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Completed

NCT Number: NCT03168971

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

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Managing Anxiety from Cancer (MAC)

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • National Institute on Aging (NIA)
  • Weill Medical College of Cornell University

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
May 30, 2017
Registry last updated
Oct 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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