Chan, C.W., Richardson, A., & Richardson, J. (2011). Managing symptoms in patients with advanced lung cancer during radiotherapy: Results of a psychoeducational randomized controlled trial. Journal of Pain and Symptom Management, 41, 347–357.
The objective of the study is to examine the effectiveness of a psychoeducational intervention (PEI) that combines patient education with progressive muscle relaxation (PMR) in the relief of a symptom cluster of anxiety, breathlessness, and fatigue in patients with advanced lung cancer receiving palliative radiotherapy (RT).
A total of 140 participants were randomized by lucky draw method to either an intervention group or a control group. Participants in the intervention group received a 40-minute educational package consisting of leaflets and discussion on the symptom cluster (breathlessness, anxiety, and fatigue) and self-care management. Coaching of PMR was delivered within one week prior to the beginning of the course of RT and reinforced three weeks after RT commencement. The intervention was delivered by RNs with two years of clinical experience who went through a two-day training session on the materials in the educational package and the practice of PMR. An audiotape in Chinese and educational leaflets were also given, and patients were encouraged to practice PMR daily and as required. Patients in the intervention group were given a telephone reminder at the end of the second week to enhance participation in the week three sessions. Those in the control group only received “usual care,” which was offered to patients in both the intervention and control groups and consisted of a mandatory individual briefing of RT procedures and a five- to seven-minute discussion of side effects focusing on skin care by a therapy radiographer. An optional group talk by an RN and a medical social worker about general care before and/or after the start of RT was also offered. Data were collected by a research assistant (RA) who was blinded to group allocation. Data collection on symptoms was obtained at four time points: prior to intervention (T0), week 3 (T1), week 6 (T2), and week 12 (T3). Patients were also asked to record adherence to the relaxation exercise in a simple health diary (calendar) for 12 consecutive weeks.
A randomized, controlled trial design was used.
At baseline, all patients had a low intensity for breathlessness (mean: 15.81; range: 0–100), but low-to-moderate fatigue (mean: 3.41; range: 0–100) and anxiety (mean: 42.04; range: 20–80) intensity scores, and an overall low-to-moderate functional score (mean: 25.14–66.41; range: 0–100). Patients in the control group, however, were noted to have significantly more advanced-stage lung cancer (p < 0.05) than the intervention group. In the intervention group, 94% of participants completed the intervention in full (based on the intervention log), the majority of whom demonstrated high attention and interest. Participants practiced about four to five sessions of PMR per week, and more than 60% both read the leaflets and listened to the audiotape. At all four time periods (T0–T4), significant and moderate positive intercorrelations among breathlessness, fatigue, and anxiety were observed (p < 0.01), thus suggesting a prominent relational effect of the three symptoms when considered as a cluster. Over time (T0–T2), a significant difference in the pattern of change in “composite” outcome (i.e., breathlessness, anxiety, and fatigue considered as a cluster) between the two study groups was observed (p = 0.003). When considered individually, univariate tests also confirmed a significant difference in pattern of symptom changes over time (T0–T2) for breathlessness (p = 0.002), fatigue (p = 0.011), and anxiety (p = 0.001), as well as functional ability (p = 0.000). Due to high attrition rates from death after T3, long-term effect of PEI at week 12 (T4) was not found to have significant difference in the pattern of change in fatigue (p = 0.034).
PEI is effective in the simultaneous relief of breathlessness, fatigue, and anxiety as a symptom cluster. The authors suggest that the total difference in symptom intensity between the intervention and control groups would have otherwise gone unrecognized if each were to be examined separately.
One limitation of the study was the higher attrition rate (due to patient mortality) experienced by the control group (42%) than the intervention group (11%) at T3 and overall attrition (27%) at the end of the 12 weeks. More patients in the control group had more advanced-stage cancer and distant metastasis than in the intervention group, thus indicating a failed randomization process. Also, due to high attrition, the authors advise that findings should be viewed with caution because of missing data. Additionally, information is lacking regarding participants’ perceptions and feelings toward the intervention process and outcomes. Other limitations related to possible confounding population characteristics that could influence symptom management include prior lung cancer treatments (especially if known pulmonary toxins), preexisting interstitial lung disease, tumor locations, and patient ages.
PEI with primarily PMR seems promising as a resource for the relief of low-intensity breathlessness in light of low-to-moderate intensity anxiety and fatigue up to at least six weeks after palliative RT. Long-term effect of PEI on this symptom cluster at 12 weeks is inconclusive. Similarly, more studies are warranted to establish if PEI is effective for higher baseline intensity of breathlessness and/or anxiety and fatigue. Cost-effectiveness of PEI (i.e., cost of material and training of personnel to deliver the intervention) should be weighed against the cost of poor symptom management (i.e., frequency of hospitalization, length of stay, and pharmacologic treatments).