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Purpose of ReviewThis review serves to provide clarity on the nature, scope, and benefits of early palliative care integration into the management of patients with gynecologic malignancies.Recent FindingsThere is increased recognition that timely referral to palliative care improves quality of life for patients and their families by providing goal-concordant care that reduces physical and emotional suffering and limits futile and aggressive measures at the end of life. Palliative care services rendered throughout the continuum of illness ultimately increase engagement with hospice services and drive down health expenditures. Despite these myriad benefits, misconceptions remain, and barriers to and disparities in access to these services persist and warrant continued attention.SummaryPalliative care should be offered to all patients with advanced gynecologic cancers early in the course of their disease to maximize benefit to patients and their families.

Background In the era of precision oncology, patients with advanced cancer are often living longer but are enduring years of fatiguing treatment. Fatigue is among the most common, chronic, and under-addressed side effects of advanced cancer treatment, and can lead to dose reductions, treatment interruptions, and discontinuation. Oral PolyADP-ribose polymerase (PARP) inhibitors have revolutionized the treatment of advanced ovarian cancer but are often accompanied by clinically-significant fatigue, and evidence-based treatments to cope with this side effect remain limited. A pilot trial suggests that telehealth acceptance and commitment therapy (ACT), a variant of cognitive behavioral therapy based on acceptance, mindfulness, and personal values, has potential to improve fatigue interference (i.e. disrupting activity and quality of life) among ovarian cancer patients on maintenance PARP inhibitors. This study protocol describes a fully-powered randomized controlled trial (RCT) of an innovative, remotely-delivered ACT intervention (‘ REVITALIZE ’) that aims to improve fatigue outcomes and PARP inhibitor adherence. Methods This two-armed, prospective RCT randomizes 240 adults with advanced ovarian cancer who report moderate to severe fatigue while on PARP inhibitors 1:1 to either REVITALIZE or education-enhanced usual care. The REVITALIZE intervention includes eight weekly one-hour individual sessions delivered via videoconference, plus two booster sessions at one- and two-month intervals thereafter. Participants, recruited from both academic and community cancer care sites across three U.S. regions, will complete assessments at baseline, mid-intervention, post-intervention, and 20 and 28-week follow-up (FU). The primary patient-reported outcome is change in fatigue interference from baseline to week 20 (FU1). Secondary patient-reported outcomes include fatigue severity, catastrophizing, self-efficacy, and quality of life. The primary behavioral outcome is monthly PARP inhibitor adherence, assessed by wireless medication adherence monitors; dose interruptions, reductions, and persistence will also be evaluated using adherence monitors and medical chart review. Discussion This paper describes a RCT that will evaluate the efficacy of the telehealth REVITALIZE intervention for improving fatigue-related outcomes and medication adherence among adults with advanced ovarian cancer taking PARP inhibitors. Findings will inform clinical practice and supportive care for adults with advanced ovarian cancer receiving treatments that cause fatigue. Trial registration Clinicaltrials.gov NCT06710548 on November 29, 2024.

Current guidelines recommend a 28-day course of enoxaparin for thromboprophylaxis after surgery for gynecologic cancer. The high cost of this medication and the low adherence rates observed in prior studies provide an opportunity to benefit patients by demonstrating the safety of a more cost-effective, easier to use thromboprophylactic. To investigate the safety and efficacy of an oral treatment alternative for thromboprophylaxis in postoperative patients with gynecologic cancer. This was a patient-based, multicenter, open-label, blinded, end point, randomized clinical trial conducted May 2015 to March 2019 in outpatient and inpatient gynecologic oncology settings. Women undergoing surgery for suspected or confirmed gynecologic cancer were approached for recruitment. The trial compared rates of major bleeding and clinically relevant nonmajor bleeding events during a 90-day follow-up period in patients taking apixaban or enoxaparin for postoperative thromboprophylaxis using a modified intent-to-treat analysis. Data analysis was performed from October to December 2019. Women were randomized to 28 days of apixaban (2.5 mg orally twice daily) or enoxaparin (40 mg subcutaneously daily). The primary outcome was major bleeding and clinically relevant nonmajor bleeding events. Secondary outcomes included incidence of venous thromboembolic events, adverse events, medication adherence, participant quality of life, and medication satisfaction. Of 500 women recruited for the study, 400 were enrolled and randomized (median age, 58.0 years; range, 18.0-89.0 years); 204 received apixaban and 196 received enoxaparin. Treatment groups did not differ in terms of race/ethnicity, cancer stage, or surgery modality (open vs robotic). There were no statistically significant differences between the apixaban and enoxaparin groups in terms of rates of major bleeding events (1 patient [0.5%] vs 1 patient [0.5%]; odds ratio [OR], 1.04; 95% CI, 0.07-16.76; P > .99), clinically relevant nonmajor bleeding events (12 patients [5.4%] vs 19 patients [9.7%]; OR, 1.88; 95% CI, 0.87-4.1; P = .11), venous thromboembolic events (2 patients [1.0%] vs 3 patients [1.5%]; OR, 1.57; 95% CI, 0.26-9.50; P = .68), adverse events, medication adherence, or quality of life between the groups. Participant satisfaction was significantly greater in the apixaban group with regard to ease of taking the medication (186 patients [98.9%] vs 110 patients [58.8%]; OR, 0.06; 95% CI, 0.01-0.25; P < .001) and pain associated with taking the medication (4 patients [2.1%] vs 92 patients [49.2%]; OR, 9.20; 95% CI, 2.67-31.82; P < .001). These findings suggest that oral apixaban is a potentially safe, less painful, and easier-to-take alternative to subcutaneous enoxaparin for thromboprophylaxis after surgery for gynecologic cancer. The efficacy of apixaban to prevent venous thromboembolic events is hypothesized as being equivalent. ClinicalTrials.gov Identifier: NCT02366871.

In the era of precision oncology, patients with advanced cancer are often living longer but are enduring years of fatiguing treatment. Fatigue is among the most common, chronic, and under-addressed side effects of advanced cancer treatment, and can lead to dose reductions, treatment interruptions, and discontinuation. Oral PolyADP-ribose polymerase (PARP) inhibitors have revolutionized the treatment of advanced ovarian cancer but are often accompanied by clinically-significant fatigue, and evidence-based treatments to cope with this side effect remain limited. A pilot trial suggests that telehealth acceptance and commitment therapy (ACT), a variant of cognitive behavioral therapy based on acceptance, mindfulness, and personal values, has potential to improve fatigue interference (i.e. disrupting activity and quality of life) among ovarian cancer patients on maintenance PARP inhibitors. This study protocol describes a fully-powered randomized controlled trial (RCT) of an innovative, remotely-delivered ACT intervention ('REVITALIZE') that aims to improve fatigue outcomes and PARP inhibitor adherence. This two-armed, prospective RCT randomizes 240 adults with advanced ovarian cancer who report moderate to severe fatigue while on PARP inhibitors 1:1 to either REVITALIZE or education-enhanced usual care. The REVITALIZE intervention includes eight weekly one-hour individual sessions delivered via videoconference, plus two booster sessions at one- and two-month intervals thereafter. Participants, recruited from both academic and community cancer care sites across three U.S. regions, will complete assessments at baseline, mid-intervention, post-intervention, and 20 and 28-week follow-up (FU). The primary patient-reported outcome is change in fatigue interference from baseline to week 20 (FU1). Secondary patient-reported outcomes include fatigue severity, catastrophizing, self-efficacy, and quality of life. The primary behavioral outcome is monthly PARP inhibitor adherence, assessed by wireless medication adherence monitors; dose interruptions, reductions, and persistence will also be evaluated using adherence monitors and medical chart review. This paper describes a RCT that will evaluate the efficacy of the telehealth REVITALIZE intervention for improving fatigue-related outcomes and medication adherence among adults with advanced ovarian cancer taking PARP inhibitors. Findings will inform clinical practice and supportive care for adults with advanced ovarian cancer receiving treatments that cause fatigue.

OBJECTIVESPre-operative opioid use is common and should be considered a comorbidity among surgical candidates. Our objective was to describe the rate of pre-operative opioid use and patterns of post-operative outpatient opioid prescribing in a cohort of gynecologic oncology patients. METHODSA retrospective cohort study was conducted with 448 gynecologic oncology surgical patients undergoing surgery for a suspected or known cancer diagnosis from January 2016 to December 2016. Pre-operative opioid users (n=97) were identified. Patient and surgical characteristics were abstracted, as was post-operative opioid prescription (type of opioid, oral morphine equivalents amount) and length of stay. For pre-operative opioid users, the type of opioid prescribed post-operatively was compared with the type of pre-operative opioid. Pre-operative opioid users were compared with non-users, stratified by surgery type. Descriptive statistics were analyzed using χ statistic, and medians were compared using a Mann-Whitney U statistic. RESULTSPre-operative opioid prescriptions were noted in 21% of patients, and 24% of these had two or more opioid prescriptions before surgery. The majority of pre-operative opioid users (51%) were maintained on the same agent post-operatively at the time of discharge, but 36% were switched to a different opioid and 7% were prescribed an additional opioid. Overall and in laparotomies, pre-operative opioid users received higher volume post-operative prescriptions than non-users. There was no difference in post-operative prescription volume for minimally invasive surgeries or in length of stay between pre-operative users and non-users. CONCLUSIONSPre-operative opioid use is common in gynecologic oncology patients and should be considered during pre-operative planning. Pre-operative opioid use was associated with a higher volume and wider range of post-operative prescription. Over 40% of opioid users were discharged with either an additional opioid or a new opioid, highlighting a potential missed opportunity to optimize opioid safety. Further research is needed to characterize the relationship between pre-operative opioid use and peri-operative outcomes and to develop strategies to manage pain effectively in this population without compromising opioid safety.