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

被引:37
作者
Lo, Chris [1 ,2 ]
Hales, Sarah [1 ,2 ]
Rydall, Anne [1 ]
Panday, Tania [1 ]
Chiu, Aubrey [1 ]
Malfitano, Carmine [1 ]
Jung, Judy [1 ]
Li, Madeline [1 ,2 ]
Nissim, Rinat [1 ,2 ]
Zimmermann, Camilla [1 ,2 ,3 ]
Rodin, Gary [1 ,2 ]
机构
[1] Univ Hlth Network, Princess Margaret Canc Ctr, Dept Support Care, Toronto, ON M5G 2M9, Canada
[2] Univ Toronto, Dept Psychiat, Toronto, ON M5T 1R8, Canada
[3] Univ Toronto, Dept Med, Toronto, ON M5G 2C4, Canada
基金
加拿大健康研究院;
关键词
Advanced cancer; Psychotherapy; Randomized controlled trial; METASTATIC BREAST-CANCER; BRIEF INDIVIDUAL PSYCHOTHERAPY; GROUP PSYCHOSOCIAL SUPPORT; POSTTRAUMATIC GROWTH; DEPRESSIVE SYMPTOMS; GROUP-THERAPY; INTERVENTION; DISTRESS; ANXIETY; SCALE;
D O I
10.1186/s13063-015-0811-1
中图分类号
R-3 [医学研究方法]; R3 [基础医学];
学科分类号
1001 ;
摘要
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.
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页数:8
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