Feasibility of CALM in Patients With Ovarian Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity Health Network, Toronto
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Single group
Treatments tested in this trial
Managing Cancer And Living Meaningfully (CALM)
Other interventionOur 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Newly Diagnosed + Recently RecurredExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
This questionnaire will be administered at all timepoints (baseline, 3 months and 6 months)2
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.
Time frame
This questionnaire will be administered at 3 months and 6 months only.Secondary outcomes
1
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.
Time frame
This questionnaire will be administered at baseline.2
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.
Time frame
This questionnaire will be administered at all timepoints (baseline, 3 months and 6 months).3
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.
Time frame
This questionnaire will be administered at all timepoints (baseline, 3 months and 6 months).4
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.
Time frame
This questionnaire will be administered at all timepoints (baseline, 3 months and 6 months).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Health Network, Toronto
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
Source ClinicalTrials.gov