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Trial record 1 of 1 for:    NCT01527409
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The Efficacy of Health Partnership Program for Cancer Patients

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ClinicalTrials.gov Identifier: NCT01527409
Recruitment Status : Unknown
Verified February 2012 by YoungSung Lee, National Cancer Center, Korea.
Recruitment status was:  Recruiting
First Posted : February 7, 2012
Last Update Posted : February 7, 2012
Sponsor:
Collaborators:
Samsung Medical Center
Seoul National University Hospital
Korea University Anam Hospital
Asan Medical Center
Ajou University School of Medicine
Kyunghee University Medical Center
Information provided by (Responsible Party):
YoungSung Lee, National Cancer Center, Korea

Study Description
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Brief Summary:

The Objectives of this study is

  1. To evaluate the efficacy for exercise, diet, and posttraumatic growth as a result of participating in tailored program (Health Partnership Program) for 24 weeks
  2. To evaluate the efficacy for quality of life, life satisfaction, health leadership, anxiety, depression, impact of event, social support, cancer belief as a result of participating in tailored program (Health Partnership Program) for 24 weeks
  3. To assess the efficacy of such intervention compared with usual care in cancer patients

Condition or disease Intervention/treatment Phase
Breast Cancer Colon Cancer Gastric Cancer Lung Cancer Behavioral: Tailored health partnership program Behavioral: Usual care and health education workshop Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 248 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Efficacy of Health Partnership Program for Cancer Patients
Study Start Date : February 2012
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimetal Arm

Providing tailored health care program, which provides various information related to exercise, diet, and posttraumatic growth.

Tailored health partnership program consists of three strategic areas (exercise, diet, and posttraumatic growth). Those areas are based on the transtheoretical model (TTM), social cognitive theory, PRECEDE-PROCEED model, and Health behavior model.

Patients who participate in the tailored health partnership program will be received tailored manual and workbook for tele-coaching that help them to lead their healthy life.

Also, patients will be provided a workshop for leadership that is dealt with controlling their healthy life.

 Behavioral: Tailored health partnership program

When intervention group participate in the tailored program, they can receive various information which is related with three strategic areas (exercise, diet, and posttraumatic growth).

Three areas are based on the transtheoretical model (TTM), social cognitive theory, PRECEDE-PROCEED model, and Health behavior model.

Patients will be received tailored manual and workbook for health tele-coaching that help them to lead their healthy life.

The health tele-coaching will be operated sixteen times for 24 weeks. Intervention group will be provided three contents (exercise, diet, and posttraumatic growth) from health partners. The health partners took a certificate that is related with health, leadership and coaching.

Also, patients will be provided a workshop for leadership that is dealt with controlling their healthy life. It will be proceeded for four hours. Three hours is for the leadership, and the last one hour is for presentation of their health mission statement.
No Intervention: Control Arm

Providing usual care. Also, patients will be provided a workshop for health education that is dealt with ten areas (smoke and drinking, diet, exercise, posttraumatic growth, distress, pain, comorbidity, sleep disturbance, pain, and energy conservation).

Twelve month later, patients will be provided the tailored health partnership program which is especially dealing with exercise, diet, and posttraumatic growth.

 Behavioral: Usual care and health education workshop

While intervention group participate in the tailored health partnership program, control group can receive various information which is related with ten contents for health management (smoke and drinking, diet, exercise, posttraumatic growth, distress, pain, comorbidity, sleep disturbance, pain, and energy conservation). They will be provided a workshop and booklet for a health education for four hours.

Twelve month later, they will be provided the tailored health partnership program which is especially dealing with exercise, diet, and posttraumatic growth as same as the intervention group.


Outcome Measures
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Primary Outcome Measures :
  1. Changes from Baseline in Exercise, Diet, and Posttraumatic Growth Inventory(PTGI) [ Time Frame: baseline, 3month, 6month, and 12month ]
    How much the patient does exercise will be measured using "MET" score. Change in diet will be observed by analyzing 3day recall.


Secondary Outcome Measures :
  1. Seven habit profile [ Time Frame: baseline, 3month, 6month, and 12month ]
  2. the European Organisation for the Research and Treatment of Cancer Quality-of-life Questionnaire-Core 30(EORTC QLQ C-30) [ Time Frame: baseline, after 3month, 6month, and 12month ]
  3. Ed Diner's Satisfaction with Life Scale [ Time Frame: baseline, after 3month, 6month, and 12month ]
  4. Impact of Event Scale-Revised [ Time Frame: baseline, after 3month, 6month, and 12month ]
  5. Social Support(MOS-SSS) [ Time Frame: baseline, after 3month, 6month, and 12month ]
  6. the Hospital Anxiety and Depression scale(HADS) [ Time Frame: baseline, after 3month, 6month, and 12month ]
  7. Cancer Belief System(CBS) [ Time Frame: baseline, after 3month, 6month, and 12month ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult(≥ 20 years)
  • Within 24 months of completion of primary treatment with curative intent (Surgery, radiotherapy, chemotherapy)
  • Breast, cervical, colorectal (except rectal cancer), lung, and stomach cancer
  • More than two problematic areas among exercise, diet (Fruit & Vegetable: F&V), and posttraumatic growth(exercise < 150min/week, ≥ 3mets, F&V < 5/day, PTGI < 71)

Exclusion Criteria:

  • Evidence of secondary tumor, metastasis and recurrence
  • Patients undergoing or planning surgery, radiation therapy or chemotherapy
  • Not Korean speaking and reading (Not communication with Korean)
  • Not understanding of the study purpose and not written informed consent
  • Participants who have an similar study experience
  • Major health problem in which exercise/nutrition intervention is contraindicated at the discretion of clinician; cardiovascular disease (congestive heart failure, angina), pulmonary disease (chronic obstructive pulmonary disease, restrictive pulmonary disease), uncontrolled hypertension, poorly controlled diabetes and severe musculoskeletal disease and so on
  • Sign of infection (body temperature ≥ 37.2℃ or WBC ≥ 11,000)
  • Being pregnant
  • Thrombocytopenia (platelet count ≤ 100,000/mcl)
  • Anemia (Hb ≤ 10g/dL)
  • SGOT or SGPT > 40 IU/L
  • Creatinine > 1.2 mg/dL
  • Severe psychiatric disorder (psychotic disorder, major depression and so on) or suicidal tendencies
  • dyspnea
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01527409


Contacts
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Contact: YoungSung Lee, Ph.D +82-31-920-2010 lee.medric@gmail.com

Locations
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Korea, Republic of
Seoul National University Boondang Hospital Recruiting
Boondang, Gyunggi, Korea, Republic of
Contact: Jae Young Lim, PhD         
Principal Investigator: Jae Young Lim, PhD         
National Cancer Center Recruiting
Goyang, Gyunggi, Korea, Republic of
Contact: Youngsung Lee, PhD       lee.medric@gmail.com   
Principal Investigator: Youngsung Lee, PhD         
Sub-Investigator: Ahreum Yoo, RN, BN         
Sub-Investigator: Borma Shin, BSW         
Sub-Investigator: Myungkyung Lee, Doctoral candidate         
Ajou University Medical Center Recruiting
Suwon, Gyunggi, Korea, Republic of
Contact: Mi Sun Chun, PhD         
Principal Investigator: Mi Sun Chun, PhD         
Keimyng University Dongsan Center Recruiting
Daegu, Korea, Republic of
Contact: Chiheum Cho, PhD         
Principal Investigator: Chiheum Cho, PhD         
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: KyungHae Jung, PhD         
Principal Investigator: KyungHae Jung, PhD         
Ewha Womans University Mokdong Hospital Recruiting
Seoul, Korea, Republic of
Contact: Soon Nam Lee, PhD         
Principal Investigator: Soon Nam Lee, PhD         
Korea University Anam Hospital Recruiting
Seoul, Korea, Republic of
Contact: Eun Sook Lee, PhD         
Principal Investigator: Eun Sook Lee, PhD         
KyungHee University Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Siyoung Kim, PhD         
Principal Investigator: Siyoung Kim, PhD         
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Sung Kim, PhD         
Principal Investigator: Sung Kim, PhD         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Young Ho Yun, PhD       lawyun08@gmail.com   
Sub-Investigator: Dong Young Noh, PhD         
Principal Investigator: Young Ho Yun, PhD         
Sponsors and Collaborators
National Cancer Center, Korea
Samsung Medical Center
Seoul National University Hospital
Korea University Anam Hospital
Asan Medical Center
Ajou University School of Medicine
Kyunghee University Medical Center
Investigators
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Principal Investigator: YoungSung Lee, MD, Ph.D National Cancer Center, Korea
More Information
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Publications:
Eun Sook Lee, M. K. L., Soo Hyun Kim, Jung Sil Ro, Han Sung Kang, Seok Won Kim, Keun Seok Lee, Young Ho Yun. (2010(Accepted) ).
Kravitz, R. L., D. J. Tancredi, et al. (2009).
Park, S. M., M. K. Lim, et al. (2007).
Shin, H. W., D. Y. Noh, et al. (2009).
Street, R. L., Jr., C. Slee, et al.
Vale, M. J., M. V. Jelinek, et al. (2003).

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: YoungSung Lee, Head, Division of Cancer Management Branch, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT01527409    
Other Study ID Numbers: NCCCTS-11-598
First Posted: February 7, 2012    Key Record Dates
Last Update Posted: February 7, 2012
Last Verified: February 2012
Keywords provided by YoungSung Lee, National Cancer Center, Korea:
Exercise
Diet
Posttraumatic growth
Additional relevant MeSH terms:
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Stomach Neoplasms
Colonic Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
 Gastrointestinal Diseases
Stomach Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Colonic Diseases
Intestinal Diseases