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


CONCLUSIONS
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.


BACKGROUND
ClinicalTrials.gov NCT01506492 4 January 2012.
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.|Department of Psychiatry, University of Toronto, 8th Floor, 250 College Street, Toronto, ON, M5T 1R8, Canada. chris.lo@utoronto.ca.
Chris
C
Lo
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.|Department of Psychiatry, University of Toronto, 8th Floor, 250 College Street, Toronto, ON, M5T 1R8, Canada. sarah.hales@uhn.ca.
Sarah
S
Hales
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.
Anne
A
Rydall
Department of Supportive Care, Princess Margaret Cancer Centre, University Health Network, 16th Floor, 610 University Avenue, Toronto, ON, M5G 2M9, Canada. tpanday@uhnresearch.ca.
Tania
T
Panday
Department of Supportive Care, Princess Margaret Cancer Centre, University Health Network, 16th Floor, 610 University Avenue, Toronto, ON, M5G 2M9, Canada. achiu@uhnresearch.ca.
Aubrey
A
Chiu
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.
Carmine
C
Malfitano
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.
Judy
J
Jung
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.|Department of Psychiatry, University of Toronto, 8th Floor, 250 College Street, Toronto, ON, M5T 1R8, Canada. madeline.li@uhn.ca.
Madeline
M
Li
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.|Department of Psychiatry, University of Toronto, 8th Floor, 250 College Street, Toronto, ON, M5T 1R8, Canada. rinat.nissim@uhn.ca.
Rinat
R
Nissim
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.|Department of Psychiatry, University of Toronto, 8th Floor, 250 College Street, Toronto, ON, M5T 1R8, Canada. camilla.zimmermann@uhn.ca.|Department of Medicine, University of Toronto, Suite RFE 3-805, 200 Elizabeth Street, Toronto, ON, M5G 2C4, Canada. camilla.zimmermann@uhn.ca.
Camilla
C
Zimmermann
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.|Department of Psychiatry, University of Toronto, 8th Floor, 250 College Street, Toronto, ON, M5T 1R8, Canada. gary.rodin@uhn.ca.
Gary
G
Rodin
D000223:Adaptation, Psychological; D001293:Attitude to Death; D002985:Clinical Protocols; D003142:Communication; D017281:Cost of Illness; D004644:Emotions; D006801:Humans; D009369:Neoplasms / Q000175:diagnosis / Q000401:mortality / Q000523:psychology / Q000628:therapy*; D009864:Ontario; D011369:Professional-Patient Relations; D011614:Psychotherapy, Brief; D011788:Quality of Life; D012107:Research Design; D013315:Stress, Psychological / Q000175:diagnosis / Q000401:mortality / Q000523:psychology / Q000628:therapy*; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome