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Study flow diagram.
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Figure 1

Study flow diagram.

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Figure 2

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Figure 3
Table 1. Study Results

Study

Results

Arbane 2011

Length of stay, mean (SD):
IG: 8.9 (3.3); CG 11.0 (8.9) days; statistically not significant differences (P value not provided)

Postoperative complications (POC):
Two a priori POCs defined in the active group and 3 in the control group; statistically not significant differences (P value not provided)

Quality of life assessed by the EORTC QLQ‐CL13 questionnaire
No significant changes for any measure of quality of life (functional, symptom and global health), either within subjects or between groups (P values not provided). Data available from 22 patients in IG and 21 in CG; measurements preoperative and 12 weeks postoperative.

EORTC‐C30 (functional), mean (SD):
IG: 81.0 (14.1) to 79.1 (19.1); CG: 79.4 (18.0) to 76.7 (22.7)

EORTC‐C30 (symptom), mean (SD):
IG: 16.1 (16.0) to 18.5 (15.2); CG: 17.8 (15.4) to 21.0 (16.4)

EORTC‐C30 (global health), mean (SD):
IG: 74.7 (27.3) to 68.2 (15.3); CG: 70.2 (21.7) to 68.1 (25.1)

Exercise tolerance: the 6‐Minute Walking Distance (6MWD), in metres:
Data available from 21 patients in IG and 16 in CG; measurements preoperative and 12 weeks postoperative. Mean (SD), IG: 466.6 (102.10) to 480.2 (110.0); CG: 455.7 (98.0) to 448.2 (95.1); (P = 0.47)

Quadriceps strength, in kg:
Data available from 17 patients in IG and 13 in CG; measurements preoperative and 12 weeks postoperative. Mean (SD), IG: 33.2 (15.2) to 34.2 (9.4); CG: 29.1 (10.9) to 26.4 (9.7); (P = 0.04 between groups).

Barton 2010

Patients’ self reported outcomes:
Mean (SD) change from baseline to week 4, based on 5 patients in single‐session group and 6 in 3‐session group. A negative change represents an improvement from baseline. Authors do not present estimates of statistical significance and P values, stating that their aims were to assess feasibility and to look for variability to power a larger RCT.

Breathlessness:
Measured by mean area under curve (AUC) from baseline to week 4 and by mean change of numerical rating scale (NRS) from baseline to week 4

Average breathlessness:
Mean AUC single session 4.7; 3 sessions 3.6 (SD 2.3); NRS single session 0.8; 3 sessions ‐2.5 (SD 3.2)

Worst breathlessness:
Mean AUC single session 5.2; 3 sessions 3.8 (SD 2.6); NRS single session ‐1.0; 3sessions ‐3.0 (SD 2.5)

Breathlessness now:
Mean AUC single session 4.2; 3 sessions 3.2 (SD 2.5); NRS single session 1.8; 3 sessions ‐3.0 (SD 1.8)

Distress from breathlessness:
Mean AUC single session 2.4; 3 sessions 2.2 (SD 2.1); NRS single session 0.0; 3 sessions 1.2 (SD 2.2)

Coping with breathlessness:
Mean AUC single session 7.2; 3 sessions 6.7 (SD 1.3); NRS single session ‐2.0; 3 sessions 3.2 (SD 4.3)

Satisfaction with care:
Mean AUC single session 8.4; 3 sessions 9.3 (SD 0.9); NRS single session 0.6; 3 sessions 1.5 (SD 1.8)

Anxiety:
Single session 0.20 (SD 4.60); 3 sessions ‐1.50 (SD 5.09)

Depression:
Single session 0.40 (SD 2.07); 3 sessions ‐2.33 (SD 3.01)

Coping strategy:
Adaptive: single session) ‐0.40 (SD 4.22); 3 sessions‐0.00 (SD 7.10). Maladaptive: single session ‐1.80 (SD 4.44); 3 sessions ‐0.83 (SD 5.98)

Quality of life and functional status:
An EQ‐5D index was calculated, but not interpretable on so few data. EQ‐5D. EQ‐VAS scores appeared to improve in the 3‐session group but were stable in the single group, but detailed data not provided.

Bredin 1999

At 8 weeks there was a favourable effect of the intervention on breathlessness at best (median change from baseline: IG = 1.3 (range: ‐7.1 to 8) versus CG = 7 (range: ‐3.3 to 8); P = 0.03), WHO performance status (median change: IG = 0 (range: ‐3 to 3) versus CG = 2 (range: ‐1 to 3); P = 0.02), physical symptom distress (median change: IG = 2.5 (range: ‐24 to 16) versus CG = 14 (range: ‐11 to 16); P = 0.04) and depression (median change from baseline: IG = 0.5 (range: ‐10 to 7) versus CG = 6 (range: ‐7 to 7); P = 0.02). Less increase in distress due to breathlessness (primary outcome) in the intervention group compared with the control group but this did not reach statistical significance (P = 0.09)
No significant differences between groups in overall activity levels although a sub‐analysis of 3 specific activities on the Rotterdam checklist showed a benefit in favour of the intervention group (stair‐climbing, walking outdoors and shopping; (IG = 0 (range: ‐6 to 9) versus CG = 5.5 (range:‐3 to 9); P = 0.05))
No significant differences between groups in breathlessness at worst, psychological distress and overall quality of life
Survival in patients who left the study was worse in the control group than in the intervention group (HR = 2.5; P < 0.05)

Chan 2011

Symptom cluster. Doubly multivariate analysis of variance revealed a significant difference (time x group interaction effect, P = 0.003) over time between the IG and CG on the pattern of change of the symptom cluster. Significant effects on the patterns of changes in breathlessness (P = 0.002), fatigue (P = 0.011), anxiety (P = 0.001) and functional ability (P = 0.000). Estimates of the effect not provided.

Corner 1996

Significant improvements from baseline in self reported breathlessness at worst, distress caused by breathlessness and functional capacity after 12 weeks in the intervention group whereas median scores in the control group were either static or worsened. Comparison of improvements from baseline between groups showed significant improvements in favour of the intervention group for breathlessness at best (intervention group (IG) = 0.5 (range: ‐0.5 to 2.8) versus control group (CG) = ‐0.5 (range: ‐5.7 to 1); P < 0.02) and at worst (IG = 3.5 (range: ‐1 to 7) versus CG = 0 (range: ‐5 to 4); P < 0.05), a decrease in the distress caused by breathlessness (IG = 5.3 (range: 0 to 9) versus CG = ‐1 (range: ‐4.5 to 3); P < 0.01), functional capacity (IG = 1.0 (range: ‐0.5 to 2) versus CG = ‐0.25 (range: ‐1 to 1), P < 0.02) and ability to undertake activities of daily living (IG = 3.0 (range: ‐3 to 8) versus CG = 0 (range: ‐3 to2); P < 0.03). No obvious survival difference between the 2 groups.

Evans 1987

Results for lung cancer sample only:
The interventions were effective in increasing caloric intake (SG and AG = 91% versus CG = 62%; P < 0.0001)
Less weight loss in intervention group than in control group but difference not significant (SG and AG = ‐1.2% versus CG = ‐3.1%; P = 0.6)
No significant differences between groups in tumour response (SG = 27.5%; AG = 20%; CG = 14.7%)
Survival similar in all groups (SG = 8 months; AG = 7 months; GC = 6 months). No significant differences between control and intervention even when both intervention groups combined (P > 0.2).
Although 60% of patients in both control groups required enteral nutrition by protocol only 10% in the SG and 7% in the AG received it. The main reason for which was patient refusal.
Median survival times similar: (CG = 6 months; SG = 8 months; AG = 7 months) with no significant differences between control and intervention groups even when data from the 2 intervention groups were combined (P > 0.2). There were no significant differences between any of the groups in either the percent of target dose of chemotherapy achieved or in the degrees of toxicity experienced.

Linn 1982

Quality of life 3 months: significant differences (P < 0.05) in mean scores in favour of intervention group for following 4/5 QOL variables (IG versus CG):
Depression:
10.8 versus 14.2; F = 7.69
Alienation:
3.2 versus 4.9; F = 4.68
Life satisfaction:
36 versus 48.1; F = 9.07
Self esteem:
43.4 versus 56.3; F = 8.23 (higher mean score indicates less favourable response)
12 months:
Significant differences (< 0.05) for all QOL variables in favour of intervention group
F‐ratio for multivariate difference = 18.78 (P < 0.001)
Functional status and degree of impairment: no significant differences
Survival: no significant differences

McCorkle 1989

Patients in the office care group experienced worsening of symptom distress one occasion (6 weeks) earlier than the 2 intervention groups (multivariate difference in adjusted symptom distress scale scores F = 5.01, df = 1.6; P = 0.03)
A similar difference was seen for social dependency. Both intervention groups were similar but patients in the office care group deteriorated 6 weeks earlier (multivariate difference in enforced social dependency scores: F = 5.72, df = 1.6; P = 0.02)
Compared with the intervention groups, the control group showed a significant improvement in self perceived health (F = 4.06, gl = 1.5; P = 0.05)
OHC group had fewer hospitalisations than the other groups (mean hospitalisations: OHC = 2.08; SHC = 2.82; OC = 2.62; not significant (NS)) but mean length of stay for those patients who were admitted was longer in the OHC (mean length hospital stay OHC = 18.4 days (SD 19.7); SHC = 17.6 (SD17.7); OC = 13.6 (SD 10.3); NS). Total length of stay in the OHC group was lower than in the other 2 groups (OHC = 258 days; SHC = 317 days; OC = 272 days; NS).

Moore 2002

Values are medians (interquartile range)

At 3 months:
‐ dyspnoea in IG patients significantly lower than the control group: (IG = 25 (16.7 to 41.7) versus CG = 33.3 (25 to 58.3); P = 0.03)
‐ greater satisfaction with care in IG, shown by higher scores (P < 0.005) on all satisfaction subscales
78% of IG patients said that they would prefer nurse care if they had to choose, compared with 17% of CG patients who said they would prefer medical attention
At 12 months: IG patients reported significantly better emotional functioning (IG = 91.7 (66.7 to 100) versus CG = 66.7 (54.2 to 87.5); P = 0.03) and less peripheral neuropathy (IG = 0 versus CG = 0 (0 to 33.3); P = 0.05). No significant survival differences between groups but there was evidence that symptomatic progression was detected sooner by the nurses than the doctors.
No significant differences between groups in overall costs but the intervention changed the pattern of resource use: IG patients had fewer hospital consultations at 3 months (P = 0.004), fewer radiographs taken at 3 months (P = 0.04) and at 6 months (P = 0.03), and were more likely to have had radiotherapy treatment at 3 months (P = 0.01). More IG patients died at home (IG = 40% versus CG = 23%; P = 0.04). The cost of the nurse programme was estimated to be 150 pounds sterling per patient per month of follow‐up.

Porter 2011

Analyses of patient outcome measures indicated significant main effects of time for ratings of worst pain (B = ‐ 0.15, SE = 0.13, P = 0.02); physical well‐being (B = 0.84, SE = 0.22, P = 0.0002); functional well‐being (B = 0.55, SE = 0.22, P = 0.03); lung cancer symptoms (B = 0.76, SE = 0.21, P = 0.0003); depression (B = 0.55, SE = 0.28, P = 0.05); and self efficacy (B = 2.31, SE = 1.03, P = 0.02)
Patients in both CST and education/support reported improvements over time in their worst pain ratings, their physical and functional well‐being, their lung cancer symptoms, their depressive symptoms and their self efficacy for controlling symptoms. There were no significant time intervention interactions.

Sarna 1998

A multivariate model showed that systematic symptom assessment was associated with less symptom distress over time: regression coefficient (in units of the symptom distress scale) = ‐1.20, standard error (SE) = 0.32, P = 0.0004). No significant relationship between the course of symptom distress and group assignment was seen on bivariate analyses of symptom distress scores with potential predictors over time (r = ‐1.20, SE = 0.32; P = 0.0004).

Stephenson 2000

Mean pre‐intervention scores for anxiety were higher than the pre‐control time scores: 53.60 (SD = 30.6) versus 39.60 (SD = 29.96) but mean postintervention scores were lower than postcontrol time scores: 20 (SD = 22.36) versus 33.60 (SD = 24.94)
Statistically significant reduction in anxiety scores after reflexology compared with before (post‐/pre‐score difference = ‐33.6; P = 0.002)
Reduction in anxiety score at the end of the control time compared with at the beginning, but not significant (post‐/initial score difference = ‐6; P = 0.99)
Difference in score reduction between control and intervention groups significant (difference = ‐27.6; P = 0.02)

Stephenson 2007

The reflexology group showed a 34% reduction in pain after intervention compared to the control group's 2% reduction; 19% of the experimental group and 11% in the control group experienced pain reduction of 2 or more scale points on the 10‐point scale. In the subgroup of patients with moderate to severe pain scores prior to treatment, the reflexology group experienced a 37% reduction in pain compared to a 6% reduction in the control group; in this subgroup 50% of the of the experimental group and 20% in the control group experienced pain reduction of 2 or more scale points

Anxiety scores for the total group showed a 62% improvement in the reflexology group compared to 23% in the control group; 48% of the experimental group and 32% in the control group experienced anxiety score reduction of 2 or more scale points on the 10‐point scale

In the moderate to severe anxiety subgroups, scores decreased by 67% compared with the control group's 31% reduction; and 74% of the experimental group and 44% in the control group experienced anxiety score reduction of 2 or more scale points on the 10‐point scale

Wall 2000

No significant differences (P = 0.08) for hope between the intervention and the control group either at baseline or at any time thereafter
No significant differences between groups in power at baseline but differences were observed at both time 2 and time 3 showing a beneficial effect over time on power, of participation in the exercise programme (F(2) = 12.09; P < 0.001). Patients in the intervention group showed significant increases in power between baseline and time 2 (t(51) = ‐2068; P = 0.01), but not between time 2 and time 3 (P = 0.07). There was a steady increase in power between time 1 and time 3 in this group (t(48) = ‐3.73; P = 0.001). Power decreased in the control group between baseline and time 2 (t(50) = 2.72; P < 0.01), and this decrease was sustained between time 2 and time 3.
No statistically significant differences between groups were found for the relation of hope and power

Wilkie 2010

Pain prescriptions, adequate analgesia, based on 76 patients in IG and 75 in CG:
IG 84%, CG 76% (P = 0.32) at the end of the study

Pain relief: based on 76 patients in IG and 75 in CG:

VAS pain relief scores (SD) at baseline and at the end of the study: IG from 66.5 (31) to 72.4 (28) (P = 0.37), CG from 66.8 (34)  to 75.8 (24)

VAS present pain intensity IG from 22.3 (22) to 24.3 (25), CG from 17.4 (19) to 19.4 (23) (P = 0.46)

MPQ pain quality scores (SD):

PRI – Sensory: IG from 11.5 (7.8) to 8.0 (7.4), CG from 9.7 (8.3) to 8.0 (8.9) (P = 0.48)

PRI – Affective: IG from 1.6 (2.0) to 0.8 (1.4), CG from 1.1 (1.8) to 1.0 (2.1) (P = 0.08)

PRI – Evaluative: IG from 1.8 (1.7) to 1.2 (1.4), CG from 1.4 (1.5) to 1.1 (1.4) (P = 0.79)

PRI – Miscellaneous: IG from 3.04 (3.14) to 1.47 (2.27), CG from 2.39 (2.79) to 2.41 (3.67) (P = 0.01)

PRI – Total: IG from 17.8 (12.5) to 11.4 (10.7), CG from 14.6 (12.6) to 12.5 (14.7) (P = 0.13)

Emotional status and coping

Detailed data not provided. Catastrophising coping, anxiety and depression scores were similar in the 2 study groups, both at baseline and study end. Catastrophising coping scores decreased slightly more in the coached group than in the not‐coached group, but not significantly so.

Those coached are more likely than those not coached to give their providers unsolicited sensory pain information and to mention it before their providers ask for it. The mean number of pain parameters discussed during the audiotaped clinic visit is statistically larger at study end for the coached group.

6MWD: Six‐Minute Walking Distance
AG: augmented nutrition group
CG: control group
CST: coping skills training
EORTC: European Organisation for Research and Treatment of Cancer
HR: hazard ratio
IG: intervention group
NRS: numerical rating scale
OC: Office Care Programme
OHC: Specialised Oncology Home Care Programme
PRI: Pain Relief Inventory
QOL: quality of life
RCT: randomised controlled trial
SD: standard deviation
SE: standard error
SG: standard nutrition group
SHC: Standard Home Care Programme
VAS: visual analogue scale
WHO: World health Organization

Figuras y tablas -
Table 1. Study Results