Patient SatisfactionNCT06459271
Feasibility of CALM in Patients With Ovarian Cancer
A study testing Managing Cancer And Living Meaningfully (CALM) in people with Patient Satisfaction and Ovarian Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Patient Satisfaction, Ovarian Cancer
- What is being tested?
- Managing Cancer And Living Meaningfully (CALM)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 10 Jun 2024to Jun 2027
- Phase
- Interventional
- 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
- new diagnosis or recurrence of stage III or stage IV OC;
- age ≥18 years
- able to complete outcome measures and engage in CALM in English.
Who cannot join
- evidence of cognitive impairment indicated in the medical record, communicated by the OC clinic team, or determined by research staff at recruitment;
- receiving psychological or psychiatric counseling from the Department of Supportive Care at PM 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.
Canada1 site, 1 recruiting
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Gary M Rodin, MD FRCPC, gary.rodin@uhn.ca
Anne Rydall, MSc, 416-910-7349, anne.rydall@uhn.ca
About this study
Official title: A Feasibility Trial of Managing Cancer and Living Meaningfully (CALM) in Patients With Newly Diagnosed and Recurrent Advanced Ovarian Cancer
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:
Read more
- Is it feasible and acceptable to implement CALM for patients with newly diagnosed or recently recurred advanced OC
- What is the patient experience of CALM-TF at new diagnosis or recurrence
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.
Read the detailed description
While CALM has demonstrated effectiveness in reducing depression, death anxiety and increasing preparation for end of life among patients with advanced cancer later in the illness trajectory, its feasibility and effectiveness in addressing traumatic stress symptoms (TSS) soon after a diagnosis of advanced cancer has not previously been established. Findings of this study could inform the potential development of a larger randomized effectiveness trial. This study will involve a multi-method, single-arm, feasibility trial, approaching a total of 100 OC patients (50 newly diagnosed and 50 recently recurred) at Princess Margaret Cancer Centre (PM). Measurements will be administered at baseline, 3 months and 6 months. Participants who declined to participate in the intervention will be invited to share their reasons for opting out, contributing valuable insights to our records. A subset of purposefully sampled participants will also complete qualitative interviews following the completion of outcome measures at 6 months.
- Conditions
- Patient Satisfaction, Ovarian Cancer
- Being tested
- Managing Cancer And Living Meaningfully (CALM)
- Keywords
- ovarian cancer, psychological care, CALM, psychotherapeutic intervention, psychological distress
- Medical subject headings
- Patient Satisfaction, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Managing Cancer And Living Meaningfully (CALM)Other
Our team has developed a brief, manualized, individual and couple-based psychotherapeutic intervention for patients living with advanced cancer and their primary caregivers called Managing Cancer and Living Meaningfully (CALM). CALM is a brief supportive-expressive therapy consisting of 3-6 sessions of 30-60 minutes delivered over the course of 3-6 months. This tailored therapy is focused on the most common challenges and concerns facing individuals living with advanced cancer. These four broad content domains are: 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 mortality. The aim is to offer patients and caregivers reflective space and a supportive environment to reflect on and process the various practical and profound aspects of their life while facing advanced illness.
| Study group | Role | What they receive |
|---|---|---|
| Newly Diagnosed + Recently Recurred | Experimental | n = 50 patients with ovarian cancer (stage III or IV) will be enrolled in the study (25 newly diagnosed and 25 recently recurred). Receives: Other: Managing Cancer And Living Meaningfully (CALM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stanford Acute Stress Reaction Questionnaire (SASRQ)
The SASRQ is a self-reported DSM-IV correspondent scale to measure a range of symptoms associated with Acute Stress Disorder (ASD), encompassing dissociation, trauma re-experiencing, avoidance behaviours, anxiety, hyperarousal, and functional impairment. The SASRQ consists of 30-items utilizing a 6-point scale that ranges from 0=not experienced to 4=very often experienced. Demonstrating robust psychometric properties, including strong test-retest reliability and consistent evidence of predictive, construct, discriminant, and convergent validity across varied populations, the SASRQ serves as a reliable and valid tool for assessment.
Measured: This questionnaire will be administered at all timepoints (baseline, 3 months and 6 months)
Clinical Evaluation Questionnaire (CEQ)-CALM
The CEQ is a 7-item validated questionnaire, created by our research team to assess the perceived benefit of interactions with health care providers in domains relevant to advanced cancer.
Measured: This questionnaire will be administered at 3 months and 6 months only.
Secondary outcomes (4)
Modified Experiences in Close Relationships (ECR-M-16)
The ECR-M-16 is a validated measure with 16-items, has been thoughtfully adapted to be less time-consuming and alleviate any potential burden for patients who may be physically unwell.
Measured: This questionnaire will be administered at baseline.
Condensed Memorial Symptom Assessment Scale (CMSAS)
The CMSAS CMSAS stands as a straightforward and validated self-report evaluation tool, comprising 14 items. It effectively gauges various aspects such as energy level, dry mouth, appetite, weight loss, pain, nausea, drowsiness etc. These facets are organized into three subscales: physical, psychological and symptom distress.
Measured: This questionnaire will be administered at all timepoints (baseline, 3 months and 6 months).
Patient Health Questionnaire (PHQ-9)
The PHQ-9 is a diagnostic tool used in primary care settings to establish criteria-based diagnoses for depression. PHQ-9 is a 9-tem, self-reported questionnaire which consists of the 9 depression criteria which is highlighted within the DSM-IV. PHQ-9 is particularly favoured due to its concise structure, which efficiently identifies the presence of depressive disorders and is also able to rate the severity of depressive symptoms.
Measured: This questionnaire will be administered at all timepoints (baseline, 3 months and 6 months).
Death and Dying Distress Scale (DADDS)
The DADDS is a tool used to evaluate the distress caused by a patients thoughts on death and dying over the previous two weeks. DADDS is a 15-items questionnaire with the aims of alleviating the fear of death and fostering psychological development (Nissim et al., 2011; Shapiro et al., 2021).The validity of DADDS has been rigorously established, with factor analysis demonstrating distress related to two factors: Finitude and Dying.
Measured: This questionnaire will be administered at all timepoints (baseline, 3 months and 6 months).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start10 Jun 2024
- Primary completionFeb 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient SatisfactionStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants (patients with newly diagnosed and recently recurred ovarian cancer) will receive the intervention.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Gary M Rodin, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06459271
- Sponsor's protocol ID
- 23-5885
- Status last verified
- Aug 2026
- First submitted
- 5 Jun 2024
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Trial of Managing Cancer and Living Meaningfully (CALM) in Patients With Newly Diagnosed and Recurrent Advanced Ovarian Cancer
- ClinicalTrials.gov ID
- NCT06459271
- Acronym / sponsor ID
- 23-5885
- Conditions
- Patient Satisfaction, Ovarian Cancer
- Keywords
- ovarian cancer, psychological care, CALM, psychotherapeutic intervention, psychological distress
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 14 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is it feasible and acceptable to implement CALM for patients with newly diagnosed or recently recurred advanced OC
- What is the patient experience of CALM-TF at new diagnosis or recurrence
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.
Detailed description
While CALM has demonstrated effectiveness in reducing depression, death anxiety and increasing preparation for end of life among patients with advanced cancer later in the illness trajectory, its feasibility and effectiveness in addressing traumatic stress symptoms (TSS) soon after a diagnosis of advanced cancer has not previously been established. Findings of this study could inform the potential development of a larger randomized effectiveness trial. This study will involve a multi-method, single-arm, feasibility trial, approaching a total of 100 OC patients (50 newly diagnosed and 50 recently recurred) at Princess Margaret Cancer Centre (PM). Measurements will be administered at baseline, 3 months and 6 months. Participants who declined to participate in the intervention will be invited to share their reasons for opting out, contributing valuable insights to our records. A subset of purposefully sampled participants will also complete qualitative interviews following the completion of outcome measures at 6 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants (patients with newly diagnosed and recently recurred ovarian cancer) will receive the intervention.
| Arm | Type | Receives |
|---|---|---|
| Newly Diagnosed + Recently Recurred | Experimental | Other: Managing Cancer And Living Meaningfully (CALM)n = 50 patients with ovarian cancer (stage III or IV) will be enrolled in the study (25 newly diagnosed and 25 recently recurred). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- new diagnosis or recurrence of stage III or stage IV OC;
- age ≥18 years
- able to complete outcome measures and engage in CALM in English.
Key exclusion criteria (2 listed)
- evidence of cognitive impairment indicated in the medical record, communicated by the OC clinic team, or determined by research staff at recruitment;
- receiving psychological or psychiatric counseling from the Department of Supportive Care at PM at the time of recruitment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Managing Cancer And Living Meaningfully (CALM)Our team has developed a brief, manualized, individual and couple-based psychotherapeutic intervention for patients living with advanced cancer and their primary caregivers called Managing Cancer and Living Meaningfully (CALM). CALM is a brief supportive-expressive therapy consisting of 3-6 sessions of 30-60 minutes delivered over the course of 3-6 months. This tailored therapy is focused on the most common challenges and concerns facing individuals living with advanced cancer. These four broad content domains are: 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 mortality. The aim is to offer patients and caregivers reflective space and a supportive environment to reflect on and process the various practical and profound aspects of their life while facing advanced illness. | Other | Newly Diagnosed + Recently Recurred |
Primary outcome
Stanford Acute Stress Reaction Questionnaire (SASRQ)
Time frame: This questionnaire will be administered at all timepoints (baseline, 3 months and 6 months)
The SASRQ is a self-reported DSM-IV correspondent scale to measure a range of symptoms associated with Acute Stress Disorder (ASD), encompassing dissociation, trauma re-experiencing, avoidance behaviours, anxiety, hyperarousal, and functional impairment. The SASRQ consists of 30-items utilizing a 6-point scale that ranges from 0=not experienced to 4=very often experienced. Demonstrating robust psychometric properties, including strong test-retest reliability and consistent evidence of predictive, construct, discriminant, and convergent validity across varied populations, the SASRQ serves as a reliable and valid tool for assessment.
Clinical Evaluation Questionnaire (CEQ)-CALM
Time frame: This questionnaire will be administered at 3 months and 6 months only.
The CEQ is a 7-item validated questionnaire, created by our research team to assess the perceived benefit of interactions with health care providers in domains relevant to advanced cancer.
4 secondary outcomes
Modified Experiences in Close Relationships (ECR-M-16)
Time frame: This questionnaire will be administered at baseline.
Condensed Memorial Symptom Assessment Scale (CMSAS)
Time frame: This questionnaire will be administered at all timepoints (baseline, 3 months and 6 months).
Patient Health Questionnaire (PHQ-9)
Time frame: This questionnaire will be administered at all timepoints (baseline, 3 months and 6 months).
Death and Dying Distress Scale (DADDS)
Time frame: This questionnaire will be administered at all timepoints (baseline, 3 months and 6 months).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gary M Rodin, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Managing Cancer And Living Meaningfully (CALM) in people with Patient Satisfaction and 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 24 Aug 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.
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 Megan A George, BSc (6475463114, megan.george@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 (SASRQ) (time frame: This questionnaire will be administered at all timepoints (baseline, 3 months and 6 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2026.