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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...

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Autores principales: Lo, Chris, Hales, Sarah, Rydall, Anne, Panday, Tania, Chiu, Aubrey, Malfitano, Carmine, Jung, Judy, Li, Madeline, Nissim, Rinat, Zimmermann, Camilla, Rodin, Gary
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4557481/
https://www.ncbi.nlm.nih.gov/pubmed/26335704
http://dx.doi.org/10.1186/s13063-015-0811-1
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author Lo, Chris
Hales, Sarah
Rydall, Anne
Panday, Tania
Chiu, Aubrey
Malfitano, Carmine
Jung, Judy
Li, Madeline
Nissim, Rinat
Zimmermann, Camilla
Rodin, Gary
author_facet Lo, Chris
Hales, Sarah
Rydall, Anne
Panday, Tania
Chiu, Aubrey
Malfitano, Carmine
Jung, Judy
Li, Madeline
Nissim, Rinat
Zimmermann, Camilla
Rodin, Gary
author_sort Lo, Chris
collection PubMed
description 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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-015-0811-1) contains supplementary material, which is available to authorized users.
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spelling pubmed-45574812015-09-03 Managing Cancer And Living Meaningfully: study protocol for a randomized controlled trial Lo, Chris Hales, Sarah Rydall, Anne Panday, Tania Chiu, Aubrey Malfitano, Carmine Jung, Judy Li, Madeline Nissim, Rinat Zimmermann, Camilla Rodin, Gary Trials Study Protocol 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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-015-0811-1) contains supplementary material, which is available to authorized users. BioMed Central 2015-09-03 /pmc/articles/PMC4557481/ /pubmed/26335704 http://dx.doi.org/10.1186/s13063-015-0811-1 Text en © Lo et al. 2015 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Lo, Chris
Hales, Sarah
Rydall, Anne
Panday, Tania
Chiu, Aubrey
Malfitano, Carmine
Jung, Judy
Li, Madeline
Nissim, Rinat
Zimmermann, Camilla
Rodin, Gary
Managing Cancer And Living Meaningfully: study protocol for a randomized controlled trial
title Managing Cancer And Living Meaningfully: study protocol for a randomized controlled trial
title_full Managing Cancer And Living Meaningfully: study protocol for a randomized controlled trial
title_fullStr Managing Cancer And Living Meaningfully: study protocol for a randomized controlled trial
title_full_unstemmed Managing Cancer And Living Meaningfully: study protocol for a randomized controlled trial
title_short Managing Cancer And Living Meaningfully: study protocol for a randomized controlled trial
title_sort managing cancer and living meaningfully: study protocol for a randomized controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4557481/
https://www.ncbi.nlm.nih.gov/pubmed/26335704
http://dx.doi.org/10.1186/s13063-015-0811-1
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