A Randomised, Comparative, Effectiveness Trial Evaluating Low- versus High-Level Supervision of an Exercise Intervention for Women with Breast Cancer: The SAFE Trial
Abstract
:Simple Summary
Abstract
1. Introduction
- real-world: representative of the model currently funded by the Australian healthcare system [14]. This involved five supervised sessions across 12 weeks, with all other exercise sessions unsupervised. This group was the “low-supervision group”.
- research: consistent with conditions commonly observed in previous exercise oncology trial protocols [10]. This involved 20 supervised sessions across 12 weeks, with all other exercise sessions unsupervised. This group was the “high-supervision group”.
2. Methods
2.1. Design and Participants
2.2. Exercise Intervention
2.3. Low-Supervision Group
2.4. High-Supervision Group
2.5. Supervised Sessions
2.6. Exercise Prescription
2.7. Data Collection
2.8. Primary Outcomes
2.9. Secondary Outcomes
2.10. Statistical Analysis
3. Results
3.1. Primary Outcome: Safety
3.2. Primary Outcome: Feasibility
3.3. Secondary Outcomes: Effect
4. Discussion
4.1. Safety and Feasibility
4.2. Effect Outcomes
4.3. Strengths and Limitations
4.4. Clinical Implications and Future Research
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Inclusion Criteria | Exclusion Criteria | |
---|---|---|
Must Meet ALL Criteria | Must Meet ≥ 1 Criterion | Meets ANY Criterion |
|
|
|
Exercise Prescription Parameter | Aerobic Exercise Prescription | |
---|---|---|
Average Participant | Deconditioned Participant; or Participant Experiencing Period of Activity-Limiting Pain or Nausea | |
Mode of Exercise a | Walk, cycle (stationary or bicycle), swim a | Walking (flat road, treadmill, shopping center) or stationary cycling a |
Frequency, sessions b per week | 3–4 | 6 |
Intensity | Moderate | Moderate |
RPE c, 6–20 Borg Scale | 12–14 | 11–13 |
Duration, minutes | ||
Individual session | 20–40 | 20 (broken into shorter bouts, as needed, throughout the day, e.g., 4 × 5 min) |
Total weekly | 110 | 120 |
Eliciting progressing overload | ||
Recommendations | Increase speed, load, or incline to maintain RPE | Increase duration of bouts until able to complete 20 min continuously |
Example | Increase pace, include hills or inclines, intervals of higher speed to maintain overall intensity target across session | Use “talk-test” to identify threshold for moderate-intensity. Symptoms (e.g., fatigue, pain) may influence RPE more than cardiovascular response |
Exercise Prescription Parameter | Resistance Exercise Prescription | |
Average Participant | Deconditioned Participant; or Participant Experiencing Period of Activity-Limiting Pain or Nausea | |
Frequency, sessions b per week | 2 | 2 |
Intensity | Moderate | Moderate |
RPE c, 6–20 Borg Scale | 12–14 | 11–13 |
Repetitions in reserve | Aim for 2–3 repetitions in reserve at the end of each set | Aim for 3–4 repetitions in reserve at the end of each set |
Duration, minutes | ||
Individual Session | 20 | 15 |
Total Weekly | 40 | 30 |
Session components | ||
Focus | Muscular strength | Muscular endurance |
Repetition range | 8–12 | 15–20+ |
Set range | 2–3 | 2 |
Example home-based resistance exercises a | ||
Lower body | Squat Calf-raise on step including dorsiflexion Lateral banded walk Resistance band deadlift | Sit-to-stand Supine bridge Side-lying hip abduction |
Upper body | Bent-over row (single-arm, dumbbell) | Resistance band row Resistance band chest press |
Exercise Recommendations | 4–5 major muscle group exercises, 1 targeted exercise (functional or injury-specific where required) | |
Eliciting progressive overload | Increase reps or sets, increase resistance or weight, alter exercise tempo |
Total n = 60 | High Group n = 30 | Low Group n = 30 | |
---|---|---|---|
Personal Characteristics | Mean (SD) or n (%) | ||
Age (years), mean (SD) | 50.1 (9.0) | 51.0 (9.5) | 49.2 (8.5) |
<50 years | 29 (48%) | 16 (53%) | 13 (43%) |
≥50 years | 31 (52%) | 14 (47%) | 17 (57%) |
Household income | |||
Lower income (bottom 40th percentiles) a | 24 (40%) | 12 (40%) | 12 (40%) |
Marital status | |||
Married/de-factor | 42 (70%) | 22 (73%) | 20 (67%) |
Private Health Insurance (Yes) | 48 (80%) | 25 (83%) | 23 (77%) |
Body-mass index (kg/m2) | 28.9 (6.2) | 29.2 (6.7) | 28.6 (5.7) |
Body-mass index (n, %) | |||
Healthy or underweight | 19 (32%) | 9 (30%) | 10 (33%) |
Overweight | 18 (30%) | 9 (30%) | 9 (30%) |
Obese | 23 (38%) | 12 (40%) | 11 (37%) |
Minutes of structured exercise/week, mean (SD) | 42.0 (57.6) | 41.0 (55.8) | 41.0 (60.1) |
Diagnostic Characteristics | Median (range) or n (%) | ||
Breast Cancer stage | |||
Stage II | 28 (47%) | 12 (40%) | 16 (54%) |
Stage III | 20 (33%) | 14 (47%) | 6 (20%) |
Stage IV | 7 (12%) | 3 (10%) | 4 (13%) |
Unsure or unknown b | 5 (8%) | 1 (3%) | 4 (13%) |
Months since diagnosis c | 18 (2–243) | 16 (2–215) | 24 (2–243) |
Side of breast cancer | |||
Dominant side | 27 (45%) | 12 (40%) | 15 (50%) |
Non-dominant side | 30 (50%) | 17 (57%) | 13 (43%) |
Bilateral | 3 (5%) | 1 (3%) | 2 (7%) |
Treatment Characteristics | n (%) | ||
Most extensive surgery | |||
Mastectomy | 43 (72%) | 19 (64%) | 24 (80%) |
Lumpectomy | 16 (27%) | 10 (33%) | 6 (20%) |
No surgery | 1 (2%) | 1 (3%) | 0 (0%) |
No. of nodes removed | |||
0 | 0 (0%) | 0 (0%) | 0 (0%) |
1–4 | 17 (28%) | 7 (23%) | 10 (33%) |
5–9 | 6 (10%) | 2 (7%) | 4 (13%) |
10+ | 25 (42%) | 13 (43%) | 12 (40%) |
Unsure or unknown | 12 (20%) | 8 (27%) | 4 (13%) |
Treatment status | |||
Currently receiving treatment c, d | 22 (37%) | 10 (33%) | 12 (40%) |
Treatments received (current or past) | |||
Chemotherapy (yes) | 55 (92%) | 25 (83%) | 30 (100%) |
Radiation therapy (yes) | 45 (75%) | 25 (83%) | 20 (67%) |
Hormone therapy (yes) | 32 (53%) | 18 (60%) | 14 (47%) |
Health Characteristics | n (%) | ||
Number of comorbidities | 1 (0–6) | 1 (0–6) | 1 (0–5) |
0 comorbidities | 21 (35%) | 9 (30%) | 12 (40%) |
1–2 comorbidities | 29 (48%) | 15 (50%) | 14 (47%) |
3–4 comorbidities | 7 (12%) | 4 (13%) | 3 (10%) |
5–6 comorbidities | 3 (5%) | 2 (7%) | 1 (3%) |
Number of side effects | 4.4 (2.1) | 4.7 (2.1) | 4.1 (2.1) |
0–2 side effects | 11 (19%) | 5 (17%) | 6 (20%) |
3–4 side effects | 24 (40%) | 10 (33%) | 14 (46%) |
5–6 side effects | 15 (25%) | 10 (33%) | 5 (16%) |
7+ side effects | 10 (17%) | 5 (17%) | 5 (16%) |
Number of side effects (≥moderate severity) | 2.8 (1.9) | 3.1 (1.9) | 2.5 (1.8) |
0–2 moderate+ side effects | 28 (47%) | 12 (40%) | 16 (54%) |
3–4 moderate+ side effects | 21 (35%) | 11 (37%) | 10 (33%) |
5–6 moderate+ side effects | 9 (15%) | 6 (20%) | 3 (10%) |
7+ moderate+ side effects | 2 (3%) | 1 (3%) | 1 (3%) |
All Women | High Group | Low Group | |
---|---|---|---|
n = 59 | n = 30 | n = 29 | |
Primary Outcome: | |||
Number of ≥ grade 3 exercise-related AE | 0 | 0 | 0 |
Adverse Events | |||
Number of AEs (total) | 177 | 136 | 41 |
Number of women reporting AEs | 41 (69%) | 23 (77%) | 18 (62%) |
Median (range) number of AEs per participant | 2 (0–19) | 4 (0–19) | 1 (0–7) |
Exercise-related Adverse Events | |||
Number of exercise-related AEs (total) | 126 | 103 | 23 |
Number of women reporting exercise-related AEs | 34 (58%) | 23 (77%) | 11 (38%) |
Median (range) number of exercise-related AEs per participants | 1 (0–14) | 3 (0–14) | 0 (0–6) |
Number of women reporting exercise-related AEs | |||
0 AEs | 26 (44%) | 7 (23%) | 19 (66%) |
1–2 AEs | 16 (27%) | 8 (27%) | 8 (28%) |
3–4 AEs | 8 (14%) | 6 (20%) | 2 (7%) |
5–10 AEs | 8 (14%) | 7 (23%) | 1 (3%) |
>10 AEs | 2 (3%) | 2 (7%) | 0 (0%) |
Baseline (T1) | Post-Intervention (T2) | Follow-Up (T3) | Δ T1 to T2 a | Δ T2 to T3 a | Δ T1 to T3 a | ||||
Mean | 95% CI | Mean | 95% CI | Mean | 95% CI | Mdiff (95% CI) | |||
PROMIS Global Physical Health | 5.91 (4.2–7.6) c,d | 0.10 (−1.6–1.7) | 6.01 (3.9–8.0) c,d | ||||||
High | 40.4 | (38.4–42.5) | 46.7 | (44.2–49.3) | 47.1 | (44.0–50.2) | |||
Low | 40.6 | (37.6–43.5) | 46.1 | (43.6–48.5) | 45.8 | (42.9–48.8) | |||
GEE b: Group p = 0.71; Time p < 0.01; Group × Timep = 0.79 | |||||||||
PROMIS Global Mental Health | 5.4 (3.6–7.0) c,d | −0.8 (−3.0–1.4) | 4.5 (2.0–7.0) c | ||||||
High | 41.6 | (39.0–44.3) | 48.4 | (45.8–51.1) | 47.0 | (44.0–50.1) | |||
Low | 41.9 | (39.3–44.5) | 45.8 | (43.1–48.5) | 45.5 | (43.0–48.0) | |||
GEE b: Group p = 0.37; Time p < 0.01; Group × Timep = 0.25 | |||||||||
Exercise-barrier self-efficacy | |||||||||
High | 35.7 | (29.1–42.2) | 47.0 | (41.0–53.0) | 49.2 | (40.9–57.5) | 11.3 (4.5–18.1) c,d | 2.2 (−5.1–9.6) | 13.5 (3.9–23.3) c,d |
Low | 32.1 | (25.7–38.5) | 33.7 | (27.5–40.0) | 29.8 | (22.5–37.2) | 1.6 (−4.4–7.7) | −3.9 (−9.3–1.5) | −2.3 (−8.4–3.9) |
GEE b: Group p = 0.002; Time p = 0.02; Group × Time p = 0.02 | |||||||||
Physical Activity e | 244.1 (172.7–315.5) c,d | −31.4 (−124.0–61.3) d | 212.7 (120.1–305.4) c,d | ||||||
High | 93.1 | (70.0–116.2) | 381.8 | (289.5–474.1) | 349.2 | (224.2–473.5) | |||
Low | 140.7 | (86.1–195.3) | 340.2 | (249.2–431.1) | 310.0 | (190.6–429.4) | |||
GEE b: Group p = 0.79; Time p < 0.01; Group × Timep = 0.42 | |||||||||
6-min walk test | 53.6 (35.7–71.4) c,d | - f | - f | ||||||
High | 494.0 | (454.0–530.0) | 547.0 | (518.0–576.0) | - f | ||||
Low | 510.0 | (479.0–541.0) | 563.0 | (541.0–585.0) | - f | ||||
GEE b: Group p = 0.39; Time p < 0.01; Group × Timep = 0.90 | |||||||||
Modified-YMCA bench press | - f | - f | |||||||
High | 27.3 | (18.0–36.7) | 43.5 | (32.6–54.4) | - f | 17.9 (5.5–30.3) c,d | |||
Low | 25.6 | (19.6–31.6) | 29.1 | (21.6–36.7) | - f | 3.6 (−0.3–7.4) | |||
GEE b: Group p = 0.18; Time p < 0.01; Group × Timep < 0.01 | |||||||||
30-s sit to stand | - f | - f | |||||||
High | 11.6 | (10.0–13.1) | 15.0 | (13.2–16.8) | - f | 3.4 (1.7–5.1) c,d | |||
Low | 11.3 | (10.1–12.5) | 12.6 | (11.4–13.8) | - f | 1.3 (0.2–2.5) c | |||
GEE b: Group p = 0.14; Time p < 0.01; Group × Timep = 0.05 |
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Spence, R.R.; Sandler, C.X.; Singh, B.; Tanner, J.; Pyke, C.; Eakin, E.; Vagenas, D.; Hayes, S.C. A Randomised, Comparative, Effectiveness Trial Evaluating Low- versus High-Level Supervision of an Exercise Intervention for Women with Breast Cancer: The SAFE Trial. Cancers 2022, 14, 1528. https://doi.org/10.3390/cancers14061528
Spence RR, Sandler CX, Singh B, Tanner J, Pyke C, Eakin E, Vagenas D, Hayes SC. A Randomised, Comparative, Effectiveness Trial Evaluating Low- versus High-Level Supervision of an Exercise Intervention for Women with Breast Cancer: The SAFE Trial. Cancers. 2022; 14(6):1528. https://doi.org/10.3390/cancers14061528
Chicago/Turabian StyleSpence, Rosalind R., Carolina X. Sandler, Benjamin Singh, Jodie Tanner, Christopher Pyke, Elizabeth Eakin, Dimitrios Vagenas, and Sandra C. Hayes. 2022. "A Randomised, Comparative, Effectiveness Trial Evaluating Low- versus High-Level Supervision of an Exercise Intervention for Women with Breast Cancer: The SAFE Trial" Cancers 14, no. 6: 1528. https://doi.org/10.3390/cancers14061528