A Pilot Study of Home-Based Exercise and Personalized Nutrition Counseling Intervention in Endometrial Cancer Survivors.

INTRODUCTION: To assess the feasibility of a home-based aerobic exercise and nutrition counseling intervention and effect on cardiorespiratory fitness, cardiovascular disease risk profile, and immune response in obese endometrial cancer survivors. METHODS: A longitudinal pilot study assessed a 12-week home-based aerobic exercise and nutrition counseling intervention in obese endometrial cancer survivors. The primary outcome was feasibility defined as 80% adherence to weekly walking sessions calculated among individuals that completed the intervention. Secondary outcomes comprised pre- and post-intervention differences in cardiorespiratory fitness, cardiovascular risk factors, and T-cell function. Descriptive statistics summarized data. Wilcoxon sign tests identified differences between and pre and post-intervention variables. RESULTS: Nineteen women with stage 1 endometrial cancer consented; 9 withdrew and one was a screen failure. Median adherence to weekly walking sessions was 83.3%. Body composition was significantly altered with a reduction in median fat mass from 52.5 kg to 46.9 kg (p=0.04), and BMI from 37.5 kg/m2 to 36.2 kg/m2 (p = 0.004). There was no significant difference in cardiorespiratory fitness or cardiovascular parameters. The percentage of CD4+ and CD8+ T-cells producing IFNγ towards MAGE-A4 significantly increased from and 5.9% to 7.2% (p=0.043) and 13.9% to 14.8% (p=0.046), respectively. There were 3 related adverse events: hip pain, back sprain, and abdominal pain. DISCUSSION: Our home-based exercise and nutrition counseling program was feasible based on 80% adherence to walking sessions and favored altered body composition. However, the discontinuation rate was high and further research is needed to overcome barriers to implementation. Improvement in cardiovascular parameters will most likely require longer and more intensive programs.

Feasibility of an online safety planning intervention for rural and urban pregnant abused women.

BACKGROUND: Intimate partner violence (IPV) in pregnancy is common and harmful to maternal-child health. Safety planning is the gold standard for intervention, but most abused women never access safety planning. Pregnant women may face increased barriers to safety planning and risk of severe IPV, particularly if they are also rural residents. Internet-based safety planning interventions may be useful, but no such interventions specific to the needs of pregnant women have been developed. OBJECTIVES: The aim was to evaluate feasibility (usability, safety, and acceptability) of Internet-based safety planning for rural and urban abused pregnant women and practicality of recruitment procedures for future trials. METHODS: An existing Internet-based safety decision aid for pregnant and postpartum women was adapted; initial content validity was established with survivors of IPV, advocates, and national IPV experts; and a convenience sample of community-dwelling abused pregnant women was recruited and randomized into two groups to test the decision aid. RESULTS: Fifty-nine participants were enrolled; 46 completed the baseline session, 41% of whom (n = 19) resided in nonmetropolitan counties. Participants' average gestational age was 20.2 weeks, and 28.3% resided with the abusive partner. Participants reported severe IPV at baseline (mean Danger Assessment score of 16.1), but all were able to identify a safe computer, and 73.9% completed the baseline session in less than 1 week, with no adverse events reported. DISCUSSION: These findings provide preliminary evidence for the feasibility, acceptability, and safety of an Internet-based safety decision aid for urban and rural abused pregnant women.

Preference-based utility scores for adverse events associated with the treatment of gynecologic cancers.

OBJECTIVE: Our goals were to (1) define a set of descriptive health states related to adverse events (AEs) associated with gynecologic cancer treatment with radical surgery and chemoradiation and (2) derive a set of quality of life-related utility scores corresponding to these health states. METHODS: We developed a list of health states for grade 3/4 AEs related to gynecologic cancer treatment. Using the visual analog scale score and time trade-off (TTO) methods, valuation of each health state was obtained through interviews of 60 volunteers (15 cervical cancer survivors treated with surgery and/or chemoradiation and 45 women without a cancer diagnosis). Health states were ranked by mean/median TTO scores. Wilcoxon rank sum test was used to compare central tendencies related to patient and volunteer characteristics. RESULTS: Patients and volunteers agreed on their preference rankings, with highest preference given to infection (median TTO = 1.0) and thrombosis (median TTO = 0.97). Lowest preference was assigned to radiation proctitis (median TTO = 0.87) and gastrointestinal fistula formation (median TTO = 0.83). Utility scores for the majority of health states were not significantly associated with age, race, parity, patient or volunteer status, history of abnormal Pap smear, stage of cervical cancer diagnosis, or personal experience of a serious treatment-related AE. CONCLUSIONS: This study helps establish preferences and quality-of-life utility scores for health states related to toxicities from surgery, radiation, and chemotherapy for gynecologic cancer treatment. Such information can be used to inform medical decision making/counseling and may be applied to future comparative effectiveness models in which radical surgery and/or chemoradiation are considered.

Utility scores and treatment preferences for clinical early-stage cervical cancer.

OBJECTIVES: To determine utility scores for health states relevant to the treatment of early-stage, high-risk cervical cancer. METHODS: Seven descriptive health states incorporating the physical and emotional aspects of medical treatment, recovery, and prognosis were developed. Forty-five female volunteers valuated each health state using the visual analogue score (VAS) and time trade off (TTO) methods. Treatment options were ranked by mean and median TTO scores. The 95% confidence intervals were calculated to determine the statistical significance of ranking preferences. The Wilcoxon rank-sum test was used to compare central tendencies related to age, race, parity, and subject history of abnormal cervical cytology. RESULTS: VAS and TTO scores were highly correlated. Volunteers ranked minimally invasive radical hysterectomy with low-risk features as most preferred (mean TTO = 0.96; median TTO = 1.00) and aborted radical hysterectomy followed by chemoradiation as least preferred (mean TTO = 0.69; median TTO = 0.83). Health states that included radical surgery were ranked higher than those that included chemoradiation, either in the adjuvant or primary setting. When survival was comparable, volunteers rated radical hysterectomy with high-risk pathology followed by adjuvant chemoradiation (mean TTO = 0.78; median TTO = 0.92; 95% CI: 0.69-0.87) similarly to chemoradiation alone (mean TTO = 0.76; median TTO 0.90; 95% CI: 0.66-0.86; p = NS). Utility scores for the majority of health states were not significantly associated with age, race, parity, or subject history of abnormal cervical cytology. CONCLUSION: Subjects consistently preferred surgical excision to treat early-stage, high-risk cervical cancer and chose a minimally invasive approach. Such utility scores can be used to incorporate quality-of-life effects into comparative-effectiveness models for cervical cancer.

Severe ulceration over mandibular torus in an ovarian cancer patient receiving bevacizumab therapy.

► Bevacizumab may increase the risk of mucosal ulceration and subsequent bone necrosis. ► Patients receiving bevacizumab should be closely monitored for dental symptoms.

Determination of quality of life-related utilities for health states relevant to ovarian cancer diagnosis and treatment.

OBJECTIVES: (1) To define a set of health state descriptions related to screening, diagnosis, prognosis, and toxicities relevant to ovarian cancer; (2) To derive a set of quality of life-related utilities to be used for cost-effectiveness analyses. METHODS: A comprehensive list of health states was developed to represent the experiences of diagnostic testing for ovarian cancer, natural history of ovarian cancer (e.g., newly diagnosed early stage ovarian cancer, recurrent progressive ovarian cancer) and the most common chemotherapy-related toxicities (e.g. alopecia, peripheral neuropathy, pain, neutropenia, fatigue). Valuation of each health state was obtained through individual interviews of 13 ovarian cancer patients and 37 female members of the general public. Interviews employed visual analog score (VAS) and time trade off (TTO) methods of health state valuation. RESULTS: Mean TTO-derived utilities were higher than VAS-derived utilities by 0.118 U (p<0.0001). Mean VAS-derived utilities for screening tests were 0.83 and 0.81 for true negative blood test and ultrasound; 0.79 and 0.78 for false negative blood test and ultrasound, respectively. Patients and volunteers generally agreed in their preference ranking of chemotherapy-associated states, with lowest rankings being given to febrile neutropenia, grades 3-4 fatigue, and grades 3-4 nausea/vomiting. For 55% of chemotherapy-associated health states, the average utility assigned was higher for patients than for volunteers. CONCLUSIONS: This study establishes societal preferences for a number of health states related to screening, diagnosis and treatment of ovarian cancer that can be used for assessing the cost-effectiveness of different ovarian cancer screening and treatment regimens.