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Trials. 2015 Sep 3;16:391. doi: 10.1186/s13063-015-0811-1.

Managing Cancer And Living Meaningfully: study protocol for a randomized controlled trial.

Lo C1,2, Hales S3,4, Rydall A5, Panday T6, Chiu A7, Malfitano C8, Jung J9, Li M10,11, Nissim R12,13, Zimmermann C14,15,16, Rodin G17,18.

Author information

1
Department of Supportive Care, Princess Margaret Cancer Centre, University Health Network, 16th Floor, 610 University Avenue, Toronto, ON, M5G 2M9, Canada. chris.lo@utoronto.ca.
2
Department of Psychiatry, University of Toronto, 8th Floor, 250 College Street, Toronto, ON, M5T 1R8, Canada. chris.lo@utoronto.ca.
3
Department of Supportive Care, Princess Margaret Cancer Centre, University Health Network, 16th Floor, 610 University Avenue, Toronto, ON, M5G 2M9, Canada. sarah.hales@uhn.ca.
4
Department of Psychiatry, University of Toronto, 8th Floor, 250 College Street, Toronto, ON, M5T 1R8, Canada. sarah.hales@uhn.ca.
5
Department of Supportive Care, Princess Margaret Cancer Centre, University Health Network, 16th Floor, 610 University Avenue, Toronto, ON, M5G 2M9, Canada. anne.rydall@uhn.ca.
6
Department of Supportive Care, Princess Margaret Cancer Centre, University Health Network, 16th Floor, 610 University Avenue, Toronto, ON, M5G 2M9, Canada. tpanday@uhnresearch.ca.
7
Department of Supportive Care, Princess Margaret Cancer Centre, University Health Network, 16th Floor, 610 University Avenue, Toronto, ON, M5G 2M9, Canada. achiu@uhnresearch.ca.
8
Department of Supportive Care, Princess Margaret Cancer Centre, University Health Network, 16th Floor, 610 University Avenue, Toronto, ON, M5G 2M9, Canada. carmine.malfitano@uhnresearch.ca.
9
Department of Supportive Care, Princess Margaret Cancer Centre, University Health Network, 16th Floor, 610 University Avenue, Toronto, ON, M5G 2M9, Canada. judy.jung@uhn.ca.
10
Department of Supportive Care, Princess Margaret Cancer Centre, University Health Network, 16th Floor, 610 University Avenue, Toronto, ON, M5G 2M9, Canada. madeline.li@uhn.ca.
11
Department of Psychiatry, University of Toronto, 8th Floor, 250 College Street, Toronto, ON, M5T 1R8, Canada. madeline.li@uhn.ca.
12
Department of Supportive Care, Princess Margaret Cancer Centre, University Health Network, 16th Floor, 610 University Avenue, Toronto, ON, M5G 2M9, Canada. rinat.nissim@uhn.ca.
13
Department of Psychiatry, University of Toronto, 8th Floor, 250 College Street, Toronto, ON, M5T 1R8, Canada. rinat.nissim@uhn.ca.
14
Department of Supportive Care, Princess Margaret Cancer Centre, University Health Network, 16th Floor, 610 University Avenue, Toronto, ON, M5G 2M9, Canada. camilla.zimmermann@uhn.ca.
15
Department of Psychiatry, University of Toronto, 8th Floor, 250 College Street, Toronto, ON, M5T 1R8, Canada. camilla.zimmermann@uhn.ca.
16
Department of Medicine, University of Toronto, Suite RFE 3-805, 200 Elizabeth Street, Toronto, ON, M5G 2C4, Canada. camilla.zimmermann@uhn.ca.
17
Department of Supportive Care, Princess Margaret Cancer Centre, University Health Network, 16th Floor, 610 University Avenue, Toronto, ON, M5G 2M9, Canada. gary.rodin@uhn.ca.
18
Department of Psychiatry, University of Toronto, 8th Floor, 250 College Street, Toronto, ON, M5T 1R8, Canada. gary.rodin@uhn.ca.

Abstract

BACKGROUND:

We have developed a novel and brief semi-structured psychotherapeutic intervention for patients with advanced or metastatic cancer, called Managing Cancer And Living Meaningfully. We describe here the methodology of a randomized controlled trial to test the efficacy of this treatment to alleviate distress and promote well-being in this population.

METHODS/DESIGN:

The study is an unblinded randomized controlled trial with 2 conditions (intervention plus usual care versus usual care alone) and assessments at baseline, 3 and 6 months. The site is the Princess Margaret Cancer Centre, part of the University Health Network, in Toronto, Canada. Eligibility criteria include: ≥ 18 years of age; English fluency; no cognitive impairment; and diagnosis of advanced cancer. The 3-6 session intervention is manualized and allows for flexibility to meet individual patients' needs. It is delivered over a 3-6 month period and provides reflective space for patients (and their primary caregivers) to address 4 main domains: symptom management and communication with health care providers; changes in self and relations with close others; sense of meaning and purpose; and the future and mortality. Usual care at the Princess Margaret Cancer Centre includes distress screening and referral as required to in-hospital psychosocial and palliative care services. The primary outcome is frequency of depressive symptoms and the primary endpoint is at 3 months. Secondary outcomes include diagnosis of major or minor depression, generalized anxiety, death anxiety, spiritual well-being, quality of life, demoralization, attachment security, posttraumatic growth, communication with partners, and satisfaction with clinical interactions.

DISCUSSION:

Managing Cancer And Living Meaningfully has the potential to relieve distress and promote psychological well-being in patients with advanced cancer and their primary caregivers. This trial is being conducted to determine its benefit and inform its dissemination. The intervention has cross-national relevance and training workshops have been held thus far with clinicians from North and South America, Europe, the Middle East, Asia and Africa.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01506492 4 January 2012.

PMID:
26335704
PMCID:
PMC4557481
DOI:
10.1186/s13063-015-0811-1
[Indexed for MEDLINE]
Free PMC Article

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