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.

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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adaptation, Psychological
  • Attitude to Death
  • Clinical Protocols
  • Communication
  • Cost of Illness
  • Emotions
  • Humans
  • Neoplasms / diagnosis
  • Neoplasms / mortality
  • Neoplasms / psychology
  • Neoplasms / therapy*
  • Ontario
  • Professional-Patient Relations
  • Psychotherapy, Brief*
  • Quality of Life*
  • Research Design
  • Stress, Psychological / diagnosis
  • Stress, Psychological / mortality
  • Stress, Psychological / psychology
  • Stress, Psychological / therapy*
  • Surveys and Questionnaires
  • Time Factors
  • Treatment Outcome

Associated data

  • ClinicalTrials.gov/NCT01506492