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. 2020 Aug;9(4):1699–1709. doi: 10.21037/tlcr.2019.12.18

Table S2. Randomized controlled trials evaluating individual palliative care interventions vs. standard/usual oncology care.

Author, year, country Aim Sample Intervention Control Outcome measures Results Conclusions
Uster et al. 2018 (33); Switzerland; Two-arm, parallel group, randomized controlled trial; single site To test the effects of a combined nutrition and physical exercise program on cancer patients with metastatic or locally advanced tumors of the gastrointestinal and lung tracts • Metastatic or locally advanced tumors of the gastrointestinal (n=38) and lung (n=20) tracts
• Total (n=58); Intervention (n=29); Control (n=29)
• NSCLC: total (n=16); intervention (n=9; 31.0%); control (n=7; 24.1%)
• SCLC: total (n=4); intervention (n=2; 6.9%); control (n=2; 6.9%)
3 month nutrition and physical exercise program Usual care (standard oncology care; maintain usual daily physical activity level; nutritional support provided only when medically indicated) Primary
• QOL—European Organization for Research and Treatment of Cancer Quality of Life Questionnaire V3.0 (EORTC QLQ-C30)
Secondary
• Dietary intake—3 day food diaries)
• Nutritional status—body weight (bioelectrical impedance analysis)
• Physical performance—handgrip strength, 6-min walk and timed sit-to-stand test
• Clinical data—unplanned admission, total length of all hospital stays, performance status (ECOG)
? No difference in global health status/quality of life (overall QoL) post intervention (improvement in both groups)
• Reduced nausea and vomiting (P=0.023) and increased protein intake (P=0.01) in the intervention group
• No statistical differences for energy intake, nutritional status and physical performance
Good adherence to a combined nutrition and exercise program; the multimodal intervention did not improve overall QOL, but contributed to an adequate protein intake and to the general well-being of the patient by reducing nausea and vomiting
Yang et al. 2018 (34); Singapore; pilot, randomized phase II trial; single site To determine feasibility and acceptability of the Enhancing Quality of Life in Patients (EQUIP) intervention; data completion rate of patient reported outcome measures in the trial; the estimated effect of the EQUIP intervention on quality of life and mood • New diagnosis of stage 3 (n=21) or 4 lung cancer (n=48)
• Total (n=69): Intervention (n=35); Control (n=34)
• Adenocarcinoma: intervention (n=19; 54.3%); control (n=22; 64.7%)
• SCLC: intervention (n=7; 20%); control (n=6; 17.7%)
• Squamous cell carcinoma: intervention (n=4; 11.4%); control (n=4; 11.8%)
• Others: intervention (n=5; 14.3%); control (n=2; 5.9%)
Usual care plus patients individually received the EQUIP intervention (4 face-to-face educational sessions with a nurse) Usual care (standard oncology care as well as referral for palliative care services if deemed appropriate by the primary oncologist) Primary
• QOL—Chinese validated Functional Assessment of Cancer Therapy-Lung (FACT-L); Lung Cancer Subscale (LCS); Trial Outcome Index (TOI)
Secondary
• Mood—Chinese validated Hospital Anxiety and Depression Scale (HADS)
· No significant difference between intervention and control groups in quality of life and mood at 12 weeks after baseline
• All patients were satisfied with the topics shared and felt they were useful
Nurse-directed face-to-face educational sessions were feasible and acceptable to patients with advanced lung cancer; however, there was no indication of benefit of the EQUIP intervention on quality of life and mood (which could be due in part to a low prevalence of targeted symptoms)
Schellekens et al. 2017 (35); The Netherlands; parallel group randomized controlled trial; multi-site To examine the effectiveness of mindfulness-based stress reduction (MBSR) added to care as usual (CAU) vs. CAU alone in reducing psychological distress in lung cancer patients and/or their partners • Patients and/or partners of patients presenting with cytologically or histologically proven NSCLC or SCLC. Both curative and palliative stage were included, with stage being based on the intent of the anticancer treatment
• Patients (n=63): CAU+MBSR (n=31); CAU (n=32)
• Caregivers (n=44): CAU+MBRS (n=21); CAU (n=23)
• NSCLC: intervention (n=28; 90%); control (n=26; 81%)
• SCLC: intervention (n=2; 7%); control (n=5; 16%)
• Mesothelioma: intervention (n=1; 3%); control (n=1; 3%)
Care as usual plus mindfulness-based stress reduction (group-based training in which participants practice mindfulness and receive teaching on stress) Care as usual Primary
• Psychological distress—Hospital Anxiety and Depression Scale (HADS)
Secondary
• QOL—EORTC QLQ-C30
• Caregiver burden—Self-Perceived Pressure from Informal Care
• Patient-caregiver relationship satisfaction (Investment Model Scale-Satisfaction subscale)
• Mindfulness skills—Five Facet Mindfulness Questionnaire
• Self-compassion—Self-Compassion Scale
• Post-traumatic stress symptoms—Impact of Event Scale
• Significantly less psychological distress (P=0.008, d=0.69) in the intervention than the control
• Baseline distress moderated outcome: those with more distress benefitted most from MBSR
• Patients showed more improvements in quality of life, mindfulness skills, self-compassion, and rumination in the intervention than the control. In partners, no differences were found between groups
Findings suggest that psychological distress in lung cancer patients can be effectively treated with MBSR; no effect was found in partners (possibly because they were more focused on patients’ well-being rather than their own)
Mosher et al. 2016 (36); USA; pilot randomized trial; Single site To examine the preliminary efficacy of telephone-based symptom management (TSM) for symptomatic lung cancer patients and their family caregivers • Diagnosis of SCLC or NSCLC; people receiving hospice care at the time of enrolment were excluded
• Total: patients (n=106); caregivers (n=106)
TSM: patients (n=51); caregivers (n=51)
• Education/support: patients (n=55); caregivers (n=55)
• NSCLC: TSM (n=44; 86.27%); Education/support (n=49; 89.09%)
• SCLC: TSM (n=7; 13.73%); Education/support (n=6; 10.91%)
4 sessions of telephone symptom management (TSM) consisting of cognitive-behavioral and emotion-focused therapy 4 sessions of education/support Primary
• Patient and caregiver depressive and anxiety—Patient Health Questionnaire; Generalized Anxiety Disorder scale (GAD-7)
• Patient physical symptoms—Brief Pain Inventory Short Form; Fatigue Symptom Inventory; Memorial Symptom Assessment Scale (frequency and severity of breathlessness and distress related to breathlessness)
Secondary
• Patients’ perceived ability to manage pain, other symptoms, and function & Caregiver confidence in their ability to manage symptoms—16-item standard self-efficacy scale modified from the arthritis literature
• Caregivers’ self-efficacy to manage own emotions—8 items
• Patient and caregiver perceived constraints on cancer-related disclosure from the other dyad member—5 item social constrains scale
• Caregiver burden—Caregiver Reaction Assessment
• No significant group differences for all patient outcomes and caregiver self-efficacy for helping the patient manage symptoms and caregiving burden at weeks 2 and 6 post-intervention
• Small effects in favor of TSM regarding caregiver self-efficacy for managing their own emotions and perceived social constraints from the patient
• No significant change over time for study outcomes in either group
? Findings suggest that the brief telephone-based psychosocial intervention was not efficacious for symptomatic improvement in lung cancer patients and their family caregivers
• Next steps include examining specific intervention components in relation to study outcomes, mechanisms of change, and differing intervention doses and modalities
Schofield et al. 2013 (37); Australia; two-group randomized controlled trial; single site To test the effectiveness of a multidisciplinary supportive care program based on systematic needs assessment in people with inoperable lung cancer • Diagnosis of inoperable lung or pleural (including mesothelioma) cancer; scheduled to receive palliative external beam radiotherapy, palliative chemotherapy or radical radiotherapy and chemotherapy
• Total (n=108): Intervention (n=55); Control (n=53)
• SCLC: intervention (n=4; 7.3%); control (n=5; 9.4%)
• NSCLC: intervention (n=48; 87.3%); control (n=45; 84.9%)
• Mesothelioma: intervention (n=3; 5.5%); control (n=3; 5.7%)
2 consultations at treatment commencement and completion and the provision of a systematic needs assessment data to the patient’s multidisciplinary team (MDT) Usual care (standard care as per hospital protocol –multidisciplinary meetings with referrals to allied health and palliative care as required; no systematic assessment/management patient need or systematic communication of patient needs) Primary
• Unmet needs—Needs Assessment for Advanced Lung Cancer Patients
• Psychological morbidity—HADS
• Global distress—Distress Thermometer (DT)
• Health related QOL—EORTC QLQ-C30 V2.0
? Trial closed prematurely
• No significant difference for any of the primary measures (all P>0.10)
• Change score analysis indicated a relative benefit from the intervention for unmet symptom needs at week 8 and 12 post-assessment (effect size =0.55 and 0.40, respectively)
Novel approach, but the hypothesis that the intervention would benefit perceived unmet needs, psychological morbidity, distress and health-related quality of life was not supported overall