AzTrials
AzTrials

Breast NeoplasmsNCT02650661

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

A study testing Online health management program, Health coaching and Workshop in people with Breast Neoplasms and Lung Neoplasms, run by Seoul National University Hospital at 4 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
Online health management program, Health coaching and Workshop
Could I receive a placebo?
No, everyone receives an active treatment
How many people
394 participants
Where
4 sitesSouth Korea
Study dates
23 Nov 2015to Jan 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • 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

Who cannot join

  • 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

Trial locations and contacts

4 sites in 1 country.

South Korea4 sites

  • Eun Sook Lee

    Ilsan, Gyeonggi-do, 10408

  • Sung Kim

    Seoul, 06351

  • Eun Mi Nam

    Seoul, 07985

  • Kyung Hae Jung

    Seoul, 138-736

Other trials in South Korea

About this study

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

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.

Read the 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.

Being tested
Online health management program, Health coaching, Workshop, Standard health educational booklet
Keywords
Cancer survivors
Medical subject headings
Breast Neoplasms, Lung Neoplasms, Colorectal Neoplasms, Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Online health management programBehavioural

    Also called "Healthing U"

    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 coachingBehavioural

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

  • WorkshopBehavioural

    Also called Group education

    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 bookletBehavioural

    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.

Study groups in NCT02650661
Study groupRoleWhat they receive
Online program & Health coachingExperimentalThis group is provided with "Online health management program", "Health coaching" and "Workshop".
Receives: Behavioral: Online health management program; Behavioral: Health coaching; Behavioral: Workshop
Online programExperimentalThis group is provided with "Online health management program".
Receives: Behavioral: Online health management program
Enhanced Usual CareActive comparatorThis group is provided with "Standard health educational booklet".
Receives: Behavioral: Standard health educational booklet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: baseline, 3, 6, and 12 months]

  2. 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)

    Measured: baseline, 3, 6, and 12 months

  3. 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)

    Measured: 3, 6, and 12 months

Secondary outcomes (7)

  1. Change in percentage of patients meeting diet goal

    Mini Dietary assessment Index (MDI) score ≥ 80

    Measured: baseline, 3, 6, and 12 months

  2. Change in execution level of health habits

    10 Rules for Highly Effective Health Behavior

    Measured: baseline, 3, 6, and 12 months

  3. 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).

    Measured: baseline, 3, 6, and 12 months

  4. 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,

    Measured: baseline, 3, 6, and 12 months

  5. 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.

    Measured: baseline, 3, 6, and 12 months

  6. 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)

    Measured: baseline, 3, 6, and 12 months

  7. Cost effectiveness analysis

    Cost effectiveness analysis

    Measured: baseline, 3, 6, and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2016 (estimated)
  2. Study start23 Nov 2015
  3. Primary completionJun 2016
  4. Study completionJan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
394 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02650661
Sponsor's protocol ID
YHYun
Status last verified
Oct 2018
First submitted
1 Oct 2015
Last updated
19 Oct 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.

    PubMed 8433390

  • Ahlberg K, Ekman T, Gaston-Johansson F, Mock V. Assessment and management of cancer-related fatigue in adults. Lancet. 2003 Aug 23;362(9384):640-50. doi: 10.1016/S0140-6736(03)14186-4.

    PubMed 12944066

  • Andersson G, Bergstrom J, Hollandare F, Carlbring P, Kaldo V, Ekselius L. Internet-based self-help for depression: randomised controlled trial. Br J Psychiatry. 2005 Nov;187:456-61. doi: 10.1192/bjp.187.5.456.

    PubMed 16260822

  • Appel LJ, Clark JM, Yeh HC, Wang NY, Coughlin JW, Daumit G, Miller ER 3rd, Dalcin A, Jerome GJ, Geller S, Noronha G, Pozefsky T, Charleston J, Reynolds JB, Durkin N, Rubin RR, Louis TA, Brancati FL. Comparative effectiveness of weight-loss interventions in clinical practice. N Engl J Med. 2011 Nov 24;365(21):1959-68. doi: 10.1056/NEJMoa1108660. Epub 2011 Nov 15.

    PubMed 22085317

  • Barsevick AM, Dudley W, Beck S, Sweeney C, Whitmer K, Nail L. A randomized clinical trial of energy conservation for patients with cancer-related fatigue. Cancer. 2004 Mar 15;100(6):1302-10. doi: 10.1002/cncr.20111.

    PubMed 15022300

  • Brendryen H, Kraft P. Happy ending: a randomized controlled trial of a digital multi-media smoking cessation intervention. Addiction. 2008 Mar;103(3):478-84; discussion 485-6. doi: 10.1111/j.1360-0443.2007.02119.x.

    PubMed 18269367

  • Burton AW, Fanciullo GJ, Beasley RD, Fisch MJ. Chronic pain in the cancer survivor: a new frontier. Pain Med. 2007 Mar;8(2):189-98. doi: 10.1111/j.1526-4637.2006.00220.x.

    PubMed 17305690

  • Courneya KS, Friedenreich CM, Sela RA, Quinney HA, Rhodes RE, Handman M. The group psychotherapy and home-based physical exercise (group-hope) trial in cancer survivors: physical fitness and quality of life outcomes. Psychooncology. 2003 Jun;12(4):357-74. doi: 10.1002/pon.658.

    PubMed 12748973

  • Courneya KS, Mackey JR, Bell GJ, Jones LW, Field CJ, Fairey AS. Randomized controlled trial of exercise training in postmenopausal breast cancer survivors: cardiopulmonary and quality of life outcomes. J Clin Oncol. 2003 May 1;21(9):1660-8. doi: 10.1200/JCO.2003.04.093.

    PubMed 12721239

  • Daley AJ, Crank H, Saxton JM, Mutrie N, Coleman R, Roalfe A. Randomized trial of exercise therapy in women treated for breast cancer. J Clin Oncol. 2007 May 1;25(13):1713-21. doi: 10.1200/JCO.2006.09.5083.

    PubMed 17470863

  • Demark-Wahnefried W, Clipp EC, Lipkus IM, Lobach D, Snyder DC, Sloane R, Peterson B, Macri JM, Rock CL, McBride CM, Kraus WE. Main outcomes of the FRESH START trial: a sequentially tailored, diet and exercise mailed print intervention among breast and prostate cancer survivors. J Clin Oncol. 2007 Jul 1;25(19):2709-18. doi: 10.1200/JCO.2007.10.7094.

    PubMed 17602076

  • Morey MC, Snyder DC, Sloane R, Cohen HJ, Peterson B, Hartman TJ, Miller P, Mitchell DC, Demark-Wahnefried W. Effects of home-based diet and exercise on functional outcomes among older, overweight long-term cancer survivors: RENEW: a randomized controlled trial. JAMA. 2009 May 13;301(18):1883-91. doi: 10.1001/jama.2009.643.

    PubMed 19436015

  • Fawzy NW. A psychoeducational nursing intervention to enhance coping and affective state in newly diagnosed malignant melanoma patients. Cancer Nurs. 1995 Dec;18(6):427-38.

    PubMed 8564938

  • Gessler S, Low J, Daniells E, Williams R, Brough V, Tookman A, Jones L. Screening for distress in cancer patients: is the distress thermometer a valid measure in the UK and does it measure change over time? A prospective validation study. Psychooncology. 2008 Jun;17(6):538-47. doi: 10.1002/pon.1273.

    PubMed 17973237

  • Lachin JM. Sample size determinants for r X c comparative trials. Biometrics. 1977 Jun;33(2):315-24. No abstract available.

    PubMed 884194

Questions about this trial

What is this clinical trial studying?

A study testing Online health management program, Health coaching and Workshop in people with Breast Neoplasms and Lung Neoplasms, run by Seoul National University Hospital at 4 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in percentage of patients meeting the exercise goal (time frame: baseline, 3, 6, and 12 months]). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02650661, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in