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NCT Number: NCT02747160

Anxiety With Cancer in the Elderly (ACE): A Cognitive-behavioral Intervention

The purpose of this study is to examine the feasibility and acceptability of and patient adherence to a telephone-administered cognitive-behavioral therapy intervention for anxiety in older adults (65 years and older) with cancer and their primary informal caregiver. This study will also examine whether the intervention has a clinically significant impact on patient anxiety (primary outcome) and depression, distress, and quality of life (secondary outcomes).

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weill Medical College of Cornell University

New York, 10065, United States

About this study

This study is a single arm pre-post evaluation of a six-session telephone-administered cognitive-behavioral therapy (CBT) intervention for anxiety in older adults with cancer and their primary informal (unpaid) caregiver. The primary purposes of this study are to evaluate the feasibility of the intervention and study procedures, acceptability of the intervention to older adults with cancer and their primary informal caregiver, and patient and caregiver adherence to the intervention. The secondary purpose is to examine changes in patient and caregiver anxiety, depression, distress, and quality of life pre to post intervention to determine whether the intervention has a clinically significant impact on these outcomes. Anxiety is the primary outcome; depression, distress, and quality of life are secondary outcomes. Patients will be 65 years of age or older and will be recruited from the myeloma, lung, lymphoma, gynecologic, and gastrointestinal cancer clinics at a single institution. Study measures will be administered by telephone prior to initiating the intervention (pre-intervention) and following intervention completion (post-intervention).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient age 65 years or older
  • Diagnosis of cancer
  • Patient and/or caregiver score of 8 or higher on the anxiety subscale of the Hospital Anxiety and Depression Scale
  • A primary informal caregiver who is willing and able to participate
  • Patient and caregiver are able to communicate over the telephone
  • Caregiver is age 21 years or older.

Exclusion criteria

  • Patient or caregiver is not fluent in English
  • Patient or caregiver is too weak or cognitively impaired to participate in the intervention
  • Patient or caregiver has received CBT since the patient's cancer diagnosis
  • Patient or caregiver has an active major psychiatric condition such as schizophrenia
  • Patient only experiences anxiety in the context of a specific medical procedure
  • Patient or caregiver endorses active suicidal ideation

Treatment and study plan

Managing Anxiety from Cancer (MAC)

Behavioral

The intervention consists of six telephone-administered sessions. Session topics include psychoeducation on anxiety, behavioral strategies for managing anxiety, cognitive restructuring, communication skills training, acceptance techniques (patient only), problem-solving strategies (caregiver only), and planning for future anxiety. Session content is tailored for older adults and caregivers of older adults with cancer.

Primary outcomes

  1. Intervention feasibility

    Time frame: Post-intervention (6-8 weeks after baseline)

    Attrition rates

  2. Intervention acceptability

    Time frame: Post-intervention (6-8 weeks after baseline)

    Likert scale ratings of perceived helpfulness and readability of the intervention

  3. Patient/caregiver adherence

    Time frame: Post-intervention (6-8 weeks after baseline)

    Sum of number of intervention exercises completed with number of sessions completed by patients and caregivers

Secondary outcomes

  1. Change in anxiety from baseline to post-intervention

    Time frame: Baseline (1-2 weeks after enrollment) and Post-intervention (6-8 weeks after baseline)

    Anxiety sub-scale of the Hospital Anxiety and Depression Scale

  2. Change in distress from baseline to post-intervention

    Time frame: Baseline (1-2 weeks after enrollment) and Post-intervention (6-8 weeks after baseline)

    Distress Thermometer

  3. Emotional health-related quality of life

    Time frame: Baseline (1-2 weeks after enrollment) and Post-intervention (6-8 weeks after baseline)

    Functional Assessment of Cancer Therapy-General: Emotional Quality of Life Sub-Scale; Caregiver Quality of Life-Cancer

  4. Change in depression from baseline to post-intervention

    Time frame: Baseline (1-2 weeks after enrollment) and Post-intervention (6-8 weeks after baseline)

    Depression sub-scale of the Hospital Anxiety and Depression Scale

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • Weill Medical College of Cornell University

Registry information

Official study title

Evaluation of an Anxiety Intervention for Older Adults With Cancer and Informal Caregivers of Older Adults With Cancer

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Apr 21, 2016
Registry last updated
Oct 14, 2020

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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