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

Primary Purpose

Anxiety, Depression, Quality of Life

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Managing Anxiety from Cancer (MAC)

About this trial

This is an interventional treatment trial for Anxiety focused on measuring Cancer, Anxiety, Cognitive behavior therapy, Elderly, Caregivers, 18-542

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Managing Anxiety from Cancer (MAC)

Usual Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Anxiety sub-scale of the Hospital Anxiety and Depression Scale

Change in anxiety from baseline to follow-up

Hamilton Anxiety Rating Scale

Change in anxiety from baseline to follow-up

Secondary Outcome Measures

Depression sub-scale of the Hospital Anxiety and Depression Scale

Change in depression from baseline to follow-up

Distress Thermometer

Change in distress from baseline to follow-up

Functional Assessment of Cancer Therapy-General: Emotional Quality of Life Sub-Scale (patients only)

Change in health-related quality of life

Caregiver Quality of Life-Cancer (caregivers only)

Change in health-related quality of life

Montgomery-Asberg Depression Scale

Change in depression from baseline to follow-up

Full Information

NCT ID

NCT03168971

First Posted

May 23, 2017

Last Updated

February 27, 2023

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT03168971

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

January 23, 2019 (Actual)

Primary Completion Date

January 21, 2024 (Anticipated)

Study Completion Date

January 21, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anxiety, Depression, Quality of Life

Keywords

Cancer, Anxiety, Cognitive behavior therapy, Elderly, Caregivers, 18-542

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Managing Anxiety from Cancer (MAC)

Arm Type

Experimental

Arm Description

Arm Title

Usual Care

Arm Type

No Intervention

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Managing Anxiety from Cancer (MAC)

Intervention Description

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 Outcome Measure Information:

Title

Anxiety sub-scale of the Hospital Anxiety and Depression Scale

Description

Change in anxiety from baseline to follow-up

Time Frame

Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline)

Title

Hamilton Anxiety Rating Scale

Description

Change in anxiety from baseline to follow-up

Time Frame

Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline)

Secondary Outcome Measure Information:

Title

Depression sub-scale of the Hospital Anxiety and Depression Scale

Description

Change in depression from baseline to follow-up

Time Frame

Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline)

Title

Distress Thermometer

Description

Change in distress from baseline to follow-up

Time Frame

Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline)

Title

Functional Assessment of Cancer Therapy-General: Emotional Quality of Life Sub-Scale (patients only)

Description

Change in health-related quality of life

Time Frame

Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline)

Title

Caregiver Quality of Life-Cancer (caregivers only)

Description

Change in health-related quality of life

Time Frame

Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline)

Title

Montgomery-Asberg Depression Scale

Description

Change in depression from baseline to follow-up

Time Frame

Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kelly Trevino, PhD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Memorial Sloan Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Links:

URL

http://www.mskcc.org

Description

Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

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