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

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ClinicalTrials.gov Identifier: NCT03168971
Recruitment Status : Recruiting
First Posted : May 30, 2017
Last Update Posted : September 6, 2019
Sponsor:
Collaborators:
Weill Medical College of Cornell University
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 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.
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 : January 23, 2019
Estimated Primary Completion Date : January 21, 2020
Estimated Study Completion Date : January 21, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Caregivers

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.



Primary Outcome Measures :
  1. Anxiety sub-scale of the Hospital Anxiety and Depression Scale [ Time Frame: Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline) ]
    Change in anxiety from baseline to follow-up

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

  2. Distress Thermometer [ Time Frame: Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline) ]
    Change in distress from baseline to follow-up

  3. Functional Assessment of Cancer Therapy-General: Emotional Quality of Life Sub-Scale (patients only) [ Time Frame: Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline) ]
    Change in health-related quality of life

  4. Caregiver Quality of Life-Cancer (caregivers only) [ Time Frame: Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline) ]
    Change in health-related quality of life

  5. Montgomery-Asberg Depression Scale [ Time Frame: Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline) ]
    Change in depression from baseline to follow-up



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03168971


Contacts
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Contact: Kelly Trevino, PhD 646-888-0026 trevinok@mskcc.org
Contact: Christian Nelson, PhD 646-888-0030 nelsonc@mskcc.org

Locations
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United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Kelly Trevino, PhD    646-888-0026    trevinok@mskcc.org   
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Weill Medical College of Cornell University
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Kelly Trevino, PhD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03168971     History of Changes
Other Study ID Numbers: 18-542
5K23AG048632 ( U.S. NIH Grant/Contract )
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Cancer
Anxiety
Cognitive behavior therapy
Elderly
Caregivers
18-542
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders