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
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The Objectives of this study is
- To evaluate the efficacy for exercise, diet, and posttraumatic growth as a result of participating in tailored program (Health Partnership Program) for 24 weeks
- 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
- 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 |

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 |

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. |
- 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.
- Seven habit profile [ Time Frame: baseline, 3month, 6month, and 12month ]
- 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 ]
- Ed Diner's Satisfaction with Life Scale [ Time Frame: baseline, after 3month, 6month, and 12month ]
- Impact of Event Scale-Revised [ Time Frame: baseline, after 3month, 6month, and 12month ]
- Social Support(MOS-SSS) [ Time Frame: baseline, after 3month, 6month, and 12month ]
- the Hospital Anxiety and Depression scale(HADS) [ Time Frame: baseline, after 3month, 6month, and 12month ]
- Cancer Belief System(CBS) [ Time Frame: baseline, after 3month, 6month, and 12month ]

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

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
Contact: YoungSung Lee, Ph.D | +82-31-920-2010 | lee.medric@gmail.com |
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 |
Principal Investigator: | YoungSung Lee, MD, Ph.D | National Cancer Center, Korea |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
Exercise Diet Posttraumatic growth |
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 |