A tailored, supportive care intervention using systematic assessment designed for people with inoperable lung cancer: a randomised controlled trial

Our plain-English summary of A tailored, supportive care intervention using systematic assessment designed for people with inoperable lung cancer: a randomised controlled trial, by P. Schofield, A. Ugalde, K. Gough, et al (Psycho-oncology, 2013).

The study

• Authors: P. Schofield, A. Ugalde, K. Gough, J. Reece, M. Krishnasamy, M. Carey, D. Ball, S. Aranda
• Journal: Psycho-oncology
• Published: 2013;22(11):2445-53
• Type of article: Randomized trial
• Cited by: 36 articles, as counted by NIH iCite
• Read it: PubMed · Publisher

Abstract

Objective: People with inoperable lung cancer experience higher levels of distress, more unmet needs and symptoms than other cancer patients. There is an urgent need to test innovative approaches to improve psychosocial and symptom outcomes in this group. This study tested the hypothesis that a tailored, multidisciplinary supportive care programme based on systematic needs assessment would reduce perceived unmet needs and distress and improve quality of life.

Methods: A randomised controlled trial design was used. The tailored intervention comprised two sessions at treatment commencement and completion. Sessions included a self-completed needs assessment, active listening, self-care education and communication of unmet psychosocial and symptom needs to the multidisciplinary team for management and referral. Outcomes were assessed with the Needs Assessment for Advanced Lung Cancer Patients, Hospital Anxiety and Depression Scale, Distress Thermometer and European Organization of Research and Treatment of Cancer Quality of Life Q-C30 V2.0.

Results: One hundred and eight patients with a diagnosis of inoperable lung or pleural cancer (including mesothelioma) were recruited from a specialist facility before the trial closed prematurely (original target 200). None of the primary contrasts of interest were significant (all p > 0.10), although change score analysis indicated a relative benefit from the intervention for unmet symptom needs at 8 and 12 weeks post-assessment (effect size = 0.55 and 0.40, respectively).

Conclusion: Although a novel approach, the hypothesis that the intervention would benefit perceived unmet needs, psychological morbidity, distress and health-related quality of life was not supported overall.

Copyright © 2013 John Wiley & Sons, Ltd.

In plain English

This randomised controlled trial tested a supportive care programme for people with inoperable lung or pleural cancer, including mesothelioma. It did not study asbestos exposure. Of 214 eligible patients, 108 were randomised: 55 to the programme, 53 to usual care. Six had mesothelioma, 3 in each group. The trial planned 200 participants but stopped recruiting early. The programme had two consultations, at the start and at the end of treatment. It included a needs assessment, active listening, self-care modules, and passing needs to the treating team. No main between-group comparison of unmet needs was statistically significant. Unmet symptom needs rose under usual care but changed little with the programme. Overall psychological morbidity (a total anxiety-and-depression score), distress and quality-of-life functioning did not differ significantly between groups. Three larger differences the authors highlighted (physical functioning at first follow-up, role and social functioning at second) all showed greater declines in the programme group. The authors concluded that their hypothesis was not supported overall. They noted the modest sample size, unmeasured adherence to self-care advice, and that the programme may not have differed enough from usual care.

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: Two-group randomised controlled trial (programme versus usual care), single institution
• Who was studied: Patients with inoperable lung or pleural cancer (including mesothelioma) at a specialist oncology facility in Australia, recruited April 2005 to November 2007. Of 214 eligible patients, 188 were approached and 111 consented. Three withdrew, leaving 108 randomised (55 intervention, 53 usual care).
• Exposure: Not an asbestos exposure study. What was tested was a tailored supportive care intervention: two consultations at the start and end of treatment, run by staff with psychology backgrounds. It included a systematic needs assessment, active listening, self-care modules and leaflets, and feedback of needs to the multidisciplinary team. The comparison group received usual hospital care.
• Main results:
  • Mesothelioma patients made up 3 of 53 (5.7%) in the usual care group and 3 of 55 (5.5%) in the intervention group. No separate results were reported for them.
  • Recruitment stopped at 111 participants rather than the planned 200.
  • None of the primary comparisons of unmet needs between groups at follow-up was statistically significant.
  • Change-score analysis showed a between-group difference in unmet symptom needs: 0.33 (effect size 0.55) at the first follow-up and 0.27 (effect size 0.40) at the second.
  • Unmet symptom needs increased from baseline in the usual care group, by 0.31 and 0.26 at the two follow-ups.
  • In the intervention group, unmet symptom needs changed very little from baseline: 0.03 and 0.01 at the two follow-ups.
  • Group differences in overall psychological morbidity (HADS total score) and in distress (Distress Thermometer) at follow-up were not statistically significant.
  • Group differences on the EORTC quality-of-life functioning scales at follow-up were not statistically significant.
  • The authors highlighted three larger between-group change-score differences: physical functioning at the first follow-up, and social and role functioning at the second. All three showed greater declines in the intervention group. These are separate from the other functioning scales, and none of the functioning comparisons was statistically significant.
• The authors' conclusion: The authors concluded that the hypothesis that the intervention would benefit perceived unmet needs, psychological morbidity, distress and health-related quality of life was not supported overall.
• Limitations the authors state:
  • The sample size was modest.
  • The authors state the study was unlikely to have been sufficiently powered to detect the expected effects.
  • Patients' adherence to self-care advice was not assessed.
  • The study was done at a single institution where patients already received coordinated care from an expert lung cancer nurse, so the intervention and usual care may not have differed enough.
  • The intervention 'dose' (the number, content or length of consultations) may not have been adequate.

Topics

The National Library of Medicine indexes this study under subjects our site covers: Lung cancer.

Medical terms in this study, explained in our Lexicon: Lung Cancer, Quality of Life, Multidisciplinary Team, Mesothelioma.

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