Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02583932 |
| Other study ID # |
MM-JGH-15-100 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
October 2015 |
| Est. completion date |
August 2020 |
Study information
| Verified date |
January 2021 |
| Source |
Jewish General Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
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.
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.
