Clinical trial NCT02650661: Efficacy of a Smart Management Strategy for Health (SMASH) Program for Overcoming Cancer Crisis and Growing Positively
Official title: A Randomized Controlled Trial of Smart Management Strategy for Health (SMASH) Program for Overcoming Cancer Crisis and Growing Positively in Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasms
Lung Neoplasms
Colorectal Neoplasms
Stomach Neoplasms
Keywords: Cancer survivors
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Samsung Medical Center
name: Asan Medical Center
name: Ewha Womans University Mokdong Hospital
name: National Cancer Center, Korea
First posted: 2016-01-08
Enrollment: 394
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the efficacy of the "Smart Management Strategy for Health (SMASH)" program, which is designed to help cancer patients overcome their cancer crisis proactively and grow positively.

Detailed description: \<Hypothesis\> This study hypothesizes that the intervention being provided (SMASH program) will demonstrate improvements in cancer survivors' health management in the fields of (i) physical activity, body mass index, and positive growth, (ii) self-management strategies of health (SMASH Assessment Tool; SAT), (iii) overall physical, mental, social, spiritual health conditions and Quality of Life (QoL), and (iv) the execution and maintenance of health habits ("10 Rules for Highly Effective Health Behavior").

\<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.

Eligibility criteria: Inclusion Criteria:

* Aware of one's diagnosis of breast, lung, colorectal or gastric cancer
* 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:

* Inability to speak or write Korean
* 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

Primary outcomes:
measure: Change in percentage of patients meeting the exercise goal
timeFrame: baseline, 3, 6, and 12 months]
measure: Change in percentage of patients meeting the body mass index (BMI) goal
timeFrame: baseline, 3, 6, and 12 months
measure: Change in percentage of patients meeting the posttraumatic growth inventory (PTGI) goal
timeFrame: 3, 6, and 12 months
Secondary outcomes:
measure: Change in percentage of patients meeting diet goal
timeFrame: baseline, 3, 6, and 12 months
measure: Change in execution level of health habits
timeFrame: baseline, 3, 6, and 12 months
measure: Change in level of anxiety and depression
timeFrame: baseline, 3, 6, and 12 months
measure: Change in level of fatigue
timeFrame: baseline, 3, 6, and 12 months
measure: Change in level of self-management strategy
timeFrame: baseline, 3, 6, and 12 months
measure: Change in level of social support and spiritual well-being
timeFrame: baseline, 3, 6, and 12 months
measure: Cost effectiveness analysis
timeFrame: baseline, 3, 6, and 12 months
Other outcomes:
Locations:
city: Ilsan
country: Korea, Republic of
facility: Eun Sook Lee
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Sung Kim
city: Seoul
country: Korea, Republic of
facility: Eun Mi Nam
city: Seoul
country: Korea, Republic of
facility: Kyung Hae Jung
Study officials:
affiliation: Seoul National University Hospital
name: Young Ho Yun, MD. PhD
role: PRINCIPAL_INVESTIGATOR
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