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Biomedical subjects

L J Fallowfield

Publications and source records attributed to L J Fallowfield.

At least 19 recordsLinked to original sources
PubMed2006

Postmenopausal women undergoing transvaginal ultrasound screening prefer not to have chaperones.

The Royal College of Radiologists has recommended chaperones of the appropriate gender for those undergoing intimate scans. This has significant implications for clinical and research programmes. Two hundred and fifty women undergoing scanning in a screening trial were sent postal questionnaires to determine their views as to the presence of chaperones and the gender of ultrasonographers. Ninety-five percent of 198 women stated that they would not like another person to be present during transvaginal scanning. Of greater consequence to women was the gender of the ultrasonographer, with 83.3% expressing a preference for a female ultrasonographer. This needs to be considered in making decisions about allocation of scarce resources.

Aged↗
PubMed2006

Communication and informed consent in phase 1 trials: a review of the literature.

Phase 1 (P1) trials are vital to the development of cancer treatments; however, the patients involved in these trials are unlikely to receive any therapeutic benefit, and there are significant possibilities that they will experience serious side effects. Ethical requirements stipulate that patients must be adequately informed before they consent to participate in P1 trials. This review focuses on studies that have measured patient comprehension of information given during the informed consent process of P1 cancer trials. Patients consenting to participate in P1 trials currently have a limited understanding of trial purpose, an unrealistic expectation of the benefits and risks associated with trial participation and a questionable appreciation of their right to abstain or withdraw. Health care professionals recruiting to P1 trials need clear and practical guidelines and training packages designed to ensure that all details of P1 trials are communicated effectively to eligible patients.

Clinical Trials, Phase I as Topic↗
PubMed2005

Patients' preferences for adjuvant endocrine therapy in early breast cancer: what makes it worthwhile?

Adjuvant endocrine therapy improves recurrence and survival rates, but has side effects and is inconvenient. The aim of this study was to determine the preferences of premenopausal women who had adjuvant endocrine therapy in a randomised trial. In all, 85 (or eighty-five) women completed semistructured interviews 6-30 months after finishing adjuvant endocrine therapy. Hypothetical scenarios based on known potential survival times (5 or 15 years) and rates (60% or 80% at 5 years) without adjuvant endocrine therapy were used to determine the smallest gains women judged necessary to make their adjuvant endocrine therapy worthwhile. Although a third of the women considered gains of 1% in survival rates or 6 months in survival times sufficient to make their adjuvant endocrine therapy worthwhile, more than half the women required gains of at least 5% in survival rates or 3 years in survival time as necessary to make adjuvant endocrine therapy worthwhile. Larger benefits were required by women who had longer treatment, worse side effects, and by those who were treated with goserelin alone. The route of administration (tablet vs injection) did not affect preferences and some women judged small benefits sufficient to make their adjuvant endocrine therapy worthwhile, but many women required larger benefits than their counterparts in similar studies of preferences for adjuvant chemotherapy.

Adult↗
PubMed2003

A qualitative study looking at the psychosocial implications of bilateral prophylactic mastectomy.

The study objective was to explore the attitudes and beliefs of women at high risk of developing breast cancer who accepted or declined bilateral prophylactic mastectomy (BPM). This qualitative study employed semi-structured interviews of 60 women who opted for BPM and 20 women who declined. Interviews took place in the women's own homes. Qualitative analysis led to the generation of a number of categories that provided conceptualisation of the women's primary experiences. These categories included: anxiety; surgery; sexual impact; information; gene testing; reconstruction and support. The study revealed that there is a clear need for information to be written specifically for this patient group and that emotional support for high-risk women offered BPM should be provided.

Adult↗
PubMed2002

The psychological impact of post-operative arm morbidity following axillary surgery for breast cancer: a critical review.

In this paper we review the published research that has investigated the psychological impact of arm morbidity associated with axillary dissection for early breast cancer. This critique is particularly timely given the drive towards minimally invasive techniques, such as sentinel node biopsy, which aim to reduce the incidence and severity of post-operative arm problems. Reported symptoms are multifactorial and include numbness, pain, swelling, weakness/stiffness, and restricted shoulder mobility of the affected arm. Conclusions from the few studies that have investigated the severity, incidence, duration and psychological impact of such disability are often limited by methodological problems. We identify these limitations and examine assessment tools used to determine the psychological impact of lymphoedema. The paper highlights the need for methodological rigor in study design, and the careful selection of appropriate, sensitive, reliable and clinically meaningful outcome measures to evaluate the impact of post-operative arm morbidity.

Journal Article↗
PubMed2002

The impact of endocrine therapy on patients with breast cancer: a review of the literature.

This paper reviews studies which have examined the impact of endocrine therapy on the quality of life (QOL) of patients with breast cancer. In patients with primary disease, published studies suggest that endocrine therapies, such as tamoxifen, significantly increase both gynaecological and vasomotor symptoms. However, few studies have been able to demonstrate the impact which these symptoms have on patients' QOL. This failure can be partially attributed to a range of methodological problems. Psychosocial research in advanced disease has largely consisted of randomized controlled studies with QOL as one of several study endpoints. Second generation treatments, such as aromatase inhibitors, have frequently been compared with older treatments, such as progestin therapies. Unfortunately, QOL data reported in these studies have tended to be fairly limited. Problems with existing QOL research in endocrine treatment are discussed and recommendations are made for further work.

Journal Article↗
PubMed2002

Truth may hurt but deceit hurts more: communication in palliative care.

Healthcare professionals often censor their information giving to patients in an attempt to protect them from potentially hurtful, sad or bad news. There is a commonly expressed belief that what people do not know does not harm them. Analysis of doctor and nurse/patient interactions reveals that this well-intentioned but misguided assumption about human behaviour is present at all stages of cancer care. Less than honest disclosure is seen from the moment that a patient reports symptoms, to the confirmation of diagnosis, during discussions about the therapeutic benefits of treatment, at relapse and terminal illness. This desire to shield patients from the reality of their situation usually creates even greater difficulties for patients, their relatives and friends and other members of the healthcare team. Although the motivation behind economy with the truth is often well meant, a conspiracy of silence usually results in a heightened state of fear, anxiety and confusion--not one of calm and equanimity. Ambiguous or deliberately misleading information may afford short-term benefits while things continue to go well, but denies individuals and their families opportunities to reorganize and adapt their lives towards the attainment of more achievable goals, realistic hopes and aspirations. In this paper, some examples and consequences of accidental, deliberate, if well-meaning, attempts to disguise the truth from patients, taken verbatim from interviews, are given, together with cases of unintentional deception or misunderstandings created by the use of ambiguous language. We also provide evidence from research studies showing that although truth hurts, deceit may well hurt more. 'I think the best physician is the one who has the providence to tell to the patients according to his knowledge the present situation, what has happened before, and what is going to happen in the future' (Hippocrates).

Adult↗
PubMed2001

Tolerability of hormone therapies for breast cancer: how informative are documented symptom profiles in medical notes for 'well-tolerated' treatments?

Hormonal therapies for cancer are often viewed as a gentler option than many other cancer treatments, but is low toxicity an accurate perception of patients' experiences? Side effects tend to be described as minimal or well tolerated, yet published symptoms from hormonal therapy vary considerably in their descriptions and frequencies. Previous research has highlighted under-reporting of side effects by clinical staff so as part of a wider study examining tamoxifen and goserelin treatment as adjuvant therapy for breast cancer, treatment-related symptoms documented in medical notes were compared with those that patients reported during a research interview. There was a significant difference in the frequency of many side effects reported by the two methods in this study. Sixty four out of 72 (89%) women who had received adjuvant tamoxifen or goserelin had side effects recorded in their medical notes, compared with 74/75 (99%) reporting side effects at interview. We compared the published frequencies of commonly reported symptoms with those found ourselves. The discrepancies between patient-reported and clinician-recorded (usually from clinical trial data) symptom profiles were similar to those found in our study. Without accurate comprehensive side effect profiles for hormone therapies, prospective patients cannot make informed judgements on proposed treatments.

Adult↗
PubMed2001

The validation of a quality of life scale to assess the impact of arm morbidity in breast cancer patients post-operatively.

This paper documents the validation of a quality of life scale (QOL) designed to assess the impact of arm morbidity on patients following breast cancer surgery. A four item arm subscale was developed to supplement a multi-dimensional, validated breast cancer QOL tool, the functional assessment of cancer therapy (FACT-B.) The new questionnaire, the FACT-B + 4, was validated on 279 women participating in a trial of sentinel node guided axillary therapy and 29 women attending a lymphoedema clinic. The subscale demonstrated good internal consistency (alpha co-efficient = 0.62 to 0.88) and stability (test-retest reliability = 0.97). Lymphoedema patients reported significantly greater arm problems than a matched sample of pre-operative trial participants. The lymphoedema group also scored lower than trial patients on the FACT-B + 4 indicating a poorer quality of life (p < 0.05). A subset of 66 trial patients who had completed three consecutive assessments was used to evaluate the sensitivity of the questionnaire to change over time. Scores on the FACT-B + 4 were found to decline significantly between the pre-operative assessment and post-operative assessment at 1 month. Arm problems significantly increased during this period. FACT-B + 4 score increased again from 1 month to 12 weeks post-surgery and symptoms reduced, as the extent of arm morbidity resolved. The FACT-B + 4 appears to be psychometrically robust and sensitive to patient rehabilitation, making it suitable for use in longitudinal surgical trials. Given the dearth of existing scales available to measure arm morbidity, we hope this new tool will prove useful to researchers.

Adult↗
PubMed2001

Are members of multidisciplinary teams in breast cancer aware of each other's informational roles?

AIM: To conduct a commissioned survey of multidisciplinary breast team members' expectations of their own and each other's roles in providing different kinds of information to women with breast cancer. DESIGN: Questionnaire based survey. SETTING AND PARTICIPANTS: Health professionals from five multidisciplinary breast care centres within a Sussex health authority. MAIN OUTCOME MEASURES: Interdisciplinary awareness of informational roles played by different team members. RESULTS AND CONCLUSIONS: The results of the team survey suggest that, in most cases, health professionals fulfilled the roles expected of them by the team, with two or three individuals identified as the main providers of information for each topic. However, many more professionals were involved in major discussions without the team's knowledge. The professional consistently playing a major "unseen" role was the breast nurse specialist.

Awareness↗
PubMed1999

How do doctors explain randomised clinical trials to their patients?

As part of a larger study designed to improve doctor-patient communication in randomised clinical trials (RCT), we audiotaped the discussions between doctor and patient in which consent was being obtained for a RCT. This paper reports on 82 discussions conducted by 5 clinical oncologists in both District General and University Hospital outpatient departments. When introducing the subject of trials, uncertainty about treatment decisions was expressed by the doctors in the majority of cases (79, 96.3%). This was most often stated in a general sense (78, 95.1%), but some mentioned personal uncertainty (12, 14.6%), an approach which helps to maintain a trusting doctor-patient relationship. The word randomization was mentioned in 51 (62.2%) consultations, although the process itself was usually described implicitly (78, 95.1%), e.g. by telling the patient that they would be allocated either one or other treatment. Analogies were used in 28 (34.1%) cases to describe the randomisation process. In addition, although treatments and side-effects were described frequently, (68, 82.9%) and (72, 87.8%) respectively, information leaflets about the trials were not given to 23 (28%) patients. The study shows that U.K. clinicians adopt individual methods when providing information and eliciting consent to trials.

Adult↗
PubMed1999

Assessment of quality of life in women undergoing hormonal therapy for breast cancer: validation of an endocrine symptom subscale for the FACT-B.

Existing quality of life instruments do not include adequate items to measure the side effects and putative benefits of hormonal treatments given in breast cancer. We report the development and validation of an 18 item endocrine subscale (ES) to accompany a standardised breast cancer quality of life measure, the Functional Assessment of Cancer Therapy (FACT-B). The FACT-ES (FACT-B plus ES) was tested initially on 268 women with breast cancer receiving endocrine treatments. Alpha coefficients for all subscales demonstrated good internal consistency (range alpha = 0.65-0.87). Test-retest reliability of the ES indicated good stability (r = 0.93, p < 0.001). Advanced breast cancer patients' quality of life was high, showing the efficacy of endocrine therapy, but women with primary disease reported better physical, social, and functional well-being and fewer breast cancer concerns. Most frequently reported symptoms were loss of sexual interest (31%), weight gain (25%), and hot flushes (24%). Significant differences were found between treatment groups for hot flushes and vaginal dryness. Two assessments of the instrument's responsiveness to change were made; 32 women in a clinical trial of endocrine therapy and 18 women without breast cancer taking HRT completed the FACT-ES at baseline, 4, 8, and 12 weeks. Trial patients reported significantly more symptoms at 8 and 12 weeks than at baseline. Women taking HRT reported significantly fewer or less severe symptoms than at baseline. In conclusion the FACT-ES has acceptable validity and reliability and is sensitive to clinically significant change, making it suitable for clinical trials of endocrine therapy.

Adult↗
PubMed1999

Sexual activity questionnaires in clinical trials: acceptability to patients with gynaecological disorders.

OBJECTIVE: To assess the feasibility and acceptability of including sexual activity questionnaires in gynaecological clinical trials. DESIGN: A longitudinal quality of life study during the Maintenance Interferon Trial and the EVALUATE Hysterectomy Trial. SETTING: Gynaecology clinics and women's homes. SAMPLE: Ninety-six women with advanced ovarian cancer participating in the Maintenance Interferon Trial and 542 women undergoing a hysterectomy in the EVALUATE Hysterectomy Trial. METHODS: Quality of life questionnaires, including the sexual activity questionnaire, were completed by women prior to randomisation and periodically after randomisation. MAIN OUTCOME MEASURES: Compliance rates of the sexual activity questionnaire, both overall and with respect to the level of sexual functioning and age of the women. Attitudes of the women towards completing the questionnaire, and suitability of using the sexual activity questionnaire in clinical trials. RESULTS: Compliance rates of over 80% were achieved in both trials, both overall and for each questionnaire completed. The age of the woman did not appear to influence the completion of the questionnaire, nor did her level of sexual functioning. Women were supportive of the research and did not find the questionnaire intrusive. CONCLUSIONS: It is feasible to include sexual activity questionnaires in gynaecological clinical trials requiring repeated assessment of quality of life over a long period of time. The sexual activity questionnaire is an appropriate tool to carry out investigations of sexual functioning and is worth considering for use in future clinical trials.

Adult↗
PubMed1998

Attitudes of patients to randomised clinical trials of cancer therapy.

The aim of this study was to test an instrument which might be useful for doctors in explaining the randomisation procedure to an individual patient. The sample comprised 323 patients with cancer attending for out-patient appointments and/or chemotherapy treatment in two major cancer centres in the U.K. 315 patients completed a self-report questionnaire--The Attitudes to Randomised Trials Questionnaire (ARTQ). The results show that the majority of subjects 287 (91.1%) believe that patients should be asked to take part in medical research, but only 242 (76.8%) would be prepared to take part in a study comparing two treatments. If treatment was randomised, only 141 (44.8%) would agree to participate. When given further information about the randomisation procedure, 119 (68.4%) of the 174 (55.2%) who initially said 'no' to randomisation or who were unsure, would change their minds and take part in a trial. The ARTQ discriminated between three categories of patient with the following prevailing attitudes: (a) those who seem comfortable with the concept of randomisation; (b) those with some concerns, who with fuller explanation are prepared to consider randomisation; and (c) those firmly against randomisation and participation in trials whatever information is provided. Prior knowledge of patients' attitudes might assist communication about trials and encourage more doctors to approach eligible patients.

Adult↗
PubMed1995

Assessment of quality of life in breast cancer.

Effective treatment for breast cancer can produce a reasonably good ten-year survival rate in comparison to many other cancer sites. Nevertheless, the potential psychological, sexual and physical dysfunction caused by both the diagnosis and treatments can have a deleterious impact on the quality of a woman's life. The range of possible treatments may have similar outcomes in terms of response and survival, but can produce very different effects on emotional well-being. Therefore, monitoring quality of life in breast cancer should be a mandatory part of follow-up in clinical trials. Data derived from various studies of quality of life can also be used to assist the doctor and patient in decision-making about treatment options. Furthermore, assessment of quality of life can help identify those patients who might profit from psychosocial interventions. In this paper some of the instruments used to assess quality of life in breast cancer will be discussed.

Breast Neoplasms↗