Introduction
Methods
Trial design
Study population
Control group
Intervention group
Outcomes
Clinical and lifestyle measures
QOL and mental health
Illness perceptions
Sample size
Randomisation and masking
Statistical methods
Process evaluation
Program delivered as planned
Program delivery costs
Program acceptability and utility
Results
Characteristics of the participants
Characteristics | No./Total (%) | ||
---|---|---|---|
EMPOWER-SMS (n = 78) | Control (n = 78) | Total (N = 156) | |
Time between finishing active treatment to enrolment, mean months (SD+) | 8 (5) | 8.1 (5) | 8 (5) |
Demographics | |||
Age (years), mean (SD) | 53.8 (9.6) | 55.7 (12.1) | 54.8 (10.9) |
Ethnicity | |||
Caucasian | 37/78 (47.4) | 32/78 (41.0) | 69/156 (44.2) |
South Asian (Bangladesh, India, Nepal, Pakistan, Sri Lanka) | 8/78 (9.0) | 13/78 (16.7) | 21/156 (13.4) |
Other Asian | 10/78 (12.8) | 20/78 (25.6) | 56/156 (35.9) |
Other | 18/78 (23.1) | 13/78 (16.7) | 31/156 (19.9) |
Country or region of birth | |||
Australia | 37/78 (47.4) | 27/78 (34.6) | 64/156 (41) |
Europe/United Kingdom | 6/78 (7.8) | 8/78 (10.2) | 14/78 (17.9) |
India | 5/78 (6.4) | 8/78 (10.2) | 13/78 (16.7) |
Middle East (Including Pakistan, Afghanistan, Egypt) | 3/78 (3.8) | 7/78 (9.0) | 10/78 (12.8) |
Southeast Asia (Philippines, Thailand, Laos) | 11/78 (14.1) | 10/78 (12.8) | 21/78 (26.9) |
Pacific Islands (Including New Zealand, Tonga, Fiji) | 9/78 (11.5) | 6/78 (7.7) | 15/78 (19.2) |
Other | 7/78 (9.0) | 12/78 (15.4) | 19/156 (24.0) |
Education | |||
Year (Grade) 12 or below | 26/76 (34.3) | 18/78 (23.1) | 44/154 (28.6) |
Diploma/technical degree | 22/76 (28.9) | 21/78 (26.9) | 43/154 (27.9) |
Undergraduate/postgraduate degree | 28/76 (36.8) | 39/78 (50.0) | 67/154 (43.5) |
Marital status | |||
Single/widowed | 16/77 (20.8) | 12/78 (15.4) | 28/155 (18.1) |
DeFacto/married | 50/77 (64.9) | 55/78 (70.5) | 105/155 (67.7) |
Separated/divorced | 11/77 (14.3) | 11/78 (14.1) | 22/155 (14.2) |
Employment status | |||
Working full/part time | 49/75 (65.3) | 44/78 (56.4) | 93/153 (60.8) |
Unemployed | 9/75 (12.0) | 13/78 (16.7) | 22/153 (14.4) |
Retired | 14/75 (18.7) | 18/78 (23.1) | 32/153 (20.9) |
Other | 3/75 (4) | 3/78 (3.8) | 6/153 (3.9) |
Children, # yes | 61/78 (78.2) | 68/78 (87.2) | 129/156 (82.7) |
Medical history | |||
Tumour removal surgery | 78/78 (100) | 77/78 (98.7) | 155/156 (99.4) |
Radiotherapy | 69/78 (88.5) | 69/78 (88.5) | 138/156 (88.5) |
Chemotherapy | 48/77 (62.3) | 50/78 (64.1) | 98/155 (63.2) |
Endocrine therapy | 52/78 (66.7) | 55/78 (70.5) | 107/156 (68.6) |
Targeted therapy | 12/78 (15.4) | 14/77 (18.2) | 26/155 (16.8) |
High cholesterol diagnosis | 11/78 (14.1) | 18/78 (23.1) | 29/156 (18.6) |
High blood pressure diagnosis | 17/78 (21.8) | 27/78 (34.6) | 44/156 (28.2) |
CVD diagnosis | 3/78 (3.8) | 4/78 (5.1) | 7/156 (4.5) |
Smoking status | |||
Current smoker | 8/78 (10.3) | 4/78 (5.1)* | 12/156 (7.7) |
Ex-smoker | 31/78 (39.7) | 15/78 (19.2)* | 46/156 (29.5) |
Never smoked | 39/78 (50) | 59/78 (75.6)* | 98/156 (62.8) |
Baseline | Six-month follow-up | |||||
---|---|---|---|---|---|---|
EMPOWER-SMS (n = 78) | Control (n = 78) | EMPOWER-SMS (n = 78) | Control (n = 78) | |||
Mean months (SD) | Mean months (SD) | Mean months (SD) | ||||
Time from randomisation to follow-up | 7.1 (1.6) | 7.1 (1.5) | 7.1 (1.5) | |||
Primary outcome | Mean (95%CI) | Mean (95%CI) | Mean difference (95%CI) | Adjusted mean (95%CI) | Adjusted mean (95%CI) | Adjusted mean difference (95%CI) |
Self-efficacy | 7.1 (6.6, 7.5) | 7.4 (7, 7.8) | − 0.3 (− 1, 0.3) | 7.6 (7.3, 7.9) | 7.6 (7.3, 7.9) | 0 (− 0.4, 0.4) |
Secondary outcomes | ||||||
Quality of life | 69 (63.8, 74.2) | 70.4 (65.3, 75.6) | − 1.4 (− 8.8, 5.9) | 74.3 (70.9, 77.7) | 73 (69.8, 76.2) | 1.3 (− 3.3, 6) |
Depressive symptoms | 18.8 (15.1, 22.4) | 17.6 (14.1, 21.2) | 1.1 (− 4, 6.2) | 17.8 (14.6, 21.1) | 18.5 (15.5, 21.5) | − 0.7 (− 5.1, 3.7) |
Anxiety symptoms | 20.7 (16.4, 25) | 17.8 (13.6, 22) | 2.9 (− 3.1, 8.9) | 19.3 (15.8, 22.8) | 20.1 (16.8, 23.4) | − 0.8 (− 5.6, 4) |
Stress symptoms | 17 (13.3, 20.7) | 14.5 (10.9, 18.2) | 2.5 (− 2.8, 7.7) | 14.5 (11.5, 17.6) | 15.6 (12.7, 18.4) | − 1 (− 5.2, 3.1) |
Physical activity, METS$ | 1668.7 (1108.2, 2229.3) | 1805.4 (1244.9, 2366) | − 136.7 (− 929.5, 656) | 1940 (1344.7, 2535.4) | 1747.4 (1152, 2342.8) | 192.6 (− 649.5, 1034.8) |
Clinical | ||||||
BMI& kg/m2 | 33.7 (27.6, 39.9) | 27.6 (21.4, 33.7) (n = 77) | 6.2 (− 2.5, 14.9) (n = 155) | 29 (27.6, 30.4) (n = 60) | 27.5 (26.2, 28.9) (n = 73) | 1.4 (− 0.5, 3.4) |
Waist circumference, cm | 95.3 (92.2, 98.3) | 91.4 (88.3, 94.4) (n = 76) | 3.9 (− 0.4, 8.2) (n = 154) | 93.1 (91.7, 94.5) (n = 56) | 92.1 (90.8, 93.3) (n = 68) | 1 (− 0.8, 2.9) |
Fat Mass Percentage % | 42.7 (41.3, 44.1) (n = 74) | 41.4 (40, 42.9) (n = 71) | 1.3 (− 0.7, 3.3) (n = 145) | 41.9 (41, 42.9) (n = 25) | 42.9 (41.9, 43.9) (n = 27) | − 1 (− 2.4, 0.4) |
Skeletal muscle mass Percentage % | 25.4 (24.8, 25.9) (n = 74) | 25 (24.3, 25.6) (n = 70) | 0.4 (− 0.4, 1.3) | 24.6 (24.1, 25.1) (n = 25) | 24.7 (24.2, 25.2) (n = 27) | − 0.1 (− 0.8, 0.6) |
Lifestyle | ||||||
Endocrine medication adherence (≥ 1 missed doses in the last 7 days) | 6/46 (13) | 6/51 (11.8) | 1.28 (− 11.87, 14.43)^ | 3/42 (7.1) | 8/47 (17) | 0.13 (0.02, 0.91)+* |
Servings of fruit per day, mean (SD#) | 1.7 (1.5, 2) (n = 77) | 1.7 (1.5, 1.9) | 0.1 (− 0.3, 0.4) | 1.5 (1.3, 1.7) | 1.7 (1.5, 1.9) | − 0.2 (− 0.4, 0) |
Servings of vegetables per day, mean (SD) | 4.5 (4.1, 4.9) (n = 77) | 3.7 (3.3, 4.1) | 0.8 (0.2, 1.4)** | 3.9 (3.5, 4.4) | 4.2 (3.8, 4.6) | − 0.3 (− 0.9, 0.3) |
Servings of red meat per week, mean (SD) | 2.6 (2.1, 3) (n = 77) | 2 (1.6, 2.5) | 0.5 (− 0.1, 1.2) | 1.8 (1.4, 2.2) | 1.8 (1.5, 2.2) | 0 (− 0.6, 0.5) |
≥ 1 Standard Alcoholic drinks per week, n/N (%) | 32/77 (41.6) | 20/78 (25.6) | 15.92 (1.25, 30.58)^* | 22/65 (33.8) | 16/74 (21.6) | 0.88 (0.68, 1.15)+ |
Mean number standard alcoholic drinks per week (95%CI) | 4.6 (3.2, 6.1) | 4.6 (2.8, 6.4) | 0.1 (− 2.2, 2.3) | 4.4 (2.8, 6) | 6.2 (4.5, 8) | − 1.8 (− 4.2, 0.5) |
Takeaway meals/week | 1.9 (1.3, 2.5) (n = 77) | 1.3 (0.7, 1.9) | 0.6 (− 0.2, 1.4) | 1.1 (0.8, 1.5) (n = 65) | 1.2 (0.9, 1.5) (n = 74) | − 0.1 (− 0.5, 0.4) |
Effectiveness of the intervention
Process evaluation
Evaluation of program delivery
Program delivery costs
Program acceptability and utility
Characteristic | No./Total (%)a |
---|---|
Usefulness and understandingb | |
Found messages useful | 58/64 (90) |
Majority of messages were easy to understand | 64/64 (100) |
Influence on motivation and behaviour changeb | |
Messages motivated lifestyle change | 43/64 (67) |
I increased by physical activity levels because of the messages | 33/64 (52) |
Messages helped remind me to take my medicinesc | 22/46 (48) |
Message saving and sharingd | |
Saved messages | 46/64 (72) |
Showed messages to family or friends | 28/64 (44) |
Forwarded messages to family or friends | 7/64 (11) |
Acceptability of program and message content | |
Read 75-100% of messages | 57/64 (89) |
Number of messages per week was appropriate or ‘just right’e | 57/63 (90) |
Language of the messages was appropriate or ‘just right’f | 56/62 (90) |
6-month program was appropriate or ‘just right’e | 51/64 (80) |
6-month program was ‘too short’ or ‘much too short’e | 10/64 (14) |
Time of day receiving messages (9 am, 12 pm, 3 pm or 6 pm) was appropriateb | 51/64 (80) |