CALM Therapy for Ovarian Cancer

Overseen By Anne Rydall, MSc

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Cognitive impairment, Receiving counseling, others

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

Approved in 8 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

50 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment CALM Therapy for Ovarian Cancer?

Research shows that CALM Therapy, used for patients with advanced cancer, can reduce psychological distress, anxiety, and depression, and improve quality of life. It has been effective in other cancers, like esophageal cancer, suggesting it may help ovarian cancer patients too. ^{1 2 3 4 5}

Is CALM Therapy safe for humans?

CALM Therapy, used for patients with advanced cancer, has been studied in several trials and is generally considered safe as it is a form of psychotherapy aimed at reducing distress. ^{1 2 3 4 6}

How is CALM Therapy different from other treatments for ovarian cancer?

CALM Therapy is unique because it focuses on helping patients manage the emotional and psychological challenges of living with cancer, aiming to improve quality of life and reduce feelings of hopelessness, unlike traditional treatments that primarily target the physical aspects of the disease. ^{7 8 9 10 11}

What is the purpose of this trial?

The goal of this feasibility trial is to determine the feasibility and acceptability of implementing a brief evidence-based psychotherapeutic intervention, Managing Cancer And Living Meaningfully (CALM), at the time of a new diagnosis and recurrence of ovarian cancer (OC). The main questions are: 1. Is it feasible and acceptable to implement CALM for patients with newly diagnosed or recently recurred advanced OC 2. What are the prevalence and correlates of traumatic stress symptoms at baseline in patients with newly diagnosed or recently recurred advanced OC Participants will be asked to complete questionnaires at baseline and at 3 and 6 months following a diagnosis or recurrence of stage III or IV OC. Participants will also be invited to participate in 3-6 sessions of CALM therapy.

Research Team

Gary M Rodin, MD

Principal Investigator

University Health Network, Toronto

Eligibility Criteria

This trial is for individuals with a new diagnosis or recent recurrence of advanced stage III or IV ovarian cancer. Participants will be asked to complete questionnaires and may attend 3-6 sessions of CALM therapy, which aims to help manage the emotional impact of their diagnosis.

Inclusion Criteria

Able to complete outcome measures and engage in CALM in English

My ovarian cancer is at stage III or IV, newly diagnosed or recurrent.

Exclusion Criteria

Evidence of cognitive impairment indicated in the medical record, communicated by the OC clinic team, or determined by research staff at recruitment

I am currently getting mental health support from PM's Supportive Care Department.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline questionnaires including SASRQ, ECR-M-16, CMSAS, PHQ-9, and DADDS

1 week

1 visit (in-person)

CALM Intervention

Participants engage in 3-6 sessions of CALM therapy

3-6 months

3-6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, completing questionnaires at 3 and 6 months

6 months

2 visits (in-person)

Treatment Details

Interventions

• Managing Cancer And Living Meaningfully (CALM)

Trial Overview The study tests the feasibility and acceptability of CALM, a psychotherapeutic intervention designed to support those newly diagnosed or with recurrent advanced ovarian cancer. It evaluates how patients cope with stress related to their condition.

Participant Groups

Group I: Newly Diagnosed + Recently Recurred Experimental Treatment 1 Intervention

n = 50 patients with ovarian cancer (stage III or IV) will be enrolled in the study (25 newly diagnosed and 25 recently recurred).

Managing Cancer And Living Meaningfully (CALM) is already approved in Canada, China, Japan for the following indications:

Approved in Canada as CALM Therapy for:

• Advanced cancer
• Metastatic cancer
• Ovarian cancer

Approved in China as CALM Therapy for:

• Advanced cancer
• Metastatic cancer

Approved in Japan as CALM Therapy for:

• Advanced cancer
• Metastatic cancer
• Ovarian cancer

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

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 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]

In a study involving 206 adult patients with advanced cancer, both the CALM therapy and a supportive psycho-oncological counselling intervention (SPI) led to significant reductions in depressive symptoms over 6 months, as measured by the BDI-II and PHQ-9 scales.

However, there was no significant difference in the severity of depression between the CALM and SPI groups, indicating that while both interventions were effective, CALM therapy did not outperform the standard supportive counselling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of the Managing Cancer and Living Meaningfully (CALM) individual psychotherapy for patients with advanced cancer: A single-blind randomized controlled trial. Mehnert, A., Koranyi, S., Philipp, R., et al.[2021]

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 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 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]

A study involving 634 women with ovarian cancer identified three main coping strategy clusters, with distinct patterns of use over time, highlighting the importance of coping mechanisms in managing their condition.

Women who accepted their diagnosis reported significantly lower levels of anxiety and depression, as well as better quality of life, suggesting that promoting acceptance and positive coping strategies could enhance mental health outcomes for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coping strategies, trajectories, and their associations with patient-reported outcomes among women with ovarian cancer. Beesley, VL., Smith, DD., Nagle, CM., et al.[2018]

In a study of 219 ovarian cancer patients, those who utilized massage therapy experienced a significant reduction in hopelessness scores, highlighting its potential as an effective complementary treatment.

Factors such as being older (65+ years), having strong faith, and maintaining good quality of life were also associated with lower levels of hopelessness, suggesting that spiritual support and symptom management are crucial for improving patient outlook.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hopelessness and complementary therapy use in patients with ovarian cancer. Gross, AH., Cromwell, J., Fonteyn, M., et al.[2013]

In a study comparing 56 ovarian cancer patients to 56 age-matched women without cancer, both groups showed a similar prevalence of anxiety at 7.1%, indicating that ovarian cancer patients do not experience higher anxiety levels than the general population after treatment.

The mean anxiety scores were also comparable between the two groups (5.0 for cancer patients vs. 6.1 for non-cancer patients), suggesting that demographic and clinical factors did not significantly influence anxiety levels in ovarian cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence of anxiety may not be elevated in thai ovarian cancer patients following treatment. Chittrakul, S., Charoenkwan, K., Wongpakaran, N.[2019]

In a study of 106 women with advanced ovarian cancer, anxiety levels were highest before surgery (74% prevalence of pathological anxiety) and decreased after surgery, while depression levels remained relatively stable throughout treatment.

Key factors contributing to anxiety included a history of abortion, presence of intestinal stoma, poor general health, residual disease, and time since diagnosis, highlighting the importance of addressing psychological well-being in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anxiety and depression in patients with advanced ovarian cancer: a prospective study. Mielcarek, P., Nowicka-Sauer, K., Kozaka, J.[2016]

Early-stage ovarian cancer survivors generally reported good physical quality of life, but many experienced significant psychological distress, with 26% showing signs of posttraumatic stress disorder (PTSD) and 40% scoring below the norm for mental health.

A majority of survivors faced sexual dysfunction, with less than 10% reporting interest in sex or being sexually active, highlighting the need for targeted interventions and better screening for psychological and sexual health issues in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term adjustment of early-stage ovarian cancer survivors. Matulonis, UA., Kornblith, A., Lee, H., 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. 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]

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

Efficacy of the Managing Cancer and Living Meaningfully (CALM) individual psychotherapy for patients with advanced cancer: A single-blind randomized controlled trial. [2021]

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

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

5. England pubmed.ncbi.nlm.nih.gov

The effects of Managing Cancer and Living Meaningfully (CALM) on psychological distress in esophageal cancer patients. [2023]

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

Managing cancer and living meaningfully (CALM) in adults with malignant glioma: a proof-of-concept phase IIa trial. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

Coping strategies, trajectories, and their associations with patient-reported outcomes among women with ovarian cancer. [2018]

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

Hopelessness and complementary therapy use in patients with ovarian cancer. [2013]

9. Thailand pubmed.ncbi.nlm.nih.gov

Prevalence of anxiety may not be elevated in thai ovarian cancer patients following treatment. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Anxiety and depression in patients with advanced ovarian cancer: a prospective study. [2016]

11. England pubmed.ncbi.nlm.nih.gov

Long-term adjustment of early-stage ovarian cancer survivors. [2018]