Jahn, P., Renz, P., Stukenkemper, J., Book, K., Kuss, O., Jordan, K., … Landenberger, M. (2009). Reduction of chemotherapy-induced anorexia, nausea, and emesis through a structured nursing intervention: A cluster-randomized multicenter trial. Supportive Care in Cancer, 17, 1543–1552.
To evaluate a multi-modular self-care program, Self-Care Improvement through Oncology Nursing (SCION), consisting of emesis treatment, nutritional support, counseling, and relaxation interventions to reduce anorexia, nausea, and emesis (ANE)
Patients were randomized to receive either standard care (control) or the SCION program, which included four modular, algorithm-based protocols. In the intervention group, all patients received Module 1, \"Information leaflet,\" and Module 2, \"Structured consultation,\" at various times during treatment. Module 3 “Nutrition counseling” and Module 4 “Relaxation” were given if a patient developed significant nausea, emesis, or weight loss. Patients in the control group received set emesis prophylaxis. Assessments were made on days 1–5 of two chemotherapy cycles and day 8 of the second cycle.
The study was conducted in inpatient and outpatient settings at two German university hospitals.
All patients were in active treatment.
This was a randomized, controlled study.
The initial hypothesis, that a structured intervention for patients receiving chemotherapy with moderate or high emetogenic potential would significantly decrease ANE intensity, was not supported. The effectiveness of the nursing intervention to reduce chemotherapy-induced ANE and increase QOL could not be supported. Rather, the intervention was reported to have a negative effect on QOL.
The SCION program had no effect in reducing distressing ANE.
Jahn, P., Kuss, O., Schmidt, H., Bauer, A., Kitzmantel, M., Jordan, K., . . . Landenberger, M. (2014). Improvement of pain-related self-management for cancer patients through a modular transitional nursing intervention: A cluster-randomized multicenter trial. Pain, 155, 746–754.
To evaluate Self Care Improvement through Oncology Nursing (SCION-PAIN), a nursing-administered program to reduce patients’ barriers and improve pain management and pain-related discharge management
The intervention was a nurse-led counseling program to improve pain management and pain-related discharge management by reducing patient-related cognitive barriers. In the intervention group, the SCION-PAIN program was administered by specially trained ward nurses in cooperation with a study nurse. Initial education was standardized, and follow-up was tailored to individual needs. Three initial sessions were provided during hospital stay, and a follow-up telephone counseling session was done two to three days after discharge. Study measures were obtained at baseline, at discharge, and on days 7, 14, and 28 after discharge.
Cluster-randomized trial
Compared to usual care, the SCION-PAIN program reduced cognitive barriers in cancer pain management more effectively (p < 0.02), and patients who participated in this program showed a significant increase in perceived knowledge of cancer pain. There was no difference between the groups in average or worst pain intensity. Patients in the intervention group adhered better to pain medications (p = 0.02).
The results of this study demonstrated the effectiveness of the SCION-PAIN program as a brief, easily administered, nurse-led intervention to improve the self-management of pain in patients with cancer. Patient education could help to empower patients to actively participate in their pain treatment and develop self-management skills, improving adherence through care transitions. Participants in the program demonstrated a lower intensity of pain.
The results of this study emphasized the integral role of nurses as part of the supportive or palliative care team. This study also confirmed that the inpatient period provides a very valuable and suitable timeframe to improve patients’ self-management and communication skills to prepare them for care transitions.
Jahangard-Rafsanjani, Z., Gholami, K., Hadjibabaie, M., Shamshiri, A.R., Alimoghadam, K., Sarayani, A., . . . Ghavamzadeh, A. (2013). The efficacy of selenium in prevention of oral mucositis in patients undergoing hematopoietic SCT: A randomized clinical trial. Bone Marrow Transplantation, 48, 832–836.
To evaluate the efficacy of selenium intake for prevention of oral mucositis (OM) in patients with hematologic malignancies who are candidates for allogeneic hematopoietic stem cell transplantation (HSCT) after receiving high-dose chemotherapy (HDC)
Patients randomly were assigned to the selenium or control group in a blocked, randomization schedule. They were given either a selenium tablet (200 mcg) or placebo tablet twice daily, from the starting day of HDC to 14 days after transplantation. Chemotherapy was the same for all patients. All patients received a similar regimen for prevention of mucositis, including nystatin, sucralfate, and mouthwashes with chlorhexidine, plus 10 cc diluted povidone-iodine every three hours. Narcotic analgesics rarely were used to alleviate OM.
The cumulative incidence of OM (WHO scale grades of 1–4) in the selenium group and control group was not significantly different. The incidence of severe OM (grades 3 and 4) was significantly lower in the selenium group (10.8% versus 35.1%, P = 0.013). Two patients in the control group experienced WHO OM grade 4, and none of the patients in the selenium group experienced grade 4. Mean duration of OM was not different between the two groups. Mean duration of OM from the beginning of grade 2, moving up to grade 4, and then returning to grade 2 was significantly lower in the selenium group. No difference was seen in the start day of OM between the two groups.
Selenium supplementation during HDC may prevent severe OM in patients undergoing allogeneic HSCT. Further testing is needed before selenium can be recommended. Further testing is needed to establish optimal dose, time to initiate, and duration of treatment with selenium.
Nurses need to be informed about possible effective methods for reducing and eliminating OM to guide their patients.
Jaguar, G.C., Prado, J.D., Nishimoto, I.N., Pinheiro, M.C., deCastro, D.O., Jr., da Cruz Perez, D.E., et al. (2007). Low-energy laser therapy for prevention of oral mucositis in hematopoietic stem cell transplantation. Oral Diseases, 13(6), 538–543.
Prophylactic laser treatment was administered daily from beginning of conditioning regimen to two days after stem cell transplantation.
Patients received gallium aluminum arsenate diode laser therapy on four anatomic sites of the oral mucosa.
660 nm 10 mW 2.5 J/cm2 was administered. Each anatomic site was illuminated for 10 seconds per point.
Patients with HSCT from Brazil aged 17-62 years
Historical control group (1999–2000): n = 25
Laser group: n = 24
The study occurred from January 2003-September 2004.
WHO
Administration of morphine
Time of parenteral nutrition
Incidence of mucositis was the same in both groups.
Percentage of grade 2, 3, and 4 mucositis was less in laser group, not SS (p = 0.12). The laser group took longer to develop grade 1 (4.36 versus 6.12 days [p = 0.01], had fewer days of pain (5.64 versus 2.45 [p = 0.04], and had fewer patients who required morphine (10 versus 4 [p = 0.07].
Limited sample size and methodology
Number of patients with grade 3–4 may have been SS with larger sample.
Jacobson, J.S., Troxel, A.B., Evans, J., Klaus, L., Vahdat, L., Kinne, D., … Grann, V.R. (2001). Randomized trial of black cohosh for the treatment of hot flashes among women with a history of breast cancer. Journal of Clinical Oncology, 19, 2739–2745.
To assess the effect of black cohosh on the frequency and intensity of hot flashes in survivors of breast cancer
The study explored the use of black cohosh for treatment of hot flashes among women with a history of breast cancer. The black cohosh and placebo were supplied by the manufacturer. Each participant received 130 tablets and took one tablet twice daily with meals for 60 days.
The study was a randomized clinical trial: two-arm randomization, double-blind, placebo-controlled.
Participants were asked to record in a diary the number of hot flashes and the intensity of each. Participants scored severity as 1 = mild, 2 = moderate, and 3 = severe, for three days before starting to take any study pills, then again on days 27 to 30, and on days 57 to 60. FSH and LH levels were measured in a subset of participants at the first and final visits.
Sample size was chosen for 90% power to detect a 30% difference between groups in mean numbers of hot flashes, with a SD of 4.0. All analyses were stratified by tamoxifen use. The primary efficacy end point was mean numbers of hot flashes at 57 to 60 days. The safety end points were changes in mean levels of FSH and LH at the start and end of study participation associated with treatment. In hot flash intensity, both groups experienced a decline during the first month of study participation. The differences between groups in intensity at the end of the study were not significant. For the overall hot flash activity score, the differences between the treatment and placebo groups adjusted for tamoxifen were not statistically significant. Changes in FSH and LH levels of also did not differ between the two groups.
Data provide little evidence of either harm or benefit from using black cohosh to control hot flashes.
A limitation of this study is that participation lasted only two months.
Jacobsen, P.B., & Jim, H.S. (2008). Psychosocial interventions for anxiety and depression in adult cancer patients: Achievements and challenges. CA: A Cancer Journal for Clinicians, 58, 214–230.
To describe an evidence-based approach to using psychosocial interventions to manage anxiety and depression in adults with cancer
Authors provided examples of psychosocial interventions found to be effective. To be effective, the interventions
Five interventions are illustrated:
Nine of the 13 publications reached positive conclusions about the efficacy of psychosocial interventions for depression in patients with cancer. Positive supporting evidence recommends behavioral therapy, counseling or psychotherapy, and either of these approaches combined with education, relaxation training for patients not undergoing surgery, and cognitive behavioral therapy. Six of eight publications reached positive conclusions about the efficacy of psychosocial interventions for anxiety. Recommended are behavioral interventions for patients undergoing treatment, relaxation training for patients not undergoing surgery, and cognitive behavioral therapy in the post-treatment period.
In “summarizing the summaries,” limitations included differences in the scope, methods, and manner of summarizing findings and determining recommendations.
Weaknesses found in nearly all the studies included
Future research should focus on men, minorities, patients with advanced disease, and those who have completed treatment. Studies must include patients who experience significant depression or anxiety prior to intervention. Combinations of interventions should also be studied. Last, timing for screening and intervening is needed as evidence to guide practice.
Jacobsen, P. B., Donovan, K. A., Vadaparampil, S. T., & Small, B. J. (2007). Systematic review and meta-analysis of psychological and activity-based interventions for cancer-related fatigue. Health Psychology, 26, 660–667.
Databases searched were PsycINFO, MEDLINE, and CINAHL through November 2005.
Seventeen randomized, controlled trials of activity-based interventions were included in the meta-analysis. Activity-based interventions included professionally supervised programs and unsupervised, home-based programs designed to promote exercise activity. To be included, a trial must have included a controlled comparison arm with either a no treatment or placebo condition, must have been a study of an activity-based intervention in adults diagnosed with cancer, one of the study outcomes must have been fatigue or the related constructs of vitality or vigor, and the reported results must have included significant testing of differences between an intervention condition and a control condition.
In all 17 studies in which fatigue, vitality, or vigor was assessed as an outcome, more than three-quarters of the studies measured the construct of fatigue. Fatigue, vitality, or vigor was a primary outcome in slightly more than half of all the studies of activity-based interventions, and it was a secondary outcome in the remainder. Activity-based interventions included professionally supervised programs and unsupervised, home-based programs designed to promote exercise activity. There were numerous differences across these studies in the type of exercise (e.g., aerobic or resistance), mode (e.g., walking or cycle ergometer), and intensity of exercise.
Sixteen of the 17 studies used no intervention control groups or wait-list control groups, and one study used a placebo control condition that involved stretching exercises. Sixty-one percent of the studies provided a home-based exercise intervention and 39% provided supervised exercise programs. No study specified the levels of fatigue, vigor, or vitality used as the eligibility criterion.
The effect size for activity-based interventions was not statistically significant (dw = 0.05; 95% confidence interval [CI] [-0.08, -0.19]), and there were no differences in effect sizes as a function of cancer type (breast cancer: dw = 0.12; 95% CI [-0.15, -0.30]) or for all other types (dw = 0.06; 95% CI [-0.11, -0.24]) or intervention modality (home-based: dw = 0.04; 95% CI [-0.13, -0.22]; supervised: dw = 0.16; 95% CI [-0.09, -0.41]).
The current results conflict with the results and conclusions made by other authors who conducted narrative systematic reviews of single studies, with meta-analyses that included both randomized and nonrandomized trials, and with the results of another meta-analysis published more recently. Close comparison of the studies reviewed by the current authors with those reviewed by Cramp and Daniel suggest that the conclusions were different in part because different randomized, controlled trials were examined. Six randomized, controlled trials of activity-based interventions with favorable effects on the outcome of cancer-related fatigue were published after the current authors completed their electronic database searches. In addition, the search strategies used by the current authors excluded two randomized, controlled trials that reported activity interventions (Galantino 2003; Dimeo 2004) that met the criteria for inclusion in their meta-analysis. Moreover, a meta-analysis published in April 2008 by the Cochrane Collaboration that included these more recently published trials together with the two trials that were inadvertently excluded by the current authors concluded that there was a small but statistically significant effect for exercise (standardized mean difference = -0.23; 95% CI [-0.33, -0.13]).
Jacobsen, P.B., Phillips, K.M., Jim, H.S., Small, B.J., Faul, L.A., Meade, C.D., . . . Wilson, R.W. (2013). Effects of self-directed stress management training and home-based exercise on quality of life in cancer patients receiving chemotherapy: A randomized controlled trial. Psycho-Oncology, 22, 1229–1235.
Evaluate the effects of stress management training and exercise, alone or in combination, on well-being, depression, and anxiety among patients during chemotherapy treatment
Patients were stratified by gender, physical activity level, treatment schedule, and whether they also were receiving radiation therapy. They then were randomly assigned to one of four groups: usual care only (UCO), exercise (EX), stress management training (SM), or exercise plus stress management training (SMEX). The SM group met with an interventionist before the first chemotherapy infusion and was provided with a 15-minute video, a booklet, and an audio recording that provided information and instructions for paced breathing, progressive muscle relaxation with guided imagery, and coping statements to manage stress. Patients were instructed on how to learn and use the techniques during chemotherapy. The EX group met with the interventionis before the first infusion and was given a video and booklet providing instructions on use of regular exercise during treatment, with an emphasis on walking. These patients also were provided with pedometers. Patients were advised to exercise for 20–30 minutes three to five times per week and were provided with heart rate targets and shown how to use pulse rate to monitor exercise intensity. The SMEX group was provided with exercise and stress management resources. All patients had the same usual care access to the full range of psychological services provided to all patients and were given information about chemotherapy with written materials. Assessments were done at baseline (T1), six weeks (T2), and 12 weeks (T3). Exercise was self-directed and home-based.
PHASE OF CARE: Active anti-tumor treatment
The SMEX group had a significant reduction in depressive symptoms compared to the UCO group (p = .048). All groups except for the UCO group showed a decrease in depressive symptoms over time. The effect size was small at its maximum (d = 0.25). BAI scores showed a positive effect in the SMEX group compared to the UCO group (p = .049). In the SMEX group, this decline occurred mainly between baseline and the first follow-up at six weeks, and then anxiety scores increased. The maximum effect size was small (d = .22). No significant differences were seen between the UCO and EX or SM groups in anxiety or depression over time. Exercise and stress management activities increased only in the SMEX group.
The combination of exercise and stress management training reduced anxiety and depressive symptoms during chemotherapy treatment. Exercise alone and stress management training alone did no show positive results. The size of the effect of SMEX was small.
Findings suggest that the combination of stress management training, using approaches such as progressive muscle relaxation and guided imagery with home-based exercise delivered via video and written guidelines, had a small effect on improving anxiety and depressive symptoms among patients receiving chemotherapy. This combination was more effective than relaxation training and exercise alone. This suggests that nurses can educate patients to use both of these approaches to manage these symptoms. Effect sizes seen here were small, and the intervention consisted of a single instructional face-to-face meeting and then patient self-directed activity using resources provided. More personal time and follow-up support and encouragement during treatment sessions may increase the magnitude of the effects. Provision of videos and written materials as used here can provide a practical approach to patient education in these areas.
Jacobsen, P.B., & Jim, H.S. (2008). Psychosocial interventions for anxiety and depression in adult cancer patients: Achievements and challenges. CA: A Cancer Journal for Clinicians, 58, 214–230.
STUDY PURPOSE: To describe an evidence-based approach to the use of psychosocial interventions to manage anxiety and depression in adults with cancer
TYPE OF STUDY: Combined systematic review and meta-analysis
PHASE OF CARE: Active treatment
APPLICATIONS: Late effects and survivorship
Nine of the 13 publications reached positive conclusions about the efficacy of psychosocial interventions for depression in patients with cancer. Positive supporting evidence yielded recommendations for behavioral therapy, counseling/psychotherapy, and either of these approaches combined with education, relaxation training for patients not undergoing surgery, and cognitive-behavioral therapy.
Six of eight publications reached positive conclusions about the efficacy of psychosocial interventions for anxiety. Recommended are behavioral interventions for patients undergoing treatment, relaxation training for patients not undergoing surgery, and cognitive-behavioral therapy in the post-treatment period.
Future research is needed, particularly focusing on men, minorities, patients with advanced disease, and patients who have completed treatment. Studies must include patients experiencing significant depression and/or anxiety prior to intervention. Combinations of interventions should also be studied. Last, timing for screening and intervening is important, but current data specify only “vulnerable times” rather than evidence to guide practice.
Jacobs, J., Herman, P., Heron, K., Olsen, S., & Vaughters, L. (2005). Homeopathy for menopausal symptoms in breast cancer survivors: A preliminary randomized controlled trial. Journal of Alternative and Complementary Medicine, 11, 21–27.
This was a preliminary trial evaluating effectiveness of two types of homeopathy for treatment of menopausal symptoms in breast cancer survivors.
At the initial visit, a homeopathic practitioner conducted a homeopathic evaluation of each participant and prescribed an individualized homeopathic medication that best matched the symptom profile for that participant. A homeopathic pharmacist randomized the participants tothree treatment groups:
All study medications were donated by the Standard Homeopathic Company. The treatments were identical in taste, appearance, and odor and were dispensed in identical containers. The combination medicine was Hyland’s Menopause, which is sold over-the-counter in the United States. It contained three homeopathic medicines: Amyl nitrate, Sanguinaria canadensis, and Lachesis.
Participants were mailed a one-week daily hot flush diary to complete during the week prior to call.
Eighty-three (83) participants completed the initial homeopathic visit and were randomized into the three treatment groups. Of this total, 28 patients (33.7%) withdrew, including 11 who reported no relief from hot flashes, 7 who had a cancer recurrence or withdrew because of other illness, 5 who said the study was inconvenient, and 4 who were lost to follow up. Sixty-six (66) participants completed at least six months of the study (80.5%).
Participants stratified by age (younger or older than 50 years), breast cancer staging, and use of tamoxifen.
The study was a randomized, double-blinded, placebo-controlled trial. Participants received controlled an individualized homeopathic single remedy, homeopathic combination medicine, or a placebo.
Homeopathic providers saw or called participants every two months for one year.
No significant difference was reported for the primary outcome measure, the hot flash severity score, or in the total hot flashes among the three groups in the univariate model adjusted for baseline, time, and tamoxifen use over the period of 1 year. The single remedy group had a lower severity score and fewer hot flashes as a whole, which was most marked during the first three months of the study, with a positive trend (p = 0.1) at three months compared to placebo. However, in the combination homeopathy group not receiving tamoxifen, there was a statistically significant increase in the hot flash severity score compared to placebo (p= 0.01) and a highly significant difference when compared to single homeopathic remedy (p= 0.001). Similarly, there was a highly significant increase in the total number of hot flashes in the combination group compared to placebo (p = 0.006) and compared to single remedy (p=0.002) in the group not receiving tamoxifen. There was also a statistically significant increase in headaches in the group receiving the homeopathic combination at 6 months (p = 0.04) and 12 months (p = 0.03). In the multivariate analysis, which included baseline values, time, age, last month in the study, and treatment group, the same statistically significant relationships between treatment group and tamoxifen/no tamoxifen were found for both severity score and total number of hot flashes.
The small sample size precludes definitive answers. Difficulty in retaining participants for one year was a major problem. Use of three arms made treatment decisions difficult, although the average number of remedy changes found over the one-year study period is not unusual in homeopathic practice. Use of the homeopathic combination medicine in an ongoing daily regimen, rather than as it is used in current over-the-counter treatment, was a major flaw in this study.