Anxiety Intervention for Cancer Patients and Caregivers

Recruiting at 6 trial locations

Overseen By Christian Nelson, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Psychotropics

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

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a seven-session anxiety treatment program, called Managing Anxiety from Cancer (MAC), benefits Latino older adults with cancer and their caregivers. The program uses cognitive behavioral therapy tools to help change negative thought patterns. Participants will join sessions via videoconference or phone with licensed social workers. This trial suits Latino older adults currently or recently undergoing cancer treatment who feel anxious and have a caregiver who can participate with them. As an unphased trial, it offers a unique opportunity for participants to access potentially beneficial anxiety management tools tailored to their needs.

Will I have to stop taking my current medications?

If you are taking psychotropic medications (medications that affect your mood, thoughts, or behavior), you must have been on them for at least 8 weeks before the first session and should not plan to change them during the study.

What prior data suggests that this anxiety treatment program is safe for Latino older adults with cancer and their caregivers?

Research has shown that the Managing Anxiety from Cancer (MAC) program is safe for participants. In earlier studies, participants engaged in a seven-session therapy program via phone or video call with trained social workers. These sessions are based on cognitive behavioral therapy (CBT), a common form of talk therapy.

The initial studies found that MAC was well-received by both older cancer patients and their caregivers, with no serious negative effects reported. Most participants completed the program, finishing all their sessions. This indicates that the treatment is not only safe but also acceptable to those who try it.

Overall, the evidence supports MAC as a safe option for managing anxiety in this group. It has shown promise in reducing anxiety without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Managing Anxiety from Cancer (MAC) is unique because it specifically targets Latino caregivers and older adults with cancer, addressing a gap in culturally tailored mental health interventions. Unlike traditional in-person therapy, MAC is delivered via videoconference or telephone, making it more accessible for participants who might face barriers to attending sessions physically. Researchers are excited about MAC's foundation in cognitive behavioral therapy (CBT), a proven approach for anxiety, but adapted here to meet the cultural and logistical needs of this specific community.

What evidence suggests that the Managing Anxiety from Cancer (MAC) program is effective for anxiety in Latino older adults with cancer and their caregivers?

Research has shown that the Managing Anxiety from Cancer (MAC) program, which participants in this trial will receive, can reduce anxiety in cancer patients and their caregivers. One study found that people in the MAC program experienced a greater decrease in anxiety compared to those receiving regular care. The program proved especially beneficial for caregivers, who felt more relief from anxiety than the patients. MAC is based on cognitive behavioral therapy, a type of talk therapy that helps manage anxiety by teaching new ways to think and act to better handle stress and anxiety. ^{1 4 6 7 8}

Who Is on the Research Team?

Kelly McConnell, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for Latino older adults with cancer and their caregivers. It aims to see if an anxiety treatment program can help them.

Inclusion Criteria

Identifies as Latino and/or Hispanic Ethnicity

Fluent in English and/or Spanish

My primary caregiver is 55 or older and willing to join the study with me.

Exclusion Criteria

Currently being treated for schizophrenia, substance use or dependence, and/or bipolar disorder

Receiving hospice care at the time of enrollment

Caregiver:

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a seven-session psychotherapy intervention delivered via videoconference and/or telephone

7 weeks

7 sessions (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Managing Anxiety from Cancer (MAC)

Trial Overview The intervention being studied is the Managing Anxiety from Cancer (MAC) program, designed to reduce anxiety in Latino older adults with cancer and their caregivers.

How Is the Trial Designed?

Group I: Latino caregivers and the Latino older adults with cancer (OACs) Experimental Treatment 1 Intervention

The intervention, MAC, is a seven-session (45- 60 minutes per session) psychotherapy intervention delivered via videoconference and/or telephone by licensed social workers. All sessions will be audio-recorded. MAC content, structure, and length are consistent with core components of cognitive behavioral therapy (CBT) (Freeman, 2004).

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

Over half of the 83 cancer patients surveyed reported that worry was at least 'somewhat of a problem,' with 15% indicating it was a significant to severe issue, highlighting the emotional burden of illness during active treatment.

Women and patients with poor social support were more likely to report problems with worry, suggesting that these factors may influence the severity of illness-related anxiety, although many aspects of worry remain unexplained.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Illness-related worry among cancer patients: prevalence, severity, and content. Stefanek, ME., Shaw, A., DeGeorge, D., et al.[2019]

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 iCAN-DO intervention, designed for cancer patients experiencing anxiety or depression, was generally well-received, with user experiences influenced by individual health situations and technical aspects of the program.

While 40% of participants were offered internet-based cognitive behavioral therapy (iCBT), feedback suggested that the program's design could benefit from more tailored features to enhance usability and engagement for users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

User Experiences of an Internet-Based Stepped-Care Intervention for Individuals With Cancer and Concurrent Symptoms of Anxiety or Depression (the U-CARE AdultCan Trial): Qualitative Study. Igelström, H., Hauffman, A., Alfonsson, S., et al.[2020]

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]

Research indicates that how patients mentally adjust to cancer may influence their disease progression, particularly in those with early-stage (non-metastatic) cancer, although this evidence is still considered provisional.

The MAC scale, a new 40-item self-rating questionnaire developed to measure mental adjustment to cancer, has shown promising initial results in a study of 235 patients, indicating it is reliable, easy to use, and valid for future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mental adjustment to cancer: its measurement and prognostic importance. Greer, S., Watson, M.[2015]

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]

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]

In a study involving 356 cancer patients, the telephone caseworker (TCW) model showed a significant improvement in physical functioning at 3 months compared to usual care, suggesting potential benefits of this intervention.

Participants in the TCW model reported better communication with their healthcare team and were more likely to have their needs addressed, indicating that this model may help in managing psychosocial needs, although no overall intervention effect was observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of two supportive care interventions on anxiety, depression, quality of life, and unmet needs in patients with nonlocalized breast and colorectal cancers. Girgis, A., Breen, S., Stacey, F., 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]

In a study of 67 informal caregivers of cancer patients, perceived emotional support was found to mediate the relationship between depression and quality of life six months after diagnosis, highlighting its importance in caregiver well-being.

The study demonstrated that higher levels of perceived emotional support can help alleviate the negative impact of depression on quality of life, suggesting that enhancing emotional support for caregivers may improve their mental health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The influence of family social support on quality of life of informal caregivers of cancer patients. García-Carmona, M., García-Torres, F., Jacek Jabłoński, M., et al.[2021]

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]

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. 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12122648/

The efficacy of psychosocial interventions on anxiety and ... Meaning-centered psychotherapy, psychoeducation, and supportive therapy are particularly effective in reducing anxiety and depression among cancer caregivers.

4. academic.oup.com academic.oup.com/jnci/article/115/8/896/7188112

Interventions to improve outcomes for caregivers of patients ... In particular, caregivers of patients with advanced cancer may have poor mental health, including depression and anxiety (7-12), as well as physical symptoms ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2347562522001627

Effectiveness and moderators of cancer patient-caregiver ... For patients, CSG reduces intimacy anxiety more than ISP. CSG appears to be more effective for partners as it reduces partner anxiety and depression and ...

6. 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 ...

7. 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 ...

8. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2023.1059605/full

Caregiving burden, depression, and anxiety among family ... Conclusion: High levels of depression, anxiety, and burden were observed among the caregivers of patients with cancer. These findings underline ...