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 |