NCT01506492

Brief Summary

The purpose of this study is to test the effectiveness of a brief manualized individual psychotherapy, called Managing Cancer and Living Meaningfully (CALM), to reduce distress and promote psychological well-being in patients with various types of cancer, including metastatic disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
305

participants targeted

Target at P50-P75 for phase_3 depression

Timeline
Completed

Started Jan 2012

Longer than P75 for phase_3 depression

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

January 1, 2012

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 10, 2012

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

September 27, 2019

Status Verified

September 1, 2019

Enrollment Period

4.8 years

First QC Date

January 4, 2012

Last Update Submit

September 26, 2019

Conditions

Depression

Keywords

Randomized controlled trialDepressionCancerPsychotherapyQuality of life

Outcome Measures

Primary Outcomes (1)

  • Patient Health Questionnaire-9 (PHQ-9)

    A reliable and valid 9-item measure of depression that has been used widely with advanced cancer patients.

    6-months

Secondary Outcomes (10)

  • Structured Clinical Interview for DSM Disorders (SCID)-Research Version

    6-months

  • Generalized Anxiety Disorders-7 (GAD-7)

    6-months

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

    6-months

  • Posttraumatic Growth Inventory (PTGI)

    6-months

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

    6-months

  • +5 more secondary outcomes

Study Arms (2)

Usual Care

NO INTERVENTION

Usual care includes routine screening for depression and other distress in oncology outpatient clinics, communication of screening information to the medical treatment team, and referral as needed.

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

Interventions

CALMBEHAVIORAL

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.

CALM

Eligibility Criteria

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

You may qualify if:

  • ≥18 years of age
  • Fluency in English
  • Confirmed diagnosis of stage III or IV lung cancer; any stage of pancreatic cancer, unresectable cholangiocarcinoma, unresectable liver cancer, unresectable ampullary/peri-ampullary cancer, or other stage IV (metastatic) gastrointestinal cancer; stage III or IV ovarian and fallopian tube cancers, or other stage IV gynecological cancers; and stage IV breast, genitourinary, sarcoma, melanoma or endocrine cancers (all with expected survival of 12-18 months)

You may not qualify if:

  • Major communication difficulties (including language barriers)
  • Inability to commit to the required 3-6 psychotherapy sessions
  • Cognitive impairment indicated in the medical record, or by the attending oncologist, or as indicated by a score \< 20 on the Short Orientation-Memory-Concentration test, unless deemed suitable at the recruiter's discretion
  • Actively seeing a psychiatrist or psychologist in the Department of Supportive Care (formerly the Department of Psychosocial Oncology and Palliative Care) at Princess Margaret Cancer Centre at the time of study approach

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (11)

  • Nissim R, Freeman E, Lo C, Zimmermann C, Gagliese L, Rydall A, Hales S, Rodin G. Managing Cancer and Living Meaningfully (CALM): a qualitative study of a brief individual psychotherapy for individuals with advanced cancer. Palliat Med. 2012 Jul;26(5):713-21. doi: 10.1177/0269216311425096. Epub 2011 Oct 31.

    PMID: 22042225BACKGROUND

  • Krause S, Rydall A, Hales S, Rodin G, Lo C. Initial validation of the Death and Dying Distress Scale for the assessment of death anxiety in patients with advanced cancer. J Pain Symptom Manage. 2015 Jan;49(1):126-34. doi: 10.1016/j.jpainsymman.2014.04.012. Epub 2014 May 28.

    PMID: 24878066BACKGROUND

  • Lo C, Hales S, Jung J, Chiu A, Panday T, Rydall A, Nissim R, Malfitano C, Petricone-Westwood D, Zimmermann C, Rodin G. Managing Cancer And Living Meaningfully (CALM): phase 2 trial of a brief individual psychotherapy for patients with advanced cancer. Palliat Med. 2014 Mar;28(3):234-42. doi: 10.1177/0269216313507757. Epub 2013 Oct 29.

    PMID: 24170718BACKGROUND

  • Neel C, Lo C, Rydall A, Hales S, Rodin G. Determinants of death anxiety in patients with advanced cancer. BMJ Support Palliat Care. 2015 Dec;5(4):373-80. doi: 10.1136/bmjspcare-2012-000420. Epub 2013 Aug 22.

    PMID: 24644177BACKGROUND

  • Lo C, Hales S, Rydall A, Panday T, Chiu A, Malfitano C, Jung J, Li M, Nissim R, Zimmermann C, Rodin G. Managing Cancer And Living Meaningfully: study protocol for a randomized controlled trial. Trials. 2015 Sep 3;16:391. doi: 10.1186/s13063-015-0811-1.

    PMID: 26335704BACKGROUND

  • Lo C, Hales S, Zimmermann C, Gagliese L, Rydall A, Rodin G. Measuring death-related anxiety in advanced cancer: preliminary psychometrics of the Death and Dying Distress Scale. J Pediatr Hematol Oncol. 2011 Oct;33 Suppl 2:S140-5. doi: 10.1097/MPH.0b013e318230e1fd.

    PMID: 21952572BACKGROUND

  • Hales S, Lo C, Rodin G. Managing Cancer And Living Meaningfully (CALM) Therapy (Chapter 62) In: Holland JC, Breitbart WS, Butow PN, Jacobsen PB, Loscalzo MJ, McCorkle R, editors. Psycho-Oncology. 3. New York: Oxford University Press; 2015. pp. 487-91.

    BACKGROUND

  • 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: 26787360BACKGROUND

  • Tong E, Deckert A, Gani N, Nissim R, Rydall A, Hales S, Rodin G, Lo C. The meaning of self-reported death anxiety in advanced cancer. Palliat Med. 2016 Sep;30(8):772-9. doi: 10.1177/0269216316628780. Epub 2016 Feb 8.

    PMID: 26857360BACKGROUND

  • Rodin G, Lo C, Rydall A, Shnall J, Malfitano C, Chiu A, Panday T, Watt S, An E, Nissim R, Li M, Zimmermann C, Hales S. Managing Cancer and Living Meaningfully (CALM): A Randomized Controlled Trial of a Psychological Intervention for Patients With Advanced Cancer. J Clin Oncol. 2018 Aug 10;36(23):2422-2432. doi: 10.1200/JCO.2017.77.1097. Epub 2018 Jun 29.

    PMID: 29958037RESULT

  • An E, Wennberg E, Nissim R, Lo C, Hales S, Rodin G. Death talk and relief of death-related distress in patients with advanced cancer. BMJ Support Palliat Care. 2020 Jun;10(2):e19. doi: 10.1136/bmjspcare-2016-001277. Epub 2017 Aug 2.

    PMID: 28768681DERIVED

MeSH Terms

Conditions

DepressionNeoplasms

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Gary Rodin, MD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

  • Sarah Hales, MD, PhD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

  • Chris Lo, PhD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2012

First Posted

January 10, 2012

Study Start

January 1, 2012

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

September 27, 2019

Record last verified: 2019-09

Locations

CA(1)