Testing Managing Cancer And Living Meaningfully for patient satisfaction
Official title: Feasibility of CALM in Patients With Ovarian Cancer
A Feasibility Trial of Managing Cancer and Living Meaningfully (CALM) in Patients With Newly Diagnosed and Recurrent Advanced Ovarian Cancer
- 1 group
- One site, in Toronto
- Recruiting
Interventions
- Other intervention
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.
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario
Eligibility Criteria
See who this study is looking for5 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +age ≥18 years
- +new diagnosis or recurrence of stage III or stage IV OC;
- +able to complete outcome measuresEndpointThe specific thing a study measures to answer its question.Read more → and engage in CALM in English.
Exclusion
- −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.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a way to improve comfort and quality of life alongside other care.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
Everyone in this study is in one group and receives Managing Cancer And Living Meaningfully (CALM).
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
There is only one group in this study, so there is no assignment to different treatments.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study lists female participants only.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 50 people.
The study is currently expected to finish around June 2027.
The main measurement is taken over: This questionnaire will be administered at all timepoints (baselineBaselineYour starting measurements, taken before treatment begins.Read more →, 3 months and 6 months).
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Stanford Acute Stress Reaction Questionnaire (SASRQ) — measured over This questionnaire will be administered at all timepoints (baselineBaselineYour starting measurements, taken before treatment begins.Read more →, 3 months and 6 months).
Clinical Evaluation Questionnaire (CEQ)-CALM — measured over This questionnaire will be administered at 3 months and 6 months only.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06459271 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About 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.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
There is only one group in this study, so there is no assignment to different treatments.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It lists female participants only.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: This questionnaire will be administered at all timepoints (baselineBaselineYour starting measurements, taken before treatment begins.Read more →, 3 months and 6 months).
The study as a whole is currently expected to finish around 2027-06.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 50 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Toronto, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About 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 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.
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.