Deficiencies in health-related quality-of-life assessment and reporting: a systematic review of oncology randomized phase III trials published between 2012 and 2016

Quality of life (QoL) is a relevant end point and a topic of growing interest by both scientific community and regulatory authorities. Our aim was to review QoL prevalence as an end point in cancer phase III trials published in major journals and to evaluate QoL reporting deficiencies in terms of under-reporting and delay of publication. All issues published between 2012 and 2016 by 11 major journals were hand-searched for primary publications of phase III trials in adult patients with solid tumors. Information about end points was derived from paper and study protocol, when available. Secondary QoL publications were searched in PubMed. In total, 446 publications were eligible. In 210 (47.1%), QoL was not included among end points. QoL was not an end point in 40.1% of trials in the advanced/metastatic setting, 39.7% of profit trials and 53.6% of non-profit trials. Out of 231 primary publications of trials with QoL as secondary or exploratory end point, QoL results were available in 143 (61.9%). QoL results were absent in 37.6% of publications in the advanced/metastatic setting, in 37.1% of profit trials and 39.3% of non-profit trials. Proportion of trials not including QoL as end point or with missing QoL results was relevant in all tumor types and for all treatment types. Overall, 70 secondary QoL publications were found: for trials without QoL results in the primary publication, probability of secondary publication was 12.5%, 30.9% and 40.3% at 1, 2 and 3 years, respectively. Proportion of trials not reporting QoL results was similar in trials with positive results (36.5%) and with negative results (39.4%), but the probability of secondary publication was higher in positive trials. QoL is not included among end points in a relevant proportion of recently published phase III trials in solid tumors. In addition, QoL results are subject to significant under-reporting and delay in publication.     

Impact of targeted therapies in metastatic renal cell carcinoma on patient-reported outcomes: Methodology of clinical trials and clinical benefit

BackgroundMolecular targeted therapies have improved progression-free survival (PFS) without translating systematically into overall survival (OS) for patients with metastatic renal cell carcinoma (mRCC). In this population, patient-reported outcomes (PROs) have become a significant outcome. We evaluated the methodological quality of the assessment of PROs in randomized controlled trials (RCTs) and the clinical benefit of the different treatments including survival and quality of life (QoL).MethodsA systematic review identified RCTs published between January 2005 and July 2014. They were evaluated according to 11 items derived from the 2013 CONSORT PROs reporting guidelines. Survival outcomes and PROs main results were analyzed and the magnitude of clinical benefit was assessed with the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS).Results12 RCTs were included with a total of 22 publications. The mean CONSORT score for all items was 4.5 on an 11-point scale. No publication reported the power of the PROs analysis and only one reported a PRO hypothesis. 50% of studies did not interpret PROs in relation to clinical outcomes and only 18% discussed specific limitations of PROs and their implications for generalizability. By adding the QoL criterion to PFS, 4 trials (36.4%) obtained a high level of proven clinical benefit according to the ESMO-MCBS.ConclusionThe methodology for assessing PROs in mRCC is not optimal. Efforts should focus on defining PROs endpoint and increasing the quality of reporting of QoL.New-generation therapies in mRCC should demonstrate a gain not only in survival but also in QoL to be included in the therapeutic arsenal.     

Systematic review and meta-analysis of patient reported outcomes for nurse-led models of survivorship care for adult cancer patients

PurposeThis systematic review aimed to determine the effectiveness of nurse-led cancer survivorship care, compared with existing models of care, on patient reported outcomes for cancer survivors.MethodsRandomised and non-randomised controlled trials and controlled before-after studies published in English between 1 January 2007 and 28 July 2017 were identified in bibliographic databases including Medline, Pubmed and PsychINFO. Included studies described nurse-led cancer care after treatment to adults (age ≥18 years) <2 years post treatment completion. Risk of bias was assessed using Joanna Briggs Institute’s tools and meta-analysis was undertaken.ResultsTwenty one publications were included describing 15 tumour-specific trials involving 3278 survivors of breast (n = 5), gynecological (n = 3), head and neck (n = 2), colorectal (n = 2), upper gastrointestinal (n = 2) and prostate (n = 1) cancers. Seven trials reported quality of life (QoL) using the EORTC QLQ-C30; participants receiving nurse-led care (4–6 months) had better cognitive (4 trials, 463 participants; mean difference [MD] = 4.04 [95% CI, 0.59–7.50]; p = 0.02) and social functioning (4 trials, 463 participants; MD = 3.06 [0.14–5.97]; p = 0.04) but worse appetite loss (3 trials, 354 participants; MD = 4.43 [0.08–8.78]; p = 0.05). After intervention completion, intervention participants had reduced fatigue (4 trials, 647 participants; MD = −4.45 [−7.93 to −0.97]; p = 0.01).ConclusionThis systematic review synthesised outcomes of models of nurse-led survivorship care and contributes a meta-analysis of patient QoL to survivorship evidence. This review was limited by the risk of bias in many included studies for blinding of treatment personnel and outcome assessors. Nurse-led care appears beneficial for cancer survivors for some QoL domains.     

Can Oncologists Predict the Efficacy of Treatments in Randomized Trials?

BackgroundDecisions about trial funding, ethical approval, or clinical practice guideline recommendations require expert judgments about the potential efficacy of new treatments. We tested whether individual and aggregated expert opinion of oncologists could predict reliably the efficacy of cancer treatments tested in randomized controlled trials.Materials and MethodsAn international sample of 137 oncologists specializing in genitourinary, lung, and colorectal cancer provided forecasts on primary outcome attainment for five active randomized cancer trials within their subspecialty; skill was assessed using Brier scores (BS), which measure the average squared deviation between forecasts and outcomes.ResultsA total of 40% of trials in our sample reported positive primary outcomes. Experts generally anticipated this overall frequency (mean forecast, 34%). Individual experts on average outperformed random predictions (mean BS = 0.29 [95% confidence interval (CI), 0.28–0.33] vs. 0.33) but underperformed prediction algorithms that always guessed 50% (BS = 0.25) or that were trained on base rates (BS = 0.19). Aggregating forecasts improved accuracy (BS = 0.25; 95% CI, 0.16–0.36]). Neither individual experts nor aggregated predictions showed appreciable discrimination between positive and nonpositive trials (area under the curve of a receiver operating characteristic curve, 0.52 and 0.43, respectively).ConclusionThese findings are based on a limited sample of trials. However, they reinforce the importance of basing research and policy decisions on the results of randomized trials rather than expert opinion or low‐level evidence.Implications for PracticePredictions of oncologists, either individually or in the aggregate, did not anticipate reliably outcomes for randomized trials in cancer. These findings suggest that pooled expert opinion about treatment efficacy is no substitute for randomized trials. They also underscore the challenges of using expert opinion to prioritize interventions for clinical trials or to make recommendations in clinical practice guidelines.     

Quel choix pour l’oncologue radiothérapeute atteint d’un cancer du larynx localement évolué ?

PurposeTo analyse the therapeutic decision considered by radiation oncologists put in a position of being diagnosed with an advanced stage cancer of the larynx accessible either to a total laryngectomy or to an organ preservation protocol.Materials and methodsProspective analysis based on an anonymous survey filled by 104 radiation oncologists.ResultsA total of 30.7% of radiation oncologists surveyed did not consider any trade in their cure rate to preserve their larynx. The median percentage of cure that they were willing to trade was 10% (2–100%); and 0.9% of them were willing to trade 100% of their chance for cure in order to “avoid” total laryngectomy. A total of 16.3% of radiation oncologists would like to receive more information before making their decision. The additional information most frequently requested concerned the precise stage of the tumour and the potential remedial treatment in case of failure of the laryngeal preservation protocol. None of the analysed demographic variables influenced the choice to trade or not survival chance to preserve the larynx, the percentage of chance that radiation oncologists would consider exchanging, and/or the wish to receive additional information.ConclusionThis prospective study highlights that larynx preservation protocol is not the main therapeutic goal shared by all radiation oncologists put in a position of being diagnosed with an advanced stage cancer of the larynx. Total laryngectomy should remain a treatment option that as organ preservation protocols to be proposed and discussed.     

Quality-of-Life Assessment and Reporting in Prostate Cancer: Systematic Review of Phase 3 Trials Testing Anticancer Drugs Published Between 2012 and 2018

Quality of life (QoL) is not included among the end points in many studies, and QoL results are underreported in many phase 3 oncology trials. We performed a systematic review to describe QoL prevalence and heterogeneity in QoL reporting in recently published prostate cancer phase 3 trials. A PubMed search was performed to identify primary publications of randomized phase 3 trials testing anticancer drugs in prostate cancer, issued between 2012 and 2018. We analyzed QoL inclusion among end points, presence of QoL results, and methodology of QoL analysis. Seventy-two publications were identified (15 early-stage, 20 advanced hormone-sensitive, and 37 castration-resistant prostate cancer [CRPC]). QoL was not listed among study end points in 23 studies (31.9%) (40.0% early stage, 40.0% advanced hormone sensitive, and 24.3% CRPC). QoL results were absent in 15 (30.6%) of 49 primary publications of trials that included QoL among end points. Overall, as a result of absent end point or unpublished results, QoL data were lacking in 38 (52.8%) primary publications (53.3% early stage, 55.0% in advanced hormone sensitive, and 51.4% in CRPC). The most commonly used QoL tools were Functional Assessment of Cancer Therapy–Prostate (FACT-P) (21, 53.8%) and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire–Core 30 (EORTC QLQ-C30) (14, 35.9%); most common methods of analysis were mean changes or mean scores (28, 71.8%), time to deterioration (14, 35.9%), and proportion of patients with response (10, 25.6%). In conclusion, QoL data are lacking in a not negligible proportion of recently published phase 3 trials in prostate cancer, although the presence of QoL results is better in positive trials, especially in CRPC. The methodology of QoL analysis is heterogeneous for type of instruments, analysis, and presentation of results.     

Including older patients in cancer trials: A qualitative study of collaboration between geriatricians and oncologists

BackgroundThe under-representation of older patients in cancer trials remains an important obstacle to the generation of data on efficacy and safety in this growing patient population. In France, geriatric oncology coordination units (UCOGs) have been created to help oncologists and geriatricians work together on research, best practice, and continuing medical education. Taking these units as a case study, this paper sheds light on the collaboration between geriatricians and oncologists in the inclusion process of older patients in cancer trials.Materials and MethodsEmpirical data were gathered in a series of sociological interviews with all 16 oncologists, geriatricians and unit coordinators in the five UCOGs in the greater Paris region of France.ResultsThe case of French geriatric oncology coordination units shows the gap between professional research cultures in oncology and geriatrics that may account for the low observed inclusion rates. It is easier to include patients in randomized clinical trials than in observational studies. UCOGs have the potential to improve research in geriatric oncology by catalyzing the development and implementation of effective collaboration tools (such as frailty assessments). The units also have the potential to promote Phase IV trials and observational research that are suitable for older patients with cancer.DiscussionBridging the cultural gap between oncologists (the dominant force in setting the cancer research agenda) and geriatricians (a source of specific knowledge and know-how) is essential for producing relevant trial protocols that match the specific yet diverse features of older patient populations.     

Barriers to clinical trial enrollment of older adults with cancer: A qualitative study of the perceptions of community and academic oncologists

ObjectivesOncologists can be one of the major barriers to older adult's participation in research. Multiple studies have described academic clinicians' concerns for not enrolling older adults onto trials. Although the majority of older adults receive their cancer care in the community, few studies have examined the unique challenges that community oncologists face and how they differ from oncologist-related barriers in academia.MethodsSemi-structured interviews were conducted by telephone or face-to-face with 44 medical oncologists (24 academic-based and 20 community-based) at City of Hope from March to June 2018. Interviews explored oncologists' perceptions of barriers to clinical trial enrollment of older adults with cancer. Data were analyzed using qualitative content analysis.ResultsOf the 44 participants, 36% were women and 68% were in practice for >10 years. Among the entire sample, stringent eligibility criteria (n = 20) and oncologist concerns for treatment toxicities (n = 15) were the most commonly cited barriers. Compared to academic oncologists, community oncologists more often cited patient attitudes, beliefs, and understanding (n = 9 vs. n = 2) and caregiver burden (n = 6 vs. n = 0). In contrast, compared to community oncologists, academic oncologists more often cited oncologist bias (n = 10 vs. n = 3) and insufficient time/support (n = 4 vs. n = 1).ConclusionsDifferences in perceptions among academic and community oncologists about trials suggest that barriers are multifaceted, complex, and vary by practice setting. Interventions to increase trial accrual among older adults with cancer may benefit from being tailored to address the unique barriers of different practice settings.     

Publication status of contemporary oncology randomised controlled trials worldwide

BackgroundLittle is known about the extent of selective publication in contemporary oncology randomised controlled trials (RCTs) worldwide. This study aimed to evaluate the rates of publication and timely publication (within 24 months) for contemporary oncology RCTs from all over the world. We also investigated the trial characteristics associated with publication and timely publication.Patients and methodsWe identified all phase III oncology RCTs registered on ClinicalTrials.gov with a primary completion date between January 2008 and December 2012. We searched PubMed and EMBASE to identify publications. The final search date was 31 December 2015. Our primary outcome measure was the time to publication from the primary completion date to the date of primary publication in a peer-reviewed journal.ResultsWe identified 598 completed oncology RCTs; overall, 398 (66.6%) had been published. For published trials, the median time to publication was 25 months (interquartile range, 16–37 months). Only 192 trials (32.1%) were published within 24 months. Timely publication was independently associated with trials completed late in 2012. Trials conducted in Asia and other regions were less likely to have timely publication, but trials conducted in different locations were all equally likely to be published. Industry- and NIH-funded trials were equally likely to be published timely or at any time after trial completion. Among 391 published trials with clear primary outcomes, there was a trend for timely publication of positive trials compared with negative trials.ConclusionsDespite the ethical obligations and societal expectations of disclosing findings promptly, oncology RCTs performed poorly.     

Enregistrement et publication du critère d’évaluation principal dans les essais contrôlés randomisés en oncologie

PurposeTo improve the quality of reporting of randomized clinical trials (RCTs), international registries for RCTs and guidelines for primary endpoint (PEP) analysis were established. The objectives of this systematic review were to evaluate concordance of PEP between publication and the corresponding registry and to assess the intrapublication consistency in PEP reporting.MethodsAll adult oncology RCTs in solid tumors published in 10 journals between 2005 and 2009 were reviewed. Registration information was extracted from international trial registries.ResultsA total 366 RCTs were identified. Trial registration was found for 215 trials and the rate increased from 43% in 2005 to 82% in 2009 (P < 0.001). There were 134 RCTs with clearly defined PEPs in registry, with the rate increasing from 15 to 67% (P < 0.001). PEP differs between registration and final publication in 14% trials with clearly defined PEPs. Reporting issues in methodology were found in 15% RCTs, mainly due to inadequate reporting of PEP or of sample size calculation. Problems with the interpretation of trial results were found in 22% publications, mostly due to negative superiority studies being interpreted as showing equivalence.ConclusionThe rates of trial registration and of trials with clearly defined PEP have improved over time, however 14% of these trials reported a different PEP in the final publication. Intrapublication inconsistencies in PEP reporting are frequent. Our findings highlight the need for investigators, peer reviewers and readers for increased awareness and scrutiny of reporting outcomes of oncology RCTs.     

Nutrition parentérale à domicile chez la personne âgée atteinte d’un cancer : une étude observationnelle prospective

IntroductionMalnutrition is a bad prognostic factor that reduces the quality of life (QoL) in patients with cancer. The objective was to assess the impact of home parenteral nutrition (HPN) on the QoL of elderly malnourished patients with cancer.Patients and methodsThis French prospective observational study included patients, aged 70 years or older, with cancer, for whom HPN was prescribed for at least 14 days. The patient, the physician and a family member or home caregiver had to fill in a questionnaire at inclusion and 28 days later.ResultsIncluded patients (n=221) were mainly suffering from a digestive cancer. After HPN intake, improved weight was noticed in 68% and 14% of patients had reached the target weight. Improved global QoL was reported in 59% of patients. Physicians noticed a significant improvement for the same compounds.ConclusionThese results suggest a benefit of the HPN on the nutritional status and QoL in elderly patients with cancer. Further controlled randomised trials are needed to prove the benefit of HPN in the routine management of these patients.     

Functional organ preservation with definitive chemoradiotherapy for T4 laryngeal squamous cell carcinoma

BackgroundRandomized trials established chemoradiotherapy as standard treatment for advanced laryngeal cancer. Patients with large-volume T4 disease (LVT4) were excluded from these trials. The purpose of this study was to report T4 laryngeal cancer patient outcome, including those with LVT4 disease, treated with chemoradiotherapy.Patients and methodsThis study is a retrospective subset analysis of 32 patients with T4 laryngeal carcinoma including LVT4 tumors treated on three consecutive protocols investigating paclitaxel (Taxol), 5-fluorouracil, hydroxyurea, and 1.5-Gy twice daily (BID) radiotherapy (TFHX).ResultsMedian follow-up is 43 months. Four-year locoregional control (LRC), disease-free survival (DFS), overall survival (OS), and laryngectomy-free survival (LFS) was 71%, 67%, 53%, and 86%, respectively. Four patients required laryngectomy for recurrent or persistent disease. Of disease-free patients with ≥1 year follow-up, 90% demonstrated normal or understandable speech. None required laryngectomy for complications. Among LVT4 patients, 4-year LRC, DFS, OS, and LFS was 71%, 65%, 56%, and 81%, respectively. Induction chemotherapy improved 4-year LRC (90% versus 46%, P = 0.03) and DFS (84% versus 42%, P = 0.03).ConclusionsPromising control and functional outcomes are achieved with TFHX for T4 laryngeal patients. LVT4 disease had outcomes similar to patients with less advanced disease treated on Radiation Therapy Oncology Group 91-11. Induction chemotherapy improved outcomes, warranting further investigation.     

Assessment of anticancer-treatment outcome in patients with metastatic castration-resistant prostate cancer—going beyond PSA and imaging,a systematic literature review

BackgroundIn the past years, there has been significant progress in anticancer drug development for patients with metastatic castration-resistant prostate cancer (CRPC). However, the current instruments to assess clinical treatment response have limitations and may not sufficiently reflect patient benefit. Our objective was to systematically identify tools to evaluate both patient benefit and clinical anticancer-treatment response as basis for an international consensus process and development of a specific pragmatic instrument for men with CRPC.MethodsPubMed, Embase and CINAHL were searched to identify currently available tools to assess anticancer-treatment benefit, other than standard imaging procedures and prostate-specific antigen measurements, namely quality of life (QoL), detailed pain assessment, physical function and objective measures of other complex cancer-related syndromes in patients with CRPC. Additionally, all CRPC phase III trials published in the last 5 years were reviewed as well as studies using physical function tools in a general cancer population. The PRIMSA statement was followed for the systematic review process.ResultsThe search generated 1096 hits, 185 full-text papers were screened and finally 73 publications were included. Additional 89 publications were included by hand-search. We identified a total of 98 tools used in CRPC trials and grouped these into three categories: 22 tools assessing QoL domains and subgroups, 47 tools for pain assessment and 29 tools for objective measures, mainly physical function and assessment of skeletal disease burden.ConclusionA wide variety of assessment tools and also efforts to standardize and harmonize patient-reported outcomes and pain assessment were identified. However, the specific needs of the increasing CRPC population living longer with their incurable cancer are insufficiently captured and objective physical outcome measures are under-represented. In the age of new anticancer drug targets and principles, new methods to monitor patient relevant outcomes of antineoplastic therapy are of utmost importance.     

The evidence base of US Food and Drug Administration approvals of novel cancer therapies from 2000 to 2020

Concerns have been raised that regulatory programs to accelerate approval of cancer drugs in cancer may increase uncertainty about benefits and harms for survival and quality of life (QoL). We analyzed all pivotal clinical trials and all non-pivotal randomized controlled trials (RCTs) for all cancer drugs approved for the first time by the FDA between 2000 and 2020. We report regulatory and trial characteristics. Effects on overall survival (OS), progression-free survival and tumor response were summarized in meta-analyses. Effects on QoL were qualitatively summarized. Between 2000 and 2020, the FDA approved 145 novel cancer drugs for 156 indications based on 190 clinical trials. Half of indications (49%) were approved without RCT evidence; 82% had a single clinical trial only. OS was primary endpoint in 14% of trials and QoL data were available from 25%. The median OS benefit was 2.55 months (IQR, 1.33-4.28) with a mean hazard ratio for OS of 0.75 (95%CI, 0.72-0.79, I² = 42). Improvement for QoL was reported for 7 (4%) of 156 indications. Over time, priority review was used increasingly and the mean number of trials per indication decreased from 1.45 to 1.12. More trials reported results on QoL (19% in 2000-2005; 41% in 2016-2020). For 21 years, novel cancer drugs have typically been approved based on one single, often uncontrolled, clinical trial, measuring surrogate endpoints. This leaves cancer patients without solid evidence that novel drugs improve their survival or QoL and there is no indication towards improvement.     

GOSAFE - Geriatric Oncology Surgical Assessment and Functional rEcovery after Surgery: early analysis on 977 patients

ObjectiveOlder patients with cancer value functional outcomes as much as survival, but surgical studies lack functional recovery (FR) data. The value of a standardized frailty assessment has been confirmed, yet it's infrequently utilized due to time restrictions into everyday practice. The multicenter GOSAFE study was designed to (1) evaluate the trajectory of patients' quality of life (QoL) after cancer surgery (2) assess baseline frailty indicators in unselected patients (3) clarify the most relevant tools in predicting FR and clinical outcomes. This is a report of the study design and baseline patient evaluations.Materials & MethodsGOSAFE prospectively collected a baseline multidimensional evaluation before major elective surgery in patients (≥70 years) from 26 international units. Short−/mid−/long-term surgical outcomes were recorded with QoL and FR data.Results1003 patients were enrolled in a 26-month span. Complete baseline data were available for 977(97.4%). Median age was 78 years (range 70–94); 52.8% males. 968(99%) lived at home, 51.6% without caregiver. 54.4% had ≥ 3 medications, 5.9% none. Patients were dependent (ADL < 5) in 7.9% of the cases. Frailty was either detected by G8 ≤ 14(68.4%), fTRST ≥ 2(37.4%), TUG > 20 s (5.2%) or ASAIII-IV (48.8%). Major comorbidities (CACI > 6) were detected in 36%; 20.9% of patients had cognitive impairment according to Mini-Cog.ConclusionThe GOSAFE showed that frailty is frequent in older patients undergoing cancer surgery. QoL and FR, for the first time, are going to be primary outcomes of a real-life observational study. The crucial role of frailty assessment is going to be addressed in the ability to predict postoperative outcomes and to correlate with QoL and FR.     

Quality of life and hepatocellular carcinoma

Hepatocellular carcinoma (HCC) is a common and rapidly fatal cancer ranking third among the leading causes of cancer-related deaths. Potentially curative therapies like surgery, transplant and ablation are not an option for most patients as they are often diagnosed when the disease is advanced. Liver directed therapy and oral targeted therapies are used in these patients to prolong life and palliate symptoms of the cancer and associated liver failure. Overall survival remains poor and hence health-related quality of life (HRQoL) is of paramount importance in these patients. As novel therapies are developed to improve outcomes, a comprehensive knowledge of available tools to assess impact on QoL is needed. Hence we reviewed all the studies in HCC patients published within the last 13 years from 2001-2013 which assessed HRQoL as a primary or secondary endpoint. A total of 45 studies and 4 meta-analysis were identified. Commonly used tools were European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) (15 studies) and the Functional Assessment of Cancer Therapy-Hepatobiliary Questionnaire (FACT-Hep) (14 studies). Of the 45 publications which incorporated HRQoL as end-point only 24 were clinical trials, 17/24 (71%) assessed systemic therapies while 7/24 (29%) assessed liver-directed therapies. Majority of the publications (trials + retrospective reviews) that had HRQoL as an endpoint in HCC patients were studies evaluating liver-directed therapies (23/45 or >50%). We discuss the measures included in the tools, their interpretation, and summarize existing QoL data that will help design future HCC trials.     

Efficacy of short-term psychodynamic psychotherapy (STPP) with depressed breast cancer patients: results of a randomized controlled multicenter trial

BackgroundThere is a lack of trials of psychodynamic treatments of depression in breast cancer patients. The purpose of this trial was to determine the efficacy of short-term psychodynamic psychotherapy (STPP) in non-metastatic breast cancer patients diagnosed with depression, one of the most frequent mental comorbidities of breast cancer.Patients and methodsIn a multicenter prospective trial, 157 breast cancer patients with comorbid depression were randomized to either individual STPP (intervention group, N = 78) or ‘treatment as usual’ (control group, TAU, N = 79). As our primary outcome measure, we hypothesized a higher rate of remission defined as no diagnosis of depression (Structured Clinical Interview for DSM-IV) and reduction in depression score by at least 2 points (Hospital Anxiety and Depression Scale, HADS-D) in STPP versus TAU at treatment termination. Secondary outcomes mainly refer to quality of life (QoL).ResultsIn the intention to treat (ITT) analysis, 44% of the STPP group achieved highly significantly more remission than TAU (23%). STPP treatment (OR = 7.64; P < 0.001) was the strongest predictor for remission post-treatment; time was also significant (OR = 0.96; P < 0.05). A high effect favoring STPP (d = 0.82) was observed for the HADS-D score post-treatment (secondary outcome). Regarding further secondary outcomes (QoL), analyses of covariance yielded main effects for group (favoring STPP with an effect size of at least d = 0.5) for global QoL, role, emotional and social functioning, pain, treatment side-effects, breast symptoms and upset by hair loss.ConclusionsSTPP is an effective treatment of a broad range of depressive conditions in breast cancer patients improving depression and functional QoL. Findings are limited by the drop-out rate (∼1/3) and delayed post-treatment assessments. Future trials may consider stepped-care approaches, tailored to patients' needs and requirements in the acute treatment phase.