A Randomized Controlled Trial of a Non-pharmacological Intervention for Cancer-Related Dyspnea

Our plain-English summary of A Randomized Controlled Trial of a Non-pharmacological Intervention for Cancer-Related Dyspnea, by P. Yates, J. Hardy, A. Clavarino, et al (Frontiers in Oncology, 2020).

The study

• Authors: P. Yates, J. Hardy, A. Clavarino, K.M. Fong, G. Mitchell, H. Skerman, V. Brunelli, I. Zhao
• Journal: Frontiers in Oncology
• Published: 2020;10:591610
• Cited by: 15 articles, as counted by NIH iCite
• Read it: PubMed · Publisher · Free full text

Abstract

Objectives: To evaluate the efficacy of a brief tailored non-pharmacological intervention comprising breathing retraining and psychosocial support for managing dyspnea in cancer patients. Design: Multicenter, single blinded, parallel group, randomized controlled trial. Setting: Four major public hospitals, Brisbane, Australia. Participants: One hundred and forty four cancer patients, including 81 who received an 8-week tailored intervention and 63 who received standard care. Inclusion Criteria: Diagnosis of small or non-small cell lung cancer, mesothelioma or lung metastases; completed first line therapy for the disease; average dyspnea rating >2 on (0-10) rating scale in past week; anticipated life expectancy ≥3 months. Outcomes: The primary outcome measure was change in "worst" dyspnea at 8 weeks compared to baseline. Secondary outcomes were change in: dyspnea "at best" and "on average"; distress; perceived control over dyspnea; functional status, psychological distress; and use of non-pharmacological interventions to manage dyspnea at 8 weeks relative to baseline. Results: The mean age of participants was 67.9 (SD = 9.6) years. Compared to the control group, the intervention group demonstrated a statistically significant: (i) improvement in average dyspnea from T1(M = 4.5, SE = 0.22) to T3 (M = 3.6, SE = 0.24) vs. (M = 3.8, SE = 0.24) to (M = 4.1, SE = 0.26); (ii) greater control over dyspnea from T1 (M = 5.7, SE = 0.28) to T3 (M = 7.5, SE = 0.31) vs. (M = 6.8, SE = 0.32) to (M = 6.6, SE = 0.33); and (iii) greater reduction in anxiety from T1 (M = 5.4, SE = 0.43) to T3 (M = 4.5, SE = 0.45) vs. (M = 4.2, SE = 0.49) to (M = 4.6, SE = 0.50). This study found no intervention effect for best and worst dyspnea, distress from breathlessness, functional status, and depression over time. Conclusions: This study demonstrates efficacy of tailored non-pharmacological interventions in improving dyspnea on average, control over dyspnea, and anxiety for cancer patients. Clinical Trial Registration: The trial is registered at the Australian New Zealand Clinical Trials Registry (http://www.anzctr.org.au). The registration number is ACTRN12607000087459.

Copyright © 2020 Yates, Hardy, Clavarino, Fong, Mitchell, Skerman, Brunelli and Zhao.

In plain English

This was a randomized controlled trial at four public hospitals in Brisbane, Australia. Between March 2008 and January 2011, 144 adults were enrolled. All had lung cancer, mesothelioma or lung metastases and were still breathless after first-line treatment. Of these, 81 were randomly assigned to a nurse-delivered program and 63 to standard care. Thirteen had mesothelioma; their results were not reported separately. The program combined breathing retraining with psychosocial support: a face-to-face session of about 60 minutes, then three weekly phone calls. Change in the main outcome, breathlessness at its worst, from the start to 8 weeks did not differ significantly between the groups (p = 0.70). The intervention group improved significantly more in average breathlessness (p = 0.018), control over breathlessness (p = 0.001) and anxiety (p = 0.025). They also used more of the recommended non-drug strategies. Depression and functional status did not differ significantly. By 8 weeks, 27 participants (19%) had left the study. The authors concluded the program improved average breathlessness, control over breathlessness and anxiety. They noted the control group fell short of its planned size and rural patients might differ.

We wrote this plain-English summary from the full article with the help of AI, and a second AI model checked each sentence against the article. It is not the authors' wording; the abstract and the article are their own account.

What the study did and found

• Design: Multicenter, single blind, parallel group, randomized controlled trial (outcome assessors and data analysts blinded; participants aware of their group)
• Who was studied: 144 patients recruited at four major public hospitals in Brisbane, Australia, March 2008 to January 2011. All had small cell or non-small cell lung cancer, mesothelioma or lung metastases, had completed first-line therapy, had an average dyspnea rating above 2 on a 0 to 10 scale and had a life expectancy of at least 3 months. 81 were randomized to the intervention and 63 to standard care.
• Exposure: Not an asbestos exposure study. The factor studied was a brief tailored nurse-delivered non-pharmacological intervention (breathing retraining plus individualized psychosocial support, with take-home materials), compared with standard care. Both groups received education on managing dyspnea and continued usual care.
• Main results:
  • Baseline: 13 of 144 participants (9.0%) had mesothelioma as their primary cancer diagnosis (7 in the intervention group, 6 in the control group). Results were not reported separately for them.
  • Primary outcome, dyspnea at worst: there was no statistically significant difference between groups in change over time (p = 0.70). The mean difference between the intervention and control groups at 8 weeks relative to baseline was −0.38 (95% CI −1.30 to 0.53).
  • Dyspnea on average improved only in the intervention group (p = 0.018). The improvement relative to baseline and the control group at 8 weeks was 1.15 points on the 0 to 10 scale.
  • Perceived control over dyspnea improved significantly in the intervention group compared with the control group at 8 weeks (p = 0.001). The difference relative to baseline and the control group was 1.92 points.
  • Anxiety: there was a significant change between groups over time (p = 0.025). The intervention group had a greater reduction at 8 weeks (mean difference −1.3; 95% CI −2.38 to −0.25).
  • Depression: no statistically significant difference between groups over time (p = 0.20).
  • Functional status (ECOG): no significant difference between groups over time (p = 0.41 in the text). The odds ratio at 8 weeks was 0.87 (CI 0.53 to 1.41).
  • Dyspnea at best: the group-by-time interaction was close to significance (p = 0.06).
  • Distress caused by dyspnea: the group-by-time interaction was not significant (p = 0.07). The authors reported that the greater improvement in the intervention group at 8 weeks was statistically significant (mean difference −1.40, 95% CI −2.60 to −0.21).
  • Use of non-pharmacological strategies: the difference between groups over time was significant (p = 0.014). The intervention group used more strategies at 8 weeks (mean difference 1.25; 95% CI 0.82 to 1.68).
  • Attrition at 8 weeks was 19% (27 participants: 18 in the intervention group and 9 in the control group). The main reason was that participants were too unwell or had died.
• The authors' conclusion: The authors concluded that patients receiving the brief tailored nurse-delivered intervention showed improvement in average dyspnea, greater control over dyspnea and reduced anxiety over time.
• Limitations the authors state:
  • Participants came from major metropolitan hospitals and may differ from patients in rural and remote areas, so the results might not generalize.
  • The group sizes were imbalanced, most likely because simple 1:1 randomization was used rather than blocked randomization.
  • The control group did not reach the minimum planned size of 71 participants, giving slightly less than 90% power.
  • Possible drop-out bias, given 19% attrition at 8 weeks.
  • Possible time-related bias, given the long recruitment period.

Topics

Medical terms in this study, explained in our Lexicon: Dyspnea, Non-Small Cell Lung Cancer, Mesothelioma, Life Expectancy, Clinical Trial.

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