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Context and objectives The impact of complementary and integrative medicine (CIM) on adherence to chemotherapy regimens is unclear. We explored the effect of patient-tailored CIM treatments on the relative dose intensity (RDI) of chemotherapy among patients with breast and gynecological cancer. Methods Chemotherapy-treated patients with breast or gynecological cancer were referred by their oncology healthcare professional to a CIM treatment program. Adherence to integrative care (AIC) was defined as ≥4 CIM treatments, with ≤30 days between each treatment. Relative dose intensity (RDI) of chemotherapy was compared between CIM-treated patients and controls, and among adherence sub-groups. Results RDI was calculated for 106-treated patients (62 AIC) and 75 controls. Baseline-to-6-week RDI values were similar in both study arms, with a lower % RDI <1.0 among controls at 12 weeks (47 vs. 57.5%; P  = 0.036). Adherence sub-groups had similar RDI values, though at 6 weeks, the AIC group had lower % RDI <1.0 (33.9 vs. 54.5%, P  = 0.046). Total administered medication dose/planned dose was higher in the AIC group at 6 weeks for paclitaxel (82%/50%, P  = 0.025) and carboplatin (87%/67%, P  = 0.028), with no difference in cytoxan/adriamycin dosages. Conclusion A patient-tailored CIM program for patients with breast or gynecological cancer may be associated with a lower percentage of reduced RDI at 6 weeks, this in a sub-group of patients with higher adherence to CIM, and for specific chemotherapy agents, though this benefit did not persist after 12 weeks. Further research is needed to better understand the impact of CIM in cancer care.

BackgroundRecurrent gynecologic cancer patients experience symptoms that affect psychologic, emotional, social, and physical well-being. Chemotherapy can further exacerbate these symptoms. Poor mood, pain, and fatigue are linked and are detrimental to quality of life. Interventions targeting these symptoms may improve patient-reported outcomes and performance status.ObjectivesTo determine the ability of a humorous digital media attention diversion to improve symptom domains of positive and negative mood during chemotherapy for patients with recurrent gynecologic cancers.Study designThis randomized, crossover clinical trial enrolled women with recurrent gynecologic cancers. Subjects participated over three cycles of chemotherapy. The primary outcome was the change in mood on the validated Positive and Negative Affect Scale-Extended (PANAS-X) instrument, which measures positive and negative affect domains. All subjects completed the PANAS-X after receiving chemotherapy during cycle 1 on study. In atudy arm 1, subjects watched their choice of humorous movies on a digital media device while receiving chemotherapy during cycle 2 on study. They selected from non-humorous movies during cycle 3 on study. In arm 2, the order of movies was reversed. After each cycle, mood, fatigue, and other patient-reported outcomes were assessed for comparison with baseline measurements.ResultsThe target enrollment of 66 subjects was achieved. Subjects watched humorous content for an average of 96.0 min and non-humorous content for an average of 62.5 min. Negative mood improved after exposure to humorous (p=0.017) and non-humorous content (p=0.001). Patient-reported fear also improved after exposure to both humorous (p=0.038) and non-humorous content (p=0.002). Subjects reported higher use of affiliating and self-effacing humor types.ConclusionsOffering patients a choice of digital media during chemotherapy significantly improved negative mood and fear. This was seen with both humorous and non-humorous content. This low-cost and low-risk intervention should be implemented as an attention diversion to improve negative mood and fear for patients receiving chemotherapy.

Background Treatment for gynaecological cancer often entails challenges that negatively affect quality-of-life. While exercise has been shown to improve physical and psychosocial well-being during cancer recovery, affected women often avoid exercise due to the specific health challenges they face after treatment. The Enhancing treatment outcomes after gynaecological cancer (ACUMEN) program aims to enhance health-related quality of life in this group by promoting lifelong exercise habits. Methods The ACUMEN trial is a single-blind, multi-centre randomised controlled trial that evaluates the impact of a structured exercise intervention on quality of life in women who have completed primary treatment for gynaecological cancer within the last 60 months. A total of 342 participants will be randomly assigned to either usual care or an intervention group. The intervention involves a 12-week personalised exercise program, where participants will complete three 1-h exercise sessions per week. During the first six weeks, participants will receive two supervised sessions with accredited exercise physiologists or physiotherapists and self-manage one session per week. In the following six weeks, this shifts to one supervised session and two self-managed sessions weekly, with goal of fostering sustainable, self-managed exercise habits. Assessments will take place at baseline, Week 12 (end of intervention), and Week 24 (end of maintenance). The primary outcome is health-related quality of life, measured by the Short Form-36. Secondary outcomes include exercise self-efficacy, body composition, symptoms of lymphoedema, physical fitness, biological markers, and habitual physical activity levels. For intervention group participants assigned accredited exercise physiologists or physiotherapists will track attendance, adherence, feasibility, and safety. Discussion The ACUMEN trial will evaluate whether a structured exercise program improves health-related quality of life in women recovering from gynaecological cancer treatment. The findings will help determine if the intervention is effective and sustainable, with a simultaneous cost-effectiveness analysis conducted to assess its value for money. Results from this study could inform future exercise-based interventions to enhance cancer recovery. Trial registration Australian New Zealand Clinical Trial Registry (ACTRN12621000050853, registered 19/01/2021).

Background Sexual dysfunction, fueled by body image stress, is prevalent in women with a history of breast or gynecologic cancer. Preliminary data support that mind–body connections may improve sexual health outcomes through improving body image. Objective This randomized controlled trial compared hypnosis to progressive muscle relaxation (PMR). The primary outcome was body image at week 6 as measured by the Impact of Treatment Scale for women who have or have had breast or gynecologic cancer. Interventions/Methods Consented participants were randomized 2:1 to hypnosis or PMR. Both arms consisted of three face-to-face sessions delivered by a trained therapist. Sessions were every 2 weeks for 6 weeks; participants practiced at home between sessions using an audio recording. Results Eighty-seven women were randomized, 59 to hypnosis and 28 to PMR. Both groups reported significant improvements on body image over time (within group effect size Cohen’s d  = 0.49–0.75) with no significant difference between groups ( p  = 0.15). Secondary outcomes were not significantly different between groups. The hypnosis group improved more in sexual satisfaction and sexual interest while the PMR group improved more in positive affect. Conclusions Interventions facilitating mind–body connections such as hypnosis and PMR may help to improve body image. This study suggests that stress relieving strategies of hypnosis and PMR may contribute to providing a re-connection to one’s body, improved positive affect, and overall better sexual health.

Background Clinically significant levels of fear of cancer recurrence (FCR) affect up to 49 % of cancer survivors and are more prevalent among women. FCR is associated with psychological distress, lower quality of life, and increased use of medical resources. Despite its prevalence, FCR is poorly addressed in clinical care. To address this problem, we first developed, and pilot tested a 6-week, 2 h, Cognitive-existential group intervention therapy that targeted FCR in survivors of breast or gynecological cancer. Following the positive outcome of the pilot, we are now testing this approach in a randomized clinical trial (RCT). Goal and hypotheses : This multicenter, prospective RCT aims to test the efficacy of the intervention. The study hypotheses are that, compared to a control group, cancer survivors participating in the intervention (1) will have less FCR, (2) will show more favorable outcomes on the following measures: cancer-specific distress, quality of life, illness uncertainty, intolerance of uncertainty, perceived risk of cancer recurrence, and coping skills. We further postulate that the between-group differences will persist three and 6 months post-intervention. Methods Sixteen groups of seven to nine women are being allocated to the intervention or the control group. The control group receives a 6-week, 2 h, structurally equivalent support group. We are recruiting 144 cancer survivors from four hospital sites in three Canadian cities. The sample size was based on the moderate pre/post-test changes found in our pilot study and adjusted to the drop-out rates. Measurements : The primary outcome, FCR, is measured by the Fear of Cancer Recurrence Inventory. Secondary outcomes measured include cancer-specific distress, perceived risk of cancer recurrence, illness uncertainty, intolerance of uncertainty, coping, and quality of life. We use reliable and recognized valid scales. Participants are to complete the questionnaire package at four times: before the first group session (baseline), immediately after the sixth session, and 3 and 6 months post-intervention. Analysis : In the descriptive analysis, comparison of group equivalent baseline variables, identification of confounding/intermediate variables and univariate analysis are planned. Each participant’s trajectory is calculated using Generalized Estimating Equation models to determine the time and group effects, after considering the correlation structures of the groups. An intent-to-treat analysis approach may be adopted. Discussion Our Fear of Recurrence Therapy (FORT) intervention has direct implications for clinical service development to improve the quality of life for patients with breast (BC) and gynecological cancer (GC). Based on our pilot data, we are confident that the FORT intervention can guide the development of effective psychosocial cancer survivorship interventions to reduce FCR and improve psychological functioning among women with BC or GC. Trial registration Dr. Christine Maheu registered the trial with ISRCTN registry (Registration number: ISRCTN83539618 , date assigned 03/09/2014).

Background: Fear of cancer recurrence (FCR), cancer-distress, depression, and anxiety are prevalent concerns among women with gynecologic and other understudied cancers, especially among women of color and lower socioeconomic status (SES). Evidence indicates that mind-body interventions are effective in reducing such distress. This study evaluates (1) proof-of-concept of an integrated group yoga and psychological intervention in alleviating distress among women with gynecologic, gastrointestinal, and thoracic cancers and (2) differences in efficacy across social and economic factors. Methods: One hundred twenty-five participants were enrolled in a 10-week, single-arm, integrated group intervention utilizing mindfulness meditation, psychotherapy skills, and yoga. They completed measures of FCR, cancer-distress, depression, and anxiety at baseline and following intervention. Mixed-linear models evaluated change in outcomes across the intervention and moderating effects of age, minority status, and SES among 51 participants with available data. Results: Reductions in total (b = −2.06, P = .012) and somatic depressive symptoms (b = −1.79, P = .002) and state anxiety (b = −6.21, P = .005) were observed across the sample. Higher SES was associated with greater reductions in psychosocial distress related to FCR (b = −0.74, P = .050), and in total (b = −1.06, P = .049) and affective depressive symptoms (b = −0.76, P = .006). Women of color experienced greater declines in somatic symptoms compared to non-Hispanic White women (b = −2.71, P = .031), with women of color experiencing lower SES exhibiting greatest reduction in these symptoms (b = 1.73, P = .026). Conclusions: This study demonstrates proof-of-concept that an integrated psychological and yoga intervention may reduce depressive symptoms and state anxiety among women with gynecologic, gastrointestinal, and thoracic cancers, with racial and/or ethnic minority status and SES moderating some of these effects. Future research should examine intervention feasibility and acceptability among diverse women with cancer and evaluate efficacy using a randomized controlled trial design. Trial registration: ClinicalTrials.gov NCT03385577

ObjectiveTo evaluate outcomes of European cross-border multidisciplinary tumor boards in terms of participation, adherence to treatment recommendations, and access to novel treatment strategies.MethodsThe European reference network for rare gynecological tumors (EURACAN G2 domain) aims to improve the diagnosis, management, and treatment of patients with these cancers. Cross-border multidisciplinary tumor boards were initiated to facilitate intercollegiate clinical discussions across Europe and increase patients’ access to specialist treatment recommendations and clinical trials. All G2 healthcare providers were invited to participate in monthly multidisciplinary meetings. Patient data were collected using a standardized form and case summaries were distributed before each meeting. After each tumor board, a meeting summary with treatment recommendations was sent to all participants and the project manager at the coordinating center. The multidisciplinary tumor board format and outcomes were regularly discussed at G2 domain meetings. Anonymized clinical data and treatment recommendations were registered in a prospective database. For this report, clinical data were collected between November 2017 and December 2020 and follow-up data retrieved until May 2021.ResultsDuring the 3-year period, 31 multidisciplinary tumor boards were held with participants from 10 countries and 20 centers. 91 individual patients were discussed between one and six times for a total of 109 case discussions. Follow-up data were retrieved from 64 patients and 80 case discussions. Adherence to treatment recommendations was 99%. Multidisciplinary tumor board recommendations resulted in 11 patients getting access to off-label treatment and one patient being enrolled in a clinical trial in another European country. 14/91 patients were recommended for surveillance only when additional treatment had been considered locally.ConclusionCross-border multidisciplinary tumor boards enable networking and clinical collaboration between healthcare professionals in different countries. Surveillance strategies, off-label drug use, and increased participation in clinical trials are possible benefits to patients with rare gynecological tumors.

Purpose Gynecologic cancer survivors often hesitate to raise sexual health concerns with their clinicians. We pilot tested Starting the Conversation (STC), a theory-guided intervention aimed at facilitating survivors’ clinical communication about sexual health. Methods Survivors ( N  = 32) were randomized 2:1 to STC (23-min video and accompanying workbook grounded in social cognitive theory that provides information and skills training for communicating with providers about sexual concerns, and resource guide) or control (resource guide only). Feasibility was assessed through enrollment, retention, and intervention completion rates (benchmarks: 60%, 80%, 70%); acceptability was assessed through post-intervention program evaluations (benchmark: 75%). Preliminary effects were assessed for sexual health communication (self-reported after next clinic encounter), self-efficacy for clinical communication about sexual health (post-intervention and 2-month follow-up), and sexual activity and anxiety/depressive symptoms (2-month follow-up). Results All feasibility/acceptability benchmarks were surpassed; 76% enrolled, 97% retained, ≥ 95% used intervention materials, and 100% endorsed STC as acceptable. Positive STC effects were seen for increases in self-efficacy (Cohen’s d’s = 0.45 at post-intervention; 0.55 at follow-up). In STC, 35% and 45% of women raised or asked about sexual health concerns during the post-intervention clinic visit, respectively, versus 0 and 27% in the control arm. Other measures showed little change. Conclusions Data support the STC intervention as feasible and acceptable, with promising effects for gynecologic cancer survivors’ communication about sexual health concerns. Because sexual health communication is relevant across the treatment trajectory, we included both on-treatment and post-treatment survivors. While this may be a limitation, it could also enhance sample generalizability. A larger trial is needed to determine efficacy. Implications for Cancer Survivors Communication about sexual health is important yet lacking for cancer survivors. Patient-focused interventions may help address concerns and improve survivors’ health outcomes.

BackgroundDehydroepiandrosterone (DHEA) is helpful for treating vaginal symptoms. This secondary analysis evaluated the impact of vaginal DHEA on hormone concentrations, bone turnover, and vaginal cytology in women with a cancer history.MethodsPostmenopausal women, diagnosed with breast or gynecologic cancer, were eligible if they reported at least moderate vaginal symptoms. Participants could be on tamoxifen or aromatase inhibitors (AIs). Women were randomized to 3.25 versus 6.5 mg/day of DHEA versus a plain moisturizer (PM) control. Sex steroid hormone levels, biomarkers of bone formation, vaginal pH, and maturation index were collected at baseline and 12 weeks. Analysis included independent t tests and Wilcoxon rank tests, comparing each DHEA arm with the control.ResultsThree hundred forty-five women contributed evaluable blood and 46 contributed evaluable cytology and pH values. Circulating DHEA-S and testosterone levels were significantly increased in those on vaginal DHEA in a dose-dependent manner compared to PM. Estradiol was significantly increased in those on 6.5 mg/day DHEA but not in those on 3.25 mg/day DHEA (p < 0.05 and p = 0.05, respectively), and not in those on AIs. Biomarkers of bone formation were unchanged in all arms. Maturation of vaginal cells was 100% (3.25 mg/day), 86% (6.5 mg/day), and 64% (PM); pH decreased more in DHEA arms.ConclusionDHEA resulted in increased hormone concentrations, though still in the lowest half or quartile of the postmenopausal range, and provided more favorable effects on vaginal cytology, compared to PM. Estrogen concentrations in women on AIs were not changed. Further research on the benefit of vaginal DHEA is warranted in hormone-dependent cancers.

The aim of the Complementary Nursing in Gynecologic Oncology study was to investigate the effects of a complex, nurse‐led, supportive care intervention using Complementary and Integrative Medicine (CIM) on patients’ quality of life (QoL) and associated patient‐reported outcomes. In this prospective, pragmatic, bicentric, randomized controlled trial, women with breast or gynecologic cancer undergoing a new regimen of chemotherapy (CHT) were randomly assigned to routine supportive care plus intervention (intervention group, IG) or routine care alone (control group, CG). The intervention consisted of CIM applications and counseling for symptom management, as well as CIM information material. The primary endpoint was global QoL measured with the EORTC‐QLQ‐C30 before and after CHT. Mixed linear models considering fixed and random factors were used to analyze the data. In total, 126 patients were randomly assigned into the IG and 125 patients into the CG (median age 51 years). The patients’ medical and socio‐demographic characteristics were homogenous at baseline and at follow‐up. No group effects on QoL were found upon completion of CHT (estimate −1.04 [−4.89; 2.81]; P = 0.596), but there was a significant group difference in favor of the IG 6 months later (estimate 6.643 [1.65; 11.64]; P = 0.010). IG patients did also experience significant better emotional functioning (P = 0.007) and less fatigue (P = 0.027). The tested supportive intervention did not improve patients’ QoL outcomes directly after CHT (T3), but was associated with significant QoL improvements when considering the change from baseline to the time point T4, which could be assessed 6 months after patients’ completion of CHT. This delayed effect may have resulted due to a strengthening of patients’ self‐management competencies. During and after chemotherapy (CHT), patients report high levels of symptoms, in particular fatigue, pain, nausea/vomiting, or distress, strongly affecting their quality of life (QoL). To cope with such burden, patients report high usage of complementary therapies (CIM), however, the evidence of CIM supportive programs is scarce. The results of the Complementary Nursing in Gynecologic Oncology‐study indicate that CIM interventions administered regularly from the beginning of CHT treatment, have potential to improve patients’ QoL, but the effects need time to develop, and can only be clearly demonstrated 6 months after completion of CHT.