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

NCT02650661 | Completed DMC

• 1 other identifier: YHYun
• Study Type: interventional
• Target: 394
• Locations: 1 country
• Sites: 4

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.

Conditions

Breast Neoplasms; Lung Neoplasms; Colorectal Neoplasms; Stomach Neoplasms

Keywords

Cancer survivors

Outcome Measures

Primary Outcomes (3)

• 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]

• 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

• 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 Outcomes (7)

• Change in percentage of patients meeting diet goal

  baseline, 3, 6, and 12 months

• Change in execution level of health habits

  baseline, 3, 6, and 12 months

• Change in level of anxiety and depression

  baseline, 3, 6, and 12 months

• Change in level of fatigue

  baseline, 3, 6, and 12 months

• Change in level of self-management strategy

  baseline, 3, 6, and 12 months

Study Arms (3)

Online program & Health coaching

EXPERIMENTAL

This group is provided with "Online health management program", "Health coaching" and "Workshop".

Behavioral: Online health management program; Behavioral: Health coaching; Behavioral: Workshop

Online program

EXPERIMENTAL

This group is provided with "Online health management program".

Behavioral: Online health management program

Enhanced Usual Care

ACTIVE COMPARATOR

This group is provided with "Standard health educational booklet".

Behavioral: Standard health educational booklet

Interventions

Online health management program BEHAVIORAL

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".

Also known as: "Healthing U"

Online program; Online program & Health coaching

Health coaching BEHAVIORAL

Personalized tele-coaching for 6 months by health coaches who were trained by the Smart Management and Coaching for Health (SMACH) program

Online program & Health coaching

Workshop BEHAVIORAL

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.

Also known as: Group education

Online program & Health coaching

Standard health educational booklet BEHAVIORAL

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.

Enhanced Usual Care

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Samsung Medical Center: collaborator
• Asan Medical Center: collaborator
• Ewha Womans University Mokdong Hospital: collaborator
• National Cancer Center, Korea: collaborator

Study Sites (4)

Eun Sook Lee

Ilsan, Gyeonggi-do, 10408, South Korea

Location

Sung Kim

Seoul, 06351, South Korea

Location

Eun Mi Nam

Seoul, 07985, South Korea

Location

Kyung Hae Jung

Seoul, 138-736, South Korea

Location

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MeSH Terms

Conditions

Breast Neoplasms; Lung Neoplasms; Colorectal Neoplasms; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Stomach Diseases

Study Officials

• Young Ho Yun, MD. PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 1, 2015
• First Posted: January 8, 2016
• Study Start: November 23, 2015
• Primary Completion: June 1, 2016
• Study Completion: January 1, 2018
• Last Updated: October 19, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (4)