Randomized Controlled Trial of the Meaning-Making Intervention (MMi) In Newly Diagnosed Advanced Cancer

Advanced Cancer Clinical Trial

Official title: Randomized Controlled Trial of the Meaning-Making Intervention (MMi) In People Newly Diagnosed With Advanced Cancer: Full Trial

Status Completed

Clinical Trial Summary

To test whether the Meaning-Making intervention (MMi)(Lee, 2004) plus usual care increases the sense of meaning in life in people newly diagnosed with any type of advanced cancer, compared to similar people who receive 1) usual care alone or 2) usual care plus visits from an empathic visitor, at 2 months after randomization to one of these treatments. The investigators will also evaluate whether any effect is present at 4 and 6 months post-randomization, and the MMi's impact on anxiety/depression, quality of life, existential wellbeing, and posttraumatic growth. To answer our research questions 471 newly diagnosed (<6 months) advanced cancer patients (stages III or IV) will be studied.

Clinical Trial Description

Background: Psychosocial interventions are effective for all types of cancer in preventing and addressing distress and enhancing quality of life. However, most neglect existential issues. Issues of meaning and meaninglessness are especially important existential concerns for advanced cancer patients and crucial in determining their quality of life. Adaptation can be promoted and current and/or future existential crises curtailed by an early, psychologically growth-promoting intervention such as the Meaning-Making intervention (MMi)(Lee, 2006), helping patients adapt more quickly or fully, and preparing them for stormy periods ahead such as the end of life. However, it is not known whether: 1) the MMi can help patients newly diagnosed with advanced cancer; 2) it increases a sense of meaning in life; 3) its impact lasts beyond the end of the intervention; and 4) the effect shown is due to the MMi or a similar effect could be obtained by having someone listen empathically for the same amount of time as it takes to administer the MMi.

The investigators now want to test its efficacy in a full 3-arm randomized controlled trial for newly diagnosed advanced cancer patients. They will roll in the feasibility pilot study data (n=60) since it demonstrated that the initial protocol was feasible and the investigators therefore did not view or analyze the outcome data (it was viewed only by the research coordinator) and the design stayed the same (ClinicalTrials.gov Identifier: NCT01693991). .

Primary Hypothesis: Adding the MMi to usual care (experimental group) enhances meaning in life on the FACIT-Sp-12 meaning subscale among newly diagnosed advanced cancer patients, compared with those receiving usual care plus meetings with an empathic non-professional visitor (i.e., attention-control group) or usual care alone, at 2 months post-randomization. "Meaning in life" (primary outcome) is defined as the belief that one's life has significance and purpose (i.e., global meaning) and "newly diagnosed advanced cancer patient" is defined as the 6 months after first occurrence of, progression to, or recurrence of stage III or IV cancer.

Secondary hypotheses: The Experimental Group will have decreased anxiety and depression (Hospital Anxiety and Depression Scale), increased overall quality of life (McGill Quality of Life Questionnaire (MQOL) Total), existential wellbeing (MQOL Existential Wellbeing), and posttraumatic growth (Post-Traumatic Growth Inventory), compared to the Attention-Control and Usual Care groups at 2 months post-randomization. Furthermore, the MMi effects are present at 4 and 6 months post-randomization. Additional analyses: The investigators plan subgroup analyses of effect modifiers such as gender, degree of baseline perceived life-threat, initial level of psychological distress, initial level of meaning in life, and degree of experienced physical wellbeing.

Design and method: RCT with 471 newly diagnosed advanced cancer patients assigned randomly to the Experimental Group, Attention-Control, or Usual Care. Patients will complete self-report questionnaires measuring outcomes at baseline, 2, 4 and 6 months post-randomization.

Significance of the research: Advanced cancer patients are confronted with the possibility of imminent death and consequently struggle to search for meaning in their plight. An early, psychologically growth-promoting intervention is especially important for these patients to prevent further distress within a lifespan that is likely to be limited. Interventions designed to promote psychological wellbeing and enhance quality of life usually fail to address this important existential dimension and pathway to improved wellbeing. The MMi offers a promising avenue to help advanced cancer patients adjust to their diagnosis and improve their quality of life, helping them to adapt more quickly or fully. If the results of this RCT are positive, focus groups and interviews with key stakeholders indicate that it will be integrated into routine cancer care, with outreach activities designed to equip the oncology healthcare community to address meaning and existential issues in clinical practice. ;

Related Conditions & MeSH terms

• Advanced Cancer
• Neoplasms

• NCT number: NCT02583932
• Study type: Interventional
• Source: Jewish General Hospital
• Status: Completed
• Phase: Phase 3
• Start date: October 2015
• Completion date: August 2020