Trial Title:
Personalized Self-Management Training Compared to Standardized Self-Management Training in Colorectal Cancer Patients.
NCT ID:
NCT05984589
Condition:
Colorectal Cancer
Healthy Lifestyle
Behavior, Health
Health Behavior
Conditions: Official terms:
Colorectal Neoplasms
Conditions: Keywords:
self-management training
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
RISE Personalized Self-Managament Training (PSMT)
Description:
Along with patient education and internalization of self-determination, the RISE
intervention focuses on replacing unhealthy habits with health-promoting habits. Ongoing
practice and guidance in generating and enacting SMART (specific, measurable, achievable,
realistic, and time-bound) health goals is the centerpiece of the RISE intervention.
Working one-on-one with the PI, participants will set goals and develop practical
strategies to establish sustainable healthy behavior (HB) change. Motivational
interviewing, cognitive behavioral therapy, and patient education will accompany
intensive collaborative problem-solving and creation of accountability structures to
create lasting change. The 6-week intervention includes 2 in-person visits and 4
videoconference sessions.
Arm group label:
RISE-PSMT
Intervention type:
Behavioral
Intervention name:
Standardized Self-Managament Training (SSMT)
Description:
Participants randomized to the control condition will receive 6 standardized sessions
from one of the OT interveners, matched to the PSMT for setting. At these visits,
participants will be presented with slides containing pre-specified, standardized
didactic content about the World Cancer Research Fund/American Institute for Cancer
Research (WCRF/AICR) healthy behavior recommendations (HBRs). We hypothesize that these
visits will control for the effect of research participation and increased knowledge
about HBRs, and that simply providing standardized didactic content as an intervention
modality without any personalization will have negligible effects on participants'
healthy behaviors (HBs), self-efficacy, or quality of life. Content will follow the
WCRF/AICR HBRs. Weeks 1-2 will focus on physical activity; weeks 3-4 will focus on diet
and alcohol, and weeks 5-6 will focus on weight management and generalized strategies for
HB change.
Arm group label:
SSMT
Summary:
This is a Phase 2 prospective, randomized, controlled, double-arm study to assess
personalized self-management training (PSMT) intervention efficacy and patient
experiences compared to standardized self-management training (SSMT). A total of 120
colorectal cancer (CRC) patients will be enrolled and randomized 1:1 to complete a 6-week
self-management training program (either PSMT or SSMT) to be carried out by licensed
occupational therapists with doctoral training.
This study aims to examine whether PSMT is more effective in increasing adherence to
healthy behavior recommendations compared to SSMT in CRC patients.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age ≥18 years at the time of consent.
2. History of Stage I-III colorectal cancer (CRC) within the past 12 months prior to
enrollment.
3. Ability to speak, write, and read English sufficiently to allow for program
participation.
4. Identified by self-report as having willingness and interest to work on at least one
lifestyle-related risk factor. Lifestyle-related risk factors include diet, physical
activity, body composition, alcohol use.
5. Scoring ≤3.5 on the World Cancer Research Fund/American Institute for Cancer
Research (WCRF/AICR) Health Behavior Adherence Scale (Table 1) consistent with
moderate to low adherence to healthy behavior recommendations (HBRs).
6. Written informed consent obtained from subject and ability for subject to comply
with the requirements of the study.
Exclusion Criteria:
1. Cognitive or mental impairments that in the opinion of the Principal Investigator or
study physician would hinder the program participation.
2. Planning to have active anti-cancer treatment (including radiation, chemo, and/or
major surgery) within 6 months after initial interventional or control session.
Long-term hormonal/biologic therapy is acceptable.
3. Known metastatic disease (Stage IV cancers).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Cedars-Sinai Medical Center
Address:
City:
Los Angeles
Zip:
90048
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ana Martin, MD
Phone:
310-423-8887
Email:
ana.martin@cshs.org
Investigator:
Last name:
Andrew Hendifar, MD, MPH
Email:
Sub-Investigator
Investigator:
Last name:
Jun Gong, MD
Email:
Sub-Investigator
Investigator:
Last name:
Stephen Freedland, MD
Email:
Sub-Investigator
Investigator:
Last name:
Pamela Roberts, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Sarah Salvy, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Patricia Thompson, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Arash Asher, MD
Email:
Sub-Investigator
Investigator:
Last name:
Philip Chang, MD
Email:
Sub-Investigator
Investigator:
Last name:
LJ Amaral, MS, RD, CSO
Email:
Sub-Investigator
Start date:
March 1, 2024
Completion date:
February 27, 2026
Lead sponsor:
Agency:
Arash Asher, MD
Agency class:
Other
Collaborator:
Agency:
National Institutes of Health (NIH)
Agency class:
NIH
Collaborator:
Agency:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Agency class:
NIH
Source:
Cedars-Sinai Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05984589
