Yorke, J., Lloyd-Williams, M., Smith, J., Blackhall, F., Harle, A., Warden, J., . . . & Molassiotis, A. (2015). Management of the respiratory distress symptom cluster in lung cancer: A randomised controlled feasibility trial. Supportive Care in Cancer, 23, 3373–3384. 

DOI Link

Study Purpose

To test the feasibility of a new nonpharmacologic intervention to manage the symptom cluster of respiratory distress including breathlessness, cough, and fatigue in patients with lung cancer

Intervention Characteristics/Basic Study Process

Participants received psychoeducational counseling, which consisted of controlled breathing techniques, cough-easing techniques, acupressure, and supplementary information. Participants attended two one-hour face-to-face teaching sessions, the second session given one week after the first, and then received a telephone call two weeks after the second session. The interventions were delivered by a complementary therapy team. The training for the team consisted of one three-hour face-to-face session and a follow-up refresher at the half point of the trial. Participants were asked to complete a daily diary for the first four weeks and then weekly until week 12. Participants were also asked to assess and document the usefulness of each core component or intervention; and to practice breathing and calming techniques twice a day, use education for identifying warning signs of a cough, use a modified swallow technique and relaxed throat breathing, apply pressure to identified acupressure points for one minute at least twice a day, and review information in an information packet.

Sample Characteristics

  • N = 101   
  • AGE = 67.7 years
  • MALES: 47%, FEMALES: 53%
  • CURRENT TREATMENT: Not applicable
  • KEY DISEASE CHARACTERISTICS: Primary lung cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: Participants with an expected prognosis of at least three months, a World Health Organization (WHO) performance status of 0–2, and who were bothered with two of the cluster symptoms (breathlessness, cough, fatigue)

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Outpatient    
  • LOCATION: Two specialist cancer settings and two general hospitals in northern England

Phase of Care and Clinical Applications

  • PHASE OF CARE: Multiple phases of care
  • APPLICATIONS: Palliative care 

Study Design

  • Randomized, controlled trial comparing the intervention group and the control group

Measurement Instruments/Methods

Participants were randomized to either the control arm or intervention (RDSI) arm. Outcome assessments were collected at baseline, week 4, and week 12 at the end of the study. Breathlessness was measured using numerical rating scales and the dyspnea-12 scale, cough was assessed using the Manchester Cough in Lung Cancer scale (MCLC), and fatigue was assessed using Functional Assessment of Cancer Therapy–Fatigue (FACIT-F). In addition, the EQ-5D-3L was used to describe the value of quality of life (QOL), and the Hospital Anxiety and Depression Scale (HADS) was used to measure anxiety and depression.

Results

Numerical rating scales were scored lowest for ease of use and relevance, and EQ-5D-3L was scored best for ease of use and relevance. Patients rated dyspnea-12 better for ease of completion and relevance, and EQ-5D-3L and HADS demonstrated a positive pattern in improvement for the intervention group. Participants reported a high adherence to interventions with breathing exercises and acupressure, and the lower use of cough-easing techniques was likely related to the lower number of participants bothered by cough in the intervention group. The majority of participants responded favorably to breathing exercises in responses, stating that it was useful at least a little bit, and cough and acupuncture responses also were favorable but had a higher number of responses saying that it was not useful at all. No significant difference existed in breathlessness between groups.

Conclusions

This study demonstrated the feasibility and acceptability of nonpharmacologic interventions to manage symptoms of breathlessness, cough, and fatigue in patients with lung cancer. The study gave insight to the best tools/instruments to measure outcomes for larger trials that will determine improved patient outcomes with interventions. This study also revealed patients' willingness to learn new strategies and complete study requirements for data collection. The results trended better outcomes in the treatment group, but the trial was not large enough to draw conclusions.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Findings not generalizable
  • Subject withdrawals ≥ 10% 
  • The sample size calculation indicated that a larger sample size is needed to determine whether or not the intervention resulted in improved patient outcomes and is cost-effective compared to the control group.

Nursing Implications

Nurses play an important role in identifying and managing patients with the respiratory distress symptom cluster. The study suggests the potential role for nurses to educate patients or to refer patients to complementary practioners who will instruct them on breathing techniques, cough-easing techniques, and acupressure.