MAC Therapy for Anxiety in Cancer Patients

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Schizophrenia, Substance use, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 7 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new therapy called Managing Anxiety from Cancer (MAC) to determine if it reduces anxiety in cancer patients and their caregivers more effectively than usual care. MAC employs a structured plan to manage anxiety, with sessions conducted over the phone by trained therapists. It targets older adults with specific types of cancer who are currently receiving treatment or have completed it within the last six months. Participants should reside in New York and have a caregiver willing to join the study. Ideal candidates for this trial experience high anxiety and can communicate by phone. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative research aimed at improving anxiety management for cancer patients and their caregivers.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study staff or your doctor.

What prior data suggests that MAC therapy is safe for managing anxiety in cancer patients?

Research shows that Managing Anxiety from Cancer (MAC) therapy is safe for people. An initial study found MAC to be practical, meaning it can be done without major problems, and no serious side effects were reported. This therapy uses cognitive-behavioral therapy (CBT), a well-known approach that helps people change their thinking to manage anxiety.

Another study found that MAC reduced anxiety more than regular care, especially for caregivers. Since MAC uses phone sessions over several weeks, it easily fits into people's schedules, making it more convenient and less stressful. Overall, evidence suggests that MAC is a well-tolerated and safe option for reducing anxiety in older cancer patients and their caregivers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Managing Anxiety from Cancer (MAC) therapy because it offers a unique approach to helping older adults with cancer manage anxiety. Unlike standard treatments that primarily involve medication or in-person therapy sessions, MAC is delivered over the phone, providing a convenient and accessible option for patients who may have difficulty attending in-person sessions. This therapy is based on cognitive-behavioral techniques, which are structured and goal-oriented, allowing for personalized support tailored to each individual's needs. By involving both patients and their caregivers, MAC aims to provide comprehensive support that addresses the emotional well-being of everyone involved.

What evidence suggests that MAC therapy is effective for managing anxiety in cancer patients?

Research has shown that Managing Anxiety from Cancer (MAC) therapy, which participants in this trial may receive, reduces anxiety more effectively than usual care for cancer patients and their caregivers. One study found that MAC led to a greater reduction in anxiety levels for both patients and caregivers compared to standard care. The effect of MAC was even stronger for caregivers than for the patients themselves. MAC uses cognitive-behavioral therapy to change negative thinking patterns and improve mental health. These findings suggest that MAC therapy can be a useful tool for managing anxiety in people dealing with cancer. ^{1 2 3 5 6}

Who Is on the Research Team?

Kelly Trevino, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for older adults (65+) with certain types of cancer and their caregivers, who live in New York or can attend sessions there. Participants must speak English well, be able to consent, and use the phone for sessions. At least one member of each patient-caregiver pair should have noticeable anxiety. Exclusions include suicidal thoughts, severe weakness or cognitive impairment, recent cognitive-behavioral therapy, schizophrenia, substance issues, bipolar disorder or pregnancy in caregivers.

Inclusion Criteria

If you have a caregiver, at least one of you reports feeling very anxious on a test called the Hospital Anxiety and Depression Scale (HADS).

You agree to have your voice recorded during assessments and study sessions if needed.

I have been diagnosed with a specific type of cancer and am currently undergoing treatment or have completed treatment within the last six months.

Exclusion Criteria

I have undergone cognitive-behavioral therapy since my cancer diagnosis.

I am too weak or have cognitive issues to participate in the study.

As per self-report, currently being treated for schizophrenia, substance use or dependence, and/or bi-polar disorder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a seven-session cognitive-behavior therapy intervention administered over the telephone

7 weeks

7 sessions (telephone)

Follow-up

Participants are monitored for changes in anxiety, depression, and quality of life

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Managing Anxiety from Cancer (MAC)

Trial Overview The MAC intervention is being tested against usual care to see if it better manages anxiety in older adults with cancer and their caregivers. MAC includes a proven plan tailored for those aged 65+ and involves primary caregivers to enhance support.

How Is the Trial Designed?

Group I: Managing Anxiety from Cancer (MAC) Experimental Treatment 1 Intervention

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.

Group II: Usual Care Active Control 1 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 Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Weill Medical College of Cornell University

Collaborator

Trials

1,103

Recruited

1,157,000+

Published Research Related to This Trial

Anxiety is a common and fluctuating response among cancer patients, with a significant number experiencing clinically relevant anxiety due to various factors, highlighting the need for effective treatment strategies.

Evidence supports the use of both psychosocial and psychopharmacologic interventions to manage anxiety in cancer patients, although treatment accessibility and patient preferences must be considered in planning care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based treatment of anxiety in patients with cancer. Traeger, L., Greer, JA., Fernandez-Robles, C., et al.[2013]

Anxiety is a common issue among cancer patients, and it is crucial for cancer care professionals to recognize and manage it, even if they are not mental health specialists.

Understanding the individual significance of cancer-related events and employing effective communication strategies can help alleviate anxiety in patients, highlighting the need for tailored approaches in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anxiety in cancer patients. Stark, DP., House, A.[2022]

In a study of 339 breast cancer patients, the quality of life improved post-treatment, particularly in emotional function and future prospects, despite some worsening in physical function and symptomatology.

Anxiety levels significantly decreased after treatment, with severe anxiety being more common among patients who were married or widowed and those taking anxiolytic medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of life and anxiety in women with breast cancer before and after treatment. Villar, RR., Fernández, SP., Garea, CC., et al.[2018]

The Managing Anxiety from Cancer (MAC) intervention, a 7-session telephone-based cognitive-behavioral therapy, was beneficial for both an older cancer patient and her caregiver, providing them with anxiety management skills.

Although assessment data did not show a decrease in anxiety levels, both participants reported personal benefits and planned to use the skills learned, suggesting potential long-term efficacy despite the confounding effects of the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilizing a manualized therapy to provide parallel treatment to older adults with cancer and their caregivers: A case study. Stern, A., Hershkowitz, R., Trevino, KM.[2023]

A systematic review of 13 trials involving 606 breast cancer patients found that arts therapies, including music and art therapy, significantly reduce anxiety levels, with a standardized mean difference of -1.10.

However, the review did not find significant effects of arts therapies on depression, quality of life, pain, or other emotional states, indicating that while beneficial for anxiety, their overall impact on other aspects of well-being remains unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arts therapies for anxiety, depression, and quality of life in breast cancer patients: a systematic review and meta-analysis. Boehm, K., Cramer, H., Staroszynski, T., et al.[2023]

In a randomized controlled trial with 70 patients undergoing chemotherapy, lavender oil aromatherapy significantly reduced trait anxiety levels compared to the control group, suggesting its potential as a supportive therapy for cancer-related anxiety.

The study also found that lavender oil improved sleep quality, as indicated by significant changes in the Pittsburgh Quality Sleep Index (PSQI) measurements before and after chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aromatherapy: The Effect of Lavender on Anxiety and Sleep Quality in Patients Treated With Chemotherapy Ozkaraman, A., Dügüm, Ö., Özen Yılmaz, H., et al.[2022]

The Mental Adjustment to Cancer (MAC) Scale was developed and validated with 235 cancer patients, demonstrating its effectiveness in measuring how patients adjust psychologically to their illness.

The scale is user-friendly and well-accepted by patients, showing strong reliability and internal consistency, making it a valuable tool for clinical research on cancer adjustment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a questionnaire measure of adjustment to cancer: the MAC scale. Watson, M., Greer, S., Young, J., et al.[2022]

The study analyzed responses from 632 breast cancer patients using the Mental Adjustment to Cancer (MAC) Scale, revealing satisfactory reliability for the Fighting Spirit and Helpless-hopelessness scales, but lower reliability for Anxious Preoccupation and Fatalism.

Exploratory factor analysis identified six independent constructs related to mental adjustment to cancer, suggesting a need for refinement of the MAC Scale, while maintaining good concurrent validity with established measures of anxiety and coping.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Mental Adjustment to Cancer (MAC) scale: replication and refinement in 632 breast cancer patients. Osborne, RH., Elsworth, GR., Kissane, DW., et al.[2019]

Guided imagery, used for 20 minutes daily over one week, significantly reduced anxiety and depression in cancer patients undergoing chemotherapy compared to a control group.

Patients who practiced guided imagery also reported improvements in side effects related to chemotherapy, particularly in pain, insomnia, appetite, and nausea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guided Imagery: Reducing Anxiety, Depression, and Selected Side Effects Associated With Chemotherapy. Mahdizadeh, MJ., Tirgari, B., Abadi, OSRR., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8085071/

Managing Anxiety from Cancer (MAC): A pilot randomized ... MAC was associated with a greater reduction in anxiety among dyads than usual care, the effect of MAC was greater in caregivers than in patients, and ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03168971

Testing an Intervention for Anxiety in Older Adults With ... 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12035791/

Effectiveness of Managing Cancer and Living Meaningfully ... Our study demonstrated that CALM therapy significantly alleviated anxiety and depression symptoms, a finding supported by a systematic review ...

4. withpower.com withpower.com/trial/anxiety-intervention-for-cancer-patients-and-caregivers-003ca

Anxiety Intervention for Cancer Patients and Caregivers The Managing Anxiety from Cancer (MAC) intervention, a 7-session telephone-based cognitive-behavioral therapy, was beneficial for both an older cancer patient ...

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.23.00293

Management of Anxiety and Depression in Adult Survivors ... To update the American Society of Clinical Oncology guideline on the management of anxiety and depression in adult cancer survivors.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33818370/

A pilot randomized controlled trial of an anxiety intervention for ... MAC was associated with a greater reduction in anxiety among dyads than usual care, the effect of MAC was greater in caregivers than in patients, and ...