Digital therapeutic to improve cancer-related well-being: a pilot randomized controlled trial.

OBJECTIVE: This randomized waitlist controlled pilot study aimed to evaluate the feasibility and preliminary efficacy of Mika, an app-based digital therapeutic intervention hypothesized to improve management and the support of cancer patients. METHODS: Patients with gynecological malignancies undergoing post-operative or routine outpatient chemotherapy were randomized (5:2) into intervention (Mika plus treatment-as-usual) and control (treatment-as-usual alone). Feasibility outcomes including dropout rate, reasons for dropout, and intervention adherence, as well as efficacy outcomes including depression, fatigue, and health literacy were assessed at baseline, 4, 8, and 12 weeks. Changes in efficacy outcomes from baseline to week 12 were evaluated in the intervention group only by means of Wilcoxon signed-rank tests. RESULTS: Seventy participants (intervention group, n=50; control group, n=20) with gynecological cancer (ovarian, cervical, and endometrial) were randomized. The dropout rate increased from 15.7% (11/70) between baseline and week 4 to 37.1% (26/70) between weeks 8 and 12. Primary reasons for dropout were death (n=10) and health status deterioration (n=11). The initial high intervention adherence observed between baseline and week 4 (86% usage rate, average usage time: 120 min, average number of logins: 16.7) declined in weeks 8 to 12 (46% usage rate, average usage time: 41 min, average number of logins: 9). Participants in the intervention group showed significant intra-individual reductions in depressive symptoms by 42% (d=0.85) and fatigue symptoms by 23.1% (d=0.5) from baseline to 12 weeks. CONCLUSIONS: This pilot study provides initial evidence of the feasibility and efficacy of Mika in improving the well-being of cancer patients. The high initial intervention adherence and significant reductions in depressive and fatigue symptoms suggest that Mika has the potential to improve the management and support of cancer patients. TRIAL REGISTRATION: German Clinical Trials Register (DRKS) ID: DRKS00023791; retrospectively registered on February 24, 2022.

Prognostic Value and Therapeutic Implications of Pleural Carcinosis and Malignant Pleural Effusion in Advanced Epithelial Ovarian Cancer.

AIM: To demonstrate the prognostic value of pleural carcinosis/effusion in a cohort of patients with advanced epithelial ovarian cancer (EOC) and the associated therapeutic implications. PATIENTS AND METHODS: Overall, data for 388 patients with EOC with confirmed malignant pleural effusion (MPE) or pleural carcinosis were retrospectively analyzed. Exclusion criteria were non-epithelial ovarian malignancies and presence of other comorbidities associated with pleural effusions. RESULTS: The prognosis after the occurrence of MPE during the EOC in relapsed cases was poor with an overall survival of 9.9 months. In the multivariate analysis, the time point of the manifestation of the pleural effusion (p<0.001), platinum sensitivity (p=0.003), performance status (p=0.045) and presence of ascites (p=0.004) were significant prognostic factors for overall survival. CONCLUSION: Even in this less favorable collective, well-established EOC prognostic factors were associated with a significantly better overall survival. This suggests that the overall behavioral pattern of the disease has strong similarities in patients with and without pleural effusion or carcinosis and merits an equally high therapeutic effort.

A meta-analysis on the impact of platinum-based adjuvant treatment on the outcome of borderline ovarian tumors with invasive implants.

BACKGROUND: Treatment of borderline ovarian tumors (BOTs) remains contentious, and there is no consensus regarding therapy for BOTs with invasive implants (BOTi). The benefits of platinum-based adjuvant treatment were evaluated in patients with BOTi at primary diagnosis. METHODS: The PubMed database was systematically searched for articles using the following terms: ((borderline) OR (low malignant potential) AND (ovarian)) AND ((tumor) OR (cancer)) AND (invasive implants) AND ((follow-up) OR (survival) OR (treatment) OR (chemotherapy) OR (adjuvant treatment) OR (surgery) OR (surgical treatment)). RESULTS: We identified 27 articles including 3,124 patients, 181 with invasive implants. All studies provided information regarding mortality or recurrence rates. Central pathological examination was performed in 19 studies. Eight studies included more than 75% stage I patients; 7 included only advanced-stage patients, and 14 included only serous BOT. The pooled recurrence estimates for both treatment groups (adjuvant treatment: 44.0%, upfront surgery: 21.3%) did not differ significantly (p = .114). A meta-analysis of the 6 studies providing separate mortality data for both treatment groups favored surgical treatment only, but this difference did not reach statistical significance (.05 < p < .1; odds ratio: 0.33; 95% confidence interval: 0.09-1.71; p = .086). We were unable to pool the results of the included studies because not all studies registered events in both treatment groups. Egger's regression indicated low asymmetry of the studies (p = .39), and no heterogeneity was found (I(2) = 0%). CONCLUSION: We did not find evidence supporting platinum-based adjuvant therapy for BOT with invasive implants.

Limited efficacy of platinum-based adjuvant treatment on the outcome of borderline ovarian tumors.

Adjuvant treatment of borderline ovarian tumors (BOT) remains highly debatable. This article evaluates the benefits of platinum-based adjuvant treatment in patients with BOT. The PubMed and Cochrane Library databases were systematically searched for articles using the terms ((Borderline) OR (low malignant potential) AND (ovarian)) AND ((tumor) OR (cancer)) AND ((follow-up) OR (survival) OR (treatment) OR (chemotherapy) OR (adjuvant treatment)). We identified 31 articles including 4965 patients. Together, 592 patients presented non-invasive-, 244 invasive- and 77 unspecified implants. Central pathological examination was performed in 23 studies. Nine studies included more than 90% stage I patients, while 11 included only advanced stage patients. Nineteen studies reported patients undergoing complete cytoreduction, ten reported response rates and eight compared survival outcomes. All studies provided information regarding either mortality or recurrence rates. A meta-analysis of the 13 studies providing separate mortality data for both treatment groups, including 2206 women, favored surgical treatment only (OR=7.44; 95% CI=3.39-16.32; p<0.0005) albeit with moderate heterogeneity of the studies (I(2)=35.0%) but no asymmetry (Egger's test p=0.44). Regarding survival data, 4 studies reported no difference between groups. In the adjuvant setting, 4 reported worse outcome and 1 reported a nonsignificant trend to worse outcome. At present, there is no evidence to support the use of adjuvant treatment in patients with BOT.