Randomized clinical trial of a family intervention for prostate cancer patients and their spouses

BACKGROUND: Few intervention studies have been conducted to help couples manage the effects of prostate cancer and maintain their quality of life. The objective of this study was to determine whether a family-based intervention could improve appraisal variables (appraisal of illness or caregiving, uncertainty, hopelessness), coping resources (coping strategies, self-efficacy, communication), symptom distress, and quality of life in men with prostate cancer and their spouses. METHODS: For this clinical trial, 263 patient-spouse dyads were stratified by research site, phase of illness, and treatment; then, they were randomized to the control group (standard care) or the experimental group (standard care plus a 5-session family intervention). The intervention targeted couples' communication, hope, coping, uncertainty, and symptom management. The final sample consisted of 235 couples: 123 couples in the control group and 112 couples in the experimental group. Data collection occurred at baseline before randomization and at 4 months, 8 months, and 12 months. RESULTS: At 4-month follow-up, intervention patients reported less uncertainty and better communication with spouses than control patients, but they reported no other effects. Intervention spouses reported higher quality of life, more self-efficacy, better communication, and less negative appraisal of caregiving, uncertainty, hopelessness, and symptom distress at 4 months compared with controls, and some effects were sustained to 8 months and 12 months. CONCLUSIONS: Men with prostate cancer and their spouses reported positive outcomes from a family intervention that offered them information and support. Programs of care need to be extended to spouses who likely will experience multiple benefits from intervention.     

The effectiveness of a self-care management interactive multimedia module.

PURPOSE/OBJECTIVES: To develop and test an interactive multimedia module prototype designed to accommodate adults with limited literacy and without computer skills. DESIGN: Experimental, randomized, controlled, pretest, post-test. SETTING: Cancer treatment centers in California, Louisiana (pilot). New Hampshire, Pennsylvania, and Texas. SAMPLE: Outpatients who were at least 18 years old with a minimum fifth-grade reading level; 86 experimental treatment, 88 control. METHODS: Experimental treatment involved use of the interactive multimedia module; the control group received customary Instruction. FINDINGS: As compared to the control group, subjects in the experimental group had significant improvement (p = 0.0001; 257% gain) in self-care ability regardless of age, sex race, education, geographic location, reading ability, computer experience, or preferred learning style; a 6.515% increase in fatigue content covered and 16.775% Increase in instructional duration; and significantly greater benefit from sleep-related activities and a consistent, positive pattern of self-care behavior. CONCLUSIONS: The program is instructionally effective, appropriate for a wide and geographically diverse audience, and feasible for use in the ambulatory setting. IMPLICATIONS FOR NURSING PRACTICE: The interactive multimedia module is an effective, self-directed resource for individualized patient fatigue education.     

Implementing guidelines for cancer pain management: results of a randomized controlled clinical trial.

PURPOSE: Pain and symptom management is an integral part of the clinical practice of oncology. A number of guidelines have been developed to assist the clinician in optimizing comfort care. We implemented clinical guidelines for cancer pain management in the community setting and evaluated whether these guidelines improved care. PATIENTS AND METHODS: Eighty-one cancer patients, aged 37 to 76 years, were enrolled onto a prospective, longitudinal, randomized controlled study from the outpatient clinic settings of 26 western Washington-area medical oncologists. A multilevel treatment algorithm based on the Agency for Health Care Policy and Research Guidelines for Cancer Pain Management was compared with standard-practice (control) pain and symptom management therapies used by community oncologists. The primary outcome of interest was pain (Brief Pain Inventory); secondary outcomes of interest were all other symptoms (Memorial Symptom Assessment Scale) and quality of life (Functional Assessment of Cancer Therapy Scale). RESULTS: Patients randomized to the pain algorithm group achieved a statistically significant reduction in usual pain intensity, measured as slope scores, when compared with standard community practice (P < .02). Concurrent chemotherapy and patient adherence to treatment were significant mediators of worst pain. There were no significant differences in other symptoms or quality of life between the two treatment groups. CONCLUSION: This guideline implementation study supports the use of algorithmic decision making in the management of cancer pain. These findings suggest that comprehensive pain assessment and evidence-based analgesic decision-making processes do enhance usual pain outcomes.     

Randomized clinical trial to assess the effectiveness of breast irradiation following lumpectomy and axillary dissection for node-negative breast cancer.

BACKGROUND: Although the conservation management of breast cancer has become a routine method of treatment in most centers, there is still considerable controversy surrounding the ultimate minimum treatment required for node-negative breast cancer to achieve adequate local control. PURPOSE: Our purpose was to assess the value of breast irradiation in reducing breast relapse following conservation surgery for node-negative breast cancer. We attempted to define low-risk groups of women for breast and distant site relapse (i.e., recurrence outside the breast) who might be spared breast irradiation or adjuvant systemic therapy. METHODS: Eight hundred thirty-seven patients were randomly assigned to receive radiation therapy or no radiation therapy following lumpectomy and axillary dissection for node-negative breast cancer. RESULTS: Breast irradiation reduced relapse in the breast from 25.7% in the controls to 5.5% in the irradiated patients. There was no difference in survival between the two groups (median follow-up, 43 months). A low-risk group (less than 5% chance of relapse in the breast without irradiation) could not be defined. Tumor size (greater than 2 cm), age (less than 40 years), and poor nuclear grade were important predictors for breast relapse. Age (less than 50 years) and poor nuclear grade were important predictors for mortality. The presence of ductal carcinoma in situ did not predict breast relapse. CONCLUSIONS: Breast irradiation significantly reduces breast relapse, but it does not influence survival. Important predictors of breast relapse are age, tumor size, and nuclear grade, but not the presence of ductal carcinoma in situ. Age and, in particular, nuclear grade predict survival. IMPLICATIONS: Further follow-up may define an acceptable low-risk group for breast relapse. Until then, we recommend that all patients receive breast irradiation. Systemic adjuvant therapy should be considered for patients with poor nuclear grade tumors.     

Randomized trial of a clinic-based weight loss intervention in cancer survivors

Background

This trial examined the efficacy of a clinic-based weight loss intervention in cancer survivors.

Methods

This single-center phase II trial randomized survivors of solid tumors and hematologic malignancies to a 15-week group-based weight loss intervention that included caloric restriction and physical activity (n = 30) or a wait-list control intervention (n = 30). The primary study outcome was body mass. Secondary study outcomes included body composition using dual-energy X-ray absorptiometry, physical fitness using the 6-min walk test (6MWT), and concentrations of serum biomarkers.

Results

Participants in the intervention group lost 5.6 ± 4.4% of baseline weight (4.6 ± 3.9 kg), whereas participants in the control group gained 0.2 ± 2.4% of baseline weight (0.2 ± 2.0 kg); intervention effect ? 5.8% (95% CI ? 7.8, ? 3.8); ? 4.8 kg (95% CI ? 6.6, ? 3.0); P = 0.0001. A larger proportion of participants in the intervention group lost ≥ 5% of baseline weight compared to the control group (43 vs 0%; P < 0.0001). The intervention led to reductions in fat mass (? 3.2 ± 0.7 kg; P < 0.0001), improvements in physical fitness (an increase of 22.6 ± 10.8 m on 6MWT; P = 0.03), and reductions in concentrations of insulin (? 7.7 ± 3.5 μU/mL; P = 0.004) and leptin (? 7.3 ± 4.0 ng/mL; P = 0.04).

Conclusion

A 15-week clinic-based weight loss intervention resulted in significant weight loss and improvements in body composition, physical fitness, and concentrations of serum biomarkers in cancer survivors.

Implications for cancer survivors

Weight loss programs provide a number of benefits for cancer survivors; survivors should inquire about the availability of lifestyle programs offered at their cancer center and within their local communities.

     

Randomized controlled trial to assess the effectiveness of a videotape about radiotherapy

In a randomized controlled trial, the additional provision of information on videotape was no more effective than written information alone in reducing pre-treatment worry about radiotherapy. Images of surviving cancer patients, however, may provide further reassurance to patients once therapy is completed.     

Does a symptom management intervention affect depression among cancer patients: results from a clinical trial

Cancer patients diagnosed with solid tumors and undergoing a first course of chemotherapy were randomized to either conventional care or a 10 contact 20 week cognitive behavioral intervention designed to reduce emotional distress. Three hypotheses were tested. First, a test for a group effect found that patients in the intervention who entered the trial with higher symptom severity reported significantly lower depression at 10 but not 20 weeks. Patients in the experimental group who entered with higher depression were more depressed at 10 weeks than patients in the control group. The second hypothesis compared the intervention in two sub-indices of symptom severity; one comprised of symptoms with a depressive component, the other of symptoms not associated with depression. The intervention was more effective in lowering depression at 10 weeks through an interaction with the non-depressive symptom sub-index. At 20 weeks, a significant main effect for the intervention on depression was observed. No interaction with either sub-index was observed. The third hypothesis found no main or interaction effect between psychotropic drugs and the intervention. In conclusion, behavioral interventions may influence depression differently over time. Initially, the intervention lowered depression through certain symptoms and only later did it effect depression directly. Symptoms with an affective component are relatively unaffected by the intervention which was independent of the presence of psychotropic medications.     

Interventions to improve patient understanding of cancer clinical trial participation: a systematic review

Patient misunderstanding of cancer clinical trial participation is identified as a critical issue and researchers have developed and tested a variety of interventions to improve patient understanding. This systematic review identified nine papers published between 2000 and 2013, to evaluate the effects of interventions to improve patient understanding of cancer clinical trial participation. Types of interventions included audio‐visual information, revised written information and a communication training workshop. Interventions were conducted alone or in combination with other forms of information provision. The nine papers, all with methodological limitations, reported mixed effects on a small range of outcomes regarding improved patient understanding of cancer clinical trial participation. The methodological limitations included: (1) the intervention development process was poorly described; (2) only a small element of the communication process was addressed; (3) studies lacked evidence regarding what information is essential and critical to enable informed consent; (4) studies lacked reliable and valid outcome measures to show that patients are sufficiently informed to provide consent; and (5) the intervention development process lacked a theoretical framework. Future research needs to consider these factors when developing interventions to improve communication and patient understanding during the informed consent process.     

Randomized clinical trial of an implantable drug delivery system compared with comprehensive medical management for refractory cancer pain: impact on pain, drug-related toxicity, and survival.

PURPOSE: Implantable intrathecal drug delivery systems (IDDSs) have been used to manage refractory cancer pain, but there are no randomized clinical trial (RCT) data comparing them with comprehensive medical management (CMM). PATIENTS AND METHODS: We enrolled 202 patients on an RCT of CMM versus IDDS plus CMM. Entry criteria included unrelieved pain (visual analog scale [VAS] pain scores >/= 5 on a 0 to 10 scale). Clinical success was defined as >/= 20% reduction in VAS scores, or equal scores with >/= 20% reduction in toxicity. The main outcome measure was pain control combined with change of toxicity, as measured by the National Cancer Institute Common Toxicity Criteria, 4 weeks after randomization. RESULTS: Sixty of 71 IDDS patients (84.5%) achieved clinical success compared with 51 of 72 CMM patients (70.8%, P =.05). IDDS patients more often achieved >/= 20% reduction in both pain VAS and toxicity (57.7% [41 of 71] v 37.5% [27 of 72], P =.02). The mean CMM VAS score fell from 7.81 to 4.76 (39% reduction); for the IDDS group, the scores fell from 7.57 to 3.67 (52% reduction, P =.055). The mean CMM toxicity scores fell from 6.36 to 5.27 (17% reduction); for the IDDS group, the toxicity scores fell from 7.22 to 3.59 (50% reduction, P =.004). The IDDS group had significant reductions in fatigue and depressed level of consciousness (P <.05). IDDS patients had improved survival, with 53.9% alive at 6 months compared with 37.2% of the CMM group (P =.06). CONCLUSION: IDDSs improved clinical success in pain control, reduced pain, significantly relieved common drug toxicities, and improved survival in patients with refractory cancer pain.     

Breakthrough cancer pain: review and calls to action to improve its management

In this paper, we review the current state of breakthrough cancer pain (BTcP) management. BTcP is a heterogeneous condition and a global problem for cancer     

Randomized controlled trial of a clinic-based survivorship intervention following adjuvant therapy in breast cancer survivors

In 2006, the IOM released a report citing the importance of “survivorship plans” to improve quality of life and care coordination for cancer survivors, but little has been done to evaluate their efficacy. Women with early-stage breast cancer were randomized within 6 weeks of completing adjuvant therapy to a survivorship intervention group (SI) or control group (CG). All subjects were given the NCI publication, “Facing Forward: Life after Cancer Treatment.” The SI also met with a nurse/nutritionist to receive a treatment summary, surveillance, and lifestyle recommendations. Both groups completed questionnaires on the impact of cancer (IOC), patient satisfaction (FACIT-TS-PS), and assessment of survivor concerns (ASC) at baseline, 3 and 6 months. Within and between group t tests and linear regression analyses were performed. Among 126 women (60 CG, 66 SI), mean age was 54 years, 48 % were Hispanic, and the groups were well-balanced by baseline characteristics. No significant differences between the CG and SI on the FACIT-TS-PS or IOC at 3 and 6 months were seen. The ASC health worry subscale was lower (less worry) in the SI compared to CG (p = 0.02). At all time-points, Hispanic women had higher (worse) health worry (p = 0.0008), social-life interference (p = 0.009), and meaning of cancer scales (p = 0.0004), and more trust in medical professionals (p = 0.03) compared to non-Hispanic women. While the SI did not lead to significant improvements in most patient-reported outcomes, it was associated with decreased health worry. Future interventions should determine the most efficient and effective method for delivering survivorship care plans.