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

Trial Summary

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 data supports the effectiveness of the treatment Managing Anxiety from Cancer (MAC) for cancer patients and caregivers?

The MAC treatment, which includes techniques from Acceptance and Commitment Therapy and Problem-Solving Therapy, was reported to benefit both a cancer patient and her caregiver by helping them manage anxiety and improve communication, despite the stress of the COVID-19 pandemic potentially affecting the results. ^{1 2 3 4 5}

Is the Managing Anxiety from Cancer (MAC) treatment safe for cancer patients and caregivers?

The Managing Anxiety from Cancer (MAC) treatment, which includes cognitive-behavioral strategies, was used with an older adult cancer patient and her caregiver, and both reported benefits without any mention of safety concerns. ^{1 6 7 8 9}

How is the treatment Managing Anxiety from Cancer (MAC) different from other treatments for anxiety in cancer patients and caregivers?

Managing Anxiety from Cancer (MAC) is unique because it is a 7-session telephone-delivered therapy that combines strategies from Acceptance and Commitment Therapy and Problem-Solving Therapy, allowing both cancer patients and their caregivers to learn and apply the same anxiety-management techniques together. ^{1 8 10 11 12}

What is the purpose of this trial?

The purpose of this study is to find out if an anxiety treatment program is practical and effective for Latino older adults with cancer (OACs) and their caregivers.

Research Team

Kelly McConnell, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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 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]

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]

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]

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 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]

References

1. 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]

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

Mental adjustment to cancer: its measurement and prognostic importance. [2015]

3. England pubmed.ncbi.nlm.nih.gov

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

4. England pubmed.ncbi.nlm.nih.gov

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

5. United States 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. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Illness-related worry among cancer patients: prevalence, severity, and content. [2019]

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

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

8. England pubmed.ncbi.nlm.nih.gov

Anxiety in cancer patients. [2022]

9. Brazil pubmed.ncbi.nlm.nih.gov

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

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

The influence of family social support on quality of life of informal caregivers of cancer patients. [2021]

11. Canada 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. [2020]

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

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