This was a randomized controlled trial that evaluated the efficacy of a stage-tailored intervention based on the LEACH program from April 2012 through August 2013, using usual care as a control. The LEACH program consists of comprehensive, multifaceted core strategies from the TTM of health behavior change, the leadership model of “Seven Habits of Highly Effective People” , and a Coaching Model . The intervention includes 1) a TTM-based health education booklet and workbook for cancer survivors, 2) a workshop for empowerment of patients’ leadership skills, and 3) TTM-based telephone coaching with a health coaching manual (repeated assessment of stage of change, and planning how to achieve target health levels in accordance with their preferences and abilities) (Additional file 1: Table S1). The LEACH program covers physical activity, diet, and distress management.
We used cancer registries from 10 South Korean teaching hospitals, each with a different health partner and health master coach. Cancer survivors who completed primary cancer treatment (in situ, localized, or regional with a favorable prognosis) within the last 24 months for breast, stomach, colon (other than rectal), and lung cancer within 18 months of completion of primary treatment were identified. To be included in the study, a patient had to 1) be ≥20 years old, 2) have a platelet count ≥100,000/mm3, 3) have a serum hemoglobin ≥10 g/dl, and 4) have not already met two or more behavioral goals aimed for in the study (i.e., i) energy expenditure achieved by at least moderate exercise for at least 150 min/week; ii) intake of ≥5 servings of fruit and vegetables per day; iii) a total score > 72 points in the Post Traumatic Growth Inventory). Patients were excluded from the study if they 1) were currently receiving cancer treatment, 2) had a progressive malignant disease or a recurrent, metastasized, or additional primary cancer, 3) had a condition that might compromise adherence to an unsupervised exercise program (e.g., uncontrolled congestive heart failure or angina, recent myocardial infarction, breathing difficulties requiring oxygen use or hospitalization, unable to walk without a walker or wheelchair, or were planning to receive hip or knee replacement surgery), 4) had a condition that could interfere with ingestion of a diet high in vegetables and fruit (e.g., kidney failure or need for chronic warfarin, 5) a serious psychological disorder (e.g., bipolar disease, schizophrenia, or an eating disorder), 6) had an infection (body temperature ≥ 37.2 °C or WBC ≥11,000 mm3), 7) had visual or motor dysfunction, or 8) were pregnant.
Permission to contact patients was obtained from the patients’ physician. Recruitment was either by a mailed letter of invitation or by direct approach by a research staff member in an outpatient department in a study hospital. The letters of invitation, which were stamped with an official approval seal from the Institutional Review Board, included an explanation of the LEACH study, a LEACH study promotional leaflet, a preaddressed, postage-paid return envelope, and a brief instrument that screened for ineligibility factors. After the prescreening, an oncologist and a research staff member in each study hospital confirmed that patients met the eligibility criteria by reviewing medical records and by blood tests. Research staff then related the details of the study to participants who met the eligibility criteria and who provided written informed consent. This study was approved by the Institutional Review Boards of each hospital.
With the aid of a computerized random number generator (SAS 9.1.3, Proc plan), we randomly assigned eligible participants, two-to-one, to the intervention or the usual care group. To minimize the effects of potentially confounding variables on outcomes, we performed block randomization with 8 strata defined by type of cancer (breast, stomach, colon, or lung) and number of behavior goals practiced at the study entry (0 or 1 out of 3 defined possible behaviors).
Training programs for health master coach and health partner
For the LEACH study, we developed two training programs: the “Health Master Coach Program” for professionals and the “Health Partner Program” for long-term cancer survivors. “Health Partners” were trained by the “Health Partner Program” and are mentored and supervised by a Health Master Coach. Health Master Coaches were trained by the Health Master Coach Program, which consists of three components, such as education on health management in survivorship care planning (i.e., regular exercise, balanced diet, distress management, regular screening, no smoking and drinking, and management of chronic fatigue), leadership, coaching, and facilitator training. The education on the teaching and learning methods was a 72-h group session in parallel with actual practice. The health partners had been trained by the “Health Partner Program,” which is 3-month program consisting of health behavior management (8 h), leadership (16 h), and actual health coaching practice on prior learning via eight sessions using a multilateral telephone system (24 h).
The LEACH program is based on 3 concepts—health education, leadership, and coaching, and it is managed through the interaction of a health master coach, health partners, and cancer patients. Health partners were long-term cancer survivors who formed partnerships with cancer patients and helped them achieve the target levels set for their health behaviors. Health master coaches were health professionals who mentored and supervised health partners.
First, patients were given a 1-h health education workshop (physical activity, dietary habits, and distress management) and a 3-h leadership workshop (Seven Habits of Highly Effective People with Cancer). Next, the Intervention group was also offered individual coaching by telephone for a 24-week period. A total of 16 sessions of tele-coaching were conducted: 30 min per week for 12 sessions, 30 min per 2 weeks for 2 sessions, and 30 min per month for 2 sessions were offered for the intervention group. Throughout the LEACH program, participants in the intervention group were provided individual coaching by telephone to practice patient health behaviors (such as regular exercise, balanced diet, and positive thinking) that have been reported to help in self-management. Based on the baseline health status assessment, health partners kept written records of their coaching, and master coaches gave feedback by reviewing those records. The principle investigator supervised these processes. The aim of the intervention was to achieve success in more than two health behaviors among three primary outcomes (physical activity ≧12.5 metabolic equivalents of task (METs) hours per week, daily intake of fruit and vegetables ≧5 dishes per day, and total PTGI ≧72). The secondary outcomes were to improve QOL and leadership of cancer survivors.
Health education materials
Health education materials based on the TTM of health behavior change included information about 3 intervention areas—physical activity, dietary habits, and distress management. We made the material easy for health partners to understand so that they, in turn, could make it easy for patients to understand.
Health leadership-coaching workbook
Typically, patient health education does not involve interactions. We changed this by developing a leadership-coaching workbook that patients could work with to target their goal, set their action plan, and practice health leadership skills. The health education material in the workbook was based on a TTM model, self-leadership, and coaching strategy. The workbook was provided to health partners and patients.
Health coaching manual
Since health partners were not coaching professionals, we developed a coaching manual that they could use to guide patients on how to achieve the target levels for their health in accordance with their preferences and abilities using a TTM model, self-leadership, and coaching strategy.
The control group was encouraged to continue their usual care and was given a health education booklet on physical activity, dietary habits, and distress management that was not based on the core strategies from the TTM of health behavior change, as well as a 4-h health education lecture on physical activity, dietary habits, distress management, and screening for a 2nd cancer.
Quality assurance covered study personnel, Health Partners , Health Master Coach training programs , experts’ supervision of the LEACH interventions, and the quality assurance committees. All research staff involved in screening and recruiting participants passed their local institution certification requirements for the ethical conduct of research (The Collaborative Institutional Training Initiatives).
The patients were evaluated at 0, 3, 6, and 12 months. However, due to the lack of participants in the 6-month period, we did not include the 6-month follow-up results in the statistical analyses for this study. The primary outcomes were improvements in physical activity, diet, and post-traumatic growth. Physical activity was measured in METs (kcal/kg/week) using survey responses about the time, length, and intensity of physical activity  following the ACSM’s guidelines for exercise testing and prescription . Diet was evaluated with validated questions about daily intake of vegetables and fruits, and dietary pattern was checked with a questionnaire based on the “Rules for National Cancer Prevention: Dietary Practice Guideline,” which contains 10 questions exploring nutrition balance and dietary habits, such as eating speed and frequency [21, 22]. To evaluate diet, the survey questionnaire was modified based on the Korean National Health and Nutrition Examination Survey data . Posttraumatic growth was measured with the Posttraumatic Growth Inventory (PTGI), a 21-item scale that assesses positive outcomes from persons who experienced traumatic events . Each item was scaled on a 6-point Likert score from 0 to 5.
The secondary outcomes were improvement in leadership, HRQOL, satisfaction with life, depression and anxiety, distress in response to a specific traumatic event, perceived social support, and number of the Ten Rules for Highly Effective Health Behavior adhered to. All of the secondary outcome questionnaires were validated in a Korean version with cancer survivors [3, 25, 26].
Cancer survivors’ leadership
We measured the 7 habits of highly effective people with cancer using the Seven Habit Profile (7HP) . Each question was scored on a 6-point Likert scale, with the sum of the 3 questions covering one subscale, therefore, the total score of each domain was 18. The total of 27 questions consists of 9 subscales, higher scores representing the closer alignment with leadership criteria.
Health related quality of life
HRQOL was assessed using the 30-item European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) based on a 4-point Likert scale [26, 27]. Global life satisfaction was assessed using Diener’s Satisfaction with Life Scale (SWLS), which is scored from 1 to 7 so that the possible range is from 5 to 35; higher scores indicate higher satisfaction . Psychological distress was assessed using the Hospital Anxiety and Depression Scale (HADS) ; total scores range from 0 to 21 for each of the anxiety and depression subscales. Self-reported current subjective cancer-induced distress in response to a specific traumatic event was rated using the Impact of Events Scale-Revised (IES-R) . The 22-item scale is composed of 3 subscales representative of the major symptom clusters of post-traumatic stress and this questionnaire is scored with 5-point Likert scales, which comprise 0 (not at all), 1 (a little bit), 2 (moderately), 3 (quite a bit), and 4 (extremely). Perceived social support was assessed using the 20-item Medical Outcomes Study Social Support Survey (MOS-SSS) . To obtain a score for overall support, the average of all 19 item scores are calculated and then can be transformed to a 0–100 scale; however, one item rates the number of close friends or relatives.
Patients were also asked to rate how they applied the following Ten Rules for Highly Effective Health Behavior  (i.e., positive thinking, regular exercise, balanced diet, etc.) to improve QOL. Health behavior stages (pre-contemplation, contemplation, preparation, action, and maintenance) were based on the TTM . Behavior stages range from 1 (pre-contemplation) to 5 (maintenance stage) for each item .