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

Area of Science:

• Psychotherapeutic interventions
• Oncology
• Psychosocial oncology

Background:

• A novel brief psychotherapeutic intervention, Managing Cancer And Living Meaningfully (MACL), was developed for advanced cancer patients.
• Distress and reduced well-being are significant challenges for individuals with advanced or metastatic cancer.

Purpose of the Study:

• To describe the methodology of a randomized controlled trial (RCT) evaluating the efficacy of the MACL intervention.
• To assess the potential of MACL to alleviate distress and promote psychological well-being in patients with advanced cancer.

Main Methods:

• An unblinded RCT comparing MACL plus usual care versus usual care alone.
• The study includes 3-6 sessions delivered over 3-6 months, with assessments at baseline, 3, and 6 months.
• Primary outcome is depressive symptom frequency; secondary outcomes include anxiety, quality of life, and spiritual well-being.

Main Results:

• Primary endpoint for depressive symptoms is at 3 months.
• Secondary outcomes assess a range of psychological and quality-of-life indicators.
• Results are pending as the trial is ongoing.

Conclusions:

• The MACL intervention shows potential for relieving distress and enhancing psychological well-being in advanced cancer patients and their caregivers.
• The RCT aims to determine the clinical benefit of MACL and inform its future dissemination.
• The intervention has international relevance, with training conducted across multiple continents.