01.12.2017 | Research article | Ausgabe 1/2017 Open Access

A randomized controlled trial of physical activity, dietary habit, and distress management with the Leadership and Coaching for Health (LEACH) program for disease-free cancer survivors
- Zeitschrift:
- BMC Cancer > Ausgabe 1/2017
Electronic supplementary material
Background
Methods
Study design
Eligibility criteria
Participant recruitment
Random assignment
Training programs for health master coach and health partner
Study conditions
Intervention (LEACH)
Intervention materials
Health education materials
Health leadership-coaching workbook
Health coaching manual
Control material
Quality assurance
Primary outcome
Secondary outcomes
Cancer survivors’ leadership
Health related quality of life
Statistical approach
Results
Participants
Baseline characteristics of participants
Characteristic
|
Control group
|
Intervention group
|
All participants
|
P-value
|
---|---|---|---|---|
(
N = 72)
|
(
N = 134)
|
(
N = 206)
|
||
No. Coaching attendees
|
10.63 (6.29)
|
|||
Age, years
|
51.04 (7.55)
|
50.52 (10.21)
|
50.68 (9.43)
|
|
Sex - no.(%)
|
||||
Male
|
18 (25.00)
|
24 (17.91)
|
42 (20.39)
|
0.229
|
Female
|
54 (75.00)
|
110 (82.09)
|
164 (79.61)
|
|
Marital status- no.(%) (missing = 2)
|
||||
Married
|
63 (87.50)
|
106 (80.30)
|
169 (82.84)
|
0.193
|
Widowed/Divorced/separated/single
|
9 (12.50)
|
26 (19.70)
|
35 (17.16)
|
|
Education - no.(%) (missing = 2)
|
||||
High-school graduate or less
|
39 (54.17)
|
66 (50.00)
|
105 (51.47)
|
0.569
|
College graduate
|
33 (45.83)
|
66 (50.00)
|
99 (48.53)
|
|
Religion - no.(%) (missing = 4)
|
||||
No
|
16 (22.86)
|
47 (41.17)
|
64 (31.19)
|
0.063
|
Yes
|
54 (77.14)
|
85 (64.39)
|
139 (68.81)
|
|
Household income –no.(%) (missing = 4)
|
||||
< 300million won
|
25 (34.72)
|
49 (37.69)
|
49 (47.62)
|
0.675
|
≥ 300million won
|
47 (65.28)
|
81 (82.38)
|
128 (63.37)
|
|
Cancer stage (missing = 7)
|
||||
0
|
2 (2.94)
|
3 (2.29)
|
5 (2.51)
|
0.476
|
I
|
31 (45.59)
|
69 (52.67)
|
100 (52.67)
|
|
II
|
28 (41.19)
|
38 (29.01)
|
66 (33.17)
|
|
III
|
4 (5.88)
|
16 (12.21)
|
20 (10.05)
|
|
IV
|
1 (1.47)
|
1 (0.76)
|
2 (1.01)
|
|
Other (5,6)
|
2 (2.94)
|
4 (3.05)
|
6 (3.02)
|
|
Type of cancer
|
||||
Stomach
|
17 (23.94)
|
34 (25.76)
|
51 (25.12)
|
|
Lung
|
3 (2.80)
|
5 (5.20)
|
5 (3.79)
|
|
Breast
|
42 (59.15)
|
81 (79,98)
|
123 (60.59)
|
|
Colorectal
|
5 (7.04)
|
6 (4.55)
|
11 (5.42)
|
|
Gynecologic
|
4 (5.63)
|
5 (3.79)
|
9 (4.43)
|
|
Other
|
0 (0)
|
1 (0.76)
|
1 (0.49)
|
|
Type of treatment (missing = 10)
|
||||
Surgery
|
68 (98.55)
|
127 (100.00)
|
195 (99.49)
|
0.174
|
Radiotherapy
|
39 (56.52)
|
61 (64.80)
|
100 (51.02)
|
0.256
|
Chemotherapy
|
43 (62.32)
|
76 (59.84)
|
119 (60.71)
|
0.735
|
Hormonal therapy
|
20 (50.0)
|
31 (40.26)
|
51 (43.59)
|
0.314
|
Weight, kg (missing = 1)
|
56.31 (8.36)
|
57.53 (8.72)
|
57.10 (8.59)
|
0.330
|
BMI (missing = 1)
|
21.70 (2.67)
|
22.23 (3.00)
|
22.05 (2.89)
|
0.213
|
Hemoglobin (missing = 14)
|
13.05 (1.25)
|
13.06 (1.22)
|
13.05 (1.23)
|
0.955
|
Total Cholesterol-mg/dl (missing = 21)
|
173.72 (28.62)
|
181.9 (34.60)
|
178.96 (11.44)
|
0.103
|
Systolic blood pressure, mm Hg (missing = 87)
|
116.33–72.94
|
112.9–72.93
|
117.52–72.94
|
0.462/0.999
|
Baseline
|
||||
Vegetable intake 5 plates/day, no. (%)
|
||||
Yes
|
22 (30.56)
|
45 (33.58)
|
67 (32.52)
|
0.659
|
No
|
50 (69.44)
|
89 (66.42)
|
139 (67.48)
|
|
Total-MET
|
27.53 (19.82)
|
26.67 (27.50)
|
26.97 (25.04)
|
0.799
|
Posttraumatic Growth Inventory
|
||||
Relating to others
|
20.83 (6.17)
|
21.40 (6.64)
|
21.21 6.47)
|
0.568
|
New possibilities
|
14.36 (5.10)
|
14.61 (4.70)
|
14.52 (4.83)
|
0.723
|
Personal strength
|
11.28 (4.37)
|
11.90 (4.01)
|
11.68 (4.14)
|
0.308
|
Spiritual change
|
5.07 (3.09)
|
4.72 (4.20)
|
4.84 (3.08)
|
0.444
|
Appreciation for life
|
10.21 (3.18)
|
10.46 (2.92)
|
10.37 (3.01)
|
0.576
|
Total
|
61.78 (18.91)
|
63.09 (18.51)
|
62.63 (18.61)
|
0.631
|
Effect of health partnership program
Time point
|
Intervention group
|
Control group
|
P-value
†
|
||
---|---|---|---|---|---|
Total no.
|
Success no. (%)
|
Total no.
|
Success no. (%)
|
||
Baseline
|
134
|
47 (35.1)
|
72
|
25 (34.7)
|
0.960
|
3 months
|
100
|
44 (44.0)
|
55
|
20 (36.4)
|
0.356
|
12 months
|
92
|
42 (45.7)
|
50
|
16 (32.0)
|
0.114
|
Unadjusted estimates, mean (SD)
|
Adjusted analysis for intervention vs usual care
a
|
|||||
---|---|---|---|---|---|---|
Intervention group
|
Control group
|
Intervention group
|
Control group
|
P value
1)
|
||
MET/h/day
|
Baseline
|
26.7 (27.5)
|
27.5 (19.8)
|
|||
3 months
|
27.1 (25.4)
|
24.3 (24.6)
|
26.2 (2.2)
|
23.9 (3.0)
|
0.540
|
|
12 months
|
23.5 (23.6)
|
22.9 (24.6)
|
22.9 (2.3)
|
22.8 (3.3)
|
0.975
|
|
PTGI-Total
|
Baseline
|
63.1 (18.5)
|
61.8 (18.9)
|
|||
3 months
|
63.6 (19.3)
|
61.2 (18.6)
|
62.7 (1.3)
|
62.1 (1.7)
|
0.791
|
|
12 months
|
66.6 (19.3)
|
60.2 (19.1)
|
66.3 (1.6)
|
61.2 (2.2)
|
0.065*
|
|
Vegetable intake n(%), ≥5 serves/day
|
Baseline
|
45 (33.6)
|
22 (30.6)
|
|||
3 months
|
52 (42.6)
|
27 (40.9)
|
33.6 (4.9)
|
31.0 (6.3)
|
0.819
|
|
12 months
|
41 (36.9)
|
26 (42.6)
|
31.0 (5.4)
|
37.3 (6.7)
|
0.413
|
|
Leadership
|
Baseline
|
121.3 (21.2)
|
120.1 (20.8)
|
|||
3 months
|
125.0 (21.7)
|
121.6 (20.2)
|
123.1 (1.3)
|
121.8 (1.9)
|
0.552
|
|
12 months
|
127.7 (22.1)
|
122.8 (20.6)
|
125.4 (1.6)
|
123.3 (2.2)
|
0.433
|
|
HADS
|
||||||
Anxiety
|
Baseline
|
5.7 (3.4)
|
5.9 (3.1)
|
|||
3 months
|
5.0 (3.0)
|
6.1 (3.1)
|
5.2 (0.2)
|
6.0 (0.3)
|
0.025**
|
|
12 months
|
5.1 (3.0)
|
5.8 (2.9)
|
5.2 (0.3)
|
5.7 (0.4)
|
0.228
|
|
Depression
|
Baseline
|
6.4 (3.5)
|
6.1 (3.1)
|
|||
3 months
|
5.5 (3.3)
|
5.4 (2.8)
|
5.6 (0.2)
|
5.6 (0.3)
|
0.986
|
|
12 months
|
5.4 (3.4)
|
5.6 (3.1)
|
5.3 (0.3)
|
5.7 (0.4)
|
0.428
|
|
EORTC QLQ-C30
|
||||||
Functional scales
|
||||||
Global health status
|
Baseline
|
64.5 (19.9)
|
63.4 (18.7)
|
|||
3 months
|
67.7 (18.7)
|
65.7 (17.5)
|
67.0 (1.6)
|
66.0 (2.3)
|
0.705
|
|
12 months
|
70.1 (17.1)
|
65.3 (17.9)
|
69.0 (1.6)
|
66.0 (2.2)
|
0.269
|
|
Physical functioning
|
Baseline
|
78.6 (13.5)
|
77.9 (11.1)
|
|||
3 months
|
80.0 (12.1)
|
78.4 (12.0)
|
79.4 (0.9)
|
79.3 (1.3)
|
0.942
|
|
12 months
|
82.9 (13.1)
|
78.2 (12.4)
|
81.9 (1.2)
|
78.7 (1.6)
|
0.123
|
|
Role functioning
|
Baseline
|
79.4 (21.4)
|
77.9 (19.8)
|
|||
3 months
|
80.9 (18.1)
|
77.3 (18.4)
|
80.3 (1.5)
|
78.5 (2.2)
|
0.497
|
|
12 months
|
82.7 (19.8)
|
79.9 (18.9)
|
80.9 (1.8)
|
81.1 (2.4)
|
0.958
|
|
Emotional functioning
|
Baseline
|
76.8 (19.4)
|
73.0 (23.0)
|
|||
3 months
|
78.0 (19.1)
|
74.5 (16.5)
|
76.7 (1.5)
|
75.3 (2.2)
|
0.602
|
|
12 months
|
78.0 (19.9)
|
75.9 (18.3)
|
76.2 (1.9)
|
77.7 (2.4)
|
0.625
|
|
Cognitive functioning
|
Baseline
|
76.7 (19.9)
|
72.6 (20.9)
|
|||
3 months
|
80.1 (17.2)
|
72.5 (20.2)
|
77.6 (1.4)
|
75.1 (2.4)
|
0.322
|
|
12 months
|
78.1 (14.9)
|
76.5 (19.2)
|
76.8 (1.6)
|
78.4 (2.1)
|
0.552
|
|
Social functioning
|
Baseline
|
75.8 (26.8)
|
73.1 (23.4)
|
|||
3 months
|
85.4 (19.3)
|
76.3 (20.2)
|
84.8 (1.8)
|
77.4 (2.5)
|
0.018
|
|
12 months
|
85.3 (19.5)
|
78.2 (22.4)
|
84.8 (2.2)
|
79.0 (2.9)
|
0.123
|
|
Symptom scales
|
||||||
Fatigue
|
Baseline
|
38.6 (20.9)
|
40.8 (21.6)
|
|||
3 months
|
33.5 (17.8)
|
38.1 (17.7)
|
34.3 (1.5)
|
37.6 (2.2)
|
0.214
|
|
12 months
|
33.8 (16.1)
|
42.4 (21.4)
|
34.8 (1.6)
|
41.9 (2.1)
|
0.010**
|
|
Nausea/vomiting
|
Baseline
|
4.6 (10.0)
|
4.2 (10.6)
|
|||
3 months
|
5.7 (10.6)
|
5.3 (9.8)
|
5.6 (0.9)
|
6.2 (1.3)
|
0.733
|
|
12 months
|
6.4 (14.5)
|
7.8 (15.3)
|
6.5 (1.6)
|
7.7 (2.1)
|
0.660
|
|
Pain
|
Baseline
|
15.4 (19.2)
|
21.4 (19.0)
|
|||
3 months
|
11.9 (16.0)
|
19.6 (19.6)
|
13.6 (1.5)
|
17.4 (2.1)
|
0.146
|
|
12 months
|
13.1 (17.6)
|
19.7 (21.4)
|
15.5 (1.8)
|
16.2 (2.3)
|
0.810
|
|
Dyspnea
|
Baseline
|
11.9 (19.9)
|
19.4 (21.0)
|
|||
3 months
|
8.2 (15.9)
|
13.7 (16.6)
|
10.3 (1.3)
|
11.3 (1.9)
|
0.668
|
|
12 months
|
10.6 (19.5)
|
13.6 (17.9)
|
12.1 (2.0)
|
11.3 (2.6)
|
0.797
|
|
Insomnia
|
Baseline
|
28.8 (30.0)
|
30.3 (28.9)
|
|||
3 months
|
24.1 (24.50
|
26.7 (26.9)
|
25.0 (2.1)
|
25.7 (3.1)
|
0.850
|
|
12 months
|
26.2 (27.9)
|
32.0 (27.2)
|
27.6 (2.5)
|
29.1 (3.4)
|
0.732
|
|
Appetite loss
|
Baseline
|
12.8 (20.9)
|
15.4 (24.8)
|
|||
3 months
|
10.7 (17.6)
|
17.3 (23.6)
|
11.3 (1.8)
|
17.7 (2.6)
|
0.048
|
|
12 months
|
11.6 (17.6)
|
13.6 (20.3)
|
12.1 (2.0)
|
13.7 (2.6)
|
0.631
|
|
Constipation
|
Baseline
|
16.9 (26.7)
|
18.9 (24.1)
|
|||
3 months
|
14.7 (23.3)
|
16.3 (21.6)
|
16.5 (1.8)
|
16.0 (2.7)
|
0.882
|
|
12 months
|
12.6 (18.1)
|
17.7 (20.5)
|
19.5 (2.2)
|
16.5 (2.9)
|
0.414
|
|
Diarrhea
|
Baseline
|
13.8 (20.7)
|
11.4 (18.8)
|
|||
3 months
|
12.6 (18.1)
|
14.0 (17.9)
|
19.8 (4.1)
|
10.0 (5.4)
|
0.151
|
|
12 months
|
20.5 (45.6)
|
9.5 (20.4)
|
11.9 (1.5)
|
15.3 (2.2)
|
0.211
|
|
Financial Difficulties
|
Baseline
|
20.3 (28.6)
|
23.4 (26.0)
|
|||
3 months
|
15.5 (25.5)
|
26.8 (37.1)
|
17.4 (2.6)
|
27.0 (3.7)
|
0.036 **
|
|
12 months
|
18.9 (26.6)
|
20.4 (27.9)
|
18.9 (2.5)
|
19.3 (3.3)
|
0.920
|
|
The MOS-SSS
|
Baseline
|
65.6 (20.9)
|
65.6 (20.6)
|
|||
3 months
|
66.3 (21.1)
|
67.9 (19.3)
|
66.9 (1.4)
|
65.7 (2.0)
|
0.621
|
|
12 months
|
66.6 (21.1)
|
68.0 (19.7)
|
67.1 (1.7)
|
65.3 (2.4)
|
0.535
|
|
Health Behavior
|
Baseline
|
4.9 (3.1)
|
5.2 (2.7)
|
|||
3 months
|
6.4 (2.7)
|
5.5 (3.0)
|
6.9 (0.3)
|
6.2 (0.4)
|
0.147
|
|
12 months
|
7.0 (2.8)
|
6.3 (2.7)
|
6.3 (0.2)
|
5.3 (0.3)
|
0.015**
|
|
IES-R
|
Baseline
|
2.3 (0.8)
|
2.5 (0.7)
|
|||
3 months
|
2.2 (0.7)
|
2.2 (0.7)
|
2.3 (0.1)
|
2.2 (0.1)
|
0.759
|
|
12 months
|
2.1 (0.7)
|
2.3 (0.8)
|
2.1 (0.1)
|
2.3 (0.1)
|
0.068 *
|