Ignite Creation Date:
2024-05-06 @ 12:55 AM
Last Modification Date:
2024-10-26 @ 10:57 AM
Study NCT ID:
NCT01693991
Status:
COMPLETED
Last Update Posted:
2014-07-10
First Post:
2012-09-18
Brief Title:
Randomized Controlled Trial of the Meaning-Making Intervention MMi
Sponsor:
Jewish General Hospital
Organization:
Jewish General Hospital
Study Overview
Official Title:
Randomized Controlled Trial of the Meaning-Making Intervention MMi in Patients Newly Diagnosed With Advanced Cancer A Pilot Study
Status:
COMPLETED
Status Verified Date:
2014-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Research questions Pilot study research questions Primary 1Can we recruit a sufficient number ie at least 60 patients over 9 months and retain a sufficient proportion of both men and women ie at least 80 at 2 4 or 6 months post-randomization with advanced cancer in all 3 trial arms to allow completion of a full study in 4 years 2Is MMi acceptable to a general ACP to both men and women Secondary 1Is it feasible to complete the intervention in 3-4 weeks 2How long is it feasible to test MMi effects 2 4 or 6 months post-randomizationretention rate80 3Which recruitment strategies are most helpful 4What sample size is needed for a full study Full-study research questions Primary Does adding the MMi to usual care experimental group or EG enhance meaning in life among newly diagnosed ACP compared with those receiving usual care plus meetings with an empathic non-professional visitor ie attention-control group or AC or usual care alone UC at x months post-randomization time determined in pilot Meaning in life primary outcome is defined as the belief that ones life has significance and purpose ie global meaning and newly diagnosed ACP is defined as the 6 months after first occurrence of progression toward or recurrence of stage III or IV cancer TNM classification system Secondary In our future full-study we plan to evaluate MMi effects on secondary outcomes such as existential wellbeing MQOL existential wellbeing and posttraumatic growth Post-Traumatic Growth Inventory We also plan to test a theoretical model where sense of meaning in life has a protective moderating effect on tertiary outcomes such as physical QoL MQOL physical subscale anxiety and depression Hospital Anxiety and Depression Scale HADS and overall QoL MQOL Total in EG patients Methodology RCT pilot study with 60 newly diagnosed ACP stages III or IV within 2 months of referral and 6 months of randomization assigned randomly to 1 EG 2 AC or 3 UC Patients will complete self-report questionnaires including outcome measures as well as sociodemographic and medical variables at 2 4 and 6 months post-randomization
Detailed Description:
See above
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None