The Efficacy of Health Partnership Program for Cancer Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 248
- 试验地点
- 20
- 主要终点
- Changes from Baseline in Exercise, Diet, and Posttraumatic Growth Inventory(PTGI)
研究概览
简要总结
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
详细描述
***Background
Improving cancer patients' quality of life has been increasing subject of research for several years. Especially, the patients and their families who are needed to deal with specific care on diverse aspects, such as social, spiritual, existential, psychological aspect should be provided integrated program.
Multidimensional characteristics of the health partnership program were addressed in National Cancer Center (NCC) for exercise, diet, and posttraumatic growth based on transtheoretical (TTM) model, social cognitive theory, health behavioral model, and coaching strategies. This program points out the importance of behavioral approaches in managing their healthy life according to improve patterns of three areas (exercise, diet, and posttraumatic growth).
Strategies that investigators mentioned above can lead those three areas to be effective.
To objective of this study is to support cancer patients to cope with exercise, diet, and posttraumatic growth through tailored program (the health partnership program), and then evaluate the efficacy of the health partnership program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Tailored health partnership program (Behavioral)
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.
干预措施: Usual care and health education workshop (Behavioral)
结局指标
主要结局
Changes from Baseline in Exercise, Diet, and Posttraumatic Growth Inventory(PTGI)
时间窗: 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.
次要结局
- Social Support(MOS-SSS)(baseline, after 3month, 6month, and 12month)
- Cancer Belief System(CBS)(baseline, after 3month, 6month, and 12month)
- Seven habit profile(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)(baseline, after 3month, 6month, and 12month)
- Ed Diner's Satisfaction with Life Scale(baseline, after 3month, 6month, and 12month)
- Impact of Event Scale-Revised(baseline, after 3month, 6month, and 12month)
- the Hospital Anxiety and Depression scale(HADS)(baseline, after 3month, 6month, and 12month)
研究者
YoungSung Lee
Head, Division of Cancer Management Branch
National Cancer Center, Korea