Breast Neoplasms, Lung Neoplasms, Colorectal Neoplasms, Stomach Neoplasms
Conditions
Keywords
Cancer survivors
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.
Interventions
BEHAVIORALOnline 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.
BEHAVIORALHealth coaching
Personalized tele-coaching for 6 months by health coaches who were trained by the Smart Management and Coaching for Health (SMACH) program
BEHAVIORALWorkshop
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.
BEHAVIORALStandard 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.
Sponsors
Samsung Medical Center
Asan Medical Center
Ewha Womans University Mokdong Hospital
National Cancer Center, Korea
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in percentage of patients meeting the exercise goal | baseline, 3, 6, and 12 months] | moderate exercise for ≥150 min/week or strenuous exercise for ≥75 min/week (\* ≥12.5 MET-hr/week for lung cancer patients; no limit on exercise strength) |
| Change in percentage of patients meeting the body mass index (BMI) goal | baseline, 3, 6, and 12 months | BMI in kg/m\^2 goal 18.5-22.9 (≥18.5 for lung cancer patients) |
| Change in percentage of patients meeting the posttraumatic growth inventory (PTGI) goal | 3, 6, and 12 months | General is a quality of life measure with higher scores indicating better quality of life (range 0-105) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in level of fatigue | baseline, 3, 6, and 12 months | The Brief Fatigue Inventory (BFI) scale, which consists of 9 items that rate fatigue severity and interference on a 0-to-10 scale, |
| Change in level of self-management strategy | baseline, 3, 6, and 12 months | We assessed the SM strategies of health with the SMASH Assessment Tool (SAT), which is a three-set, 16-factor, 91-item tool (i.e., the core strategies with 28 items, preparation strategies with 30 items, and implementation strategies with 33 items) that assesses the patients' ability to overcome their health-related crisis. |
| Change in percentage of patients meeting diet goal | baseline, 3, 6, and 12 months | Mini Dietary assessment Index (MDI) score ≥ 80 |
| Cost effectiveness analysis | baseline, 3, 6, and 12 months | Cost effectiveness analysis |
| Change in level of social support and spiritual well-being | baseline, 3, 6, and 12 months | The social support (2 items) and spiritual (6 items) scales of the McGill Quality of Life (McGill QOL) |
| Change in execution level of health habits | baseline, 3, 6, and 12 months | 10 Rules for Highly Effective Health Behavior |
| Change in level of anxiety and depression | baseline, 3, 6, and 12 months | We measured psychologic distress with the Hospital Anxiety and Depression Scale (HADS), which consists of 14 items (7 for anxiety and 7 for depression). |
Countries
South Korea
Outcome results
None listed