Efficacy of a Smart Management Strategy for Health (SMASH) Program for Overcoming Cancer Crisis and Growing Positively
NCT ID: NCT02650661
Last Updated: 2018-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
394 participants
INTERVENTIONAL
2015-11-23
2018-01-31
Brief Summary
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Detailed Description
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\<Patient registry\> Cancer survivors, who have just completed their cancer treatments (surgery, radiation, chemotherapy), will be recruited from five medical centers in Korea and randomly allocated to one of following three groups: 2 experiment groups and 1 attention control group. This recruitment process would start after the approval of protocol by the Institutional Review Board (IRB), and proceed through following steps: (i) the physician in charge confirms that the patient has finished his or her treatment and determines whether the patient is eligible to participate in the study by checking the recent (less than one year) results of the patient's basic medical exams (blood pressure, body temperature, heart rate, respiratory rate, weight, and height) and basic lab tests (blood chemistry, electrocardiogram, chest PA, complete blood count, liver function test, BUN/Cr), (ii) A nurse explains the purpose and method of the study to the patient, and asks to complete informed consent form, (iii) the patient who agrees for participation will complete a brief screening questionnaire (Godin's Leisure Time Exercise, weight/height, and PostTraumatic Growth Inventory(PTGI)), (iv) the patient meeting the criteria as determined by the screening questionnaire is asked to complete the baseline assessment questionnaire at home, (v) cases who finish the baseline assessment questionnaire and meet all criteria are considered study participants and are randomly assigned to one of the three study arms.
\<Quality control (patient data)\> This study assumes that patients who are directly referred to the study by collaborating physicians are valid cancer cases. Data collected from study participants on screening forms will be reviewed by researchers at the central institution for missing responses and inconsistencies.
\<Sample size\>
The sample size of 477 participants was based upon the following assumptions:
* a two-sided Type I error of 0.05
* drop-out rate of 10%
* an attainment of goal behavior of 5% in the active comparator arm and 20% in the experiment arm, and a power of 90% to detect a between-arm difference
\<Statistical analysis plan \> The primary endpoint was based on three-outcome composite achievement of PA, weight and PTGI score at 12 months. All analyses will be conducted on the basis of intention-to-treat. Arm differences at 3, 6, and 12 months in behavior change (physical activity, body mass index, posttraumatic growth) will be tested with logistic regression, controlling for the respective baseline values. Arm differences in levels of Mini Dietary Assessment Index (MDI), execution of health habits, SMASH Assessment Tool (SAT), Quality of Life (QoL), health condition, incurred medical expenses, incurred Complementary and Alternative Medicine (CAM) expenses will be explored using a mixed model that estimates the effect of SMASH program over time, which will correlate repeated observations on particular participants after adjustment for baseline scores.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Online program & Health coaching
This group is provided with "Online health management program", "Health coaching" and "Workshop".
Online health management program
Web-based health management program designed according to SMASH strategy, which includes (i) Assessment, (ii) Acceptance, (iii) Preparation for change, (iv) Commitment, (v) Planning, (vi) Promoting environment, (vii) Execution, (viii) Feedback and Maintenance, and (ix) Core perspectives, for 6 months.
The program consists of four areas: self-assessment, self-planning, self-learning, and self-monitoring. The learning session includes SMASH strategies and "10 Rules for Highly Effective Health Behavior".
Health coaching
Personalized tele-coaching for 6 months by health coaches who were trained by the Smart Management and Coaching for Health (SMACH) program
Workshop
Total three sessions are to be held at 3-, 5-, and 7-month after the initiation of the enrollment. Each session includes 30-minute health education, 1-hour health management strategy workshop, and 30-minute team coaching.
Online program
This group is provided with "Online health management program".
Online health management program
Web-based health management program designed according to SMASH strategy, which includes (i) Assessment, (ii) Acceptance, (iii) Preparation for change, (iv) Commitment, (v) Planning, (vi) Promoting environment, (vii) Execution, (viii) Feedback and Maintenance, and (ix) Core perspectives, for 6 months.
The program consists of four areas: self-assessment, self-planning, self-learning, and self-monitoring. The learning session includes SMASH strategies and "10 Rules for Highly Effective Health Behavior".
Enhanced Usual Care
This group is provided with "Standard health educational booklet".
Standard health educational booklet
Standard health educational booklets about "10 Rules for Highly Effective Health Behavior" that are organized according to the Trans-theoretical Model (TTM).
Booklets are provided at 0-, 2-, and 4-month after the enrollment.
Interventions
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Online health management program
Web-based health management program designed according to SMASH strategy, which includes (i) Assessment, (ii) Acceptance, (iii) Preparation for change, (iv) Commitment, (v) Planning, (vi) Promoting environment, (vii) Execution, (viii) Feedback and Maintenance, and (ix) Core perspectives, for 6 months.
The program consists of four areas: self-assessment, self-planning, self-learning, and self-monitoring. The learning session includes SMASH strategies and "10 Rules for Highly Effective Health Behavior".
Health coaching
Personalized tele-coaching for 6 months by health coaches who were trained by the Smart Management and Coaching for Health (SMACH) program
Workshop
Total three sessions are to be held at 3-, 5-, and 7-month after the initiation of the enrollment. Each session includes 30-minute health education, 1-hour health management strategy workshop, and 30-minute team coaching.
Standard health educational booklet
Standard health educational booklets about "10 Rules for Highly Effective Health Behavior" that are organized according to the Trans-theoretical Model (TTM).
Booklets are provided at 0-, 2-, and 4-month after the enrollment.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* less than 2 months has passed since one's completion of primary cancer treatment (including surgery, radiation, or chemotherapy)
* Performs poorly at baseline on at least one goal behavior, which includes the followings:
(i) moderate exercise ≥150 min/week or strenuous exercise ≥75 min/week (\*exception: ≥12.5 MET-hr/week for lung cancer patients) (ii) BMI within normal range (18.5-22.9) (\*exception: ≥18.5 for lung cancer patients) (iii) Posttraumatic Growth Inventory (PTGI) score ≥72
Exclusion Criteria
* Medical conditions that would limit adherence to an unsupervised health management program (as confirmed by their referring physician; e.g. major depression, dyspnea)
* Currently pregnant or planning to be within the next year
19 Years
ALL
No
Sponsors
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Samsung Medical Center
OTHER
Asan Medical Center
OTHER
Ewha Womans University Mokdong Hospital
OTHER
National Cancer Center, Korea
OTHER_GOV
Seoul National University Hospital
OTHER
Responsible Party
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Young Ho Yun
Professor
Principal Investigators
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Young Ho Yun, MD. PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Eun Sook Lee
Ilsan, Gyeonggi-do, South Korea
Sung Kim
Seoul, , South Korea
Eun Mi Nam
Seoul, , South Korea
Kyung Hae Jung
Seoul, , South Korea
Countries
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References
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Other Identifiers
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YHYun
Identifier Type: -
Identifier Source: org_study_id
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