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Ovarian Cancer (OvCa)Phase 3CALM-TFNCT07286162

Trauma-Focused Managing Cancer And Living Meaningfully (CALM-TF) for Newly Diagnosed and Recurrent Ovarian Cancer

A Phase 3 study testing Trauma-Focused Managing Cancer and Living Meaningfully in people with Ovarian Cancer (OvCa) and Recurrent Ovarian Cancer, run by University Health Network, Toronto at 1 site in Canada.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to investigate if CALM-TF (Trauma-Focused Managing Cancer and Living Meaningfully) is effective in treating traumatic stress symptoms in women with advanced ovarian cancer. It will also learn whether the efficacy differs at new diagnosis versus at recurrence. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Trauma-Focused Managing Cancer and Living Meaningfully
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteCanada
Study dates
1 Mar 2026to 31 Dec 2031
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Newly diagnosed stage III or IV ovarian cancer OR recurrent ovarian cancer within six months of diagnosis or recurrence
  • Age 18 years or older
  • Able to speak and read English
  • Able to provide informed consent

Who cannot join

  • Significant cognitive impairment that would interfere with the ability to participate in psychotherapy or complete study questionnaires
  • Active psychosis or severe psychiatric condition requiring immediate psychiatric intervention
  • Receiving ongoing psychotherapy at the time of recruitment

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Gary Rodin, MD contact

416-946-4504

gary.rodin@uhn.ca

Anne Rydall, MSc contact

416-910-7349

anne.rydall@uhn.ca

Canada1 site

  • Princess Margaret Cancer Centre

    Toronto, Ontario

    Anne Rydall, MSc, 416-910-7349, anne.rydall@uhn.ca

Other trials in Canada

About this study

Official title: Trauma-Focused Managing Cancer And Living Meaningfully (CALM-TF): A Phase III Randomized Controlled Trial of an Intervention Targeting Traumatic Stress in Patients With Advanced Ovarian Cancer

The goal of this clinical trial is to investigate if CALM-TF (Trauma-Focused Managing Cancer and Living Meaningfully) is effective in treating traumatic stress symptoms in women with advanced ovarian cancer. It will also learn whether the efficacy differs at new diagnosis versus at recurrence.

The main questions it aims to answer are:

Read more
  1. What is the effectiveness of CALM-TF in reducing traumatic stress symptoms in patients with newly diagnosed or recurrent advanced ovarian cancer, as measured at 3 and 6 months?
  2. What are the effects of CALM-TF on depression, quality of life, and patient-perceived benefit of the intervention compared to usual care alone?
  3. What are patient perceptions of their care experiences as explored through qualitative interviews?

Researchers will compare CALM-TF to usual standard of care (which includes regular conversations with medical teams and meetings with social workers) to see if CALM-TF works to treat traumatic stress.

Participants will:

  • Receive 3-6 sessions of CALM-TF over 3-6 months (45-60 minutes each) via video call, telephone, or in-person based on preference, OR receive usual care only
  • Complete questionnaires at baseline, 3 months, and 6 months
  • Continue to receive their standard cancer care throughout the study
  • Some participants may be invited to participate in qualitative interviews at 6 months
Read the detailed description

This study examines whether a brief psychotherapy called Trauma-Focused Managing Cancer and Living Meaningfully (CALM-TF) can help women with advanced ovarian cancer who are experiencing traumatic stress symptoms.

Traumatic stress refers to the psychological impact of traumatic events, which in cancer care includes the diagnosis, progression, or recurrence of advanced disease. Research shows that up to 45% of patients with ovarian cancer experience clinically significant traumatic stress symptoms that meet diagnostic criteria for acute stress disorder.

CALM-TF is a manualized psychotherapeutic intervention that builds on an established therapy called CALM (Managing Cancer and Living Meaningfully), which has previously been shown to reduce depression and improve communication with healthcare providers in patients with advanced cancer. CALM-TF incorporates trauma-focused components specifically designed to address traumatic stress symptoms that arise at the time of diagnosis or recurrence of ovarian cancer.

The intervention consists of 3-6 individual therapy sessions delivered over 3-6 months, with each session lasting 45-60 minutes. Sessions can be conducted via secure video conferencing, telephone, or in-person based on participant preference. The therapy focuses on four interconnected content areas: symptom management and communication with healthcare providers; changes in self and relationships with close others; sense of meaning and purpose in life; and hopes and fears about the future and mortality, with trauma-focused components integrated throughout.

This is a multi-site randomized controlled trial enrolling 300 women with newly diagnosed stage III or IV ovarian cancer or recurrent ovarian cancer (within six months of diagnosis or recurrence). Participants are randomly assigned in a 1:1 ratio to receive either CALM-TF plus usual care or usual care alone. Usual care includes regular conversations with medical teams and meetings with social workers regarding financial or practical issues, with access to specialized psychological support through referral.

The study uses validated questionnaires to measure traumatic stress symptoms, depression, quality of life, death anxiety, and perceived benefit of care at three time points: baseline, 3 months, and 6 months after enrolment. The primary outcome is traumatic stress symptoms at 6 months measured by the Stanford Acute Stress Reaction Questionnaire-II (SASRQ-II), a 30-item instrument with scores ranging from 0-150, where scores above 40 indicate clinically significant symptoms.

A subset of up to 30 participants will be invited to participate in qualitative interviews after completing their 6-month assessment to share their experiences with the intervention or usual care, explore factors that influenced their traumatic stress experience, and discuss how the therapy was integrated into their daily lives. The study also includes a health economic evaluation to assess the cost-effectiveness of CALM-TF compared to usual care over the 6-month period.

The findings of this RCT will inform healthcare policy and clinical practice guidelines for comprehensive psychosocial care, with potential for CALM-TF to be integrated into standard care.

Being tested
Trauma-Focused Managing Cancer and Living Meaningfully
Keywords
randomized controlled trial, ovarian cancer, recurrence, newly diagnosed, CALM, Managing Cancer And Living Meaningfully, Psychotherapy, psychosocial support
Medical subject headings
Ovarian Neoplasms, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trauma-Focused Managing Cancer and Living MeaningfullyBehavioural

    Also called CALM-TF

    CALM-TF is a brief, manualized psychotherapeutic intervention that incorporates trauma-focused elements into the established CALM framework. It includes a present-oriented focus with particular attention to affect regulation, relational support, and attachment security, specifically designed to address traumatic stress symptoms triggered by a diagnosis or recurrence.

    The intervention consists of 3-6 sessions delivered over 3-6 months, with each session lasting 45-60 minutes. Sessions are delivered by trained therapists through multiple modalities including secure web-conferencing software (Microsoft Teams), telephone, or in-person visits based on patient preference.

    CALM-TF focuses on four broad and interconnected content domains: (1) symptom management and communication with healthcare providers; (2) changes in self and in relationships with close others; (3) sense of meaning and purpose in life; and (4) hopes and fears about the future and mortal

Study groups in NCT07286162
Study groupRoleWhat they receive
CALM-TF plus Usual CareExperimentalParticipants 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.
Receives: Behavioral: Trauma-Focused Managing Cancer and Living Meaningfully
Usual Care AloneNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Stanford Acute Stress Reaction Questionnaire-II (SASRQ-II)

    Traumatic stress symptoms are measured by the Stanford Acute Stress Reaction Questionnaire-II (SASRQ-II), a validated 30-item self-report instrument specifically designed to assess traumatic stress symptoms based on DSM-5 criteria. The SASRQ-II provides a total score range of 0-150, where higher scores reflect increasing symptom severity and cut-off scores of >40 indicate clinically significant traumatic stress symptoms.

    Measured: From enrolment to the end of study at 6 months

Secondary outcomes (7)

  1. Experiences in Close Relationships-Modified-16 (ECR-M-16)

    Attachment security is measured by the ECR-M-16, a validated 16-item measure adapted to measure close relationships in patients with advanced cancer. Two 8-item subscales are derived from this measure, reflecting levels of anxious attachment and avoidant attachment, which can be helpful to understand and address attachment issues in patients with advanced cancer. Items are rated from 1 (agree) to 7 (disagree), with higher scores reflecting greater attachment insecurity.

    Measured: Baseline only

  2. Condensed Memorial Symptom Assessment Scale (CMSAS)

    Physical symptoms commonly experienced by cancer patients are measured by the Condensed Memorial Symptom Assessment Scale (CMSAS), a validated 14-item instrument that assesses distress related to symptoms including pain, fatigue, nausea, and drowsiness. Serves as an important covariate to control for physical symptom burden that may influence psychological outcomes. Symptoms are rated as present or not, with the level of distress associated with physical symptoms rated from 0 (not at all) to 4 (very much), and the frequency of psychological symptoms (worry, feeling sad, feeling nervous) rated 1 (rarely) to 4 (almost constantly). Higher scores reflect increasing symptom burden.

    Measured: From enrolment to the end of the study at 6 months

  3. Patient Health Questionnaire (PHQ-9)

    Depression severity is measured by the Patient Health Questionnaire (PHQ-9), a validated 9-item instrument assessing depression severity that has demonstrated reliability and validity in cancer populations. Scores may range from 0-27, with higher scores reflecting increasing severity of depressive symptoms. A cut-off score of 10 is used to reflect moderate depressive symptoms.

    Measured: From enrolment to the end of the study at 6 months

  4. Death and Dying Distress Scale (DADDS)

    Distress related to thoughts on death and dying are measured by the Death and Dying Distress Scale (DADDS), a validated 15-item questionnaire evaluating distress caused by a patient's thoughts on death and dying. Factor analysis demonstrates distress related to two factors: Finitude and Dying. Total scores may range from 0-75, with higher scores indicating greater death-related distress.

    Measured: From enrolment to the end of the study at 6 months

  5. EuroQol 5-Dimension 5-Level Health Questionnaire (EQ-5D-5L Health Questionnaire)

    Health-related quality of life is measured by the EQ-5D-5L Health Questionnaire, a validated instrument that measures quality of life across five dimensions (mobility, self-care, activities, pain, and anxiety) using a 5-level scale. It provides both a health state profile and a single utility index value. Dimension scores are rated from 1 (no problems) to 5 (extreme problems), with higher scores reflecting worse health status. The single utility index score is rated from 0 (worst imaginable health) to 100 (best imaginable health).

    Measured: From enrolment to the end of the study at 6 months

  6. Short Form 6-Dimensions Health Survey (SF-6D Health Survey)

    Health-related quality of life is measured by the SF-6D Health Survey, derived from the Short Form-36 health questionnaire. It evaluates six health dimensions (physical functioning, role limitations, social functioning, pain, mental health, and vitality), each rated from 0 (worst health state, e.g. death) to 1.0 (best health state, e.g., full health). This measure also allows for the calculation of quality adjusted life years (QALYs), which can be used to evaluate cost-effectiveness of health care interventions.

    Measured: From enrolment to the end of the study at 6 months

  7. Clinical Evaluation Questionnaire (CEQ)

    Perceived benefit of interactions with healthcare providers are measured by the Clinical Evaluation Questionnaire (CEQ), a validated 7-item patient-reported experience questionnaire that assesses perceived benefit in domains relevant to advanced cancer, including patient-provider communication and perceived quality of care. Items are rated on perceived helpfulness of the interactions, ranging from 0 (not at all) to 4 (very much), with an option to answer 'not applicable'. A total score is calculated by summing the item scores; 'not applicable' responses are considered missing data. Higher scores reflect greater perceived benefit of the interactions with healthcare providers.

    Measured: At 3 and 6 month time points.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2025
  2. Study start1 Mar 2026 (estimated)
  3. Primary completion1 Mar 2031 (estimated)
  4. Study completion31 Dec 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants randomized to the intervention arm of the trial will receive: Usual care, plus Trauma focused Managing Cancer and Living Meaningfully (referred to as CALM-TF), a psychotherapeutic intervention that aims to alleviate traumatic stress symptoms in patients with advanced cancer. Participants randomized to the control arm of the trial will receive: Usual care alone, which may include referral for psychosocial/psychiatric support should the patient request it, or should their clinician deem such support necessary. The trial team will not interfere with usual care referrals, but such referrals will be documented in the trial records.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07286162
Sponsor's protocol ID
OZUHN-045
Acronym
CALM-TF
Status last verified
Jan 2026
First submitted
3 Dec 2025
Last updated
27 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The data sharing plan for this study has not yet been finalized. Decisions regarding individual participant data (IPD) sharing will be made in consultation with the study sponsor, institutional policies, and applicable regulations. Any data sharing would occur only after completion of primary analyses and would require appropriate data use agreements to protect participant privacy and confidentiality. The study team will consider requests for de-identified data from qualified researchers for purposes of meta-analyses or secondary research questions aligned with the original study aims.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Trauma-Focused Managing Cancer and Living Meaningfully in people with Ovarian Cancer (OvCa) and Recurrent Ovarian Cancer, run by University Health Network, Toronto at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gary Rodin, MD (416-946-4504, gary.rodin@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stanford Acute Stress Reaction Questionnaire-II (SASRQ-II) (time frame: From enrolment to the end of study at 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07286162.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.

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