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

26 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests MAC therapy, a program to help manage cancer-related anxiety, in people aged 65 and older and their caregivers. The therapy provides tools and support to reduce anxiety by involving both patients and 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.

Is MAC Therapy for Anxiety in Cancer Patients safe?

The MAC therapy, which includes techniques from Acceptance and Commitment Therapy and Problem-Solving Therapy, was used in a case study with an older woman with cancer and her caregiver. Both reported benefits from the therapy, and no safety concerns were mentioned, suggesting it is generally safe for use in humans. ^{1 2 3 4 5}

How is the MAC treatment for anxiety in cancer patients different from other treatments?

The MAC treatment is unique because it is a 7-session telephone-delivered therapy that combines strategies from Acceptance and Commitment Therapy and Problem-Solving Therapy, specifically designed to help both cancer patients and their caregivers manage anxiety together. ^{1 2 6 7 8}

What data supports the effectiveness of the treatment Managing Anxiety from Cancer (MAC) for anxiety in cancer patients?

The MAC treatment, which includes techniques from Acceptance and Commitment Therapy and Problem-Solving Therapy, was used with an older cancer patient and her caregiver, who both reported benefits and planned to use the skills learned to manage anxiety. Although the assessment data did not show a decrease in anxiety, the stress of the COVID-19 pandemic may have affected these results. ^{1 2 9 10 11}

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 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]

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]

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]

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]

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]

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]

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]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Anxiety in cancer patients. [2022]

2. England pubmed.ncbi.nlm.nih.gov

The impact of short-term psycho-oncological interventions on the psychological outcome of cancer patients of a surgical-oncology department - a randomised controlled study. [2011]

3. United States pubmed.ncbi.nlm.nih.gov

Utilizing a manualized therapy to provide parallel treatment to older adults with cancer and their caregivers: A case study. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Guided Imagery: Reducing Anxiety, Depression, and Selected Side Effects Associated With Chemotherapy. [2020]

5. Brazil pubmed.ncbi.nlm.nih.gov

Quality of life and anxiety in women with breast cancer before and after treatment. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Evidence-based treatment of anxiety in patients with cancer. [2013]

7. England pubmed.ncbi.nlm.nih.gov

Clinical anxiety disorders in the context of cancer: A scoping review of impact on resource use and healthcare costs. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Aromatherapy: The Effect of Lavender on Anxiety and Sleep Quality in Patients Treated With Chemotherapy [2022]

9. England pubmed.ncbi.nlm.nih.gov

Development of a questionnaire measure of adjustment to cancer: the MAC scale. [2022]

10. England pubmed.ncbi.nlm.nih.gov

The Mental Adjustment to Cancer (MAC) scale: replication and refinement in 632 breast cancer patients. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Arts therapies for anxiety, depression, and quality of life in breast cancer patients: a systematic review and meta-analysis. [2023]