Reach Outcomes
Of the participants approached to join HLaC + Txt across the four CCs (n = 189), 96% (n = 182) were eligible and 64% of these (n = 115) consented to participate (Fig. 2). There were statistically significant differences in reach across CCs (Chi Square p = .004) ranging from 47% in CC4 to 80% in CC1 (Additional File 4). Of the 115 participants who commenced the HLaC + Txt intervention, 88 (77%) completed the 6-month intervention. The overall retention rate for assessments from pre- to post-HLaC + Txt assessments was 89% (316/356) (intervention cohort 97%, 111/115; control cohort 86%, 144/167). The retention rate for the follow-up assessment after 6-months no-contact for the HLaC + Txt intervention cohort was 81%, 93/115.
Participants in the HLaC + Txt trial (n = 282) were mostly female (n = 253/90%) survivors of breast cancer (n = 181, 64%), who were on average 1.9 years (SD ± 3.0) since diagnosis and had a mean age of 58.3 (SD ± 10.9) years and at the pre-HLaC assessment, had a mean BMI of 27.7kg/m2 (SD ± 5.7). Those in the control cohort (n = 167) were largely similar to those in the HLaC + Txt intervention cohort (n = 115) (Table 3), but had a significantly higher intake of vegetables (serves/day) (p < .05) at the pre-HLaC + Txt assessment and received a slightly lower (yet statistically significant) number of intervention calls (10.0, SD ± 1.6) during the HLaC program than the intervention cohort (10.6, SD ± 1.5) (Additional File 5). Those who declined intervention participation (n = 67) and those in the control cohort had lower scores for symptom interference than the intervention cohort and a lower number of intervention calls during the HLaC program, and those who declined intervention participation had lower scores for fat intake than the intervention cohort (Additional Files 5 and 6). When compared with the cancer survivor population in Australia (41) the trial participants (n = 282) were more likely to be female (90% v 44%, p < .001), and the females were more likely to have breast cancer (72% v 36%, p < .001) and the males more likely to have lymphoma (21% v 5%, p < .001) (Additional File 7).
Table 3
Baseline health and demographic characteristics (at Pre-HLaC assessment) of HLaC + Txt trial participants
|
HLaC + Txt Intervention cohort (n = 115)
|
Control cohort
(n = 167)
|
|
Mean (SD) or n (%)
|
Age (years)
Gender (% female)
CC1 enrolled in (%)
CC1
CC2
CC3
CC4
Referral source (% from within CC)
Live in major city (% yes)
Caucasian (% yes)
Education (% post school qualifications)
Employed (% yes)
Married/ living together (% yes)
Cancer diagnosis (%)
Breast
Lymphoma
Colorectal
Prostrate
Other
Years since cancer diagnosis
Treatment
Surgery
Radiotherapy
Chemotherapy
Mean number of comorbidities
Mental health issue (% depression &/or anxiety &/or nervous disorder)
Smoking (% ever smoked)
|
57.5 (10.4)
105 (91.3)
40 (34.8)
31 (27.0)
19 (16.5)
25 (21.7)
67 (58.3)
92 (80.0)
102 (89.5)
90 (78.3)
54 (47.0)
75 (65.2)
79 (68.7)
7 (6.1)
10 (8.7)
2 (1.7)
17 (14.8)
1.76 (2.36)
102 (88.7)
67 (58.3)
81 (70.4)
2.2 (1.8)
52 (45)
39 (33.9)
|
58.9 (11.2)
148 (88.6)
52 (31.1)
48 (28.7)
32 (19.2)
35 (21.0)
108 (64.7)
119 (72.1)
158 (94.6)
136 (81.4)
82 (49.1)
115 (68.9)
102 (61.1)
18 (10.8)
14 (8.4)
11 (6.6)
22 (13.2)
2.05 (3.3)
142 (85.0)
98 (58.7)
110 (65.9)
2.08 (1.7)
71 (42.5)
61 (36.5)
|
1CC=Cancer Council |
Implementation outcomes
Staff training
All 16 staff who delivered the tailoring interviews attended the first 30- minute telephone-delivered tailoring interview training session and four staff attended the second 12-week tailoring interview training session (the two HLaC telephone coaches with motivational interviewing training and two research assistants who had no motivational interviewing training).
Intervention delivery
The mean number of weeks participants received the text message intervention ranged from 18.5–22.2 weeks across CCs (mean 21.1, SD = 1.7) (Additional File 8) with some CC adapting the 24-week intervention based on their perceptions at the 12-week tailoring interview of participants’ needs. Participants received a mean of 83 text messages over the length of the intervention ranging from 40 for CC4 to 112 for CC1. The mean (± SD) call duration of the initial tailoring interview was 25.9 (± 15.1) minutes and the second tailoring interview was 20.0 (± 11.4) minutes. Of the 115 participants who completed the first tailoring interview, 97 (84%) completed the second, ranging from 82–91% across CCs. Participants did not receive the second tailoring interview if they withdrew or discontinued from the intervention prior to the second tailoring interview, they were unable to be contacted, or a decision was made at the second tailoring interview that they did not wish to continue with the intervention (early graduation). Withdrawal/graduation rates varied across CCs from 18% (CC1) to 48% (CC4) (Additional File 4). The percent of goal checks participants responded to was a median (25th, 75th percentile) of 70% (50.0, 85.0) and a median (25th, 75th percentile) of 30% (10.0, 55.6) required a goal check response to be triggered by the researcher. Sixty five percent of participants (n = 75) replied to the goal re-set texts sent at weeks 6 and 18. At the 12-week tailoring interview 84% (n = 97) of participants changed their preference for text message content, frequency and/or timing. Of the 115 participants in the program, 25 put the text-messages on hold for between one and seven weeks for holidays (n = 21) or illness (n = 4). Apart from stopping the texts altogether (n = 10), no participant changed the timing or frequency of the texts via a text message to the coach.
Qualitative interviews with staff
Interviews were conducted with seven delivery staff (two health coaches and five research assistants) (Additional File 9). A key theme was that staff perceptions about implementation aligned with differences in the qualifications of the staff conducting the intervention (i.e. CC HLaC telephone coaches versus CC research assistants). The HLaC coaches felt the tailoring interview flowed well from discussions with participants during the telephone-coaching program, about maintaining lifestyle behaviour changes, “it helps guide.... their goals going forward”. In contrast, the CC research assistants identified that their lack of coaching contact with participants meant that they had greater challenges with delivering the tailoring interviews. The qualitative interviews also highlighted differences between the coaches in their support for participant graduation from the intervention at the 12-week tailoring interview. One coach reported that participants “on a whole” were keen to receive the full six months of text messages as per the intervention protocol, whereas another coach graduated some participants at the 12-week interview “I think three months is the limit, I think that beyond that I don’t know that they need it as much”.
Participant Satisfaction with program: At the post-HLaC + Txt assessment most participants were ‘satisfied’ or ‘extremely satisfied’ (77%, 90/110) with the text message program and found the texts ‘useful’ or ‘extremely useful’ for supporting them to meet their behaviour goals (68%, 75/110). Qualitative interviews were conducted with 28 participants (Additional File 10). Participants perceived that HLaC + Txt provided: reminders for maintaining their diet and physical activity behaviours established during HLaC and provided a continuing connection with the program. For some, the switch of coach from the HLaC telephone coach to the researcher who signed off the texts caused a loss of accountability to the program. A common theme throughout the qualitative interviews with participants were reported personal stressors or barriers to achieving their diet, physical activity and weight goals, such as: social issues (employment, finances, family); ongoing treatment side effects and cancer-related symptoms (disturbed sleep, fatigue, cravings, taste changes, mental health issues and joint pain); and chronic conditions such as arthritis.
Cost of Delivery
A researcher spent a total of 8.5 hours training 16 CC staff in the delivery of the HLaC + Txt tailoring interviews. CC delivery staff spent an average of 30 minutes per participant preparing for and delivering the initial tailoring interview (n = 115) and 28 minutes per participant for the second tailoring interview (n = 95). A researcher spent an average of 25 minutes per participant to enter the data from the first tailoring interview into the text messaging platform and 15 minutes per participant to enter the second tailoring interview data. A researcher spent an average of one minute/response (n = 613) to manually trigger replies to goal checks which were not automatically recognised by the platform. A total of 9,502 text messages were sent during the intervention at a cost of $AUD0.15 per text message for a total of $AUD1425.30 (an average of $AUD12.39 per participant). Staff time was costed at $43.85/hour. The total cost per participant for delivering HLaC + Txt was on average $AUD85.00.
Effectiveness Outcomes
Within-cohort changes
Both HLaC + Txt and control cohorts had significantly worsened outcomes for body weight, MVPA, vegetable intake, and fat and fibre index scores between the pre- and post-HLaC + Txt assessments (Table 4). The intervention cohort maintained fruit intake while fruit intake worsened for the control cohort. Whilst there was no significant change in waist circumference for the intervention cohort, and physical and mental quality of life outcomes for both cohorts, the confidence intervals for these changes were greater than the MDI and the results were therefore inconclusive.
Between-cohort effects
No significant intervention effects were seen for changes between the pre- and post-HLaC + Txt assessment in any of the anthropometric, dietary, MVPA or quality of life measures (Table 4). Results, however, were inconclusive for MVPA and quality of life as the confidence intervals included the MDI.
Sensitivity Analysis
The results of the multiple imputation analyses (Additional File 11) generally supported the main analyses results, except, that due to slightly narrower confidence intervals in the multiple imputation analyses the increase in waist circumference in controls and decrease in physical activity in both cohorts was ‘inconclusive’ (rather than ‘worsened’) as the change was not significant. Fibre intake in the intervention cohort was ‘maintained’ rather than ‘worsened’ and physical quality of life in the control cohort ‘worsened’ rather than being ‘inconclusive’.
Table 4
Anthropometric/behavioural data: HLaC + Txt intervention and control cohorts: baseline HLaC#, change from: HLaC pre- to post-survey#, HLaC + Txt pre- to post-survey, HLaC + Txt post- to follow-up-survey and HLaC + Txt intervention effects
|
Intervention
|
Control
|
Intervention effect
(HLaC + Txt – control)
|
|
n
|
Mean change (95% CI)a
|
n
|
Mean change (95% CI)a
|
Mean difference (95% CI)b
|
Weight (kg)
|
|
|
|
|
|
HLaC
|
|
|
|
|
|
Pre survey/ baseline - Mean (SD)
Change pre- to post-survey
|
115
|
77.90 (16.46)
|
167
|
78.03 (18.93)
|
|
114
|
-2.13 (-2.91, -1.35) 4
|
167
|
-2.56 (-3.13, -2.00) 4
|
|
HLaC + Txt
|
|
|
|
|
|
Change pre- to post-survey
Change post- to follow-up-survey
|
111
|
1.10 (0.57, 1.63) 1
|
142
|
1.19 (0.59, 1.79) 1
|
0.09 (-0.71, 0.89)5
|
93
|
0.12 (-0.48, 0.73) 2
|
|
NR
|
|
Waist circumference (cm)
|
|
|
|
|
|
HLaC
|
|
|
|
|
|
Pre survey/ baseline - Mean (SD)
Change pre- to post-survey
|
115
|
97.12 (13.84)
|
167
|
96.58 (14.96)
|
|
113
|
-5.01 (-6.33, -3.70) 4
|
165
|
-4.35 (-5.38, -3.32) 4
|
|
HLaC + Txt
|
|
|
|
|
|
Change pre- to post-survey
|
107
|
0.68 (-0.36, 1.72)3
|
144
|
0.97 (0.07, 1.86) 1
|
-0.29 (-1.68, 1.10)3
|
Change post- to follow-up-survey
|
88
|
0.01 (-1.08, 1.10)3
|
|
NR
|
|
Physical activity Moderate-vigorous (min/week)
|
|
|
|
|
|
HLaC
|
|
|
|
|
|
Pre survey/ baseline - Mean (SD)
Change pre- to post-survey
|
115
|
209.67 (202.62)
|
167
|
207.95 (222.03)
|
|
115
|
164.87 (106.87, 222.87) 4
|
167
|
135.16 (100.79, 169.54) 4
|
|
HLaC + Txt
|
|
|
|
|
|
Change pre- to post-survey
Change post- to follow-up-survey
|
111
|
-90.80 (-128.17, -53.43)1
|
144
|
-84.62 (-117.39, -51.86)1
|
-6.20 (-56.14, 43.78)3
|
93
|
-6.87 (-47.09, 33.36) 3
|
144
|
NR
|
|
Fruit (serves/day)
|
|
|
|
|
|
HLaC
|
|
|
|
|
|
Pre survey/ baseline - Mean (SD)
Change pre- to post-survey
|
115
|
1.79 (1.07)
|
167
|
1.80 (1.15)
|
|
115
|
0.20 (0.04, 0.36) 4
|
167
|
0.32 (0.16, 0.49) 4
|
|
HLaC + Txt
|
|
|
|
|
|
Change pre- to post-survey
Change post- to follow-up-survey
|
111
|
-0.05 (-0.19, 0.09)2
|
142
|
-0.14 (-0.26, -0.02)1
|
0.09 (-0.10, 0.27) 5
|
93
|
-0.06 (-0.22, 0.11)2
|
|
NR
|
|
Vegetables (serves/day)
|
|
|
|
|
|
HLaC
|
|
|
|
|
|
Pre survey/ baseline - Mean (SD)
Change pre- to post-survey
|
115
|
3.18 (1.84)
|
167
|
3.26 (1.86)
|
|
115
|
0.66 (0.31, 1.01) 4
|
167
|
1.07 (0.77, 1.38) 4
|
|
HLaC + Txt
|
|
|
|
|
|
Change pre- to post-survey
Change post- to follow-up-survey
|
111
|
-0.45 (-0.73, -0.17)1
|
144
|
-0.47 (-0.72, -0.23)1
|
0.02 (-0.35, 0.40) 5
|
93
|
-0.69 (-1.00, -0.38)1
|
|
NR
|
|
FFBQ Fat index (score 0–5)
|
|
|
|
|
|
HLaC
|
|
|
|
|
|
Pre survey/ baseline - Mean (SD)
Change pre- to post-survey
|
113
|
3.16 (0.53)
|
167
|
3.26 (0.49)
|
|
113
|
0.33 (0.24, 0.42) 4
|
167
|
0.32 (0.27, 0.38) 4
|
|
HLaC + Txt
|
|
|
|
|
|
Change pre- to post-survey
Change post- to follow-up-survey
|
108
|
-0.14 (-0.20, -0.08)1
|
142
|
-0.11 (-0.17, -0.06)1
|
-0.03 (-0.12, 0.06) 5
|
90
|
-0.04 (-0.11, 0.03)2
|
|
NR
|
|
FFBQ Fibre index (score 0–5)
|
|
|
|
|
|
HLaC
|
|
|
|
|
|
Pre survey/ baseline - Mean (SD)
Change pre- to post-survey
|
115
|
2.85 (0.54)
|
|
2.78 (0.48)
|
|
103
|
0.21 (0.12, 0.30) 4
|
160
|
0.26 (0.18, 0.33) 4
|
|
HLaC + Txt
|
|
|
|
|
|
Change pre- to post-survey
Change post- to follow-up-survey
|
98
|
-0.08 (-0.15, -0.00)1
|
138
|
-0.11 (-0.17, -0.06)1
|
0.04 (-0.05, 0.13)5
|
81
|
0.03 (-0.05, 0.11)2
|
|
NR
|
|
Quality of Life Physical (SF-12), 0-100
|
|
|
|
|
|
HLaC
|
|
|
|
|
|
Pre survey/ baseline - Mean (SD)
Change pre- to post-survey
|
115
|
39.98 (10.89)
|
167
|
39.64 (10.04)
|
|
115
|
5.38 (3.38, 7.39) 4
|
167
|
7.19 (5.59, 8.78) 4
|
|
HLaC + Txt
|
|
|
|
|
|
Change pre- to post-survey
Change post- to follow-up-survey
|
111
|
-0.89 (-2.46, 0.68)3
|
144
|
-1.12 (-2.49, 0.26)3
|
0.66 (-1.43, 2.75)3
|
93
|
-1.32 (-3.14, 0.50)3
|
|
NR
|
|
Quality of Life Mental (SF-12), 0-100
|
|
|
|
|
|
HLaC
|
|
|
|
|
|
Pre survey/ baseline - Mean (SD)
Change pre- to post-survey
|
115
|
48.17 (10.42)
|
167
|
49.38 (10.22)
|
|
115
|
1.80 (-0.08, 3.68) 4
|
167
|
1.94 (0.50, 3.39) 2
|
|
HLaC + Txt
|
|
|
|
|
|
Change pre- to post-survey
Change post- to follow-up-survey
|
111
|
-1.39 (-2.92, 0.14)3
|
144
|
-0.48 (-1.82, 0.86)3
|
-0.91 (-2.95, 1.14)3
|
93
|
-1.29 (-2.91, 0.34)3
|
|
NR
|
|
# Presented for context (unadjusted mean changes estimated by paired t-test within completers). |
aMean changes estimated within groups and between group difference using linear regression models for completers [adjusted for HLaC + Txt pre-survey values of the outcome, CC and gender (regardless of significance), and other confounders that were significant (p < 0.02) (Additional File Table 3)]. |
Statistical significance at p < .05. Within cohort: 1 Worsened 2 Maintained 3 Inconclusive 4Improved, Between cohort: 3 Inconclusive 5 Similar NR = not recorded |
Table 4: Anthropometric/behavioural data: HLaC + Txt intervention and control cohorts: baseline HLaC#, change from: HLaC pre- to post-survey#, HLaC + Txt pre- to post-survey, HLaC + Txt post- to follow-up-survey and HLaC + Txt intervention effects
Maintenance outcomes (participant level)
Within-cohort change
The HLaC + Txt cohort maintained outcomes for weight, fruit intake, and fat and fibre index scores between post-HLaC + Txt and follow-up (after 6-months no contact) (Table 4). Results during this same time period were inconclusive for waist circumference, MVPA, physical and mental quality of life outcomes for the intervention cohort as the confidence intervals included the MDI.
Sensitivity Analysis
The results of the multiple imputation analyses (Additional File 11) supported the main analyses results for changes during 6-months no contact for the HLaC + Txt cohort.
Maintenance outcomes (setting level)
To date, the initial HLaC program is being adapted and offered by three CC at a reduced scale or in a web-based format (27). The CCs are funding the delivery of these adapted programs, as the research grant funding is complete and at the time of publishing this manuscript no CCs were continuing to offer text-message delivered extended contact.