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

NCT ID: NCT03168971

Last Updated: 2025-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-23
• Study Completion Date: 2025-10-27

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.

Conditions

Anxiety; Depression; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Managing Anxiety from Cancer (MAC)

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kelly Trevino, PhD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Countries

United States

Related Links

http://www.mskcc.org

Memorial Sloan Kettering Cancer Center

Other Identifiers

5K23AG048632

Identifier Type: NIH

Identifier Source: secondary_id

View Link

18-542

Identifier Type: -

Identifier Source: org_study_id