Jones, R.B., Pearson, J., Cawset, A.J., Bental, D., Barrett, A., White, J., . . . Gilmour, W.H. (2006). Effect of different forms of information produced for cancer patients on their use of the information, social support, and anxiety: Randomised trial. BMJ, 332, 942–948.
The interventions included a variety of patient education materials delivered by the following methods.
Participants were divided into eight groups (three factors, 2 x 2 x 2).
Measurements were taken at baseline, after intervention, and at three months follow-up.
Western Scotland
A longitudinal, randomized trial design was used.
At three months follow-up, 45% of patients had improved anxiety scores. There were no statistically significant differences among the three intervention factors using a general linear model.
Johns, S.A., Brown, L.F., Beck-Coon, K., Talib, T.L., Monahan, P.O., Giesler, R.B., . . . Kroenke, K. (2016). Randomized controlled pilot trial of mindfulness-based stress reduction compared to psychoeducational support for persistently fatigued breast and colorectal cancer survivors. Supportive Care in Cancer, 24, 4085–4096.
To compare mindfulness-based stress reduction (MBSR) with psychoeducation/support groups (PES) as interventions to treat cancer-related fatigue (CFR) and associated symptoms of anxiety, depression, vitality, sleep disturbances, and pain. An active treatment control group (PES) was used to determine the effect size of MBSR in reducing CRF.
Breast cancer survivors (BCSs) and colorectal cancer survivors (CRCSs) were blinded and randomized into the MBSR group or the PES intervention. The primary outcome was CRF interference, and secondary outcomes of CRF were severity, vitality, anxiety, depression, sleep disturbances, and pain at baseline (T1), postintervention (T2) and at six months postintervention (T3). Both arms of the study included a structured curriculum that lasted two hours weekly for eight weeks. As the MBSR cohort had required exercises and practice assigned between classes, the PES arm was also given between-session practice and supplemental readings related to class topics. Treatment fidelity to each of the interventions was maintained by use of standardized manuals for each (MBSR and PES), audio recordings of the sessions with review by investigators using checklists created to evaluate the interventions. The MBSR intervention was adapted from standard approaches to eliminate the use of a retreat, the addition of psychoeducation, a brief body scan at bedtime, and shorter home practices. The PES program incorporated group discussions.
PHASE OF CARE: Late effects and survivorship
Single-blind, two-armed, randomized clinical pilot trail
The primary outcome of CRF interference did not significantly differ between MBSR and PES, although a trend (insignificant) toward MBSR was observed at T2 (d = –0.46, p = 0.073). Secondary outcome of vitality demonstrated moderate and significant effect size in the MBSR arm compared to the PES arm (d = 0.53, p = 0.003) at T2; however, the between group difference did not last through the T3 measurement. The MBSR maintained improvement in vitality, whereas vitality improved in the PES group. In addition, at T2, the MBSR participants were significantly more likely to report CRF global improvement (58.8 versus 34.3%, respectively, X2 (1) = 4.176, p = 0.041). Both groups continued to report similar global improvements in CRF at T3 (MBSR = 45.5 versus PES = 54.3%, X2 (1) = 0.53, p = 0.467). Pain was the only between group secondary outcome in which MBSR demonstrated moderate and significant improvement at T3 compared to PES (d = –0.50, p = 0.014).
Within group effects: Both MBSR and PES participants demonstrated moderate to large effects and significant improvements on all fatigue outcomes at T2 and T3 compared to T1. Participants in both groups also reported moderate to large effects and significant improvements at T2 and T3 from baseline in depression (p < 0.001), anxiety (p < 0.001), and sleep disturbance (p < 0.001).
Although the aim of this study was to rigorously test MBSR as an intervention for CRF in preparation for a phase-III randomized, controlled trial, the study supported the strength of PES as an intervention as well.
Although MBSR has been shown an effective intervention for numerous cancer-related symptoms, including CRF, a structured PES intervention was also clearly effective in helping survivors manage fatigue and other symptoms. However, given the more immediate effect of MBSR for participants, MBSR may provide results sooner. Both interventions are efficacious and therefore provide cancer survivors a choice in interventions effective in reducing CRF and its interference in daily life through anxiety, depression, and sleep disturbance.
Johns, S.A., Von Ah, D., Brown, L.F., Beck-Coon, K., Talib, T.L., Alyea, J.M., . . . Giesler, R.B. (2016). Randomized controlled pilot trial of mindfulness-based stress reduction for breast and colorectal cancer survivors: Effects on cancer-related cognitive impairment. Journal of Cancer Survivorship, 10, 437–448.
To examine the effect of an eight-week Mindfulness-Based Stress Reduction (MBSR) program compared to an eight-week education and support (ES) program on subjectively and objectively assessed cognitive function among breast and colorectal survivors experiencing fatigue
PHASE OF CARE: Late effects and survivorship
Two-arm, randomized, clinical trial, pilot study
This pilot study demonstrated that MBSR offers significant and sustained improvements in both subjectively and objectively measured chemotherapy-related cognitive impairment. The findings indicated that the MBSR intervention addressed issues of executive function and attentional control in breast and colorectal survivors reporting cancer-related fatigue and cognitive impairment.
The findings of this study suggest that MBSR may improve late effect cognitive/emotional fatigue and cognitive impairment in patients with cancer. As no identified adverse effects of MBSR training or mindfulness meditation exist, this low-risk intervention may be beneficial for patients.
Johnston, J.M., Kurtz, C.B., Drossman, D.A., Lembo, A.J., Jeglinski, B.I., MacDougall, J.E., . . . Currie, M.G. (2009). Pilot study on the effect of linaclotide in patients with chronic constipation. American Journal of Gastroenterology, 104, 125–132.
To evaluate the safety, tolerability, and efficacy of linaclotide in patients with chronic constipation.
Patients recorded data related to daily bowel habits and called into a voice response system daily to record their medications taken and bowel movements. Patients were randomized to receive 100, 300, or 1,000 mcg of linaclotide or placebo once daily in the morning, in the fasting state.
This was a randomized, double-blind, placebo-controlled, parallel group, phase IIA study.
Linaclotide appeared to improve symptoms of chronic constipation and was well-tolerated overall.
The usefulness of linaclotide for patients with cancer who have constipation is not yet known. This medication is a peptide that binds to specific receptors on the membrane of intestinal enterocytes and may increase efflux into the intestinal lumen with concomitant fluid secretion. Those effects may improve stool consistency and transit time. Nurses should be aware that a variety of new medications aimed at management of constipation with various mechanisms of action are being developed. Applicability to patients with cancer has not yet been studied.
Johnston, M. F., Hays, R. D., Subramanian, S. K., Elashoff, R. M., Axe, E. K., Li, J. J., . . . Hui, K. K. (2011). Patient education integrated with acupuncture for relief of cancer-related fatigue randomized controlled feasibility study. BMC Complementary and Alternative Medicine, 11, 49.
This small pilot study had two objectives: (1) to design a strategy for recruitment tailored to the institutional environment and therapeutic intervention and (2) to collect evidence of preliminary effects.
In a two-part intervention, patients were first taught to improve self-care with regard to exercise, nutrition, and cognitive-behavioral techniques over a four-week period. They were then provided with eight weekly 50-minute acupuncture sessions. This therapeutic protocol references a conceptual framework derived from two theories—Social Cognitive Theory and Integrative Medicine Theory—but did not provide a description of the theory to match the interventions (exercise, nutrition, cognitive therapy, or acupuncture) with conceptual variables in the model.
This was a randomized, controlled feasibility study.
Failure of the recruitment methods led to the development of a tailored recruitment strategy. The intervention was said to be associated with a 2.38-point decline in fatigue (BFI) (90% confidence interval [0.586, 5.014]; p < 0.10). Differences in perceived cognitive dysfunction outcomes were not statistically significant between the two groups over time. The authors talked about using a pooled standard deviation for the BFI at baseline to compare the means of the two groups to determine the effect size.
An effective recruitment strategy is necessary for the execution of any randomized, controlled trial. The conceptual framework integrating social cognitive theory and integrative medicine was not effectively operationalized.
Investigation into outcomes attributed to specific patient education interventions might first be warranted before blending such an educational intervention with a complimentary/alternative therapy studying efficacy on cancer-related fatigue.
Johnston, R.L., Lutzky, J., Chodhry, A., & Barkin, J.S. (2009). Cytotoxic T-lymphocyte-associated antigen 4 antibody-induced colitis and its management with infliximab. Digestive Diseases and Sciences, 54, 2538–2540.
To review the use of corticosteroids and infliximab in the treatment of patients with immune-mediated colitis secondary to anti-CTLA-4 antibody treatment
Five patients in a phase III trial for malignant melanoma treatment who developed diarrhea after receiving anti-CTLA-4 antibody treatment were evaluated. Four patients received tremelimumab, and one received ipilimumab. All five patients presented with acute diarrhea within a median of 35 days (range 10–53) after the last anti-CTLA-4 dose. Diarrhea was defined as loose or watery, nonbloody, and occurring four to eight times daily. Laboratory results were benign, and infection diarrhea was ruled out. Each patient underwent flexible sigmoidoscopy that revealed edema, erythema, ulcerations, and fibrinopurulent exudates. All five patients were treated with high-dose corticosteroids (prednisone 40–60 mg by mouth daily) for one week. Patients with continued, relapsed, or partial response beyond one week of treatment were treated with infliximab 5 mg/kg.
Prospective, observational trial
Case series report
Treatment with infliximab resulted in a resolution of symptoms within two to three days in all patients. Resolution was defined as a return to baseline bowel habits of one to two solid bowel movements per day. One patient had recurrence of symptoms within three weeks and was given a second treatment with infliximab with success. All patients had a four- to six-week follow-up to ensure resolution. None had a repeat sigmoidoscopy. The authors concluded that, to their knowledge, no untoward side effects to inflixamab have occurred, including infection. The discussion refers to this regimen as based on one article (Beck et al.). The discussion also raises concerning issues about the affect of infliximab on tumor response. The current authors further state that the drug could affect other immune suppressant properties, predisposing patients to serious infection and cancer progression.
Infliximab was effective in resolving immunotherapy-related diarrhea in this small group of patients.
Anti-CTLA-4 antibody treatment can cause immune-mediated colitis. Nurses must be knowledgeable about advances in the treatment of immune-related adverse reactions, such as colitis.
Johnson, J.A., Rash, J.A., Campbell, T.S., Savard, J., Gehrman, P.R., Perlis, M., . . . Garland, S.N. (2015). A systematic review and meta-analysis of randomized controlled trials of cognitive behavior therapy for insomnia (CBT-I) in cancer survivors. Sleep Medicine Reviews, 27, 20–28.
PHASE OF CARE: Multiple phases of care
CBT-I resulted in a significant improvement on sleep efficiency relative to control from pre- to postintervention (p < 0.01), with a medium effect size pooled across studies (0.53, 95% CI [0.39; 0.68]); and improvement at six-month follow-up (p < 0.01), with effect size (0.33, 95% CI [0.11, 0.54]). There were significant improvement on sleep onset latency relative to control from pre- to postintervention (p < 0.01), with a small to medium effect size pooled across studies (0.43, 95% CI [0.27, 0.58]); and it persisted at six months (p < 0.01), with effect size pooled across studies (0.27, 95% CI [0.11, 0.44]). And, finally, there were significant improvements on wake after sleep onset from pre- to post-intervention (p < 0.01), with a small to medium effect size pooled across studies (0.41, 95% CI [0.24, 0.59]) persisting at six months (p < 0.01), with effect size pooled across studies (0.27, 95% CI [0.11, 0.44]). Overall, there were statistically significant improvements in insomnia severity following CBT-I relative to control from pre- to postintervention (p < 0.01), with a large effect size pooled across studies (0.77, 95% CI [0.6, 0.93]). Four RCTs reported data on insomnia severity at six months (p < 0.01), with effect size pooled across studies (0.54, 95% CI [0.37, 0.73]).
The results of the meta-analysis indicate that survivors of cancer treated with CBT-I showed improvements in sleep efficiency, sleep onset latency, and wake after sleep onset as measured by sleep diaries, and insomnia symptom severity as measured by the ISI when compared to the usual care, waitlist control, or active comparator conditions. In addition, the observed effects persisted at six-month follow-up, suggesting that CBT-I provides significant, lasting improvements in sleep. Future research should examine the mechanisms by which CBT-I improves sleep in the cancer population. And specifically, the relative impact of behavioral versus cognitive change is unclear.
It was not possible to directly compare the efficacy of CBT-I as delivered either individually, in a group, online, or via video. Majority of included trials were conducted in women with stage I-III breast cancer, and it is unclear how well the observed results will generalize across the cancer continuum.
Individuals diagnosed with cancer are particularly vulnerable to insomnia with a prevalence rate almost twice that of the general population (50%–60% versus 12%–25%). CBT-I was effective across diverse treatment modalities, intervention lengths, and cancer diagnoses or stages in improving sleep diary outcomes that were durable at six months.
Johnson, J.R., Crespin, D.J., Griffin, K.H., Finch, M.D., & Dusek, J.A. (2014). Effects of integrative medicine on pain and anxiety among oncology inpatients. Journal of the National Cancer Institute. Monographs, 2014, 330–337.
To investigate the effectiveness of integrative medicine therapies on pain and anxiety among patients with cancer
The integrative medicine (IM) therapies included in this study were in three different categories, (a) bodywork, which included craniosacral therapy, medical massage, and reflexology, (b) mind-body and energy (MBE) therapies, which were further divided into separate categories, and (c) traditional Chinese medicine, which included acupressure, acupuncture, and Korean hand therapy. Patients could receive therapy from one category or from more than one in combination therapy.
This retrospective, observational study collected data from electronic medical records.
The results of this study indicated that IM therapies need more extensive research to validate findings, suggesting a correlation between improved self-reported pain and anxiety scores and use of these therapies alone or in combination.
Nurses in the oncology inpatient and outpatient settings are instrumental in research evaluating pain management techniques such as IM therapies. Nurses conduct, lead, and participate in every aspect of these studies evaluating patient outcomes from pain management interventions for patients with cancer. Observational studies and qualitative research will be instrumental in developing future evidence-based guidelines.
Johnson, R. L., Block, I., Gold, M. A., Markwell, S., & Zupancic, M. (2010). Effect of methylphenidate on fatigue in women with recurrent gynecologic cancer. Psycho-Oncology, 19, 955–958.
To evaluate the effect of methylphenidate on fatigue in women with recurrent gynecologic cancer.
Women with recurrent gynecologic cancer currently receiving chemotherapy and reporting fatigue at baseline were prescribed methylphenidate. The dose started at 5 mg taken at 8 am and noon and was titrated up to 10 mg at two weeks if the patient reported a limited response. Data were obtained at baseline and two, four, and eight weeks.
Patients were undergoing the active treatment on chemotherapy phase of care.
The study was a prospective trial.
Thirty-two women were initially enrolled; only 13 completed the eight-week follow-up. Scores on the FSI decreased statistically significantly from baseline at all measurement points (week 2, p = 0.0088; week 3, p = 0.0007; week 3, p = 0.0001). BSI scores also decreased, with scores at weeks 4 and 8 significantly lower than baseline (p = 0.015 and 0.0015, respectively). There was an overall change in FACT-G scores over time (p = 0.0351), with significant change in physical well-being (p = 0.0235) and emotional well-being (p = 0.0099). There was no change in family/social and functional well-being.
Methylphenidate may be beneficial to women with recurrent gynecologic cancer experiencing treatment-related fatigue.
Findings suggest that methylphenidate may be beneficial in this small select type of patients. No adverse drug information was formally collected (the authors reported several patients withdrew from the study due to blurred vision, confusion, and dizziness but did not address whether these might be drug- or disease-related); thus, nurses would need to monitor patients closely who receive these drugs.
Johnson, C.D., Berry, D.P., Harris, S., Pickering, R.M., Davis, C., George, S., . . . Sutton, R. (2009). An open randomized comparison of clinical effectiveness of protocol-driven opioid analgesia, celiac plexus block or thoracoscopic splanchnicectomy for pain management in patients with pancreatic and other abdominal malignancies. Pancreatology: Official Journal of the International Association of Pancreatology 9(6), 755–763.
To assess the effectiveness, after two months, of celiac plexus block (CPB) versus thoracoscopic splanchnicectomy (TS) in patients receiving appropriate medical management (MM) for the pain of pancreatic and other abdominal malignancies
Patients were randomized to one of three treatment groups (MM, MM+CPB, or MM+TS) in blocks of three, stratified by treatment center, tumor type, and current opioid status (opioid naive, not taking strong opioids or started strong opioids within three days before recruitment, or taking strong opioids for more than three days prior to recruitment). Clinical assessments and data collection occurred at randomization, at weeks 2 and 4, and then monthly. Local researchers were not blinded to procedure. Patients completed a daily diary for two months and completed questionnaires at follow-up visits. Oral modified-release morphine was prescribed according to standard practice in each setting and increased 30%–50% as needed for pain control. Rescue medication for breakthrough pain was immediate-release oral morphine. Adjuvant analgesic agents—including amitriptyline, valproate, or gabapentin—were also used as needed for neuropathic pain. NSAIDs or dexamethasone was used for liver capsule pain. Opioid switching occurred as needed to avoid side effects or because of a patient's inability to take oral medications. Opioid rotation was not used. Patients maintained a daily diary of pain assessment.
Open randomized comparison
Pain relief was achieved in one third of patients at two weeks and in just under half of all patients at two months. Researchers observed no differences between groups in pain scores or total opioid consumption at any time point. Two months after randomization, 73% of subjects were taking opioids. Four serious adverse events occurred in three patients: One patient in the MM group was hospitalized for confusion eventually thought to be unrelated to the study medication, one patient was hospitalized for wound infection after TS, and one patient in the TS group had intraoperative bleeding that was resolved with sutures. Of all participants, 53% took opioids regularly during the study and 11.8% took adjuvant analgesics. Worst pain and average pain declined somewhat in all groups.
Authors reported no significant intergroup differences in pain scores or opioid consumption and no correlation between continued use of opioids and effective pain relief. The absence of any benefit from interventions led researchers to question the value of the interventions.
The study presents insufficient evidence to support the efficacy of one treatment over the others.