Background
Methods
Patients and eligibility
Intervention
Feasibility outcomes
Ethics
Results
Feasibility and acceptability as measured by recruitment and retention
Characteristics | Number (%) |
---|---|
Gender | |
Male | 26 (87) |
Female | 4 (13) |
Age | 59 (range 49–79) |
Disease site | |
Oropharynx | 18 (60) |
Oral | 5 (17) |
Nasopharynx | 3 (10) |
Larynx | 2 (7) |
Hypopharynx | 1 (3) |
Unknown primary | 1 (3) |
Stage | |
0 | 1 (3) |
1 | 2 (6) |
2 | 13 (43) |
3 | 7 (24) |
4 | 7 (24) |
Nodes | |
0 | 3 (10) |
1 | 7 (24) |
2 | 20 (66) |
Treatment | |
Chemoradiotherapy | 19 (63) |
Surgery and radiotherapy +/− chemotherapy | 9 (30) |
Surgery | 1 (3.5) |
Radiotherapy | 1 (3.5) |
Time post-treatment (months) | Median 4 (IQR, Range 3,13; 1–60) |
Partner | Yes (23) |
No (7) |
Feasibility and acceptability as measured by intervention fidelity
CB-EST Interventions | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Therapy goal | Swallowing exercises | Swallowing posture recommendation | Texture modification advice | Food selection/preparation advice | Size and positioning of bolus advice | Education on eating | Education on management of choking | Sleep/fatigue management | Graded behavioural experiments | Activity scheduling | Exposure/graded tasks | Thought records | Identifying unhelpful thinking habits |
To get feeding tube out (n = 11) | x | x | x | x | x | x | x | x | x | x | x | x | x |
To increase eating amount (n = 8) | x | x | x | x | |||||||||
To increase confidence in socialising (n = 4) | x | x | x | x | |||||||||
Become more confident about eating (n = 4) | x | x | x | x | x | x | |||||||
Feel better about changes to eating and drinking (n = 2) | x | x | x | x | x | x | x | x | |||||
To adjust to life without eating and drinking (n = 1) | x | x | x | x | x |
Acceptability and utility of candidate outcome measures
Measure | Pre-CB-EST | Post CB-EST | 3 months | ANOVA, Effect size (ES) | Pre to post [95% CI] | Pre to 3 m [95% CI] | Post to 3 m [95% CI] |
---|---|---|---|---|---|---|---|
MDADI |
n = 25 (100%)
|
n = 23 (92%)
|
n = 24 (96%)
| ||||
53.1 (15.1) | 61.2 (15.6) | 61.8 (16.0) |
p = 0.002 (2,42) F = 8.8 ES = 0.29* |
p = 0.03 [0.7–15.5] |
p = 0.003 [2.6–14.6] |
p = 1.0 [3.6–4.7] | |
QLQ-C30 |
n = 25 (100%)
|
n = 22 (88%)
|
n = 19 (76%)
| ||||
Physical | 63.7 (21.8) | 74.1 (21.9) | 74.4 (21.8) |
p = 0.006 (2,34) F = 5.9 ES = 0.26 |
p = 0.05 [0.1–28.8] |
p = 0.03 [0.7–20.8] |
p = 1.0 [−8.1–7.2] |
Role | 48.1(38.3) | 61.1(34.7) | 72.2(34.3) |
p = 0.03 (1,20) F = 4.8 ES = 0.22* |
p = 0.5 [10.9–36.8] |
p = 0.06 [1.2–49.4] |
p = 0.01 [2.3–19.9] |
Emotional | 67.6 (31.0) | 75.9 (31.7) | 75.4 (24.8) |
p = 0.15 (1,17) F = 2.3 ES = 0.11 |
p = 0.06 [0.4–17.1] |
p = 0.4 [5.9–21.7] |
p = 1.0 [11.9–12.9] |
Cognitive | 70.4 (34.6) | 75.9 (34.9) | 87.0 (19.4) |
p = 0.06 (2,21) F = 3.8 ES = 0.18* |
p = 0.2 [2.4–13.5] |
p = 0.1 [2.6–35.9] |
p = 0.4 [7.8–30.0] |
Social | 44.4 (37.0) | 65.7 (36.8) | 62.9 (36.8) |
p = 0.004 (2,34) F = 6.5 ES = 0.28 |
p = 0.03 [1.1–41.4] |
p = 0.01 [3.8–33.2] |
p = 1.0 [12.9–18.5] |
Symptoms
| |||||||
Fatigue | 40.7(24.9) | 33.9 (26.8) | 26.5(25.6) |
p = 0.02 (2,34) F = 4.2 ES = 0.2 |
p = 0.79 [8.8–22.4] |
p = 0.02 [1.4–27.0] |
p = 0.2 [2.7–17.5] |
Nausea | 12.9 (25.9) | 5.5 (9.9) | 8.3 (17.4) |
p = 0.2 (2,34) F = 1.6 ES = 0.1 |
p = 0.41 [5.1–19.9] |
p = 0.86 [−6.5–15.8] |
p = 1.0 [−11.7–6.2] |
Pain | 31.5 (32.3) | 29.9 (34.8) | 26.8 (30.3) |
p = 0.71 (2,34) F = 0.3 ES = 0.02 |
p = 1.0 [14.4–25.5] |
p = 1.0 [18.5–27.7] |
p = 1.0 [12.7–14.5] |
QLQ-H&N35 |
n = 25 (100%)
|
n = 22 (88%)
|
n = 22 (88%)
| ||||
Oral pain | 32.2 (19.8) | 23.3 (22.7) | 27.1 (21.9) |
p = 0.29 (2,38) F = 1.3, ES = 0.06 |
p = 0.29 [−4.0–19.8] |
p = 1.0 [−9.8–17.5] |
p = 1.0 [−17.3–9.8] |
Swallow | 45.8 (31.2) | 35.0 (26.0) | 28.3 (18.2) |
p = 0.006 (2,38) F = 5.9, ES = 0.24 |
p = 0.2 [−4.1–25.7] |
p = 0.01 [3.8–31.1] |
p = 0.46 [−5.1–18.4] |
Senses | 45.5 (29.4) | 32.5 (21.2) | 22.5 (26.6) |
p < 0.0001 (2,38) F = 10.7, ES = 0.36 |
p = 0.09 [−1.8–21.2] |
p = 0.003 [6.3–33.7] |
p = 0.02 [1.4–18.6] |
Speech | 40.8 (35.6) | 28.3 (35.9) | 20.8 (22.8) |
p = 0.01 (2,38) F = 5.1, ES = 0.21 |
p = 0.02 [1.1–28.9] |
p = 0.04 [0.8–39.2] |
p = 0.89 [−10.9–25.8] |
Social eating | 58.7 (37.8) | 36.1(27.0) | 38.3 (35.1) |
p = 0.006 (2,38) F = 5.9, ES = 0.24 |
p = 0.03 [1.2–44.1] |
p = 0.05 [−0.5–41.4] |
p = 1.0 [−16.0–11.6] |
Social context | 31.0 (25.9) | 16.3 (22.7) | 15.7 (17.5) |
p = 0.001 (2,38) F = 9.0, ES = 0.32 |
p = 0.01 [2.7–26.6] |
p = 0.004 [4.5–26.1] |
p = 1.0 [−8.6–9.9] |
Sexuality | 53.3 (44.1) | 48.3 (46.2) | 35.0 (46.1) |
p = 0.12 (2,38) F = 0.23, ES = 0.11 |
p = 1.0 [−21.8–31.8] |
p = 0.06 [−0.7–37.4] |
p = 0.47 [−10.3–37.0] |
CFS |
n = 25 (100%)
|
n = 24 (96%)
|
n = 22 (88%)
| ||||
20.3 (5.0) | 16.2 (6.8) | 15.9 (5.9) |
p = 0.002 (2,42) F = 7.3, ES = 0.39 |
p = 0.04 [0.1–8.1] |
p = 0.04 [0.1–8.1] |
p = 1.0 [2.5–2.9] | |
WASA |
n = 25 (100%)
|
n = 23 (92%)
|
n = 22 (88%)
| ||||
20.0 (9.2) | 13.9(11.6) | 16.9 (22.5) |
p = 0.34(2,40) F = 1.1, ES = 0.05* |
p = 0.07 [0.5–12.7] |
p = 1.0 [9.2–15.3] |
p = 1.0 [9.2–15.3] | |
HADS |
n = 25 (100%)
|
n = 23 (92%)
|
n = 22 (88%)
| ||||
Anxiety | 6.9 (4.9) | 6.6 (5.9) | 5.9 (4.1) |
p = 0.54 (2,38) F = 0.6, ES = 0.03 |
p = 1.0 [−1.8–2.7] |
p = 0.8 [−1.4–3.3] |
p = 1.0 [−1.6–2.6] |
Depression | 6.0 (3.4) | 5.6 (4.1) | 4.9(4.1) |
p = 0.49 (2,38) F = 0.7, ES = 0.37 |
p = 1.0 [−2.0–2.8] |
p = 0.78 [−1.4–3.6] |
p = 1.0 [−1.6–3.0] |
Total | 12.8 (7.1) | 12.0 (9.6) | 10.8 (3.4) |
p = 0.38 (2,38) F = 1.0, ES = 0.05 |
p = 1.0 [−2.9–4.6] |
p = 0.58 [−1.9–6.0] |
p = 1.0 [−2.7–5.1] |
PSS Diet |
n = 25 (100%)
|
n = 25 (100%)
|
n = 24 (96%)
| ||||
39.2 (19.9) | 55.0 (14.4) | 61.3 (18.5) |
p < 0.0001 (2,46) F = 15.0, ES = 0.4* |
p = 0.002 [5.3–26.4] |
p = 0.001 [8.3–35.8] |
p = 0.8 [0.4–12.9] | |
Feeding tube |
n = 30
|
n = 25
|
n = 25
| ||||
None | 14 (56%) | 22 (88%) | 22 (88%) | ||||
Nasogastric | 9 (30%) | 1 (4%) | 0 | ||||
Gastrostomy | 7 (24%) | 2 (8%) | 3 (12%) |
Feasibility and acceptability as measured by participant interviews
Gender | |
---|---|
Male | 9 |
Female | 3 |
Age | 61 (range 49–70) |
Disease site | |
Oropharynx | 8 |
Oral | 1 |
Nasopharynx | 2 |
Larynx | 1 |
T Stage | |
2 | 5 |
3 | 5 |
4 | 2 |
Node stage | |
0 | 2 |
1 | 3 |
2 | 7 |
Treatment | |
Chemoradiotherapy | 9 |
Surgery and radiotherapy +/− chemotherapy | 3 |
Time post-treatment (months) | Median 5 range 1–60 |
MDADI pre to post CB-EST | |
Decreased (4–19 points) | 3 |
Similar (0–4 points) | 3 |
Increased (5–36 points) | 6 |
Duration and frequency
‘The timeframe between that was just balanced nicely and allowed me to kind of make those plans and have an experience to then come back and talk about it, so yeah it worked well’ (S3 aged 51 yrs).
Timing
‘Maybe it should be part of the initial journey and treatment … not everybody might take it but at least it is there isn’t it’ (S7 aged 61 years).
Suitability
‘It will not fit everybody. Some people probably won’t want to sit there and say about their life and say how your wife was in tears and say how you were in tears and talk about things like that‘(S10 aged 54 years).