The effect of ovarian cancer screening on sexual activity and functioning: results from the UK collaborative trial of ovarian cancer screening RCT.

BACKGROUND: To examine the impact of multimodal (MMS) and ultrasound (USS) screening on the sexual activity and functioning of 22 966 women in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) RCT. METHODS: Fallowfield's Sexual Activity Questionnaire (FSAQ) was completed prior to randomisation, then annually in a random sample (RS) of women from MMS, USS and control groups. Any women in the study who required repeat screening due to unsatisfactory results formed an Events Sample (ES); they completed questionnaires following an event and annually thereafter. RESULTS: Over time in the RS (n=1339) there was no difference between the MMS and USS groups in sexual activity compared with controls. In the ES there were significant differences between the USS group (n=10 156) and the MMS group (n=12 810). The USS group had lower pleasure scores (mean difference=-0.14, P=0.046). For both groups women who had ⩾2 repeat screens, showed a decrease in mean pleasure scores compared with their annual scores (mean difference=-0.16, P=0.005). Similarly mean pleasure scores decreased following more intensive screens compared with annual screening (mean difference=-0.09, P=0.046). CONCLUSIONS: Ovarian cancer screening did not affect sexual activity and functioning unless a woman had abnormal results and underwent repeated or higher level screening.

Psychosocial Factors Associated With Withdrawal From the United Kingdom Collaborative Trial of Ovarian Cancer Screening After 1 Episode of Repeat Screening.

OBJECTIVE: The United Kingdom Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) aims to establish the efficacy of 2 different ovarian cancer screening schedules. The psychosocial substudy examines the psychological factors associated with the screening program. METHODS: Women aged 50 to 75 years from 16 UK gynecologic centers randomized to annual multimodal screening or ultrasound screening (US) groups were followed up for 7 years. Psychosocial data from women who withdrew from the study after a repeat screen were examined. RESULTS: Sixteen percent (3499/21,733) of women requiring a repeat screening test in addition to annual screen withdrew from the study: 12.9% (1560/12,073) from the multimodal group and 20.1% (1939/9660) from the US group. An estimated relative risk of withdrawal is 1.46 (95% confidence interval, 1.36-1.56; P ≤ 0.001) for the US arm. High anxiety trait and increased psychological morbidity significantly influenced withdrawal, even when age, screening center, and group were taken into account (P < 0.001). The risk of withdrawal decreased significantly the longer a woman stayed in UKCTOCS, irrespective of the number of screens and intensity in the preceding year. CONCLUSIONS: Withdrawal rate was greater in women undergoing US screening and in those who had repeats earlier in UKCTOCS. Having a high predisposition to anxiety, high current state anxiety, and above threshold general psychological morbidity all increased the withdrawal rate.

Adjuvant chemotherapy in elderly women with breast cancer: patients' perspectives on information giving and decision making.

BACKGROUND: Decisions about adjuvant chemotherapy in older women with early stage breast cancer (EBC) are often challenging. Uncertainty about benefits due to limited data about treatment efficacy and outcomes complicates decision making. This qualitative study explored older patients' experiences and preferences towards information giving and ultimate decisions about adjuvant chemotherapy. METHODS: Clinicians from 24 UK breast cancer teams reported on adjuvant chemotherapy decisions for women aged ≥70 years with EBC from April 2010 to December 2011. Women who were offered chemotherapy were invited to participate in structured interviews. Self-reported quality of life (QoL) and functional ability were assessed. Qualitative methods were used to identify themes associated with information giving and decision making. RESULTS: A total of 58/95 eligible women (61%) participated. Median age was 73 years (range 70-83). Mean total scores for QoL and functional ability were average. The majority of women preferred to make their treatment decisions collaboratively with a clinician (59%) or on their own (19%). The main reasons influencing decisions to accept chemotherapy were categorised as prevention of recurrence and clinician recommendation. Side effects, length of treatment, impact on QoL, low survival benefits and clinician recommendation influenced decisions to decline chemotherapy. The majority (80%) were satisfied with information provision, the communication with their clinician and explanation of treatment. CONCLUSIONS: Older women with EBC preferred to be involved in clinical decision making. Clinician recommendation plays a significant role in either accepting or declining chemotherapy. Well-informed decision making and effective communication between clinicians, older women and their family members are therefore important.

The views of patients and the general public about expensive anti-cancer drugs in the NHS: a questionnaire-based study.

OBJECTIVES: To determine the views of patients and members of the public about who should pay for expensive new cancer drugs not recommended by the National Institute for Health and Clinical Excellence (NICE). DESIGN: A study-specific questionnaire was used to elicit the views of patients and the general public between April and June 2010. It examined whether participants thought patients should be told about all possible cancer treatments, if the NHS should always fund non-NICE recommended drugs and attitudes towards self-funding/co-payments. The influence of sociodemographic factors on responses was also examined. SETTING: Oncology clinics in Sussex and various locations including old persons' lunch clubs, parks, sports venues and support groups. PARTICIPANTS: Two hundred and 10 patients with common solid tumours, and 416 members of the general public MAIN OUTCOME MEASURES: Frequencies of responses to items regarding payments for expensive anti-cancer drugs stratified by sociodemographic factors and comparison of responses between patients and members of the public. RESULTS: Most respondents (70% [147/210] of patients and 64% [266/416] of the general public) had heard of NICE. Both groups believed that doctors should tell patients about all available cancer treatments even if the NHS cannot pay (94%, 196/208; 93%, 388/415). However, only 49% (101/207) of patients and 36% (146/409) of the public believed that the NHS should always fund all new cancer drugs that have failed health technology assessments. Strong predictors of willingness to purchase expensive new cancer drugs included younger age (<45 years), sex (female) and higher educational level. CONCLUSION: The general population appear realistic about the difficulties of providing funding for expensive new drugs. A communication skills training course has been developed to help clinicians with these difficult consultations.

Anastrozole and letrozole: an investigation and comparison of quality of life and tolerability.

Previous studies have demonstrated that both anastrozole and letrozole are well tolerated. Letrozole suppresses estrogen to a greater degree than anastrozole in the serum and breast tumor. Concerns have been raised that greater potency may adversely affect patients' quality of life (QOL). One hundred eighty-one postmenopausal women with invasive estrogen receptor-positive breast cancers were randomized to receive either 12 weeks of letrozole followed by 12 weeks of anastrozole or the reverse sequence. One hundred and six received immediate adjuvant aromatase inhibitors (AIs) following surgery, and 75 received extended adjuvant therapy. The Functional Assessment of Cancer Therapy Endocrine Subscale (FACT-B-ES) QOL questionnaires were completed to assess QOL on each drug. Additional side-effect profiles were collected. Each patient completed a patient preference form. Twenty-one patients withdrew before study end, 10/179 (5.6%) while taking letrozole and 4/173 (2.3%) while taking anastrozole (P = 0.12). Tamoxifen-naïve patients had a higher mean ES (endocrine symptoms subscale) score at entry versus those having extended therapy (66.0 vs. 61.9; P = 0.001). There was no significant change in FACT-B-ES (overall) scores or ES scores while patients were taking anastrozole or letrozole and no significant differences between drugs. Nearly 80% of patients reported one or more side effects with either agent. No differences in frequency, grade, or range of side effects were seen between drugs. Of 160 patients, 49 (30.6%) preferred letrozole, 57 (35.6%) preferred anastrozole, and 54 (33.8%) had no preference (P = 0.26, Pearson's Chi-squared test). In conclusion, both AIs are equally well tolerated. There were no significant differences in QOL scores between the two drugs.

What oncologists believe they said and what patients believe they heard: an analysis of phase I trial discussions.

UNLABELLED: PURPOSE; Evaluation of the communication and informed consent process in phase I clinical trial interviews to provide authentic, practice-based content for inclusion in a communication skills training intervention for health care professionals. PATIENTS AND METHODS: Seventeen oncologists and 52 patients from five United Kingdom cancer centers consented to recording of phase I trial discussions. Following each consultation, clinicians completed questionnaires indicating areas they felt they had discussed, and researchers conducted semistructured interviews with patients examining their recall and understanding. Patients and oncologists also completed the Life Orientation Test-Revised questionnaire, measuring predisposition toward optimism. Independent researchers coded the consultations identifying discussion of key information areas and how well this was done. Observed levels of agreement were analyzed for each consultation between oncologist-coder, oncologist-patient, and patient-coder pairs. RESULTS: In several key areas, information was either missing or had been explained but was interpreted incorrectly by patients. Discussion of prognosis was a frequent omission, with patients and coders significantly more likely to agree that oncologists had not discussed it (odds, 4.8; P < .001). In contrast, coders and oncologists were more likely to agree that alternate care plans to phase I trial entry had been explained (odds, 2.5; P = .023). CONCLUSION: These data indicate that fundamental components of communication and information sharing about phase I trial participation are often missing from interviews. Important omissions included discussion of prognosis and ensuring patient understanding about supportive care. These findings will inform educational initiatives to assist communication about phase I trials.

Information needs and experiences: an audit of UK cancer patients.

As part of a multi-centred UK study evaluating multidisciplinary team communication, the information needs, decision making preferences and information experiences of 394 cancer patients were audited. A majority of patients (342/394, 87%) wanted all possible information, both good and bad news. Assuming that all clinicians had equal skill, the majority of patients (350/394, 89%) expressed no preference for the sex of their doctor. The largest proportion of patients (153/394, 39%) wanted to share responsibility for decision making, preference was significantly influenced by age (chi2=17.42, df=4 P=0.002) with older patients more likely to prefer the doctor to make the decisions. A majority of patients reported receiving information regarding their initial tests (313/314, 100%), diagnosis (382/382, 100%), surgery (374/375, 100%) and prognosis (308/355, 87%), fewer recalled discussions concerning clinical trials (119/280, 43%), family history (90/320, 28%) or psychosocial issues, notably sexual well-being (116/314, 37%). Cancer patients want to be fully informed and share decision making responsibility, but do not report receiving sufficient information in all areas. Multidisciplinary cancer teams need to ensure that where appropriate, someone provides patients with information about clinical trials, familial risk and psychosocial issues. Regular audits highlight gaps and omissions in the information given to patients.

Post-operative arm morbidity and quality of life. Results of the ALMANAC randomised trial comparing sentinel node biopsy with standard axillary treatment in the management of patients with early breast cancer.

This study is the first large prospective RCT of sentinel node biopsy (SNB) compared with standard axillary treatment (level I-III axillary lymph node dissection or four node sampling), which includes comprehensive and repeated quality of life (QOL) assessments over 18 months. Patients (n = 829) completed the Functional Assessment of Cancer Therapy - Breast (FACT-B+4) and the Spielberger State/Trait Anxiety Inventory (STAI) at baseline (pre-surgery) and at 1, 3, 6, 12, and 18 months post-surgery. There were significant differences between treatment groups favouring the SNB group throughout the 18 months assessment. Patients in the standard treatment group showed a greater decline in Trial Outcome Index (TOI) scores (physical well-being, functional well-being and breast cancer concerns subscales in FACT-B+4) and recovered more slowly than patients in the SNB group (p < 0.01). The change in total FACT-B+4 scores (measuring global QOL) closely resembled the TOI results. 18 months post-surgery approximately twice as many patients in the standard group compared with the SNB group reported substantial arm swelling (14% versus 7%) (p = 0.002) or numbness (19% versus 8.7%) (p < 0.001). Despite the uncertainty about undergoing a relatively new procedure and the possible need for further surgery, there was no evidence of increased anxiety amongst patients randomised to SNB (p > 0.05). For 6 months post-surgery younger patients reported less favourable QOL scores (p < 0.001) and greater levels of anxiety (p < 0.01). In view of the benefits regarding arm functioning and quality of life, the data from this randomised study support the use of SNB in patients with clinically node negative breast cancer.