| Literature DB >> 28135050 |
Kathi H Mooney1, Susan L Beck1, Bob Wong1, William Dunson1, Debra Wujcik1, Meagan Whisenant1, Gary Donaldson1.
Abstract
Technology-aided remote interventions for poorly controlled symptoms may improve cancer symptom outcomes. In a randomized controlled trial, the efficacy of an automated symptom management system was tested to determine if it reduced chemotherapy-related symptoms. Prospectively, 358 patients beginning chemotherapy were randomized to the Symptom Care at Home (SCH) intervention (n = 180) or enhanced usual care (UC) (n = 178). Participants called the automated monitoring system daily reporting severity of 11 symptoms. SCH participants received automated self-management coaching and nurse practitioner (NP) telephone follow-up for poorly controlled symptoms. NPs used a guideline-based decision support system. Primary endpoints were symptom severity across all symptoms, and the number of severe, moderate, mild, and no symptom days. A secondary endpoint was individual symptom severity. Mixed effects linear modeling and negative binominal regressions were used to compare SCH with UC. SCH participants had significantly less symptom severity across all symptoms (P < 0.001). On average, the relative symptom burden reduction for SCH participants was 3.59 severity points (P < 0.001), roughly 43% of UC. With a very rapid treatment benefit, SCH participants had significant reductions in severe (67% less) and moderate (39% less) symptom days compared with UC (both P < 0.001). All individual symptoms, except diarrhea, were significantly lower for SCH participants (P < 0.05). Symptom Care at Home dramatically improved symptom outcomes. These results demonstrate that symptoms can be improved through automated home monitoring and follow-up to intensify care for poorly controlled symptoms.Entities:
Keywords: Chemotherapy; decision support systems; eHealth; evidence-based clinical practice guidelines; patient-reported outcomes; symptom management; telehealth
Mesh:
Substances:
Year: 2017 PMID: 28135050 PMCID: PMC5345623 DOI: 10.1002/cam4.1002
Source DB: PubMed Journal: Cancer Med ISSN: 2045-7634 Impact factor: 4.452
Figure 1CONSORT 1 Flow Diagram
Participant's characteristics
| Characteristics | UC | SCH | All ( |
|
|---|---|---|---|---|
| M (SD) | M (SD) | M (SD) | ||
| Age | ||||
| 56.79 (10.54) | 54.77 (12.17) | 55.77 (11.42) | 0.10 | |
|
|
|
| ||
| Gender | 0.85 | |||
| Female | 135 (76) | 135 (75) | 270 (75) | |
| Male | 43 (24) | 45 (25) | 88 (25) | |
| Ethnicity | 0.47 | |||
| Non‐Hispanic | 171 (96) | 170 (94) | 341 (95) | |
| Hispanic | 7 (4) | 10 (6) | 17 (5) | |
| Race | 0.25 | |||
| White | 154 (86) | 143 (80) | 297 (83) | |
| Black | 19 (11) | 22 (12) | 41 (12) | |
| Asian | 2 (1) | 3 (2) | 5 (1) | |
| Native American | 1 (1) | 4 (2) | 5 (1) | |
| Other/unknown | 2 (1) | 8 (4) | 10 (3) | |
| Marital status | 0.91 | |||
| Married or living with a partner | 116 (65) | 117 (65) | 233 (65) | |
| Single | 32 (18) | 30 (17) | 62 (17) | |
| Other (divorced, separated, widowed) | 30 (17) | 33 (18) | 63 (18) | |
| Education | 0.24 | |||
| Less than high school graduate | 18 (10) | 10 (5) | 28 (8) | |
| High school graduate/GED | 37 (21) | 46 (26) | 83 (24) | |
| Some college/technical school or Associate's degree | 60 (34) | 70 (39) | 130 (36) | |
| Bachelor's degree | 38 (21) | 28 (16) | 66 (18) | |
| Postgraduate education | 25 (14) | 26 (14) | 51 (14) | |
| Annual Household Income | 0.45 | |||
| Less than $19,999 | 34 (19) | 38 (21) | 72 (20) | |
| $20,000–49,999 | 47 (26) | 44 (25) | 91 (25) | |
| $50,000–69,999 | 19 (11) | 20 (11) | 39 (11) | |
| $70,000 and higher | 61 (34) | 64 (36) | 125 (35) | |
| Declined to answer | 17 (10) | 13 (7) | 30 (9) | |
| Employment | 0.09 | |||
| Not employed outside the home | 60 (34) | 77 (43) | 137 (38) | |
| Employed part or full‐time | 54 (30) | 56 (31) | 110 (31) | |
| Other (Retired, sick leave, or disability) | 64 (36) | 47 (26) | 111 (31) | |
| Cancer diagnosis | 0.50 | |||
| Breast | 73 (41) | 83 (46) | 156 (44) | |
| Lung | 28 (16) | 33 (18) | 61 (17) | |
| Ovarian | 15 (9) | 21 (12) | 36 (10) | |
| Colorectal | 16 (9) | 10 (6) | 26 (7) | |
| Pancreatic | 11 (6) | 10 (6) | 21 (6) | |
| Head and neck | 7 (4) | 6 (3) | 13 (4) | |
| Endometrial | 6 (3) | 3 (2) | 9 (3) | |
| Other | 22 (12) | 14 (8) | 36 (10) | |
| Cancer stage | 0.11 | |||
| I | 20 (11) | 21 (12) | 41 (11) | |
| II | 28 (16) | 45 (25) | 73 (20) | |
| III | 47 (26) | 34 (19) | 81 (23) | |
| IV | 83 (47) | 80 (44) | 163 (46) | |
Symptom Care at Home Intervention Group (SCH), Usual Care (UC).
Prevalence of symptoms reported at moderate or severe levels one or more days
| Symptoms | % ( |
|---|---|
| Fatigue | 86 |
| Pain | 80 |
| Trouble sleeping | 78 |
| Nausea/vomiting | 60 |
| Depressed mood | 52 |
| Feeling nervous/anxious | 49 |
| Trouble thinking/concentrating | 48 |
| Numbness/tingling | 42 |
| Diarrhea | 38 |
| Sore mouth | 38 |
| Concern with changes in appearance | 34 |
Figure 2Daily values for total symptom severity summed across all 11 symptoms
Intent‐to‐treat maximum‐likelihood mixed effects analysisa
| Effect | Coefficient | SE |
|
|
|---|---|---|---|---|
| Fixed | ||||
| Regression on baseline | 0.276 | 0.035 | 7.96 | <0.001 |
| Treatment impact | 3.589 | 0.721 | 4.98 | <0.001 |
| Adjusted means | ||||
| UC ( | 8.384 | 0.510 | 17.32 | <0.001 |
| SCH ( | 4.795 | 0.509 | 9.420 | <0.001 |
| Adjusted treatment impact | ||||
| Day 7 | 2.95 | 0.734 | 4.02 | <0.001 |
| Day 30 | 3.41 | 0.721 | 4.72 | <0.001 |
| Day 60 | 3.77 | 0.724 | 5.21 | <0.001 |
| Day 90 | 4.05 | 0.736 | 5.51 | <0.001 |
| Day 120 | 4.28 | 0.750 | 5.71 | <0.001 |
| Treatment Impact on rate‐of‐change | 0.1607 | 0.042 | 3.827 | <0.001 |
| Rate within arm | ||||
| UC | −0.0077 | 0.031 | −0.254 | 0.799 |
| SCH | −0.1684 | 0.029 | −5.747 | <0.001 |
| Random | ||||
| Individual gain |
Var = 29.86 | 0.46 | 64.91 | <0.001 (Wald) |
| Within‐person residual |
Var = 43.44 | 3.00 | 14.48 | <0.001 (Wald) |
| Intraclass correlation | 0.41 | |||
All observations, analyzing square root of study day to reduce impact of positive skew.
Regression of outcome on baseline, assumed equal across groups.
Primary endpoint contrast: Overall treatment impact estimated as the difference in baseline‐adjusted symptom means evaluated at the overall means of the covariates (the sample mean square root of study day).
Estimated postrandomization adjusted symptom means (evaluated at mean square root of study day).
Difference in mean rate‐of‐change between groups.
Within‐treatment arm rate‐of‐change expressed as expected change in symptom severity per unit increase in square root of study day.
Model‐inferred variation in systematic individual symptom change from baseline.
Nonsystematic variation about systematic fixed and individual effects.
SCH, Symptom Care at Home Intervention Group; UC, Usual Care.
Mean estimates and odds ratios from negative binomial regression modeling of highest symptom severity days
| UC | SCH | OR [95% CI] |
| |
|---|---|---|---|---|
| Total reporting days | 76.24 (3.33) | 77.43 (3.23) | 0.99 [0.88–1.11] | 0.797 |
| Severe days (8–10) | 16.93 (2.33) | 5.64 (0.67) | 3.00 [2.10–4.29] | < 0.001 |
| Moderate days (4–7) | 21.81 (2.20) | 13.20 (1.39) | 1.65 [1.24–2.20] | 0.001 |
| Mild days (1–3) | 10.59 (1.46) | 17.42 (2.69) | 0.61 [0.41–0.91] | 0.016 |
| No symptom days (0) | 47.54 (3.93) | 63.05 (3.83) | 0.75 [0.62–0.92] | 0.006 |
Symptom Care at Home Intervention Group (SCH), Usual Care (UC).
Estimated mean difference of symptom severity between SCHb (n = 180) and UCb (n = 178) groupsa
| Estimated mean difference (SCH | SEM | df | t |
| |
|---|---|---|---|---|---|
| Fatigue severity | −0.685 | 0.167 | 324.688 | −4.107 | <0.001 |
| Pain severity | −0.605 | 0.164 | 320.533 | −3.691 | <0.001 |
| Trouble sleeping severity | −0.281 | 0.0962 | 277.144 | −2.920 | 0.004 |
| Nausea/vomiting severity | −0.291 | 0.105 | 295.69 | −2.769 | 0.006 |
| Depressed mood severity | −0.241 | 0.085 | 247.62 | −2.850 | 0.005 |
| Feeling nervous/anxious severity | −0.206 | 0.092 | 273.081 | −2.247 | 0.025 |
| Trouble thinking/concentrating severity | −0.319 | 0.115 | 287.657 | −2.775 | 0.006 |
| Numbness/tingling severity | −0.329 | 0.107 | 346.996 | −3.067 | 0.002 |
| Diarrhea severity | −0.081 | 0.047 | 248.547 | −1.732 | 0.085 |
| Sore mouth severity | −0.257 | 0.081 | 282.720 | −3.172 | 0.002 |
| Concern with changes in appearance severity | −0.219 | 0.072 | 297.663 | −3.039 | 0.003 |
Negative value indicates decreased symptom severity compared to UC.
Symptom Care at Home Intervention Group (SCH), Usual Care (UC).