Patient Perceptions in a Nonblinded Randomized Trial of Radiation Therapy Technologies: A Novel Survey Study Exploring Therapeutic Misconception.

PURPOSE: Therapeutic misconception is the tendency for a clinical trial participant to overlook the scientific objective of a clinical trial and instead believe that an experimental intervention is intended for personal therapeutic benefit. We sought to evaluate this tendency in the setting of a clinical trial of a new radiation therapy technology. METHODS: Patients with left-sided, node positive breast cancer enrolled in a randomized clinical trial evaluating intensity modulated radiation therapy with deep inspiration breath hold (IMRT-DIBH) versus 3-dimensional conformal radiation therapy (3DCRT). Patients who enrolled completed surveys at baseline, after randomization, and upon completion of radiation therapy to evaluate expectations, satisfaction, and experiences. RESULTS: Forty women participated in the survey study, with 20 in each arm. Most participants endorsed the perception that participation in the trial might result in better treatment than the current standard treatment (77%) and more medical attention than being off trial (54%). At baseline, most women (74%) believed that a new treatment technology is superior than an established one. Before randomization, 43% of participants believed IMRT-DIBH would be more effective than standard treatment with 3DCRT, none believed that 3DCRT would be more effective, 23% believed that they would be the same, and 34% did not know. None believed that IMRT-DIBH would cause worse long-term side effects, whereas 37% thought that 3DCRT would. Most (71%) reported that they would choose to be treated with IMRT-DIBH; none would have elected 3DCRT if given a choice. Nearly half (44%) in the 3DCRT arm wished that they had been assigned to the IMRT-DIBH arm; none in the IMRT-DIBH arm expressed a wish for crossover. CONCLUSIONS: Most participants reported the perception that trial participation would result in better treatment and more medical attention than off trial, hallmarks of therapeutic misconception. Our observations provide empirical evidence of a fixed belief in the superiority of new technology and highlight the importance of adjusting expectations through informed consent to mitigate therapeutic misconception.

Long-Term Patient-Reported Outcomes From a Phase 3 Randomized Prospective Trial of Conventional Versus Hypofractionated Radiation Therapy for Localized Prostate Cancer.

PURPOSE: To assess the long-term quality of life (QoL) outcomes from a phase 3 trial comparing 2 modes of intensity modulated radiation therapy (IMRT): conventional IMRT (CIMRT) versus hypofractionated IMRT (HIMRT) in patients with localized prostate cancer. METHODS AND MATERIALS: Between 2002 and 2006, 303 men with low-risk to high-risk prostate cancer were randomized to 76 Gy in 38 fractions (CIMRT) versus 70.2 Gy in 26 fractions (HIMRT). QoL was compared by use of the Expanded Prostate Cancer Index Composite (EPIC), the International Prostate Symptom Score (IPSS), and EuroQoL (EQ5D) questionnaires. The primary outcome of the QoL analysis was a minimum clinically important difference defined as a 0.5 standard deviation change from baseline for each respective QoL parameter. Treatment effects were evaluated with the use of logistic mixed effects regression models. RESULTS: A total of 286, 299, and 218 patients had baseline EPIC, IPSS, or EQ5D data available and were included in the analysis. Overall, there was no statistically significant difference between the 2 treatment arms in terms of EPIC, IPSS, or EQ5D scores over time, although there was a trend toward lower EPIC urinary incontinence scores in the HIMRT arm. More patients in the HIMRT arm had a lower EPIC urinary incontinence score relative to baseline versus patients in the CIMRT arm with long-term follow-up. On multivariable analysis, there was no association between radiation fractionation scheme and any QoL parameter. When other clinical factors were examined, lymph node radiation was associated with worse EPIC hormonal scores versus patients receiving no lymph node radiation. In general, QoL outcomes were generally stable over time, with the exception of EPIC hormonal and EQ5D scores. CONCLUSIONS: In this randomized prospective study, there were stable QoL changes in patients receiving HIMRT or CIMRT. Our results add to the growing body of literature suggesting that HIMRT may be an acceptable treatment modality in clinically localized prostate cancer.

Continued Benefit to Rectal Separation for Prostate Radiation Therapy: Final Results of a Phase III Trial.

PURPOSE: SpaceOAR, a Food and Drug Administration-approved hydrogel intended to create a rectal-prostate space, was evaluated in a single-blind phase III trial of image guided intensity modulated radiation therapy. A total of 222 men were randomized 2:1 to the spacer or control group and received 79.2 Gy in 1.8-Gy fractions to the prostate with or without the seminal vesicles. The present study reports the final results with a median follow-up period of 3 years. METHODS AND MATERIALS: Cumulative (Common Terminology Criteria for Adverse Events, version 4.0) toxicity was evaluated using the log-rank test. Quality of life (QOL) was examined using the Expanded Prostate Cancer Index Composite (EPIC), and the mean changes from baseline in the EPIC domains were tested using repeated measures models. The proportions of men with minimally important differences (MIDs) in each domain were tested using repeated measures logistic models with prespecified thresholds. RESULTS: The 3-year incidence of grade ≥1 (9.2% vs 2.0%; P=.028) and grade ≥2 (5.7% vs 0%; P=.012) rectal toxicity favored the spacer arm. Grade ≥1 urinary incontinence was also lower in the spacer arm (15% vs 4%; P=.046), with no difference in grade ≥2 urinary toxicity (7% vs 7%; P=0.7). From 6 months onward, bowel QOL consistently favored the spacer group (P=.002), with the difference at 3 years (5.8 points; P<.05) meeting the threshold for a MID. The control group had a 3.9-point greater decline in urinary QOL compared with the spacer group at 3 years (P<.05), but the difference did not meet the MID threshold. At 3 years, more men in the control group than in the spacer group had experienced a MID decline in bowel QOL (41% vs 14%; P=.002) and urinary QOL (30% vs 17%; P=.04). Furthermore, the control group were also more likely to have experienced large declines (twice the MID) in bowel QOL (21% vs 5%; P=.02) and urinary QOL (23% vs 8%; P=.02). CONCLUSIONS: The benefit of a hydrogel spacer in reducing the rectal dose, toxicity, and QOL declines after image guided intensity modulated radiation therapy for prostate cancer was maintained or increased with a longer follow-up period, providing stronger evidence for the benefit of hydrogel spacer use in prostate radiation therapy.

Neoadjuvant radiotherapy followed by mastectomy and immediate breast reconstruction : An alternative treatment option for locally advanced breast cancer.

BACKGROUND: The optimal sequence of mastectomy with immediate breast reconstruction (IBR) and radiotherapy (RT) for the treatment of locally advanced breast cancer (LABC) is still under debate. Increased rates of postoperative complications are described following postmastectomy RT. Neoadjuvant RT aims to improve the aesthetic results and simplify the reconstructive pathway. PATIENTS: A total of 22 patients diagnosed with LABC and treated with neoadjuvant RT followed by mastectomy and IBR between 04/2012 and 03/2015 were retrospectively analyzed. RT consisted of external beam RT to the breast and the regional lymphatics, if indicated. Both implant-based and autologous tissue-transfer reconstruction techniques were used. RESULTS: At the time of RT, 10 patients had no prior surgery and 12 patients had previously undergone breast-conserving surgery (BCS) with positive resection margins without the possibility to perform a second BCS. Additional neoadjuvant chemotherapy was administered in 18 patients prior to RT. A complete pathological response was achieved in 55.0% of patients. The 2­year overall survival rate was 89.3%, the 2­year disease-free-survival 79.8% and the local-recurrence-free survival was 95.2%. The cosmetic result was excellent or good in 66% of the patients treated with upfront mastectomy and 37% of the patients who had previously undergone BCS. Among patients who received implant-based IBR, 4 patients developed serious wound-healing problems with implant loss. The most satisfactory results were achieved with autologous tissue reconstruction. CONCLUSION: A sequential neoadjuvant chemo-/radiotherapy to allow IBR following mastectomy in selected cases of LABC seems feasible and can be safely attempted. Careful patient selection, close monitoring, and continuous patient support is mandatory to ensure compliance in this treatment strategy.

Local control and intermediate-term cosmetic outcome following IMRT for nasal tumors : An update.

OBJECTIVE: This study aims to evaluate local control and intermediate-term cosmetic outcome in patients with cancer of the nose treated with intensity-modulated radiotherapy (IMRT). METHODS: From June 2008 to September 2015, 36 consecutive patients presenting with nasal cavity, ala of the nose, or nasal vestibule tumors were treated at the Department of Radiation Oncology, University Hospital Zurich either postoperatively (n = 14; 3/14 with nasal ablation) or with definitive IMRT (n = 22). Of these 36 patients, 8 presented with recurrent disease after surgery only and 1/36 with N1 disease. Concurrent systemic therapy was administered in 18/36 patients (50%). Nasal follow-up (FU) imaging documentation of 13 patients with preserved organ and >6 months FU offers a pre/post IMRT FU comparison. In addition, these patients' subjective evaluation of cosmesis was assessed. RESULTS: Mean/median FU was 41/33 months (range 5-92 months). Salvage ablation with curative intent was undergone by 3 patients with local relapse after definitive (n = 2) and postoperative (n = 1) IMRT. The 3­year local control, ultimate local control, and overall survival rates were 90, 97, and 90 %, respectively. Subjective and objective cosmetic outcome after IMRT is very satisfying so far. CONCLUSION: IMRT for nasal tumors was found to be effective and well tolerated. Intermediate-term cosmetic results are good. Radical surgical procedures may be saved for curative salvage treatment.

Patient's quality of life after high-dose radiation therapy for thoracic carcinomas : Changes over time and influence on clinical outcome.

PURPOSE: Quality of life (QoL) is an important factor in patient care. This analysis is focused on QoL before and after radio(chemo)therapy in patients with thoracic carcinomas, as well as on its influence on clinical follow-up and survival, and the correlation with treatment-related toxicities. MATERIALS AND METHODS: The analysis included 81 patients with intrathoracic carcinoma receiving radio(chemo)therapy. For analysis of QoL, the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the lung cancer-specific supplement (EORTC QLQ-LC13) were used. QoL data were collected before radiation treatment (RT), and 6 weeks, 12 weeks, 6 months, and 12 months after RT. Other factors were additionally analyzed, including clinical outcome, survival, and side effects. RESULTS: The functional scales showed maximum values or at least a recovery 12 weeks after RT. Symptoms with a high mean symptom score (> 40) at all appointments were fatigue, dyspnea, and coughing. Insomnia, peripheral neuropathy, appetite loss, dyspnea (from QLQ-LC13), and all pain parameters had an intermediate mean score (10-40). There were low mean scores of < 10 for nausea and vomiting, diarrhea, sore mouth, and hemoptysis. There was a significant correlation between clinical dysphagia and radiation pneumonitis with the associated symptom scales. None of the QoL scores had a significant influence on local and distant control or survival. CONCLUSION: 12 weeks after RT the QLQ-C30 functional scales show the highest scores or at least a temporary recovery. The symptom scales accurately reflect the common symptoms and treatment-related toxicities. QoL did not prove to be a significant predictor for local and distant control or survival.

Predictors of Dysgeusia in Patients With Oropharyngeal Cancer Treated With Chemotherapy and Intensity Modulated Radiation Therapy.

OBJECTIVE(S): Dysgeusia is a significant factor reducing quality of life and worsening dysphagia in patients receiving chemoradiation therapy for head and neck cancer. The factors affecting dysgeusia severity are uncertain. We investigated the effects on patient-reported dysgeusia of doses to the oral cavity, salivary output (required to dissolve food particles), and patient-reported xerostomia. METHODS AND MATERIALS: Seventy-three patients with stage III to IV oropharyngeal cancer (OPC) (N=73) receiving definitive intensity modulated radiation therapy concurrently with chemotherapy participated in a prospective, longitudinal study of quality of life (QOL), including assessment of patient-reported gustatory function by taste-related questions from the Head and Neck QOL instrument (HNQOL) and the University of Washington Head and Neck-related QOL instrument (UWQOL), before therapy and periodically after treatment. At these intervals, patients also completed a validated xerostomia-specific questionnaire (XQ) and underwent unstimulated and stimulated major salivary gland flow rate measurements. RESULTS: At 1, 3, 6, and 12 months after treatment, dysgeusia improved over time: severe dysgeusia was reported by 50%, 40%, 22%, and 23% of patients, respectively. Significant associations were found between patient-reported severe dysgeusia and radiation dose to the oral cavity (P=.005) and tongue (P=.019); normal tissue complication probability for severe dysgeusia at 3 months showed mean oral cavity D50 doses 53 Gy and 57 Gy in the HNQOL and WUQOL questionnaires, respectively, with curve slope (m) of 0.41. Measured salivary output was not statistically significantly correlated with severe taste dysfunction, whereas patient-reported XQ summary scores and xerostomia while eating scores were correlated with severe dysgeusia in the UWQOL tool (P=.04). CONCLUSIONS: Taste impairment is significantly correlated with mean radiation dose to the oral cavity. Patient-reported xerostomia, but not salivary output, was correlated with severe dysgeusia in 1 of the 2 QOL questionnaires. Reduction in oral cavity doses is likely to improve dysgeusia.

Course of Quality of Life After Radiation Therapy for Painful Bone Metastases: A Detailed Analysis From the Dutch Bone Metastasis Study.

PURPOSE: To study the course of quality of life (QoL) after radiation therapy for painful bone metastases. PATIENTS AND METHODS: The Dutch Bone Metastasis Study randomized 1157 patients with painful bone metastases between a single fraction of 8 Gy and 6 fractions of 4 Gy between 1996 and 1998. The study showed a comparable pain response of 74%. Patients filled out weekly questionnaires for 13 weeks, then monthly for 2 years. In these analyses, physical, psychosocial, and functional QoL domain scores and a score of general health were studied. Mixed modeling was used to model the course of QoL and to study the influence of several characteristics. RESULTS: In general, QoL stabilized after 1 month. Psychosocial QoL improved after treatment. The level of QoL remained stable, steeply deteriorating at the end of life. For most QoL domains, a high pain score and intake of opioids were associated with worse QoL, with small effect sizes (-0.11 to -0.27). A poor performance score was associated with worse functional QoL, with a medium effect size (0.41). There is no difference in QoL between patients receiving a single fraction of 8 Gy and 6 fractions of 4 Gy, except for a temporary worsening of physical QoL after 6 fractions. CONCLUSION: Although radiation therapy for painful bone metastases leads to a meaningful pain response, most domains of QoL do not improve after treatment. Only psychosocial QoL improves slightly after treatment. The level of QoL is related to the actual survival, with a rather stable course of QoL for most of the remaining survival time and afterward a sharp decrease, starting only a few weeks before the end of life. Six fractions of 4 Gy lead to a temporary worse physical QoL compared with a single fraction of 8 Gy.

Prospective Study of Patient-Reported Symptom Burden in Patients With Non-Small-Cell Lung Cancer Undergoing Proton or Photon Chemoradiation Therapy.

CONTEXT: Intensity-modulated radiation therapy (IMRT), three-dimensional conformal radiation therapy (3DCRT), and proton-beam therapy (PBT) are chemoradiotherapy modalities for treating locally advanced non-small-cell lung cancer. Although therapy is carefully planned to maximize treatment benefit while minimizing risk for adverse side effects, most patients develop radiation-induced symptom burden. OBJECTIVES: To demonstrate the MD Anderson Symptom Inventory's ability to detect fine differences in symptom development among these modalities. METHODS: This was a longitudinal observational study. Patients with unresectable primary or recurrent non-small-cell lung cancer (n = 82) underwent 3DCRT, IMRT, or PBT. Patients rated MD Anderson Symptom Inventory symptoms weekly for up to 12 weeks. We used mixed-effect modeling to estimate development of symptoms and functional interference. RESULTS: The PBT group received a significantly higher radiation target dose than did the IMRT and 3DCRT groups (P < 0.001). Fatigue was the most severe symptom over time for all groups. Controlling for patient and clinical factors (age, sex, race, cancer stage, performance status, body mass index, previous cancer therapy, total radiation dose), we found that pain, as a major esophagitis-related symptom, increased more during therapy (P = 0.019) and decreased more after (P = 0.013) therapy in the 3DCRT and IMRT groups than in the PBT group. Compared with the PBT group, the 3DCRT and IMRT groups reported greater decrease in systemic symptoms (fatigue, drowsiness, lack of appetite, disturbed sleep) after therapy (P = 0.016). CONCLUSION: Patients receiving PBT reported significantly less severe symptoms than did patients receiving IMRT or 3DCRT. These results should be confirmed in a randomized study with comparable tumor burden among therapies.

Residual deficits in quality of life one year after intensity-modulated radiotherapy for patients with locally advanced head and neck cancer: Results of a prospective study.

PURPOSE: Patients with locally advanced head and neck cancer (LAHNC) undergo life-changing treatments that can seriously affect quality of life (QoL). This prospective study examined the key QoL domains during the first year after intensity-modulated radiotherapy (IMRT) and identified predictors of these changes in order to improve patient outcomes. PATIENTS AND METHODS: A consecutive series of patients with LAHNC completed the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core module (QLQ-C30) and the HNC-specific QLQ-HN35 before (t0) and at the end (t1) of definitive or adjuvant IMRT, then at 6-8 weeks (t2), 6 months (t3), and 1 year (t4) after IMRT. RESULTS: Patients (n = 111) completing questionnaires at all five time points were included (baseline response rate: 99%; dropout rate between t0 and t4: 5%). QoL deteriorated in all domains during IMRT and improved slowly during the first year thereafter. Many domains recovered to baseline values after 1 year but problems with smelling and tasting, dry mouth, and sticky saliva remained issues at this time. Increases in problems with sticky saliva were greater after 1 year in patients with definitive versus adjuvant IMRT (F = 3.5, P = 0.05). CONCLUSION: QoL in patients with LAHNC receiving IMRT takes approximately 1 year to return to baseline; some domains remain compromised after 1 year. Although IMRT aims to maintain function and QoL, patients experience long-term dry mouth and sticky saliva, particularly following definitive IMRT. Patients should be counseled at the start of therapy to reduce disappointment with the pace of recovery.

Migration from full-head mask to "open-face" mask for immobilization of patients with head and neck cancer.

To provide an alternative device for immobilization of the head while easing claustrophobia and improving comfort, an "open-face" thermoplastic mask was evaluated using video-based optical surface imaging (OSI) and kilovoltage (kV) X-ray radiography. A three-point thermoplastic head mask with a precut opening and reinforced strips was developed. After molding, it provided sufficient visible facial area as the region of interest for OSI. Using real-time OSI, the head motion of ten volunteers in the new mask was evaluated during mask locking and 15minutes lying on the treatment couch. Using a nose mark with reference to room lasers, forced head movement in open-face and full-head masks (with a nose hole) was compared. Five patients with claustrophobia were immobilized with open-face masks, set up using OSI and kV, and treated in 121 fractions, in which 61 fractions were monitored during treatment using real-time OSI. With the open-face mask, head motion was found to be 1.0 ± 0.6 mm and 0.4° ± 0.2° in volunteers during the experiment, and 0.8 ± 0.3 mm and 0.4° ± 0.2° in patients during treatment. These agree with patient motion calculated from pre-/post-treatment OSI and kV data using different anatomical landmarks. In volunteers, the head shift induced by mask-locking was 2.3 ± 1.7 mm and 1.8° ± 0.6°, and the range of forced movements in the open-face and full-head masks were found to be similar. Most (80%) of the volunteers preferred the open-face mask to the full-head mask, while claustrophobic patients could only tolerate the open-face mask. The open-face mask is characterized for its immobilization capability and can immobilize patients sufficiently (< 2 mm) during radiotherapy. It provides a clinical solution to the immobilization of patients with head and neck (HN) cancer undergoing radiotherapy, and is particularly beneficial for claustrophobic patients. This new open-face mask is readily adopted in radiotherapy clinic as a superior alternative to the standard full-head mask.

Late toxicity and patient self-assessment of breast appearance/satisfaction on RTOG 0319: a phase 2 trial of 3-dimensional conformal radiation therapy-accelerated partial breast irradiation following lumpectomy for stages I and II breast cancer.

PURPOSE: Late toxicities and cosmetic analyses of patients treated with accelerated partial breast irradiation (APBI) on RTOG 0319 are presented. METHODS AND MATERIALS: Patients with stages I to II breast cancer ≤3 cm, negative margins, and ≤3 positive nodes were eligible. Patients received three-dimensional conformal external beam radiation therapy (3D-CRT; 38.5 Gy in 10 fractions twice daily over 5 days). Toxicity and cosmesis were assessed by the patient (P), the radiation oncologist (RO), and the surgical oncologist (SO) at 3, 6, and 12 months from the completion of treatment and then annually. National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0, was used to grade toxicity. RESULTS: Fifty-two patients were evaluable. Median follow-up was 5.3 years (range, 1.7-6.4 years). Eighty-two percent of patients rated their cosmesis as good/excellent at 1 year, with rates of 64% at 3 years. At 3 years, 31 patients were satisfied with the treatment, 5 were not satisfied but would choose 3D-CRT again, and none would choose standard radiation therapy. The worst adverse event (AE) per patient reported as definitely, probably, or possibly related to radiation therapy was 36.5% grade 1, 50% grade 2, and 5.8% grade 3 events. Grade 3 AEs were all skin or musculoskeletal-related. Treatment-related factors were evaluated to potentially establish an association with observed toxicity. Surgical bed volume, target volume, the number of beams used, and the use of bolus were not associated with late cosmesis. CONCLUSIONS: Most patients enrolled in RTOG 0319 were satisfied with their treatment, and all would choose to have the 3D-CRT APBI again.

Decision regret in men undergoing dose-escalated radiation therapy for prostate cancer.

PURPOSE: Decision regret (DR) is a negative emotion associated with medical treatment decisions, and it is an important patient-centered outcome after therapy for localized prostate cancer. DR has been found to occur in up to 53% of patients treated for localized prostate cancer, and it may vary depending on treatment modality. DR after modern dose-escalated radiation therapy (DE-RT) has not been investigated previously, to our knowledge. Our primary aim was to evaluate DR in a cohort of patients treated with DE-RT. METHODS AND MATERIALS: We surveyed 257 consecutive patients with localized prostate cancer who had previously received DE-RT, by means of a validated questionnaire. RESULTS: There were 220 responses (85.6% response rate). Image-guided intensity modulated radiation therapy was given in 85.0% of patients and 3-dimensional conformal radiation therapy in 15.0%. Doses received included 73.8 Gy (34.5% patients), 74 Gy (53.6%), and 76 Gy (10.9%). Neoadjuvant androgen deprivation (AD) was given in 51.8% of patients and both neoadjuvant and adjuvant AD in 34.5%. The median follow-up time was 23 months (range, 12-67 months). In all, 3.8% of patients expressed DR for their choice of treatment. When asked whether they would choose DE-RT or AD again, only 0.5% probably or definitely would not choose DE-RT again, compared with 8.4% for AD (P<.01). CONCLUSION: Few patients treated with modern DE-RT express DR, with regret appearing to be lower than in previously published reports of patients treated with radical prostatectomy or older radiation therapy techniques. Patients experienced more regret with the AD component of treatment than with the radiation therapy component, with implications for informed consent. Further research should investigate regret associated with individual components of modern therapy, including AD, radiation therapy and surgery.

A longitudinal study of distress (depression and anxiety) up to 18 months after radiotherapy for head and neck cancer.

OBJECTIVE: The aim of the study was to assess symptoms of depression and anxiety in patients with head and neck cancer up to 18 months after radiotherapy. METHODS: Prospective observational study of consecutive head and neck outpatients was conducted at a tertiary cancer centre (n = 101). Eligibility included diagnosis of cancer in the head and neck region, where the patient agreed to radiotherapy with curative intent. Data were collected before commencement of radiotherapy and 3 weeks and 18 months after completion. Symptoms of depression and anxiety were assessed by the Hospital Anxiety and Depression Scale. Tumour/treatment-related physical symptoms were assessed using the 'Additional Concerns' subscale of the Functional Assessment of Chronic Illness Therapy for Head and Neck Cancer. RESULTS: The prevalence of identified probable cases of depression was 15% at baseline, increasing to 29% 3 weeks post-treatment, falling to 8% at 18-month follow-up. The number of probable cases of anxiety was 20% at baseline, 17% at 3 weeks post-treatment and 22% at 18-month follow-up. Depression scores significantly increased from baseline to 3 weeks post-treatment and decreased at 18-month follow-up. Variability in depression scores was accounted for by tumour/treatment-related physical symptoms. Anxiety scores significantly decreased between baseline and 3-week post-treatment and increased at 18-month follow-up. Younger age and more tumour/treatment-related physical symptoms predicted anxiety scores. CONCLUSIONS: The rates of depression in head and neck cancer patients increase following cancer treatment and are related to tumour/treatment-related physical symptoms. Anxiety levels are higher pre-treatment, lower immediately following cancer treatment but rise to near pre-treatment levels more than a year after completion of cancer treatment.

Changes over time in occurrence, severity, and distress of common symptoms during and after radiation therapy for breast cancer.

CONTEXT: Little is known about changes over time in multiple dimensions of the symptom experience in patients with breast cancer undergoing radiation therapy (RT). OBJECTIVES: This study evaluated for changes in and predictors of occurrence, severity, and distress of six common symptoms (lack of energy, worrying, difficulty sleeping, feeling drowsy, sweats, and pain) during RT for breast cancer. METHODS: Patients (n = 188) completed the Memorial Symptom Assessment Scale before, during, and after the completion of RT, over a six-month period. Changes in symptom occurrence were evaluated using multilevel logistic regression analysis. Changes in severity and distress scores were evaluated using multilevel proportional odds ordinal logistic regression. The impact of five demographic and clinical characteristics (age, functional status, comorbidities, axillary lymph node dissection, and previous chemotherapy) was evaluated in these analyses. RESULTS: The trajectories for occurrence, severity, and distress for the six symptoms followed similar patterns. For three of the six symptoms (lack of energy, feeling drowsy, and worrying), all three dimensions changed over time. For the other three symptoms (difficulty sleeping, sweats, and pain), no changes over time occurred for any of the symptom dimensions. The overall effect of the five covariates was to increase symptom burden across all three dimensions. CONCLUSION: Findings from this study provide a more complete picture of the symptom experience of women who undergo RT for breast cancer. These findings can be used to identify patients at higher risk for more severe symptoms before, during, and after RT.

[Quality of life after radiotherapy for prostate cancer]. / Qualité de vie après radiothérapie pour un cancer localisé de la prostate.

The goal of localized prostate cancer radiotherapy is to cure patients. The decision-making must integrate the survival but also the quality of life of patients. Some French validated self-reported questionnaires are available to evaluate quality of life. Whatever the treatments (radical prostatectomy, brachytherapy, external beam radiation, with or without hormonotherapy), even if patients report more sequelae, their long-term quality of life is similar to that of the general population, except for patients treated with hormonotherapy who complain more decline of physical quality of life. In comparison with prostatectomy, patients treated with external beam radiation report less long-lasting urinary symptoms, but more bowel side effects, with no difference in global quality of life. Sexual disorders are initially less important with external beam radiation but increase over time. Brachytherapy shows no sexual function preservation benefit relative to radiation and may be less favourable with more urinary sequelae. The association of hormonotherapy and external beam radiation decreases the quality of life of the patients, with a negative impact on vitality, sexuality and increase urinary disorders. Intensity-modulated radiotherapy (IMRT) seems to better preserve the long-term digestive quality of life in comparison with conformal radiation therapy. Post-prostatectomy could induce more digestive toxicity, such as rectal irritation. The adjunction of hormonotherapy to radiation, the previous medical history of abdominal surgery, the field of radiation and the acute reactions to radiation are the main predictive factors to late toxicity and should be considered in the choice of initial treatment and for the follow-up.

Audiovisual interventions to reduce the use of general anaesthesia with paediatric patients during radiation therapy.

Clinical audiovisual interventions were implemented to avoid the use of general anaesthesia with children undergoing radiation therapy treatment. A retrospective audit and case study review was conducted to evaluate the utility of distraction interventions aimed at improving immobilisation and reducing separation anxiety for children aged between 2 and 6 years old who received radiation therapy. A simple, inexpensive audiovisual system was established using commercially available equipment. Paediatric patients could elect to (i) use a closed-circuit TV system that allowed them to see their carer(s); (ii) watch a DVD movie; or (iii) listen to carer(s) on a microphone during their treatment. Over a 2-year period (March 2007-May 2009), 37 paediatric patients aged 2-6 years received radiation therapy at the centre. Twenty-four children participated in audiovisual interventions, and 92% (n = 22) of these children did not require the use of general anaesthesia for some or all of their treatment. Case study review illustrates the utility and limitations of the system. The audit and case studies suggest that the audiovisual interventions provided supportive care and reduced the need to anaesthetise children undergoing radiation therapy treatment.

Changes of symptoms and depression in oral cavity cancer patients receiving radiation therapy.

The purposes of this study were to (1) examine changes in symptom severity and depression within 3 months of first undergoing radiation therapy (RT) or concurrent chemoradiation therapy (CCRT), and (2) identify factors involved in changes in symptom severity in newly diagnosed oral cavity cancer patients undergoing post-operative RT or CCRT. A prospective panel survey was conducted to assess changes in symptoms, depression, and disease- or treatment-related characteristics within 3 months of beginning RT or CCRT (pre-treatment and 1, 2, and 3 months from first receiving RT). A total of 76 eligible oral cavity cancer patients were recruited from the outpatient radiation department of a medical center in northern Taiwan. The results showed mild-to-moderate overall symptom and depression levels during treatment, with the five most distressing symptoms being swallowing difficulty, poor appetite, oral mucositis, pain, and fatigue. The severity of symptoms and depression peaked at approximately 2 months from beginning RT or CCRT (T3). Changes in overall symptom severity were found to be significantly related to patients' radiation dose and depression level. These results can help advance understanding of changes in symptoms and facilitate prevention and management of symptoms associated with RT or CCRT. Psychological distress, particularly, depression, requires careful monitoring and management in oral cavity cancer patients undergoing RT or CCRT.

Longitudinal analysis of quality of life in patients receiving conformal radiation therapy for prostate cancer.

PURPOSE: To prospectively assess quality of life (QoL) in patients receiving conformal radiation therapy (CRT) for prostate cancer. PATIENTS AND METHODS: 78 men with definitive CRT for prostate cancer were entered into the study. Patients were assessed before CRT, at 40 and 60 Gy, and 2, 12 and 24 months after the end of treatment. QoL was assessed using the EORTC Quality of Life Questionnaire C30 and the prostate module PR25. Changes in mean QoL scores with time of >or= 10 points were considered clinically relevant. RESULTS: Global QoL did not change statistically significant during CRT and was slightly above baseline levels during follow-up. CRT had a statistically significant negative short-term impact on role functioning, fatigue, and PR25 urinary symptoms. The scores recovered within 2 months to 1 year after CRT. Emotional functioning and social functioning scores slightly increased during and after CRT. Role functioning decreased by > 10 points at 60 Gy and urinary symptoms decreased by > 10 points at 40 and 60 Gy. All other differences were < 10 points. A high number of concomitant diseases and having no children were negative pretreatment predictors for long-term global QoL. CONCLUSION: Definitive CRT for prostate cancer does not compromise global QoL during therapy and up to 2 years after treatment. It has a limited negative effect on role functioning, urinary symptoms and, to a lesser extent, on fatigue with restitution within 2 months to 1 year after treatment.

Breast cancer patients' experience of external-beam radiotherapy.

Radiotherapy is a critical component of treatment for the majority of women with breast cancer, particularly those who receive breast conserving surgery. Although medically beneficial, radiotherapy can take a physical and psychological toll on patients. However, little is known about the specific thoughts and feelings experienced by women undergoing breast cancer radiotherapy. Therefore, the study aim was to use qualitative research methods to develop an understanding of these thoughts and feelings based on 180 diary entries completed during radiotherapy by 15 women with stage 0 to stage III breast cancer. Thematic analysis identified four primary participant concerns: (a) a preoccupation with time, (b) fantasies (both optimistic and pessimistic) about life following radiotherapy, (c) the toll their side-effect experience takes on their self-esteem, and (d) feeling mystified by radiotherapy. These themes are consistent with previous literature on illness and identity. These findings have implications for the treatment and care of women undergoing breast cancer radiotherapy.