Short-term integrated rehabilitation for people with newly diagnosed thoracic cancer: a multi-centre randomized controlled feasibility trial

Our plain-English summary of Short-term integrated rehabilitation for people with newly diagnosed thoracic cancer: a multi-centre randomized controlled feasibility trial, by J. Bayly, L. Fettes, E. Douglas, et al (Clinical Rehabilitation, 2020).

The study

• Authors: J. Bayly, L. Fettes, E. Douglas, M.J. Teixiera, N. Peat, I. Tunnard, V. Patel, W. Gao, A. Wilcock, I.J. Higginson, M. Maddocks
• Journal: Clinical Rehabilitation
• Published: 2020;34(2):205-219
• Type of article: Randomized trial
• Cited by: 8 articles, as counted by NIH iCite
• Read it: PubMed · Publisher

Abstract

Objectives: The main objective of this study is to determine the feasibility of recruiting and retaining patients recently diagnosed with thoracic cancer to a trial of short-term integrated rehabilitation; evaluate uptake of theoretically informed components targeting physical function, symptom self-management and participation; estimate sample size requirements for an efficacy trial.

Design: Parallel group randomized controlled feasibility trial.

Setting: Three U.K. hospitals.

Participants: Patients ⩽eight weeks of thoracic cancer diagnosis, Eastern Cooperative Oncology Group Performance Status 0-3, any cancer stage and treatment plan.

Interventions: Participants randomly allocated (1:1) to short-term integrated rehabilitation and standard care or standard care alone over 30 days.

Main Measures: Primary: participant recruitment and retention, targeting ⩾30% of eligible patients enrolling and ⩾50% of participants reporting outcomes at 30 days. Secondary: intervention fidelity; missing data and performance of outcome measures for self-efficacy, symptoms, physical activity and health-related quality of life.

Results: Of 159 eligible patients approached, 54 (34%) were recruited. A total of 44 (82%) and 39 (72%) participants reported outcomes at 30 and 60 days, respectively. Intervention fidelity was high. Rehabilitation was delivered across 3 (1-3) sessions over 32 (22-45) days (median (range)). Changes in clinical outcomes were modest but most apparent at 60 days for health-related quality of life: Functional Assessment of Cancer Therapy Lung Cancer score median (interquartile range) change 9.7 (-12.0 to 16.0) rehabilitation versus 2.3 (-15.0 to 14.5) standard care.

Conclusion: A trial to examine efficacy of short-term integrated rehabilitation for people newly diagnosed with thoracic cancer is feasible. A sample of 336 participants could detect a meaningful effect on health-related quality of life as the primary outcome.

In plain English

This was a randomized feasibility trial at three U.K. hospitals. It tested whether a larger trial of a short rehabilitation programme for people newly diagnosed with thoracic cancer could be run. It did not study asbestos exposure. Of 374 patients screened, 159 were eligible and 54 (34%) enrolled. Five had pleural mesothelioma; the rest had lung cancer or neuroendocrine tumours. Participants were randomly assigned to standard care alone (28 people) or standard care plus up to three sessions with a physiotherapist (26 people). The sessions covered symptom self-management, physical activity and daily activities. Outcome questionnaires were returned by 82% of participants at 30 days and 72% at 60 days. No serious adverse events related to the intervention occurred. Changes in outcomes were modest and were not tested statistically. At 60 days, a quality-of-life score (FACT-Lung) had improved by a median of 9.7 in the rehabilitation group, compared with 2.3 in the standard care group. The authors concluded that a full trial is feasible and estimated it would need 336 participants. They noted that all mesothelioma participants had been assigned to standard 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: Multi-centre parallel group randomized controlled feasibility trial (1:1 allocation), not designed to test effectiveness
• Who was studied: 54 adults within eight weeks of a diagnosis of primary lung cancer (stage I to IV) or pleural mesothelioma, recruited at three U.K. hospitals (two in London, one in Nottingham), February 2018 to January 2019. 28 were in standard care and 26 in rehabilitation. 5 had pleural mesothelioma, all in the standard care group.
• Exposure: No asbestos exposure was studied. The comparison was short-term integrated rehabilitation (up to three sessions with a physiotherapist over six weeks) plus standard care, versus standard care alone.
• Main results:
  • Recruitment: of 374 patients screened, 159 (42%) were eligible and 54 (34%) enrolled, meeting the target of at least 30%.
  • Retention: 82% of participants returned outcome measures at 30 days and 72% at 60 days.
  • Among the 26 rehabilitation participants, 69 sessions were delivered (median three per participant), and 21 (84%) attended all three sessions.
  • No serious adverse events related to the intervention occurred.
  • At 60 days, the median (interquartile range) change in FACT-Lung quality-of-life score was 9.7 (-12.0 to 16.0) in the rehabilitation group versus 2.3 (-15.0 to 14.5) in the standard care group. No significance testing was done.
  • All pleural mesothelioma participants (5 of 54) were randomized to standard care.
  • The estimated sample size for a future efficacy trial was 336 participants, assuming a 6-point FACT-Lung difference and 25% attrition.
• The authors' conclusion: The authors concluded that a trial to examine the efficacy of short-term integrated rehabilitation for people newly diagnosed with thoracic cancer is feasible, and that 336 participants could detect a meaningful effect on health-related quality of life.
• Limitations the authors state:
  • The trial did not aim to test effectiveness, and no inferential statistical tests were done.
  • All mesothelioma participants were randomized to standard care. The authors suggested balancing for diagnosis in a larger trial.
  • Few participants with poorer performance status (2 to 3) were recruited.
  • Missing or unclear service-use data made access to rehabilitation services hard to evaluate.
  • Integration with other oncology services was harder than anticipated.

Topics

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

Medical terms in this study, explained in our Lexicon: Performance Status, Quality of Life, Lung Cancer.

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