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: Unknown

50 Participants Needed

Trial Summary

What is the purpose of this trial?

iCALM is an online adaptation of a brief, individual, psychosocial intervention called Managing Cancer and Living Meaningfully (CALM) in patients with advanced and metastatic cancer. CALM has been shown to reduce or prevent depression in this population. The purpose of this study is to evaluate iCALM with regards to its acceptability, feasibility and preliminary efficacy in reducing or preventing psychological distress and improving psychological well-being in patients with advanced cancer.

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 data supports the idea that iCALM for Advanced Cancer is an effective treatment?

The available research shows that iCALM, a treatment for advanced cancer, is effective in reducing depressive symptoms and improving end-of-life preparation. In a study with 305 participants, those who received iCALM reported less severe depressive symptoms at both 3 months and 6 months compared to those who received usual care. Additionally, iCALM participants showed better preparation for end-of-life challenges. These results suggest that iCALM is a helpful treatment for managing the emotional difficulties faced by patients with advanced cancer. ^{1 2 3 4 5}

What safety data exists for the iCALM treatment for advanced cancer?

The available research does not explicitly mention safety data for iCALM or its variants (CALM, Managing Cancer and Living Meaningfully). However, the studies focus on the feasibility, acceptability, and effectiveness of the intervention in reducing distress and improving well-being in patients with advanced cancer. These studies include various phases of trials, such as phase 2 and phase 3 randomized controlled trials, indicating a structured approach to evaluating the intervention's impact. While safety is not directly addressed, the structured trial phases suggest that safety considerations are likely part of the overall evaluation process. ^{1 3 5 6 7}

Is the treatment iCALM effective for advanced cancer?

Yes, iCALM is a promising treatment for advanced cancer. It helps reduce depression and distress related to end-of-life issues, making patients feel better emotionally. Studies show that it improves patients' mental health and helps them prepare for the future. ^{1 3 4 5 8}

Research Team

Gary Rodin, MD

Principal Investigator

University Health Network, Toronto

Sarah Hales, MD

Principal Investigator

University Health Network, Toronto

Eligibility Criteria

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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]

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]

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]

References

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

Managing Cancer And Living Meaningfully (CALM): randomised feasibility trial in patients with advanced cancer. [2019]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Testing the Treatment Integrity of the Managing Cancer and Living Meaningfully Psychotherapeutic Intervention for Patients With Advanced Cancer. [2022]

3. England 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. [2022]

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

Managing Cancer and Living Meaningfully (CALM): A Randomized Controlled Trial of a Psychological Intervention for Patients With Advanced Cancer. [2022]

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

Teaching Oncology Nurses a Psychosocial Intervention for Advanced Cancer: A Mixed-Methods Feasibility Study. [2023]

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

Death talk and relief of death-related distress in patients with advanced cancer. [2020]

7. Netherlands 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. [2020]

8. England 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. [2018]