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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Active, not recruiting

Conditions: Quality of Life; Depression; Anxiety

Treatments: Behavioral: Managing Anxiety from Cancer (MAC)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03168971

5K23AG048632 (U.S. NIH Grant/Contract)

18-542

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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26 participants in 2 patient groups

Managing Anxiety from Cancer (MAC)

Experimental group

Description:

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.

Treatment:

Behavioral: Managing Anxiety from Cancer (MAC)

Usual Care

No Intervention group

Description:

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.