NCT02353546

Brief Summary

Managing Cancer And Living Meaningfully (CALM) is a brief psychotherapy designed to alleviate distress in advanced cancer. In an earlier intervention-only pilot trial, CALM was associated with reductions in depressive symptoms and death anxiety and an increase in spiritual wellbeing. The purpose of this study is to assess the feasibility of a large-scale randomized controlled trial (RCT) of CALM and to identify preliminary effects in advanced cancer. This phase 2b pilot RCT employed intervention and usual care arms with 3 and 6 month follow-ups. The primary outcome was depressive symptoms (PHQ-9) and secondary outcomes included diagnosis of major depression (SCID), death anxiety, attachment security and spiritual wellbeing. Multilevel regression was used to compare change over time between groups. 60 patients with advanced cancer will be recruited from the Princess Margaret Cancer Centre, Toronto, Canada, and equally randomized into intervention and usual care conditions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Jun 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 2, 2015

Completed
Last Updated

August 7, 2023

Status Verified

August 1, 2023

Enrollment Period

1.2 years

First QC Date

January 28, 2015

Last Update Submit

August 2, 2023

Conditions

Depression

Keywords

affective symptomscancerdepressionpalliative carepilot trialpsychotherapy

Outcome Measures

Primary Outcomes (1)

  • Patient Health Questionnaire-9 (PHQ-9)

    6-months

Secondary Outcomes (9)

  • Major Depression Structured Clinical Interview for DSM Disorders (SCID)

    6-months

  • Generalized Anxiety Disorder-7 (GAD-7)

    6-months

  • Death and Dying Distress Scale (DADDS)

    6-months

  • Functional Assessment of Chronic Illness Therapy-Spiritual Well-being Scale (FACIT-Sp-12)

    6-months

  • Modified Experiences in Close Relationships (ECR M-16)

    6-months

  • +4 more secondary outcomes

Study Arms (2)

CALM

EXPERIMENTAL

Patients assigned to the intervention arm will receive 3-6 CALM therapy sessions over 3-6 months delivered by a trained therapist at our center.

Behavioral: CALM

Usual Care

NO INTERVENTION

Interventions

CALMBEHAVIORAL
CALM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • Fluent in English
  • Confirmed diagnosis of Stage IIIB or IV lung cancer, Stage III or IV ovarian cancer, Stage IV endocrine, breast, gastrointestinal, genitourinary or gynecologic cancer, or pancreatic cancer at any stage

You may not qualify if:

  • Short Orientation-Memory-Concentration Test (score of \<20)
  • Individuals receiving in-hospital psychiatric or psychological treatment at the time of recruitment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (1)

  • Lo C, Hales S, Chiu A, Panday T, Malfitano C, Jung J, Rydall A, Li M, Nissim R, Zimmermann C, Rodin G. Managing Cancer And Living Meaningfully (CALM): randomised feasibility trial in patients with advanced cancer. BMJ Support Palliat Care. 2019 Jun;9(2):209-218. doi: 10.1136/bmjspcare-2015-000866. Epub 2016 Jan 19.

    PMID: 26787360RESULT

Related Links

MeSH Terms

Conditions

DepressionAffective SymptomsNeoplasms

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Gary Rodin

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

  • Sarah Hales

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

  • Chris Lo

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2015

First Posted

February 2, 2015

Study Start

June 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

August 7, 2023

Record last verified: 2023-08

Locations

CA(1)