Jones, E., Isom, S., Kemper, K.J., & McLean, T.W. (2008). Acupressure for chemotherapy-associated nausea and vomiting in children. Journal of the Society for Integrative Oncology, 6, 141–145.
To assess the feasibility, safety, and effectiveness of acupressure therapy for preventing or reducing chemotherapy-induced nausea and vomiting (CINV) in children receiving chemotherapy
The study was conducted in a single inpatient site at a children’s hospital in North Carolina.
All participants were pediatric patients in active treatment.
This was a pilot study. It was a prospective, randomized, crossover clinical trial.
The study used modified methods of Morrow questionnaires. It did not state how the tool was modified. No reliability or validity information was provided.
Questionnaires quantified nausea on an 11-point Likert scale, collected demographics and diagnoses, and measured the following.
Although acupressure bands did not show a reduction in nausea or vomiting, patients perceived the bands as moderately effective, planned to use them in the future, and indicated they would recommend them.
The acupressure bands did not demonstrate a significant change in actual incidence of nausea and vomiting; however, this therapy may be helpful in reducing expectations of CINV.
Jones, E., Koyama, T., Ho, R.H., Kuttesch, J., Shankar, S., Whitlock, J.A., . . . Frangoul, H. (2007). Safety and efficacy of a continuous infusion, patient-controlled antiemetic pump for children receiving emetogenic chemotherapy. Pediatric Blood and Cancer, 48, 330–332.
To evaluate the safety and efficacy of antiemetic medication administration via patient-controlled infusion pump
Patients who failed a standard antiemetic regimen (including a scheduled 5HT3 and one or more additional breakthrough medication of a different class) were placed on a patient-controlled pump containing diphenhydramine 4 mg/ml, lorazepam 0.16 mg/ml, and dexamethasone 0.27 mg/ml mixed in 30 ml of normal saline. The pump ran with a basal rate of 0.1–0.2 ml per hour with a demand dose of 1–2 ml every 30 minutes. The infusion pump was used along with a scheduled 5HT3 agent.
This was a quasi-experimental trial with no comparison group. Data were from a retrospective chart review of all patients who used an antiemetic pump to control chemotherapy-induced nausea and vomiting (CINV) between March 1999 and April 2004.
Complete response (CR) was defined as no emesis and no rescue medications. If emesis occurred but no rescue medications were used, it was considered a partial response (PR). Failure was defined as the use of rescue medications. Total patient days in CR, PR, and failure were counted for cycles with and without the antiemetic pump. The total number of rescue medications used and the total number of hospital days also were compared.
Patients with an antiemetic infusion pump had more days in CR than without (45 versus 21 days). A larger number of rescue medications were required to control breakthrough nausea and emesis for the conventional prophylaxis versus the antiemetic pump (108 versus 24). Patients with an antiemetic pump had significantly shorter hospital stays.
Using an antiemetic continuous-infusion pump with demand dosing may reduce the total daily dose of each antiemetic medication used individually. Adverse events occurred in 4% of courses, and all side effects resolved with a decreased rate of infusion. No patients required the discontinuation of an infusion pump.
Preliminary data showed that using an antiemetic infusion pump with basal and demand dosing may be an effective way to manage CINV in pediatric patients who fail standard antiemetic therapy. Additional research is needed.
Jones, J.M., Lewis, F.M., Griffith, K., Cheng, T., Secord, S., Walton, T., . . . Catton, P. (2013). Helping Her Heal-Group: A pilot study to evaluate a group delivered educational intervention for male spouses of women with breast cancer. Psycho-Oncology, 22, 2102–2109.
To determine the acceptability and feasibility of HHH-G and the study methods to evaluate its impact on participating men’s skill, self confidence, and self care and to assess the impact of intervention on the participating husbands' ratings of marital quality and depressed mood
HHH-G is a group intervention program with five sessions. Intervention was delivered by two trained educational counselors over five separate 1.5-hour sessions delivered at one week intervals. The five sessions included
Each session included a short group presentation by the education counselors and skill building and efficacy enhancing group exercises. Participants were also provided with spouses' workbooks with session specific activities at home and home assignments that focused on enhancing behavioral capabilities including knowledge and skill. Data were collected at baseline, immediately after the last session, and three months later.
Phase of care: active antitumor treatment
A mixed method (one-arm, qualitative, pre-post intervention design) was used.
A moderate to favorable increase in skills was noted as measured by the spouse skill checklist (p < 0.001), including the self care and support subscale (p < 0.001) and the wife support scale (p < 0.003). A significant time effect on self efficacy was measured by CASE-S. No significant changes in depressed mood or marital functioning was noted for the husbands, but a significant reduction in depressed mood (p < 0.003) was noted for the wives.
The feasibility and acceptability of HHH-G were supported. No significant reduction in depression scores were noted for male spouses, which might have been caused by the floor effect because baseline CES-D scores were low in male spouses. A large sample size with a control group woul dneed to be studied to truly examine the effectiveness of this intervention program.
Study demonstrated promising findings on feasibility and reduction in depressed mood for the women with breast cancer. This sounds like a cost-effective approach that could be used by nurses and social workers to improve patient and caregiver outcomes, such as increasing self efficacy and marital functioning.
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.