Trial characteristics
Study | Design | Study dates | Single-centre or multicentre | Setting | Country | Aim | Patient inclusion criteria | Patients (n) | Mean age in years (SD) | Gender (male) | Tumour site/tumour stage | Cancer treatment type/stage of treatment |
Thewes et al, 200931 | Pre–post | NR | Multicentre: 3 rural outpatient oncology clinics | Outpatient oncology clinics | Australia | (1) Prospectively investigate the feasibility and acceptability of introducing a routine psychological screening programme for rural oncology clinics; (2) explore the impact of screening on rates and timeliness of referral to psychosocial services; and (3) provide pilot data on the acceptability and utility of the DT as a screening tool within the rural Australian setting | (1) Newly diagnosed with malignant disease; (2) 18 years of age or older; (3) able to give informed consent; and (4) able to read English proficiently | Unscreened cohort: 40 Screened cohort: 43 | 60.0 (10.5 SD) | 54.0% | Colorectal 22.9%, breast 30.1%, lung 14.5%, other 13.2%, haematological 9.6%, skin 6.0%, unknown primary 3.6% Localised/locally advanced 71.1%, advanced or metastatic 28.9% | Surgery 75.9%, chemotherapies 66.3%, RT 53%, endocrine therapies 32.5% Newly diagnosed patients |
Braeken et al, 2009,26 201327 and 201328 | Cluster randomised controlled trial | April 2008–October 2010 | Single | Institute Verbeeten (BVI), a radiation oncology department (Tilburg) | The Netherlands | To study the effect of the SIPP on the number and types of referrals of patients with cancer with psychosocial problems to psychosocial caregivers | (1) Receiving RT; (2) most common cancer types such as lung, prostate, bladder, rectum, breast, cervix, endometrial, skin and non-Hodgkin’s; (3) 18 years of age or older; and (4) no metastases Exclusion criteria: (1) receiving palliative treatment, ≤10 fractions of RT; (2) unable to read and speak Dutch; and (3) unable to complete questionnaires | Control group: 300 Intervention group: 268 | Control group: 62.4 (10.7 SD) Intervention group: 62.4 (10.8 SD) | Control group: 47.0% Intervention group: 31.7% | Prostate/bladder 24.1%, lung 11.3%, breast 50.0%, cervix/endometrial 1.6%, rectum 9.0%, non-Hodgkin’s lymphoma 1.7%, skin 2.3% | 100% RT SIPP before the first consultation prior to RT and SIPP2 before the consultation at the end of RT |
Ito et al, 201125 | Pre–post | UP: 1 April to 30 September 2006 PP: 1 April 1 to 30 September 2007 | Single | Outpatient treatment centre of the NCCH-E (Kashiwanoha, Kashiwa, Chiba) | Japan | To examine the usefulness (rate of referral) of a screening programme modified for outpatients with cancer who are undergoing chemotherapy | All consecutive patients with cancer who began chemotherapy at the outpatient treatment centre of NCCH-E in Japan | UP: 478 PP: 520 | UP: 61.4 (10.8 SD) PP: 62.8 (10.9 SD) | UP: 54.0% PP: 56.7% | Lung 20.0%, colon/rectum 18.2%, breast 13.8%, haematopoietic and lymphatic tissue 12.8%, stomach 7.9%, pancreas 10.2%, oesophagus 5.5%, liver, bile duct, gall bladder 4.6%, head and neck 2.8%, other 4.0% Reported for PP only: stage I 2.5%, stage II 9.6%, stage III 20.8%, stage IV or recurrent 67.1% | Chemotherapy Patients beginning chemotherapy at the outpatient treatment centre of the NCCH-E |
Zemlin et al, 201129 | Prospective consecutive study | NR | Single | Clinic for Gynaecology of the University of Marburg Hospital (Marburg) | Germany | To examine whether a screening and computer-based psycho-oncological clinical pathway can improve the diagnosis of patients with breast cancer requiring psycho-oncological support according to current guidelines | Patients with breast cancer who were in stationary treatment | Phase 1: 236 Phase II: 384 Phase III: 247 | 59.5 (12.2 SD) | 0.6% | Breast 100% Stage 0 (ductal carcinoma in situ) 11.6%, stage I 43.7%, stage II 25.5%, stage III 7.8%, stage IV 11.2% | Screening occurred on day of admission Stage of treatment NR |
Bauwens et al, 201430 | Pre–post | UP: May 2010 DB: period June 2010 | Single | Oncology Centre of the University Hospital (UZ Brussel) | Belgium | To evaluate the impact of systematic screening with the DB on detection rates of patients with elevated distress and on rates of psychosocial referral compared with usual practice | (1) Ambulatory patients; (2) 18 years and older; (3) diagnosed with cancer; (4) sufficiently fluent in the languages of the study (Dutch or French); and (5) not affected by a cognitive disorder | UP: 278 DB period: 304 | 58.92 (13.03 SD). | 32.0% | Breast 43.9%, lung 10%, colon 8.6%, prostate 3.4%, gynaecological 7.7%, skin 9.5%, brain 7.4%, other 9.5% Local disease 33%, locoregional disease 38.6%, advanced disease 28.4% | No treatment 24.3%, surgery 3.1%, RT 1.7%, chemotherapy 43.3%, medication 18.9%, RT+chemotherapy 2.1%, chemotherapy+medication 5.8%, RT+medication 0.7% Diagnosis 2.1%, active treatment curative intent 22.7%, active treatment palliative intent 53.0%, cured 9.8%, remission (partial/complete) 3.3%, palliative care 0.3%, wait and see 5.0%, recent recurrence 3.8% |
DB, Distress Barometer; DT, Distress Thermometer; NCCH-E, National Cancer Center Hospital East; NR, not reported; PP, programme period; RT, radiotherapy; SIPP, Screening Inventory Psychosocial Problems; UP, usual care period.