
First participant enrolled
January 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 27, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 27, 2025
CompletedOctober 29, 2025
October 1, 2025
6.8 years
May 23, 2017
October 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (5)
Depression sub-scale of the Hospital Anxiety and Depression Scale
Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline)
Distress Thermometer
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)
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)
Study Arms (2)
Managing Anxiety from Cancer (MAC)
EXPERIMENTALOlder 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.
Usual Care
NO INTERVENTIONOlder 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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)
- +5 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kelly Trevino, PhD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2017
First Posted
May 30, 2017
Study Start
January 23, 2019
Primary Completion
October 27, 2025
Study Completion
October 27, 2025
Last Updated
October 29, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
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.