Efficacy of a Smart Management Strategy for Health (SMASH) Program for Overcoming Cancer Crisis and Growing Positively

Breast Neoplasms Clinical Trial

Official title:

A Randomized Controlled Trial of Smart Management Strategy for Health (SMASH) Program for Overcoming Cancer Crisis and Growing Positively in Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02650661
• Other study ID #: YHYun
• Status: Completed
• Phase: N/A
• Start date: November 23, 2015
• Est. completion date: January 2018

Study information

• Verified date: October 2018
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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").

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.

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.

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 394
• Est. completion date: January 2018
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Colorectal Neoplasms
• Lung Neoplasms
• Neoplasms
• Stomach Neoplasms

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Eun Sook Lee	Ilsan	Gyeonggi-do
Korea, Republic of	Eun Mi Nam	Seoul
Korea, Republic of	Kyung Hae Jung	Seoul
Korea, Republic of	Sung Kim	Seoul

Sponsors (5)

Lead Sponsor	Collaborator
Seoul National University Hospital	Asan Medical Center, Ewha Womans University Mokdong Hospital, National Cancer Center, Korea, Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (23)

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* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in percentage of patients meeting the exercise goal	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)	baseline, 3, 6, and 12 months]
Primary	Change in percentage of patients meeting the body mass index (BMI) goal	BMI in kg/m^2 goal 18.5-22.9 (=18.5 for lung cancer patients)	baseline, 3, 6, and 12 months
Primary	Change in percentage of patients meeting the posttraumatic growth inventory (PTGI) goal	General is a quality of life measure with higher scores indicating better quality of life (range 0-105)	3, 6, and 12 months
Secondary	Change in percentage of patients meeting diet goal	Mini Dietary assessment Index (MDI) score = 80	baseline, 3, 6, and 12 months
Secondary	Change in execution level of health habits	10 Rules for Highly Effective Health Behavior	baseline, 3, 6, and 12 months
Secondary	Change in level of anxiety and depression	We measured psychologic distress with the Hospital Anxiety and Depression Scale (HADS), which consists of 14 items (7 for anxiety and 7 for depression).	baseline, 3, 6, and 12 months
Secondary	Change in level of fatigue	The Brief Fatigue Inventory (BFI) scale, which consists of 9 items that rate fatigue severity and interference on a 0-to-10 scale,	baseline, 3, 6, and 12 months
Secondary	Change in level of self-management strategy	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.	baseline, 3, 6, and 12 months
Secondary	Change in level of social support and spiritual well-being	The social support (2 items) and spiritual (6 items) scales of the McGill Quality of Life (McGill QOL)	baseline, 3, 6, and 12 months
Secondary	Cost effectiveness analysis	Cost effectiveness analysis	baseline, 3, 6, and 12 months