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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02650661
• Date of registration: 01/10/2015
• Prospective Registration: Yes
• Primary sponsor: Seoul National University Hospital
• Public title: Efficacy of a Smart Management Strategy for Health (SMASH) Program for Overcoming Cancer Crisis and Growing Positively
• Scientific title: A Randomized Controlled Trial of Smart Management Strategy for Health (SMASH) Program for Overcoming Cancer Crisis and Growing Positively in Cancer Survivors
• Date of first enrolment: November 23, 2015
• Target sample size: 394
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02650661
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Korea, Republic of

Contacts

• Name: Young Ho Yun, MD. PhD
• Affiliation: Seoul National University Hospital

Key inclusion & exclusion 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



Age minimum: 19 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Colorectal Neoplasms

Breast Neoplasms

Stomach Neoplasms

Lung Neoplasms

Intervention(s)

Behavioral: Standard health educational booklet

Behavioral: Health coaching

Behavioral: Online health management program

Behavioral: Workshop

Primary Outcome(s)

Change in percentage of patients meeting the exercise goal [Time Frame: baseline, 3, 6, and 12 months]]

Change in percentage of patients meeting the body mass index (BMI) goal [Time Frame: baseline, 3, 6, and 12 months]

Change in percentage of patients meeting the posttraumatic growth inventory (PTGI) goal [Time Frame: 3, 6, and 12 months]

Secondary Outcome(s)

Change in level of fatigue [Time Frame: baseline, 3, 6, and 12 months]

Cost effectiveness analysis [Time Frame: baseline, 3, 6, and 12 months]

Change in level of anxiety and depression [Time Frame: baseline, 3, 6, and 12 months]

Change in level of self-management strategy [Time Frame: baseline, 3, 6, and 12 months]

Change in level of social support and spiritual well-being [Time Frame: baseline, 3, 6, and 12 months]

Change in execution level of health habits [Time Frame: baseline, 3, 6, and 12 months]

Change in percentage of patients meeting diet goal [Time Frame: baseline, 3, 6, and 12 months]

Secondary ID(s)

YHYun

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Center, Korea

Asan Medical Center

Samsung Medical Center

Ewha Womans University Mokdong Hospital