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DepressionPhase 3CALMNCT01506492

Managing Cancer and Living Meaningfully (CALM): A Study to Evaluate the Effectiveness of a Psychological Intervention for Cancer Patients

A Phase 3 study testing CALM in people with Depression, run by University Health Network, Toronto at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Depression
What is being tested?
CALM
Could I receive a placebo?
No, everyone receives an active treatment
How many people
305 participants
Where
1 siteCanada
Study dates
Jan 2012to Oct 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: Managing Cancer and Living Meaningfully (CALM): A Randomized Controlled Trial of a Psychotherapeutic Intervention for Patients With Metastatic Cancer

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.

Read the detailed description

We have developed and pilot-tested a brief manualized individual psychotherapy, called Managing Cancer and Living Meaningfully (CALM), to reduce distress in patients with various types of cancer, including metastatic disease. We propose to conduct a two-arm randomized controlled trial (RCT) to test the effectiveness of CALM against usual care (UC) for the reduction of distress in patients with various types of cancer, including metastatic disease. Usual care at our center 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 for non-standardized, and primarily instrumental, psychosocial care and psychiatric assessment and treatment.

The design will be an unblinded RCT consisting of two conditions (CALM and UC), with a baseline assessment and follow-ups at three and six months. The trial will take place in Princess Margaret Cancer Centre, University Health Network, a comprehensive cancer center in Toronto, Canada. Participants will be outpatients with various types of cancer, including metastatic disease.

Conditions
Depression
Being tested
CALM
Keywords
Randomized controlled trial, Depression, Cancer, Psychotherapy, Quality of life
Medical subject headings
Depression, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CALMBehavioural

    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.

Study groups in NCT01506492
Study groupRoleWhat they receive
Usual CareNo interventionUsual 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.
CALMExperimentalPatients assigned to the intervention arm will receive 3-6 CALM therapy sessions over 3-6 months delivered by a trained therapist at our center.
Receives: Behavioral: CALM

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6-months

Secondary outcomes (10)

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

    A semi-structured interview that allows researchers to make clinical diagnoses according to DSM criteria. Portions of the Mood Disorders and Optional Disorders modules will be administered: major depressive episode and minor depressive disorder.

    Measured: 6-months

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

    A widely used and validated 7-item self-report measure designed to screen and assess the severity of GAD symptoms.

    Measured: 6-months

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

    A 12-item self-report measure of spiritual well-being, assessing spiritual meaning and peace, and faith, that has been widely used in palliative care research.

    Measured: 6-months

  4. Posttraumatic Growth Inventory (PTGI)

    A 21-item self-report scale that measures positive psychological changes after trauma. It has been used as a measure of psychological growth in cancer and as an outcome measure for intervention studies.

    Measured: 6-months

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

    A measure of quality of life in patient populations near the end of life.

    Measured: 6-months

  6. Death and Dying Distress Scale (DADDS)

    A recently developed, 15-item measure assessing death anxiety in patients with advanced cancer.

    Measured: 6-months

  7. Demoralization Scale (DS)

    A 24-item self-report measure that assesses one aspect of existential distress, which includes loss of meaning and purpose, disheartenment and helplessness.

    Measured: 6-months

  8. Experiences in Close Relationships Inventory Modified Short Form Version (ECR-M-16)

    A 16-item self-report measure of attachment security.

    Measured: 6-months

  9. Couple Communication Scale (CCS)

    A measure for participants who are married, common-law, or in a long-term relationship. This measure is concerned with an individual's feelings, beliefs, and attitudes about the communication in his/her relationship.

    Measured: 6-months

  10. Clinical Evaluation Questionnaire (CEQ)

    A 7-item measure evaluating the extent to which patients felt emotionally supported by the clinical services provided.

    Measured: 6-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2012 (estimated)
  2. Study startJan 2012
  3. Primary completionOct 2016
  4. Study completionOct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
305 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01506492
Sponsor's protocol ID
UHN REB 09-0855-C
Other IDs
CIHR
Acronym
CALM
Status last verified
Sep 2019
First submitted
4 Jan 2012
Last updated
27 Sep 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 22042225

  • 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.

    PubMed 24878066

  • 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.

    PubMed 24170718

  • 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.

    PubMed 24644177

  • 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.

    PubMed 26335704

  • 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.

    PubMed 21952572

  • 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.

  • 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.

    PubMed 26787360

  • 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.

    PubMed 26857360

  • 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.

    PubMed 29958037

  • 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.

    PubMed 28768681

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CALM in people with Depression, run by University Health Network, Toronto at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Health Questionnaire-9 (PHQ-9) (time frame: 6-months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01506492, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2019.

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