Multimodal, Technology-Assisted Intervention for the Management of Menopause after Cancer Improves Cancer-Related Quality of Life—Results from the Menopause after Cancer (Mac) Study
<p>(<b>A</b>): Schematic representing the composite intervention of the MAC study. (<b>B</b>): Flowchart demonstrating specifics of the composite intervention in the MAC study.</p> "> Figure 1 Cont.
<p>(<b>A</b>): Schematic representing the composite intervention of the MAC study. (<b>B</b>): Flowchart demonstrating specifics of the composite intervention in the MAC study.</p> "> Figure 2
<p>Compliance with MAC intervention. (<b>A</b>): Graph demonstrating the number of participants who completed the EORTC-QLQ-C30 questionnaire at each timepoint. (<b>B</b>): Chart demonstrating how often each regimen was prescribed in the study. (<b>C</b>): Graph demonstrating compliance with each drug regimen over the course of the study. (<b>D</b>): Graph demonstrating the number of participants who completed each of the six sessions of dCBT-I in Sleepio.</p> "> Figure 3
<p>Changes in all scales of the EORTC-QLQ-C30 in the ITT and PP cohorts. (<b>A</b>): Mean and 95% CI in the global health status scale in the EORTC-QLQ-C30 instrument for the ITT cohort (shown in black) and the PP cohort (shown in blue). (<b>B</b>): Box plot showing global health status scores categorized according to low, mid or high global health status scores at the baseline. Those with the lowest scores at baseline saw the greatest improvement in these scores. *** denotes statistical significance < 0.005.</p> "> Figure 4
<p>Changes in menopause and sleep outcomes ITT and PP cohorts. (<b>A</b>): Mean and 95% CI for the frequency of daytime hot flashes for the ITT cohort (shown in black) and the PP cohort (shown in blue) over the study period. (<b>B</b>): Mean and 95% CI for the frequency of night sweats for the ITT cohort (shown in black) and the PP cohort (shown in blue) over the study period. (<b>C</b>): Mean and 95% CI frequency for all VMSs for the ITT cohort (shown in black) and the PP cohort (shown in blue) over the study period. (<b>D</b>): Mean and 95% CI for Hot Flush Rating Scale scores in the ITT cohort (shown in black) and the PP cohort (shown in blue). (<b>E</b>): Mean and SEM for the Sleep Condition Indicator in the ITT cohort (shown in black) and the PP cohort (shown in blue). * denotes statistical significance <0.05, *** denotes statistical significance <0.005.</p> "> Figure 4 Cont.
<p>Changes in menopause and sleep outcomes ITT and PP cohorts. (<b>A</b>): Mean and 95% CI for the frequency of daytime hot flashes for the ITT cohort (shown in black) and the PP cohort (shown in blue) over the study period. (<b>B</b>): Mean and 95% CI for the frequency of night sweats for the ITT cohort (shown in black) and the PP cohort (shown in blue) over the study period. (<b>C</b>): Mean and 95% CI frequency for all VMSs for the ITT cohort (shown in black) and the PP cohort (shown in blue) over the study period. (<b>D</b>): Mean and 95% CI for Hot Flush Rating Scale scores in the ITT cohort (shown in black) and the PP cohort (shown in blue). (<b>E</b>): Mean and SEM for the Sleep Condition Indicator in the ITT cohort (shown in black) and the PP cohort (shown in blue). * denotes statistical significance <0.05, *** denotes statistical significance <0.005.</p> "> Figure A1
<p>CONSORT diagram for the MAC study.</p> ">
Abstract
:Simple Summary
Abstract
1. Introduction
2. Materials and Methods
- Female aged 18 or over;
- At least five VMS episodes in an average 24 h period;
- Moderate degree of bother from these symptoms defined as a score of 5.3 or higher on HFRS [43];
- A prior or current history of cancer;
- A contraindication to standard MHT;
- Confident use of a smartphone.
- Eastern Cooperative Oncology Group (ECOG) performance status of 3 or higher;
- Use of study medications to manage VMS in the preceding six months;
- Use of CBT-I in the preceding six months;
- Any contraindication to study medications;
- Limited spoken or written English;
- No internet access or not confident with smartphone use.
2.1. Non-Hormonal Pharmacotherapy
2.2. Outcomes
2.3. Sample Size Calculation
2.4. Statistical Analysis
2.5. Ethics
3. Results
3.1. Compliance
3.2. The Impact of the Composite MAC Intervention on Global Health Status
3.3. Baseline Quality of Life Was the Main Predictor of Benefit from the MAC Intervention
3.4. Menopause Outcomes
3.5. Sleep Outcomes
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
Appendix A
Appendix A.1. Digital CBT-I
Appendix A.2. myPatient Space
Appendix A.3. Support Person
Appendix B
References
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ITT (n = 204) | PP (n = 120) | ||
---|---|---|---|
Median Age (Range, IQR) | 49 (28–66, 45–53) | 50 (28–66, 46–53) | |
Ethnicity | White | 202 (99) | 118 (98.3) |
Asian/Asian Irish | 2 (1) | 2 (1.7) | |
Educational level | Primary | 1 (0.5) | 1 (0.8) |
Secondary | 29 (14.2) | 16 (13.3) | |
Third level | 138 (67.6) | 87 (72.5) | |
Third level > 4 years | 36 (17.6) | 16 (13.3) | |
Smoking status | Current smoker | 12 (5.9) | 7 (5.8) |
Ex smoker | 71 (34.8) | 42 (35) | |
Non-smoker | 121 (59.3) | 71 (59.2) | |
Alcohol consumption | Non-drinkers | 52 (25.4) | 33 (27.5) |
1–5 units/week | 109 (53.4) | 65 (54.2) | |
6–10 units/week | 36 (17.6) | 19 (15.8) | |
>10 units/week | 7 (3.4) | 3 (2.5) | |
Exercise frequency (active for >30 min) | 5–7 times/week | 112 (54.9) | 72 (60) |
1–5 times/week | 69 (33.8) | 35 (29.2) | |
Stopped | 21 (10.3) | 12 (10.8) | |
Never | 2 (1) | 0 | |
Diagnosis | Breast cancer | 167 (81.9) | 102 (85) |
Ovarian cancer | 18 (8.8) | 7 (5.8) | |
Endometrial cancer | 12 (5.9) | 7 (5.8) | |
Other | 7 (3.4) | 4 (3.3) | |
Stage at diagnosis | Stage 1 | 58 (28.4) | 32 (26.7) |
Stage 2 | 70 (34.3) | 41 (34.2) | |
Stage 3 | 44 (21.6) | 25 (20.8) | |
Stage 4 | 11 (5.4) | 7 (5.8) | |
Stage unknown | 21 (10.3) | 15 (12.5) | |
Treatment—Breast cancer | Surgery alone | 42 (25.1) | 30 (29.4) |
ITT (n = 167) | Surgery + chemotherapy | 21 (12.6) | 10 (9.8) |
PP (n = 102) | Surgery + chemotherapy + radiotherapy | 102 (61.1) | 60 (58.8) |
Chemotherapy alone | |||
2 (1.2) | 2 (1.9) | ||
Current anti-endocrine therapy * | |||
120 (71.9) | 72 (70.6) | ||
Treatment—Ovarian cancer | Surgery alone | 4 (22.2) | 2 (28.6) |
ITT (n = 18) | Surgery + chemotherapy | 14 (77.8) | 5 (71.4) |
PP (n = 7) | |||
Current anti-endocrine therapy * | 4 (22.2) | 2 (28.6) | |
Treatment—Endometrial cancer | Surgery alone | 11 (91.7) | 6 (85.7) |
ITT (n = 12) | Surgery + chemotherapy | 1 (8.3) | 1 (14.3) |
PP (n = 7) | |||
Current status | No evidence of disease | 191 (93.6) | 112 (93.3) |
Recurrent/metastatic disease | 13 (6.4) | 8 (6.7) |
Characteristic | Not Substantially Improved (n = 99) | Improvement ≥ 5 (n = 90) | Total (n = 189) | p Value |
---|---|---|---|---|
Baseline global health status | <0.001 | |||
Median (Q1, Q3) | 67.0 (58.0, 83.0) | 50.0 (42.0, 67.0) | 67.0 (50.0,75.0) | |
Started Sleepio | 0.428 | |||
No | 18 (18.2%) | 12 (13.3%) | 30 (15.9%) | |
Yes | 81 (81.8%) | 78 (86.7%) | 159 (84.1%) | |
Completed Sleepio | 0.008 | |||
No | 76 (76.8%) | 52 (57.8%) | 128 (67.7%) | |
Yes | 23 (23.2%) | 38 (42.2%) | 61 (32.3%) | |
Medications at six months | <0.001 | |||
Stopped | 42 (42.4%) | 17 (18.9%) | 59 (31.2%) | |
Not stopped | 41 (41.4%) | 60 (66.7%) | 101 (53.4%) | |
Unknown | 16 (16.2%) | 13 (14.4%) | 29 (15.3%) | |
Third level education | 1 | |||
No | 14 (14.1%) | 13 (14.4%) | 27 (14.3%) | |
Yes | 85 (85.9%) | 77 (85.6%) | 162 (85.7%) | |
Never smoked | 0.655 | |||
No | 37 (37.4%) | 37 (41.1%) | 74 (39.2%) | |
Yes | 62 (62.6%) | 53 (58.9%) | 115 (60.8%) | |
Units of alcohol | 0.86 | |||
N-Miss | 0 | 1 | 1 | |
Median (Q1, Q3) | 2.0 (0.5, 5.0) | 2.0 (0.0, 5.0) | 2.0 (0.0, 5.0) | |
Exercise ≥ 5 days/w | 0.243 | |||
No | 50 (50.5%) | 37 (41.1%) | 87 (46.0%) | |
Yes | 49 (49.5%) | 53 (58.9%) | 102 (54.0%) | |
Breast cancer diagnosis | 0.052 | |||
No | 22 (22.2%) | 10 (11.1%) | 32 (16.9%) | |
Yes | 77 (77.8%) | 80 (88.9%) | 157 (83.1%) | |
VMS same or worse at night | 0.714 | |||
No | 20 (20.2%) | 16 (17.8%) | 36 (19.0%) | |
Yes | 79 (79.8%) | 74 (82.2%) | 153 (81.0%) | |
VMS worst at night | 0.382 | |||
No | 48 (48.5%) | 50 (55.6%) | 98 (51.9%) | |
Yes | 51 (51.5%) | 40 (44.4%) | 91 (48.1%) | |
Cognitive symptoms | 0.75 | |||
No | 69 (69.7%) | 65 (72.2%) | 134 (70.9%) | |
Yes | 30 (30.3%) | 25 (27.8%) | 55 (29.1%) | |
Psychological symptoms | 0.869 | |||
No | 72 (72.7%) | 67 (74.4%) | 139 (73.5%) | |
Yes | 27 (27.3%) | 23 (25.6%) | 50 (26.5%) | |
Sexual symptoms | 0.843 | |||
No | 84 (84.8%) | 75 (83.3%) | 159 (84.1%) | |
Yes | 15 (15.2%) | 15 (16.7%) | 30 (15.9%) | |
Musculoskeletal symptoms | 0.882 | |||
N-Miss | 0 | 1 | 1 | |
No | 58 (58.6%) | 54 (60.7%) | 112 (59.6%) | |
Yes | 41 (41.4%) | 35 (39.3%) | 76 (40.4%) | |
Sleep symptoms | 0.366 | |||
No | 40 (40.4%) | 30 (33.3%) | 70 (37.0%) | |
Yes | 59 (59.6%) | 60 (66.7%) | 119 (63.0%) | |
Current anti endocrine therapy | 0.655 | |||
No | 40 (40.4%) | 33 (36.7%) | 73 (38.6%) | |
Yes | 59 (59.6%) | 57 (63.3%) | 116 (61.4%) |
n | SCI at Baseline (SEM) | Prescribed Gabapentin (n) | SCI at 6 Months (SEM) | Continued Gabapentin (n) | |
---|---|---|---|---|---|
Sleepio completers | 62 | 7.5 (0.4) | 50 | 17.4 (0.8) | 41 |
At least 1 session of Sleepio | 161 | 8.3 (0.4) | 134 | 17.1 (0.5) | 74 |
No Sleepio | 43 | 9.5 (1.2) | 35 | 18.4 (1.6) | 11 |
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Donohoe, F.; O’Meara, Y.; Roberts, A.; Comerford, L.; Valcheva, I.; Kearns, U.; Galligan, M.; Higgins, M.J.; Henry, A.L.; Kelly, C.M.; et al. Multimodal, Technology-Assisted Intervention for the Management of Menopause after Cancer Improves Cancer-Related Quality of Life—Results from the Menopause after Cancer (Mac) Study. Cancers 2024, 16, 1127. https://doi.org/10.3390/cancers16061127
Donohoe F, O’Meara Y, Roberts A, Comerford L, Valcheva I, Kearns U, Galligan M, Higgins MJ, Henry AL, Kelly CM, et al. Multimodal, Technology-Assisted Intervention for the Management of Menopause after Cancer Improves Cancer-Related Quality of Life—Results from the Menopause after Cancer (Mac) Study. Cancers. 2024; 16(6):1127. https://doi.org/10.3390/cancers16061127
Chicago/Turabian StyleDonohoe, Fionán, Yvonne O’Meara, Aidin Roberts, Louise Comerford, Ivaila Valcheva, Una Kearns, Marie Galligan, Michaela J. Higgins, Alasdair L. Henry, Catherine M. Kelly, and et al. 2024. "Multimodal, Technology-Assisted Intervention for the Management of Menopause after Cancer Improves Cancer-Related Quality of Life—Results from the Menopause after Cancer (Mac) Study" Cancers 16, no. 6: 1127. https://doi.org/10.3390/cancers16061127
APA StyleDonohoe, F., O’Meara, Y., Roberts, A., Comerford, L., Valcheva, I., Kearns, U., Galligan, M., Higgins, M. J., Henry, A. L., Kelly, C. M., Walshe, J. M., Hickey, M., & Brennan, D. J. (2024). Multimodal, Technology-Assisted Intervention for the Management of Menopause after Cancer Improves Cancer-Related Quality of Life—Results from the Menopause after Cancer (Mac) Study. Cancers, 16(6), 1127. https://doi.org/10.3390/cancers16061127