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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03168971

Collaborator

Weill Medical College of Cornell University (Other), National Institute on Aging (NIA) (NIH)

Enrollment

Location

Arms

47.9

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anxiety Depression Quality of Life	Behavioral: Managing Anxiety from Cancer (MAC)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

26 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Patient-caregiver dyads will be randomly assigned to the intervention or a usual care control condition.Patient-caregiver dyads will be randomly assigned to the intervention or a usual care control condition.

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 23, 2019

Anticipated Primary Completion Date :

Jan 21, 2023

Anticipated Study Completion Date :

Jan 21, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Anxiety sub-scale of the Hospital Anxiety and Depression Scale [Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline)]
Change in anxiety from baseline to follow-up
Hamilton Anxiety Rating Scale [Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline)]
Change in anxiety from baseline to follow-up

Secondary Outcome Measures

Depression sub-scale of the Hospital Anxiety and Depression Scale [Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline)]
Change in depression from baseline to follow-up
Distress Thermometer [Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline)]
Change in distress from baseline to follow-up
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)]
Change in health-related quality of life
Caregiver Quality of Life-Cancer (caregivers only) [Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline)]
Change in health-related quality of life
Montgomery-Asberg Depression Scale [Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline)]
Change in depression from baseline to follow-up

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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