Trauma-Focused CALM for Ovarian Cancer

(CALM-TF Trial)

Overseen By Gary Rodin, MD

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: University Health Network, Toronto

Disqualifiers: Cognitive impairment, Active psychosis, Ongoing psychotherapy

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 3-6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach called CALM-TF, a type of therapy designed to help women with advanced ovarian cancer manage traumatic stress. The researchers aim to determine if CALM-TF can more effectively reduce stress symptoms and improve quality of life compared to usual care, which includes support from medical teams and social workers. Participants will either receive sessions of CALM-TF or continue with usual care, completing questionnaires to track changes in their well-being. This study suits women recently diagnosed with advanced ovarian cancer or those who have experienced a recurrence within the last six months. As a Phase 3 trial, it represents the final step before potential FDA approval, offering participants a chance to contribute to the development of a promising therapy.

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

The trial does not specify whether you need to stop taking your current medications. You will continue to receive your standard cancer care throughout the study.

Is there any evidence suggesting that CALM-TF is likely to be safe for humans?

Research has shown that CALM-TF, a type of talk therapy, is generally safe for people with ovarian cancer. In past studies, participants responded well to CALM-TF, which appeared to help those feeling stressed about their cancer. These studies found no major safety concerns or negative effects from the therapy. Since CALM-TF doesn't involve medication, it typically has fewer physical side effects. Overall, evidence suggests that CALM-TF is a safe way to manage cancer-related stress. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Unlike the standard of care for ovarian cancer, which typically includes medical consultations and access to therapeutic referrals, CALM-TF introduces a specialized psychotherapeutic approach. Researchers are excited about CALM-TF because it focuses on trauma-specific therapy, offering 3-6 personalized sessions that help patients manage the emotional impact of their diagnosis and improve their quality of life. This therapy is flexible, delivered via video, phone, or in-person, allowing for personalized and accessible support.

What evidence suggests that CALM-TF is effective for treating traumatic stress in advanced ovarian cancer?

Research has shown that CALM-TF may help reduce depression, fear of dying, and prepare patients with advanced cancer for the end of life. It has also effectively lowered stress, anxiety, and depression while improving sleep and quality of life. CALM-TF offers structured therapy sessions that help patients manage their thoughts and feelings about cancer. Although specific data on traumatic stress is limited, CALM-TF's overall success in improving mental health for cancer patients suggests potential benefits. In this trial, participants will receive either CALM-TF plus usual care or usual care alone. The trial aims to determine if these benefits also reduce traumatic stress symptoms in women with advanced ovarian cancer. ^{1 3 4 6 7}

Who Is on the Research Team?

Gary Rodin, MD

Principal Investigator

University Health Network, Toronto

Stephanie Lheureux, MD-PhD

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

This trial is for women with advanced ovarian cancer, either newly diagnosed or experiencing a recurrence. Participants will need to be able to attend sessions and complete questionnaires over a period of 3-6 months.

Inclusion Criteria

Able to speak and read English

Able to provide informed consent

I have stage III or IV ovarian cancer, or it has come back within six months.

Exclusion Criteria

Active psychosis or severe psychiatric condition requiring immediate psychiatric intervention

Receiving ongoing psychotherapy at the time of recruitment

I do not have any cognitive issues that would stop me from participating in therapy or filling out study forms.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 3-6 sessions of CALM-TF over 3-6 months, with each session lasting 45-60 minutes, delivered via video call, telephone, or in-person based on preference

3-6 months

3-6 sessions (video call, telephone, or in-person)

Follow-up

Participants are monitored for traumatic stress symptoms, depression, quality of life, and perceived benefit of care at 3 and 6 months

6 months

Assessments at baseline, 3 months, and 6 months

Qualitative Interviews (optional)

A subset of participants may be invited to participate in qualitative interviews after completing their 6-month assessment to share their experiences with the intervention or usual care

Post 6-month assessment

What Are the Treatments Tested in This Trial?

Interventions

• CALM-TF

Trial Overview

The study tests CALM-TF, a therapy aimed at reducing traumatic stress in patients with advanced ovarian cancer. It compares the effectiveness of this therapy against usual care by assessing symptoms, depression levels, quality of life, and patient-perceived benefits.

How Is the Trial Designed?

Group I: CALM-TF plus Usual Care Experimental Treatment 1 Intervention

Participants receive Trauma-Focused Managing Cancer and Living Meaningfully (CALM-TF), a brief manualized psychotherapeutic intervention consisting of 3-6 individual sessions over 3-6 months (45-60 minutes each). Sessions delivered via secure video conferencing (Microsoft Teams), telephone, or in-person based on participant preference. Participants also continue to receive usual standard of care throughout the intervention period.

Group II: Usual Care Alone Active Control 1 Intervention

Participants receive usual standard of care only, which includes frequent conversations with their medical team regarding their care and meetings with social workers regarding financial or other practical issues. Participants have access to formal or specialized psychotherapeutic interventions upon referral by their primary physician or member of their circle of care.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07286162

Trauma-Focused Managing Cancer And Living ...

This study examines whether a brief psychotherapy called Trauma-Focused Managing Cancer and Living Meaningfully (CALM-TF) can help women with ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06459271

Feasibility of CALM in Patients With Ovarian Cancer

While CALM has demonstrated effectiveness in reducing depression, death anxiety and increasing preparation for end of life among patients with advanced cancer ...

3.

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.

4.

trialx.com

trialx.com/clinical-trials/listings/292767/feasibility-of-calm-in-patients-with-ovarian-cancer/

Feasibility of CALM in Patients With Ovarian Cancer

The goal of this feasibility trial is to determine the feasibility and acceptability of implementing a brief evidence-based psychotherapeutic ...

5.

ovariancanada.org

ovariancanada.org/articles/prevalence-and-experience-of-traumatic-stress-in-patients-with-newly-diagnosed-and-recurrent-advanced-ovarian-cancer

Prevalence and Experience of Traumatic Stress in Patients ...

CALM has been shown to be effective in relieving distress and improving well-being in patients with advanced cancer closer to the end of life. However, the ...

6.

ctv.veeva.com

ctv.veeva.com/study/trauma-focused-managing-cancer-and-living-meaningfully-calm-tf-for-newly-diagnosed-and-recurrent-o

Trauma-Focused Managing Cancer And Living Meaningfully ...

Research shows that up to 45% of patients with ovarian cancer experience clinically significant traumatic stress symptoms that meet diagnostic ...

7.

pmc.ncbi.nlm.nih.gov

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

Managing Cancer and Living Meaningfully (CALM)

The study findings suggest that participants with moderate levels of distress about dying and death benefited most from CALM therapy in terms of ...