Attention Control Arm Research Articles

Patients report improvements in continuity of care when quality of life assessments are used routinely in oncology practice: Secondary outcomes of a randomised controlled trial

Introduction and aim In a randomised trial investigating the effects of regular use of health-related quality of life (HRQOL) in oncology practice, we previously reported an improvement in communication (objective analysis of recorded encounters) and patient well-being. The secondary aims of the trial were to measure any impact on patient satisfaction and patients’ perspectives on continuity and coordination of their care. Methods In a prospective trial involving 28 oncologists, 286 cancer patients were randomised to: (1) intervention arm: regular touch-screen completion of HRQOL with feedback to physicians; (2) attention-control arm: completion of HRQOL without feedback; and (3) control arm: no HRQOL assessment. Secondary outcomes were patients’ experience of continuity of care (Medical Care Questionnaire, MCQ) including ‘Communication’, ‘Coordination’ and ‘Preferences to see usual doctor’ subscales, patients’ satisfaction, and patients’ and physicians’ evaluation of the intervention. Analysis employed mixed-effects modelling, multiple regression and descriptive statistics. Results Patients in the intervention arm rated their continuity of care as better than the control group for ‘Communication’ subscale ( p = 0.03). No significant effects were found for ‘Coordination’ or ‘Preferences to see usual doctor’. Patients’ evaluation of the intervention was positive. More patients in the intervention group rated the HRQOL assessment as useful compared to the attention-control group (86% versus 29%), and reported their doctors considered daily activities, emotions and quality of life. Conclusion Regular use of HRQOL measures in oncology practice brought changes to doctor-patient communication of sufficient magnitude and importance to be reported by patients. HRQOL data may improve care through facilitating rapport and building inter-personal relationships.

Abstract CN09-03: Capitalizing on the teachable moment of the cancer diagnosis to promote healthful lifestyle changes among women with breast cancer and their daughters: Preliminary findings of the DAMES Trial

Abstract CN09-03: Capitalizing on the teachable moment of the cancer diagnosis to promote healthful lifestyle changes among women with breast cancer and their daughters: Preliminary findings of the DAMES Trial

A randomised controlled trial to compare minimally invasive glucose monitoring devices with conventional monitoring in the management of insulin-treated diabetes mellitus (MITRE)

To evaluate whether the additional information provided by minimally invasive glucose monitors results in improved glycaemic control in people with poorly controlled insulin-requiring diabetes, and to assess the acceptability and health economic impact of the devices. A four-arm randomised controlled trial was undertaken. Participants were recruited from secondary care diabetes clinics in four hospitals in England. 404 people aged over 18 years with insulin-treated diabetes mellitus (types 1 or 2) for at least 6 months who were receiving two or more injections of insulin daily were eligible. Participants had to have had two glycosylated haemoglobin (HbA1c) values > or = 7.5% in the last 15 months. Participants were randomised to one of four groups. Two groups received minimally invasive glucose monitoring devices [GlucoWatch Biographer or MiniMed Continuous Glucose Monitoring System (CGMS)]. These groups were compared with an attention control group (standard treatment with nurse feedback sessions at the same frequency as those in the device groups) and a standard control group (reflecting common practice in the clinical management of diabetes in the UK). Change in HbA1c from baseline to 3, 6, 12 and 18 months was the primary indicator of short- to long-term efficacy in this study. Perceived acceptability of the devices was assessed by use and a self-report questionnaire. A health economic analysis was also performed. At 18 months all groups demonstrated a decline in HbA1c levels from baseline. Mean percentage changes in HbA1c were -1.4 for the GlucoWatch group, -4.2 for the CGMS group, -5.1 for the attention control group and -4.9 for the standard care control group. At 18 months the relative percentage reduction in HbA1c in each of the intervention arms was less than that in the standard care control group. In the intention to treat analysis no significant differences were found between any of the groups at any of the assessment times. There was no evidence that the additional information provided by the devices resulted in any change in the number or nature of treatment recommendations offered by the nurses. The health economics analysis indicated no advantage in the groups who received the devices; a lower cost and higher benefit were found for the attention control arm. Assessment of device use and acceptability indicated a decline in use of both devices, which was most marked in the GlucoWatch group by 18 months (20% still using GlucoWatch versus 57% still using the CGMS). The GlucoWatch group reported more side effects, greater interference with daily activities and more difficulty in using the device than the CGMS group. Continuous glucose monitors do not lead to improved clinical outcomes and are not cost-effective for improving HbA1c in unselected individuals with poorly controlled insulin-requiring diabetes. On acceptability grounds the data suggest that the GlucoWatch will not be frequently used by individuals with diabetes because of the large number of side effects.

Differences in Baseline Characteristics and Outcomes at 1- and 2-Year Follow-up of Cancer Survivors Accrued via Self-Referral versus Cancer Registry in the FRESH START Diet and Exercise Trial

Participant accrual to research studies is a challenge; oftentimes, advertisements are used to supplement cases ascertained through clinic caseloads and cancer registries. It is unknown, however, if cases ascertained through these two sources differ. In this study, we compared self-referred (n = 209) and registry-ascertained (n = 334) participants enrolled in FRESH START, a randomized controlled trial promoting a healthy diet and increased exercise among breast and prostate cancer survivors. The two groups were compared on baseline characteristics, adherence, attrition, and outcomes by study arm. Compared with participants enrolled from registries, self-referrals were significantly younger (54.1 +/- 10.4 versus 58.7 +/- 10.7 years), more likely to have later-stage disease and to have received chemotherapy (40% versus 19%), and more likely to report "fighting spirit" coping styles (50% versus 30%), lower quality-of-life (88.2 +/- 15.1 versus 92.0 +/- 12.9), fewer comorbid conditions (1.87 +/- 1.60 versus 2.24 +/- 1.78), and lower consumption of five or more daily servings of fruits and vegetables (35% versus 45%; P values <0.05). Although no differences in behavior change were observed between self-referred and registry-ascertained cases assigned to the tailored intervention arm, this was not the case within the attention control arm. Among those who received the attention control intervention of standardized materials in the public domain, self-referred versus registry-ascertained participants showed significantly greater increases in exercise at 1-year follow-up and significantly greater increases in fruit and vegetable consumption at both 1- and 2-year follow-up (P values <0.05). Several differences exist between self-referred and registry-ascertained participants, including motivation to respond to standardized educational materials, which appears significantly greater in self-referred populations.

The Diet Quality Index-Revised: A Tool to Promote and Evaluate Dietary Change among Older Cancer Survivors Enrolled in a Home-Based Intervention Trial

Objective To utilize the Diet Quality Index-Revised (DQI-R) as a framework for delivering and evaluating an intervention to improve overall diet quality among older cancer survivors. Design As part of a randomized controlled trial to improve lifestyle behaviors among older cancer survivors, we sought a dietary measure that could serve as both an intervention framework and a means to evaluate global dietary quality. The DQI-R measures overall diet quality by summing 10 subscales that relate to national guidelines. At baseline, DQI-R scores were generated from three multi-pass 24-hour dietary recalls. The 6-month intervention delivered tailored feedback on individual DQI-R subscales. Dietary recalls were repeated at 6 and 12 months. Subjects Elderly (aged ≥65 years) individuals within 18 months of diagnosis of breast or prostate cancer (n=182) were randomized postbaseline measures to intervention vs attention control arms. Results Significant differences in overall diet quality were observed between arms at 6 months, with the intervention arm improving (67.6±12.2 to 69.8±13.9), and controls declining (67.5±12.5 to 64.6±14.7) ( P=0.003). Significant differences were observed between arms over time in dietary diversity subscale scores: baseline and 6-month follow-up means among intervention and control arms were 4.8±1.3 to 4.8±1.4, and 4.7±1.2 to 4.1±1.1, respectively ( P=0.001). Conclusions The DQI-R served as an effective guide and evaluation tool for this diet-related randomized controlled trial. Like many interventions, our effect diminished after the intervention was complete. Future research should consider testing interventions that use the DQI-R, or other global diet-related indexes, as guides and evaluation tools over longer study periods, as well as in other populations.

How durable are behavioral changes? Results from FRESH START: A randomized controlled trial to improve diet and exercise behaviors in breast and prostate cancer survivors

9019 Background: A healthy diet and regular exercise may improve the health, well-being and ultimate survival of cancer survivors. Last year, results of the FRESH START trial (n=543) were presented at ASCO; significant improvements in diet and exercise behaviors of breast and prostate cancer survivors were observed with two 10-month mailed print interventions - one that was sequentially- tailored and another using non-tailored print materials in the public domain (attention control). While both arms achieved significant improvements, those receiving the tailored intervention reported significantly greater changes (all p-values &lt;.05). The durability of these changes, however, is not known. Methods: At 2-year follow-up, and after a 12-month wash-out, telephone surveys that were conducted at baseline and post-intervention (Diet History Questionnaire and 7-Day Physical Activity Recall) were repeated. Results: Ordinary Least Square analysis suggest that changes from baseline largely remain significant at 2-year follow-up for both interventions (see table ). Moreover, significant differences between arms are observed for dietary fat restriction and the practice of more lifestyle behaviors at goal level [i.e., consumption of ≥ 5 servings/day of fruits &amp; vegetables (F&amp;V), &lt; 30% kcal from fat, and &gt;150 min/week of exercise], with the tailored intervention arm achieving levels superior to those achieved in the attention control arm. Conclusions: Tailored and untailored interventions delivered over a 10-month period to cancer survivors exert durable effects on several lifestyle behaviors. However, the effects of the tailored intervention were initially more powerful and largely sustained over time (especially, with regard dietary fat restriction). No significant financial relationships to disclose. [Table: see text]

Lifestyle Intervention Development Study to Improve Physical Function in Older Adults With Cancer: Outcomes From Project LEAD

Declines in physical functioning (PF) among elderly cancer patients threaten quality of life and the ability to maintain independence. Adherence to healthy lifestyle behaviors may prevent functional decline. Project Leading the Way in Exercise and Diet (LEAD), an intervention development study of the Pepper Older Americans Independence Center, aimed to determine whether breast and prostate cancer survivors (age 65+ years) assigned to a 6-month home-based diet and exercise intervention experienced improvements in PF when compared with an attention control arm receiving general health information. An accrual target was set at 420, and PF (Short Form-36 subscale), physical activity (Community Healthy Activities Models Program for Seniors), and diet quality (index from 3-day recalls) were assessed at baseline and at 6 and 12 months (6 months after intervention). This developmental project did not achieve its accrual target (N = 182); however, PF change scores were in the direction and of the magnitude projected. Baseline to 6-month change scores in the intervention versus the control arms were as follows: PF, +3.1 v -0.5 (P = .23); physical activity energy expenditure, +111 kcal/wk v -400 kcal/wk (P = .13); and diet quality index, +2.2 v -2.9 (P = .003), respectively. Differences between arms diminished during the postintervention period. These findings suggest that home-based diet and exercise interventions hold promise in improving lifestyle behaviors among older cancer survivors, changes that trend toward improved PF. Future studies should incorporate larger sample sizes and interventions that sustain long-term effects and also take into account secular trends; these efforts will require adequate planning and resources to overcome the numerous barriers to intervening in this difficult to reach yet vulnerable population.

Can words hurt? Patient–provider interactions during invasive procedures

Patients are often prepared for procedural discomforts with descriptions of pain or undesirable experiences. This practice is thought to be compassionate and helpful, but there is little data on the effect of such communicative behavior. This study assesses how such descriptions affect patients' pain and anxiety during medical procedures. The interactions of patients with their healthcare providers during interventional radiological procedures were videotaped during a previously reported 3-arm prospective randomized trial assessing the efficacy of self-hypnotic relaxation. One hundred and fifty-nine videos of the standard care and attention control arms were reviewed. All statements that described painful or undesirable experiences as warning before potentially noxious stimuli or as expression of sympathy afterwards were recorded. Patients' ratings of pain and anxiety on 0–10 numerical scales (0=No Pain, No Anxiety at All and 10=Worst Pain Possible, Terrified) after the painful event and/or sympathizing statement were the basis for this study. Warning the patient in terms of pain or undesirable experiences resulted in greater pain ( P<0.05) and greater anxiety ( P<0.001) than not doing so. Sympathizing with the patient in such terms after a painful event did not increase reported pain, but resulted in greater anxiety ( P<0.05). Contrary to common belief, warning or sympathizing using language that refers to negative experiences may not make patients feel better. This conclusion has implications for the training in medical communication skills and suggests the need for randomized trials testing different patient–practioner interactions.