iCALM for Advanced Cancer

(iCALM Trial)

Overseen By Gary Rodin, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Cognitive impairment, Structured psychotherapy, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 9 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores an online program called iCALM, designed to help individuals with advanced cancer manage psychological stress and improve well-being. iCALM consists of online therapy sessions with videos and exercises aimed at reducing depression, specifically for those with advanced or metastatic cancer. Participants must have confirmed advanced cancer, such as stage III or IV lung cancer or stage IV breast cancer, and be patients at Princess Margaret Cancer Centre. Those who can read and write in English, access the internet, and attend online sessions might be a good fit. As an unphased trial, this study offers a unique opportunity to access innovative support tools that could enhance quality of life.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that iCALM is safe for patients with advanced cancer?

Research has shown that the original CALM therapy, on which iCALM is based, is safe and well-tolerated. CALM is a short, proven therapy designed to help individuals with advanced cancer manage feelings like depression and distress. Studies have found that participants using CALM therapy typically do not experience major negative effects. As iCALM is an online version of this therapy, it is expected to be equally safe. With no medication involved, there are no drug-related side effects to consider, making it a likely low-risk option for those interested in trying it. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about iCALM because it offers a unique, online psychotherapeutic approach tailored for patients with advanced cancer. Unlike traditional in-person counseling or medication, iCALM provides flexibility by allowing patients to access therapy from home, using digital modules that include videos and exercises. This method could make receiving psychological support easier and more accessible for those dealing with the stress of cancer, potentially improving their mental health without adding the burden of frequent hospital visits.

What evidence suggests that iCALM is effective for reducing psychological distress in advanced cancer patients?

Research has shown that the CALM (Managing Cancer and Living Meaningfully) program can reduce depression and distress in patients with advanced cancer. Studies have found that CALM helps manage distress at the end of life and improves overall well-being. In this trial, participants in the iCALM Intervention Group will receive the iCALM program, an online version of CALM for advanced cancer patients. Early results suggest that iCALM can lower psychological distress and improve mental health in this group. By focusing on personal meaning and emotional support, iCALM aims to relieve depressive symptoms and enhance quality of life. ^{1 2 3 4 6}

Who Is on the Research Team?

Sarah Hales, MD

Principal Investigator

University Health Network, Toronto

Gary Rodin, MD

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

This trial is for adults over 18 with advanced or metastatic cancer, expected to live 12-18 months. They must read/write English, commit to online sessions, have internet access, and be treated at Princess Margaret Cancer Centre. Excluded are those with cognitive impairment or in psychotherapy.

Inclusion Criteria

I can attend all required online sessions.

I am not experiencing any cognitive impairments.

I have advanced cancer and am expected to live 12-18 months.

Exclusion Criteria

I am currently in therapy at Princess Margaret Cancer Centre.

Inability to pass the cognitive screening test (Short Orientation-Memory-Concentration Test (SOMC) score <20, Katzman et al., 1983)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the iCALM intervention, an online psychotherapeutic program, over 9 weeks

9 weeks

Online modules and exercises

Follow-up

Participants are monitored for psychological well-being and intervention satisfaction

12 weeks

Assessments at 4, 8, and 12 weeks

Open-label extension (optional)

Participants in the usual care group may opt into iCALM at the end of the study

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• iCALM

Trial Overview The study tests an online program called iCALM designed to help people with advanced cancer cope better emotionally. It's based on a successful face-to-face therapy that has helped reduce depression among patients facing serious illness.

How Is the Trial Designed?

Group I: iCALM Intervention Group Experimental Treatment 1 Intervention

iCALM is a brief, online psychotherapeutic intervention for patients with advanced and metastatic cancer. It consists of one introductory module and four therapeutic modules composed of written psychoeducational material, videos, and exercises. The intervention is designed to be completed in 9 weeks.

Group II: Care as usual Active Control 1 Intervention

Participants in the usual care group (UC) will receive routine care. At Princess Margaret Cancer Centre, routine care includes a referral to Psychiatry, Psychology, or Social Work, based on patients' needs.

iCALM is already approved in Canada, United States, Japan, China for the following indications:

Approved in Canada as CALM for:

• Advanced cancer
• Metastatic cancer
• Depression
• End-of-life distress

Approved in United States as CALM for:

• Advanced cancer
• Metastatic cancer
• Depression
• End-of-life distress

Approved in Japan as CALM for:

• Advanced cancer
• Metastatic cancer
• Depression
• End-of-life distress

Approved in China as CALM for:

• Advanced cancer
• Metastatic cancer
• Depression
• End-of-life distress

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

University of Ulm

Collaborator

Trials

194

Recruited

126,000+

Published Research Related to This Trial

The CALM-Nurses (CALM-N) training program is feasible and acceptable for oncology nurses, enhancing their ability to provide psychological support to advanced cancer patients, as evidenced by participation rates and positive feedback from focus groups.

The training significantly increased nurses' self-efficacy in their roles, suggesting that CALM-N could improve nurse-patient communication and reflective practices, although it did not show significant changes in burnout or empathy levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teaching Oncology Nurses a Psychosocial Intervention for Advanced Cancer: A Mixed-Methods Feasibility Study. van Klinken, M., Hafkamp, E., Gualtherie van Weezel, A., et al.[2023]

The study aims to evaluate the efficacy of the CALM psychotherapy intervention in reducing depression and anxiety among patients with advanced cancer, using a randomized-controlled trial design with assessments at baseline, 3 months, and 6 months.

It is hypothesized that patients receiving CALM will experience significant improvements in depression, anxiety, and overall quality of life compared to those receiving standard supportive interventions, providing valuable data on psycho-oncological care in palliative settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a brief manualized intervention Managing Cancer and Living Meaningfully (CALM) adapted to German cancer care settings: study protocol for a randomized controlled trial. Scheffold, K., Philipp, R., Engelmann, D., et al.[2018]

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 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]

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]

The CALM intervention significantly reduced depressive symptoms in patients with advanced cancer compared to usual care, with improvements observed at both 3 months and 6 months after treatment.

Participants receiving CALM also reported better end-of-life preparation, and importantly, no adverse effects were noted, indicating the intervention is safe for this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing Cancer and Living Meaningfully (CALM): A Randomized Controlled Trial of a Psychological Intervention for Patients With Advanced Cancer. Rodin, G., Lo, C., Rydall, A., et al.[2022]

Patients with advanced cancer often experience significant death-related distress, characterized by fears of uncertainty and suffering, which they find difficult to communicate due to personal and relational barriers.

The CALM therapy is perceived to effectively facilitate discussions about death and dying, helping patients express their distress and improve communication with healthcare providers and loved ones.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Death talk and relief of death-related distress in patients with advanced cancer. An, E., Wennberg, E., Nissim, R., et al.[2020]

The CALM-IT intervention, a brief psychotherapeutic approach for patients with advanced cancer, is being tested in a randomized controlled trial to assess its effectiveness in reducing distress and improving well-being over 6 months.

The study will evaluate various psychological outcomes, including depressive symptoms and quality of life, with the potential for CALM-IT to be implemented nationally if proven effective, benefiting patients facing serious illness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a brief manualized intervention, Managing Cancer and Living Meaningfully (CALM), adapted to the Italian cancer care setting: Study protocol for a single-blinded randomized controlled trial. Caruso, R., Nanni, MG., Rodin, G., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6085180/

Managing Cancer and Living Meaningfully (CALM) Findings suggest that CALM is an effective intervention that provides a systematic approach to alleviating depressive symptoms in patients with ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29958037/

Managing Cancer and Living Meaningfully (CALM) CALM is a novel, brief, manualized psychotherapeutic intervention intended to treat and prevent depression and end-of-life distress in patients with advanced ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT01506492

Managing Cancer and Living Meaningfully (CALM): A ... The purpose of this study is to test the effectiveness of a brief manualized individual psychotherapy, called Managing Cancer and Living Meaningfully (CALM) ...

4. ascopubs.org ascopubs.org/doi/abs/10.1200/JCO.2017.77.1097

Managing Cancer and Living Meaningfully (CALM) Managing Cancer and Living Meaningfully (CALM): A Randomized Controlled Trial of a Psychological Intervention for Patients With Advanced Cancer.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2451865420301459

Effectiveness of a brief manualized intervention, Managing ... The secondary endpoint is 3 months and secondary outcomes are: generalized anxiety, distress about dying and death, demoralization, spiritual well-being, ...

6. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.psychotherapy.20190050

Managing Cancer and Living Meaningfully (CALM) Therapy CALM therapy is a brief, evidence-based, semistructured intervention that provides a framework to address practical issues.