Study

Results

Quality Assessment

Bredin 1999

At eight weeks there was a favourable effect of the intervention on breathlessness at best (median change from baseline: IG = 1.3 (‐7.1 to 8) versus CG = 7 (‐3.3 to 8); p = 0.03), WHO performance status (median change: IG = 0 (‐3‐3) versus CG = 2 (‐1‐3); p = 0.02), physical symptom distress (median change: IG = 2.5 (‐24 to 16) versus CG = 14 (‐11 to 16); p = 0.04) and depression (median change from baseline: IG = 0.5 (‐10 to 7) versus CG = 6 (‐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 subanalysis of three specific activities on the Rotterdam checklist showed a benefit in favour of the intervention group (stairclimbing, walking outdoors, and shopping; (IG = 0 (‐6 to 9) versus CG = 5.5 (‐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).

Randomisation: Adequate (independent office).
Allocation Concealment: Yes
Blinding: No.
Follow up reported: Yes
Sample size calculation: Yes.
Overall quality assessment: High.

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 (‐0.5 to 2.8) versus control group (CG) = ‐0.5 (‐5.7 to 1); p < 0.02) and at worst (IG = 3.5 (‐1 to 7) versus CG = 0 (‐5 to 4); p < 0.05), a decrease in the distress caused by breathlessness (IG = 5.3 (0 to 9) versus CG = ‐1 (‐4.5 to 3); p < 0.01), functional capacity (IG = 1.0 (‐0.5 to 2) versus CG = ‐0.25 (‐1 to 1), p < 0.02) and ability to undertake activities of daily living (IG = 3.0 (‐3 to 8) versus CG = 0 (‐3 to2); p < 0.03). No obvious survival difference between the two groups.

Randomisation: Not described
Randomisation concealment: Not described
Blinding: No.
Follow up reported: Yes
Sample size calculation: No.
Overall quality assessment: Low

Evans 1987

Results for lung cancer sample only:
The interventions were effective in increasing caloric intake (SG and AG = 91% vs CG = 62%; p < 0.0001).

Less weight loss in intervention group than in control group but difference not significant. (SG and AG = ‐1.2% vs 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 two 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.

Randomisation: Adequate (centralised office).
Allocation concealment: Yes.
Blinding: No.
Follow up reported: Yes.
Sample size calculation: No.

Overall quality assessment: high.

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 vs CG):
Depression: 10.8 vs 14.2; F = 7.69
Alienation: 3.2 vs 4.9; F = 4.68
Life satisfaction: 36 vs 48.1; F = 9.07
Self esteem: 43.4 vs 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

Randomisation: Adequate.
Allocation concealment: Adequate (sealed envelopes)
Blinding: Assessors blinded
Follow up reported: Data on one patient were lost
Sample size calculation: No

Overall quality assessment: Medium

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 two groups (OHC = 258 days; SHC = 317 days; OC = 272 days; NS).

Randomisation: Adequate (randomised block series in sealed envelopes).
Allocation concealment: Adequate.
Blinding: No.
Follow up reported: incomplete.
Sample size calculation: Yes.
Overall quality assessment: Medium.

Moore 2002

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.

Randomisation: Adequate (independent office).
Allocation concealment: Adequate.
Blinding: No.
Follow up: Yes
Sample size calculation Yes.
Overall quality assessment: High.

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, ES = 0.32;p = 0.0004).

Randomisation: Not reported
Allocation concealment: Not reported.
Blinding: No.
Follow up reported: Yes.
Sample size calculation: No.
Overall quality assessment: Low.

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 post‐intervention scores were lower than post‐control 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).

Randomisation: Adequate (coin toss).
Allocation concealment: No.
Blinding: No.
Follow up reported: No losses.
Sample size calculation: No.
Overall quality assessment: low.

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

Randomisation: Adequate (sealed envelopes).
Allocation concealment: Adequate.
Blinding: No.
Follow up reported: Yes
Sample size calculation: Yes.
Overall quality assessment: High.