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Completed

NCT Number: NCT02353546

CALM Phase 2b Pilot

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.

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Key information

Conditions

Depression Affective Symptoms Behavior Behavioral Symptoms Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Health Network

Toronto, Ontario, M5G 2C4, Canada

About this study

Abstract

Background Managing Cancer And Living Meaningfully (CALM) is a brief individual psychotherapy for patients with advanced cancer. In an intervention-only phase 2a trial, CALM showed promising results, leading to the present 2b pilot, which introduces procedures for randomisation and improved rigour in preparation for a phase 3 randomised controlled trial (RCT).

Aims To test trial methodology and assess feasibility of a confirmatory RCT.

Design A parallel-arm RCT (intervention vs usual care) with 3 and 6-month follow-ups. Assessment of feasibility included rates of consent, randomisation, attrition, intervention non-compliance and usual care contamination. Primary outcome: depressive symptoms (Patient Health Questionnaire-9; PHQ-9). Secondary outcomes: major depressive disorder (MDD), generalised anxiety, death anxiety, spiritual well-being, attachment anxiety and avoidance, self-esteem, experiential avoidance, quality of life and post-traumatic growth. Bayesian conjugate analysis was used in this low-powered setting.

Setting/participants 60 adult patients with advanced cancer from the Princess Margaret Cancer Centre.

Trial registration number NCT02353546.

http://dx.doi.org/10.1136/bmjspcare-2015-000866

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 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

Exclusion criteria

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

Treatment and study plan

CALM

Behavioral

Primary outcomes

  1. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: 6-months

Secondary outcomes

  1. Major Depression Structured Clinical Interview for DSM Disorders (SCID)

    Time frame: 6-months

    DSM: Diagnostic and Statistical Manual of Mental Disorders (APA, 2000)

  2. Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: 6-months

  3. Death and Dying Distress Scale (DADDS)

    Time frame: 6-months

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

    Time frame: 6-months

  5. Modified Experiences in Close Relationships (ECR M-16)

    Time frame: 6-months

  6. Rosenberg Self-esteem Scale (RSES)

    Time frame: 6-months

  7. Acceptance and Action Questionnaire-II (AAQ-II)

    Time frame: 6-months

  8. Quality of Life at the End of Life-Cancer Scale (QUAL-EC)

    Time frame: 6-months

  9. Posttraumatic Growth Inventory (PTGI)

    Time frame: 6-months

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

Managing Cancer and Living Meaningfully (CALM): Phase 2b Pilot Randomized Psychotherapy Trial in Patients With Advanced Cancer

Acronym: CALM

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 2, 2015
Registry last updated
Aug 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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