Feasibility of CALM in Patients With Ovarian Cancer

Ovarian Cancer Clinical Trial

Official title:

A Feasibility Trial of Managing Cancer and Living Meaningfully (CALM) in Patients With Newly Diagnosed and Recurrent Advanced Ovarian Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06459271
• Other study ID #: 23-5885
• Status: Recruiting
• Phase: N/A
• Start date: June 10, 2024
• Est. completion date: August 10, 2025

Study information

• Verified date: June 2024
• Source: University Health Network, Toronto
• Contact: Megan A George, BSc
• Phone: 6475463114
• Email: megan.george[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Is it feasible and acceptable to implement CALM for patients with newly diagnosed or recently recurred advanced OC 2. What are the prevalence and correlates of traumatic stress symptoms at baseline in patients with newly diagnosed or recently recurred advanced OC 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 10, 2025
• Est. primary completion date: June 10, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms
• Patient Satisfaction

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	This questionnaire will be administered at all timepoints (baseline, 3 months and 6 months)
Primary	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.	This questionnaire will be administered at 3 months and 6 months only.
Secondary	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.	This questionnaire will be administered at baseline.
Secondary	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.	This questionnaire will be administered at all timepoints (baseline, 3 months and 6 months).
Secondary	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.	This questionnaire will be administered at all timepoints (baseline, 3 months and 6 months).
Secondary	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.	This questionnaire will be administered at all timepoints (baseline, 3 months and 6 months).