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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03168971
• Other study ID #: 18-542
• Secondary ID: 5K23AG048632
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 23, 2019
• Est. completion date: January 21, 2025

Study information

• Verified date: February 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 26
• Est. completion date: January 21, 2025
• Est. primary completion date: January 21, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Quality of Life

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Institute on Aging (NIA), Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	Distress Thermometer	Change in distress from baseline to follow-up	Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline)
Secondary	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)
Secondary	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)
Secondary	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)

External Links

•   Memorial Sloan Kettering Cancer Center