AnxietyNCT03168971
Managing Anxiety From Cancer (MAC): Testing an Intervention for Anxiety in Older Adults With Cancer and Their Caregivers
A study testing Managing Anxiety from Cancer (MAC) in people with Anxiety and Depression, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Depression, Quality of Life
- What is being tested?
- Managing Anxiety from Cancer (MAC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2019to 27 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
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
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.
- Conditions
- Anxiety, Depression, Quality of Life
- Being tested
- Managing Anxiety from Cancer (MAC)
- Keywords
- Cancer, Anxiety, Cognitive behavior therapy, Elderly, Caregivers, 18-542
- Medical subject headings
- Anxiety Disorders, Depression, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Managing Anxiety from Cancer (MAC)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Managing Anxiety from Cancer (MAC) | Experimental | 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. Receives: Behavioral: Managing Anxiety from Cancer (MAC) |
| Usual Care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety sub-scale of the Hospital Anxiety and Depression Scale
Change in anxiety from baseline to follow-up
Measured: Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline)
Hamilton Anxiety Rating Scale
Change in anxiety from baseline to follow-up
Measured: Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline)
Secondary outcomes (5)
Depression sub-scale of the Hospital Anxiety and Depression Scale
Change in depression from baseline to follow-up
Measured: Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline)
Distress Thermometer
Change in distress from baseline to follow-up
Measured: Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline)
Functional Assessment of Cancer Therapy-General: Emotional Quality of Life Sub-Scale (patients only)
Change in health-related quality of life
Measured: Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline)
Caregiver Quality of Life-Cancer (caregivers only)
Change in health-related quality of life
Measured: Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline)
Montgomery-Asberg Depression Scale
Change in depression from baseline to follow-up
Measured: Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start23 Jan 2019
- Primary completion27 Oct 2025
- Study completion27 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patient-caregiver dyads will be randomly assigned to the intervention or a usual care control condition.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Weill Medical College of Cornell University, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Kelly Trevino, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03168971
- Sponsor's protocol ID
- 18-542
- Other IDs
- 5K23AG048632
- Status last verified
- Oct 2025
- First submitted
- 23 May 2017
- Last updated
- 29 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03168971
- Acronym / sponsor ID
- 18-542
- Conditions
- Anxiety, Depression, Quality of Life
- Keywords
- Cancer, Anxiety, Cognitive behavior therapy, Elderly, Caregivers, 18-542
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Weill Medical College of Cornell University, National Institute on Aging (NIA)
- Study start
- 23 Jan 2019 (actual)
- Primary completion
- 27 Oct 2025 (actual)
- Study completion
- 27 Oct 2025 (actual)
- First posted
- 30 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patient-caregiver dyads will be randomly assigned to the intervention or a usual care control condition.
| Arm | Type | Receives |
|---|---|---|
| Managing Anxiety from Cancer (MAC) | Experimental | Behavioral: 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. |
| Usual Care | No intervention | –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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Managing Anxiety from Cancer (MAC) |
Primary outcome
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
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
5 secondary outcomes
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)
Distress Thermometer
Time frame: Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline)
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)
Caregiver Quality of Life-Cancer (caregivers only)
Time frame: Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline)
Montgomery-Asberg Depression Scale
Time frame: Baseline (1-2 weeks after enrollment) and Follow-up (7-9 weeks after baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2025.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelly Trevino, PhD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Managing Anxiety from Cancer (MAC) in people with Anxiety and Depression, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2025.