CALM Therapy for Brain Cancer

Overseen By Ashlee Loughan, Ph.D

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Virginia Commonwealth University

Disqualifiers: Communication difficulties, Telehealth inability, others

Compensation: Varies

Number of Visits: Unknown

Duration: 3-6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new therapy called CALM (Managing Cancer and Living Meaningfully), designed to help people with brain cancer manage stress and find more meaning in their lives. Participants will either attend CALM sessions covering topics like symptom management and personal relationships or continue with their usual care, which may include mental health resources. Individuals with malignant brain tumors who experience high stress or depression might be a good fit for this study. As an unphased trial, this study offers a unique opportunity for participants to explore innovative ways to improve their quality of life.

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 trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that CALM therapy is safe and well-received by cancer patients. A review of 15 studies involving 1,635 cancer patients found that they generally accepted the therapy and felt less depressed and stressed. Another study found that CALM therapy improved emotional well-being without any negative effects. These consistent findings suggest that CALM therapy is safe for cancer patients, including those with brain cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about CALM Therapy for brain cancer because it offers a holistic approach that goes beyond managing physical symptoms. Unlike standard treatments that focus primarily on medical interventions, CALM addresses emotional and existential challenges through personalized sessions. This method helps patients enhance communication with healthcare providers, navigate personal relationships, find a sense of meaning, and confront future uncertainties. By focusing on these broader aspects, CALM has the potential to improve overall well-being and quality of life for patients facing brain cancer.

What evidence suggests that CALM therapy might be an effective treatment for brain cancer?

Research has shown that CALM therapy, which participants in this trial may receive, can assist individuals with brain cancer. Studies have found it significantly reduces feelings of depression and anxiety about dying. Participants also reported feeling less anxious and depressed overall. Additional benefits include reduced cancer-related fatigue, improved sleep, and enhanced overall quality of life. CALM therapy aids individuals in managing symptoms, improving communication with healthcare providers, and finding meaning and hope. ^{1 4 6 7 8}

Who Is on the Research Team?

Ashlee Loughan, Ph.D

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

This trial is for individuals with malignant brain cancer, who may also have other cancers like kidney, lung, breast, melanoma, or colon cancer. Participants should be interested in a psychotherapeutic approach to manage distress.

Inclusion Criteria

Ability to read, speak, and understand English

It has been at least 2 weeks since my brain surgery or biopsy.

My thinking and memory test score is above 20.

Exclusion Criteria

I am able to understand and sign the consent form.

Medical, psychological, or social condition that, in the opinion of the principal investigator, may increase the participant's risk of adverse events and/or prohibit the individual's participation in the intervention

I cannot use an electronic device for telehealth sessions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Day 0

Treatment

Participants receive the CALM intervention, consisting of six individual sessions of 45 to 60 minutes, delivered over a three- to six-month period

3-6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including completion of follow-up questionnaires

6 months

What Are the Treatments Tested in This Trial?

Interventions

• CALM
• Treatment as usual

Trial Overview The study compares the effectiveness of a psychotherapy called Managing Cancer and Living Meaningfully (CALM) against the standard treatment practices (TAU) in managing emotional distress in brain cancer patients.

How Is the Trial Designed?

Group I: Managing Cancer and Living Meaningfully (CALM) Experimental Treatment 1 Intervention

CALM optimally consists of six individual sessions of 45 to 60 minutes, delivered over a three- to six-month period. CALM sessions address four broad and interrelated domains found to be important and relevant in this population: (1) symptom management and communication with healthcare providers, (2) changes in personal relationships, (3) sense of meaning and purpose, and (4) the future, hope and mortality.

Group II: Treatment as Usual (TAU) Placebo Group 1 Intervention

Treatment as usual (TAU) for managing distress in brain cancer involves being provided a list of local / national resources (e.g., psychologist, social worker, or other mental health providers) if an individual chooses to seek treatment for the distress they are experiencing.

CALM is already approved in Canada, United States for the following indications:

Approved in Canada as CALM for:

• Advanced cancer
• Terminal cancer

Approved in United States as CALM for:

• Advanced cancer
• Terminal cancer
• Malignant brain cancer

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

The CALM intervention significantly improved cognitive function, reduced psychological distress, and enhanced quality of life in 74 Chinese breast cancer survivors compared to the usual care group, as measured by various assessment tools.

There was a strong positive correlation between cognitive function and quality of life both before and after the CALM treatment, suggesting that improving cognitive function may also enhance overall well-being in breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing Cancer and Living Meaningfully (CALM) Intervention on Chemotherapy-Related Cognitive Impairment in Breast Cancer Survivors. Ding, K., Zhang, X., Zhao, J., et al.[2021]

The CALM intervention significantly reduced psychological distress, anxiety, and depression in patients with esophageal cancer during treatment, as shown by assessments taken at multiple time points.

Patients also reported improved quality of life after participating in the CALM program, with these benefits lasting for at least one month after the intervention ended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of Managing Cancer and Living Meaningfully (CALM) on psychological distress in esophageal cancer patients. Cai, Y., Zhao, J., Li, W., et al.[2023]

The CALM intervention, a brief psychotherapeutic approach for patients with advanced cancer, aims to reduce depression and end-of-life distress, with a focus on feasibility and preliminary efficacy in a single-arm trial involving adult patients with expected survival of at least 6 months.

The study will assess the effectiveness of CALM through participant completion rates and improvements in depressive symptoms, with a target of at least 70% of participants completing the intervention and follow-up measures, indicating its potential as a supportive care option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief, manualised and semistructured individual psychotherapy programme for patients with advanced cancer in Japan: study protocol for Managing Cancer and Living Meaningfully (CALM) phase 2 trial. Miyamoto, S., Yamazaki, T., Shimizu, K., et al.[2022]

A randomized controlled trial is being conducted with 422 cancer patients to test the efficacy of a smartphone app called Quit2Heal, which is designed to help cancer patients quit smoking by addressing issues like shame, stigma, and anxiety related to their condition.

Quit2Heal is based on Acceptance and Commitment Therapy and aims to achieve higher smoking cessation rates compared to a standard app (QuitGuide) by focusing on the unique psychological challenges faced by cancer patients, potentially leading to better cancer treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of smartphone applications to help cancer patients quit smoking: Protocol of the Quit2Heal randomized controlled trial. Bricker, JB., Westmaas, JL., Ostroff, JS., et al.[2023]

The CALM psychotherapy program was found to be feasible and acceptable for adults with malignant glioma, with a high retention rate of 75% and positive feedback from participants, indicating its potential for this underserved population.

Participants experienced significant reductions in death anxiety, generalized anxiety, and depression after the intervention, suggesting that CALM may effectively improve psychological well-being in patients facing advanced cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing cancer and living meaningfully (CALM) in adults with malignant glioma: a proof-of-concept phase IIa trial. Loughan, AR., Willis, KD., Braun, SE., et al.[2023]

The CALM therapy for advanced cancer patients was generally applied as intended, with therapists frequently addressing symptoms and emotional concerns, but there were notable deviations in adherence to specific treatment elements, such as promoting the acknowledgment of unachievable life goals.

No significant differences were found in the treatment elements delivered by CALM therapists compared to those in the supportive psycho-oncological counseling intervention (SPI), indicating that both therapies may share overlapping components.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testing the Treatment Integrity of the Managing Cancer and Living Meaningfully Psychotherapeutic Intervention for Patients With Advanced Cancer. Koranyi, S., Philipp, R., Quintero Garzón, L., et al.[2022]

The CALM psychotherapy program for patients with advanced cancer showed promising potential effects on reducing depressive symptoms and attachment anxiety, suggesting it may be beneficial for mental health in this population.

The study demonstrated feasibility for a larger phase 3 trial, with a 32% consent rate and 78% randomization, but highlighted challenges such as non-compliance (37%) and contamination (17%) that need to be addressed in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing Cancer And Living Meaningfully (CALM): randomised feasibility trial in patients with advanced cancer. Lo, C., Hales, S., Chiu, A., et al.[2019]

An electronic health record (EHR)-based 'opt-out' referral system for tobacco treatment was successfully implemented for 210 oncology patients at the Mayo Clinic, demonstrating feasibility without requiring clinician co-signatures.

Of the referred patients, 71% scheduled appointments for tobacco treatment, but only 17% attended, highlighting the need for strategies to improve appointment attendance among cancer patients who smoke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and Pilot Implementation of an Electronic Health Record-Based System to Automatically Refer Cancer Patients to Tobacco Use Treatment. Jose, T., Ohde, JW., Hays, JT., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9909556/

Managing cancer and living meaningfully (CALM) in adults ... High perceived benefit and reductions in symptoms of death anxiety, generalized anxiety, and depression were reported by participants. These ...

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

Effectiveness of Managing Cancer and Living Meaningfully ... CALM therapy has demonstrated positive effects on psychological distress, anxiety, depression, cancer‐related fatigue, sleep disturbance, and quality of life.

3. academic.oup.com academic.oup.com/neuro-oncology/article/27/Supplement_3/iii151/8272187

P15.20.B CALM IN THE FACE OF BRAIN CANCER: INTERIM ... Managing Cancer and Living Meaningfully (CALM), a supportive-expressive psychotherapy, has proven to reduce depression and death anxiety in ...

4. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCT04852302

Managing Cancer and Living Meaningfully (CALM) ... Participants will be assigned to a CALM therapist. They will have 3 to 6 individual therapy sessions in 6 months. Each session will last 45 to 60 minutes.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04646213

NCT04646213 | Managing Cancer and Living Meaningfully The purpose of this study is to pilot test an empirically supported psychotherapeutic intervention, Managing Cancer and Living Meaningfully (CALM). Researchers ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10391815/

Evaluation of Managing Cancer and Living Meaningfully ... Assess the feasibility of the CALM intervention, outcome measures and study design to guide the development of a possible subsequent phase 3 RCT ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jocn.17754?af=R

Managing Cancer and Living Meaningfully (CALM) ... Results. Fifteen trials met the inclusion criteria for the systematic review and twelve for the meta-analysis, with a total of 1635 cancer ...

8. nature.com nature.com/articles/s41598-024-52574-7

Feasibility of online managing cancer and living ... CALM therapy was well received by the study population, and CALM therapy can reduce depression, distress, attachment avoidance while improving ...