Johnson, J.R., Burnell-Nugent, M., Lossignol, D., Ganae-Motan, E.D., Potts, R., & Fallon, M.T. (2010). Multicenter, double-blind, randomized, placebo-controlled, parallel-group study of the efficacy, safety, and tolerability of THC:CBD extract and THC extract in patients with intractable cancer-related pain. Journal of Pain and Symptom Management, 39(2), 167–179.
To compare the efficacy of a tetrahydrocannabinol:cannabidiol (THC:CBD) extract, a nonopioid analgesic endocannabinoid system modulator, and a THC extract to the efficacy of placebo in relieving the pain of patients with advanced cancer; to compare the safety and tolerability of the treatments with those of placebo
Patients with cancer pain, who experienced inadequate analgesia despite chronic opioid dosing, were randomized to THC:CBD extract (n = 60 patients), THC extract (n = 58), or placebo (n = 59) for a two-week, multicenter randomized double-blind, placebo-controlled trial.
Randomized, double-blind, placebo-controlled, parallel-group study
THC:CBD may be of benefit as an adjunct to opioid when pain is not fully controlled despite chronic opioid therapy. However, this conclusion warrants further investigation; the EORTC questionnaire showed a worsening of nausea and vomiting in the THC:CBD group, compared to the placebo group. In addition, patients in this study reported a consistent impairment of cognitive function. In addition, though authors reported at least a 30% reduction in NRS from baseline in the THC:CBD group, from baseline no change occurred, across treatment groups, in median dose of opioid background medication or mean number of doses of breakthrough medication.
THC:CBD extract—a nonopioid analgesic, endocannabinoid system modulator—may be a useful adjunct in managing the pain of patients who have inadequate analgesia from chronic opioids. However, one must consider the potential side effects (i.e. nausea, vomiting, impaired cognitive functions) that may occur as a result of adding this medication.
Johnson, M.J., Kanaan, M., Richardson, G., Nabb, S., Torgerson, D., English, A., . . . Booth, S. (2015). A randomised controlled trial of three or one breathing technique training sessions for breathlessness in people with malignant lung disease. BMC Medicine, 13, 213-015-0453-x.
To test whether three breathing training sessions are better than one in patients with intrathoracic malignancy experiencing breathlessness
Participants were randomized to receive either one or three hour sessions of training in four techniques (breathing control, pacing/prioritizing, relaxation, and anxiety management). Those randomized to three sessions had the sessions at intervals spaced one week apart. All participants received written and DVD/video reinforcement material and a telephone call from their therapist a week after the final session. The training was provided by the professional who would normally be responsible for completing such training at the given clinical site and included physiotherapists, occupational therapists, and a lung cancer clinical nurse specialists. At two sites, the professionals were described as being a part of a specialist palliative care breathlessness intervention service. Outcomes were measured at week 4 and compared to baseline.
No evidence exists that three sessions of breathing training for patients with intrathoracic malignancy with breathlessness were beneficial, and no increased distress and mastery over breathlessness occurred in those receiving three sessions over one. A single session of training is recommended if breathing training is used for breathlessness.
This study does not assess the effectiveness of breathing training over the standard of care for patients with cancer. If breathing training is considered based on other factors and other evidence, the nurse should be aware that this study does not support use of more than one session.
Johnson, J.R., Lossignol, D., Burnell-Nugent, M., & Fallon, M.T. (2013). An open-label extension study to investigate the long-term safety and tolerability of THC/CBD oromucosal spray and oromucosal THC spray in patients with terminal cancer-related pain refractory to strong opioid analgesics. Journal of Pain and Symptom Management, 46, 207–218.
To investigate the long-term safety and tolerability of 9-tetrahydrocannabinol (THC)/cannabidiol (CBD) spray and THC spray in relieving pain in patients with advanced cancer
Patients who had previously participated in a two-week parent RCT to investigate the efficacy, safety, and tolerability of THC/CBD spray and THC spray in patients with cancer-related pain were invited to take part in the long-term, open-label, follow-up study. This study took place at 22 study sites in the United Kingdom and Belgium. Visits occurred at the conclusion of the RCT study or at extension study screening, 7–10 days later, then every four weeks, and at study completion or withdrawal. Adverse events, vital signs, blood sample analyses, changes in medication dosing and in current medical conditions were monitored at each visit. A pump action oromucosal spray was used to deliver the study medication. Each 100 uL actuation of THC/CBD spray delivered 2.7 mg of THC and 2.5 mg of CBD to the oral mucosa. Each actuation of THC delivered 2.7 mg of THC, and each actuation of placebo (in the parent RCT) delivered the excipients plus colorants.
N = 43
MEAN AGE = 57.5 years for the THC/CBD group, 58.6 years for the THC group
MALES: THC/CBD: 59%, THC: 25%; FEMALES: THC/CBD: 41%, THC: 75%
KEY DISEASE CHARACTERISTICS: Breast (21%), prostate (16%), rectum (16%), lung (7%), and bone cancers (5%)
OTHER KEY SAMPLE CHARACTERISTICS: Those who had participated in the original RCT in Romania were not included in this study. The most commonly reported pain type was mixed pain, affecting more than half of all the patients, followed by neuropathic pain (37%) and bone pain (28%). Exclusion criteria included those with a history of severe cardiovascular, renal, hepatic, convulsive, or psychiatric disorder (other than depression associated with pain), patients currently taking levodopa, those pregnant or lactating or those not using adequate contraception, and those with oral cavity cancers or those whose previous treatments had included radiotherapy to the floor of the mouth.
Patients self-titrated THC/CBD spray (n = 39) or THC spray (n = 4) to symptom relief or maximum dose and were assessed regularly for safety, tolerability, and evidence of clinical benefit.
The efficacy end point of change from baseline in mean BPI-SF scores for both “pain severity” and “worst pain” domains demonstrated an improvement at each visit in the THC/CBD spray patients. The EORTC QLQ-C30 scores demonstrated an improvement from baseline in the domains of insomnia, pain, and fatigue.
Long-term use of the THC/CBD spray was generally well tolerated. No evidence was seen of a loss of effect for the relief of cancer-related pain with long-term use. Patients who continued the medication did not seek to increase their dose of THC/CBD or other pain medication over time, suggesting a useful benefit of cannabinoids in cancer-related pain.
Small sample (less than 100)
Findings not generalizable
No comparable information with the study group, making drawing conclusions from the results difficult
Discrepancy between patient continuation within the study and the level of satisfaction of clinicians with level of pain relief
For patients with cancer-related pain, pain is a major issue. The adjuvant use of cannabinoids in patient with cancer-related pain could provide a great benefit. The proportion of patients reporting satisfactory analgesia was greater for the THC/CBD spray than placebo overall. The results of this study show that patients and investigators considered that maintenance or treatment with THC/CBD spray was justified by the clinical importance of pain management in patients with cancer-related pain.
Johnson, R. A., Meadows, R. L., Haubner, J. S., & Sevedge, K. (2008). Animal-assisted activity among patients with cancer: effects on mood, fatigue, self-perceived health, and sense of coherence. Oncology Nursing Forum, 35, 225–232.
Patients assigned to the dog visit group participated in 15-minute sessions three times per week for four weeks with one or two visitor dogs. Two female dogs (a long-haired dachshund and a whippet), accompanied by a dog handler, were used. During visiting sessions, the dogs sat on the sofa with the participant. Participants combed, petted, played, and talked with the dog. The handlers ensured the participant’s safety and recorded the dog’s behavior and nature of the interaction during these sessions. Patients assigned to the friendly human visit group met with the same adult for 15-minute sessions three times per week for four weeks. Visitors were volunteer nursing students, emeritus nursing faculty, hospital administrative staff, and community members. Visitors were instructed to engage the participant in a superficial “park bench” type of conversation, such as talk about the weather, movies, and local events. All were instructed that visits should contain no discussion of personal health or controversial matters. Patients assigned to the silent reading group read research-provided magazines for 15 minutes three times per week for four weeks. Magazines were selected based on lack of content related to health and fitness, cancer and treatments, self-help, counseling, and animal-assisted therapy. Example magazines included Newsweek, Car and Driver, and Smithsonian.
Outpatient radiation therapy units of two hospitals in a midsized city in the midwestern United States
Patients were undergoing the active treatment phase of care.
The study used a longitudinal, randomized pre-/posttest design with three groups:
Profile of Mood States (POMS)
Animal-assisted therapy did not result in improved fatigue compared to other groups. All groups experienced a decrease in fatigue scores between pre- and posttest scores; however, that difference did not reach statistical significance. In addition, the decline difference score for the dog visit group was smaller than the difference for both the human visit and reading groups.
Johansson, K., Klernas, P., Weibull, A., & Mattsson, S. (2014). A home-based weight lifting program for patients with arm lymphedema following breast cancer treatment: A pilot and feasibility study. Lymphology, 47, 51–64.
To determine whether an at-home weight lifting program was feasible and effective in patients with breast cancer-related lymphedema
Prior to the start of the intervention, all participants wore compression garments according to their usual protocols (determined from the previous three months, day and night or day only) for two weeks. All garments had to be less than one month old and be of at least Compression Class (CCL) II. At the end of the control period, patients introduced resistance exercises over a four-week period, beginning with five repetitions and ending with 10 repetitions maximum. If lymphedema was not exacerbated, weights were increased by .5–1 kg every other session until the 10-repetition maximum was reached. After the four-week introduction period, patients were provided with flexible dumbbells ranging from .5–12 kg and were asked to exercise three times per week with at least one day between sessions. Patients performed four sets of the following exercises in this order, resting one to three minutes between each set: 1) shoulder flexion in a standing position, 2) shoulder adduction, 3) elbow extension in a supine position, and 4) elbow flexion in sitting position. Patients used 50% of the recommended weight for the first set and the full weight for the remaining three sets. Weight resistance levels were individually adjusted according to guidelines by the American College of Sports Medicine. Patients completed a minimum of eight repetitions per set when possible, and weight was increased by .5 kg when patients could complete more than 12 repetitions per set. Participants were not required to wear a compression garment during the exercises, but they were to put it on immediately following the exercises. Data were collected at baseline and at the end of the 12-week intervention.
Pre/post pilot study
All patients in the study followed the minimum criteria for the protocol (exercise at least two times per week). All patients who participated had lymphedema (mean lymphedema relative volume was 19.6%, SD = 11.7%, range = 5.1%–53.5%). No significant changes in arm volume were observed during the control period. At the completion of the intervention, there was a significant reduction in absolute volume from 448 ml to 427 ml (p < .03) and relative volume from 19.2% to 18% (p < .005). Multiple muscle groups showed an improvement in strength at the conclusion of the study period (shoulder flexors p = .001, shoulder adductors p = .001, elbow flexors p = .003, and elbow extensors p = .002). Ten additional participants took part in a study with an MRI. There was no significant reduction in arm volume for these participants after the intervention.
This home-based weight lifting program did not exacerbate or worsen lymphedema in this study. Participants saw some improvement in absolute arm volume and relative arm volume at the conclusion of the 12-week study period. Additional improvements were seen in the strength of multiple muscle groups. Overall, patients found the study to be feasible, and the majority of patients were at least minimally compliant with the exercise protocol.
A home-based exercise program was acceptable for women with lymphedema following breast cancer treatment. Women were able to complete the minimum requirements of the protocol and exercise at least twice per week for 12 weeks. Nurses should assess women for readiness to participate in home-based exercise programs and provide appropriate recommendations for those who are motivated to participate in such a program. Home-based weight lifting is safe for patients with lymphedema and does not make lymphedema worse. In addition, weight lifting improves the strength of multiple muscle groups.
Johansson, K., Tibe, K., Weibull, A., & Newton, R.C. (2005). Low intensity resistance exercise for breast cancer patients with arm lymphedema with or without compression sleeve. Lymphology, 38(4), 167–180.
The study took place at Lund University in Sweden.
Results showed no difference in arm volume between the the group without the compression sleeve (n = 15) and the group with the compression sleeve (n = 16). Controlled acute arm exercise program with low-intensity weights produced a slight arm volume increase that was transient and disappeared after 24 hours in the affected arm in patients with breast cancer experiencing lymphedema.
Wearing compression sleeve during exercise did not influence arm volumes but should be worn as prescribed the rest of the time.
More research is needed to validate results.
Johansson, K., Hayes, S., Speck, R.M., & Schmitz, K.H. (2013). Water-based exercise for patients with chronic arm lymphedema: A randomized controlled pilot trial. American Journal of Physical Medicine & Rehabilitation / Association of Academic Physiatrists, 92, 312–319.
To evaluate the effect of a water-based exercise program on women with breast cancer-related lymphedema
Women were randomly assigned to the exercise group or a wait list control group. The exercise intervention involved an initial instructional session followed by 30-minute sessions, three times per week for eight weeks, of specific exercises or swimming at moderate intensity on the Borg scale. After the initial instruction, sessions were unsupervised. Both groups completed weekly diaries of exercises performed. Measurement of outcomes was done at baseline and at the end of the study.
This was a single site study in an unspecified setting in Sweden.
This study has clinical applicability for late effects and survivorship.
This was a single blind, randomized controlled trial.
Perometry, bioimpedeance spectroscopy, local tissue water measurement via tissue dielectric constant measurement, shoulder range of motion (ROM) measures, and exercise diaries were used.
A quarter of the patients in the intervention group did not complete the interventions. No differences were found between groups in lymphedema. Some shoulder ROM measures were better in the exercise group (p ≤ 0.05).
The water-based exercise used was feasible, but had no obvious impact on lymphedema severity. The water-based exercise regimen was associated with better shoulder ROM compared to controls.
Water-based exercises and swimming may improve shoulder ROM but had no demonstrated effect on lymphedema severity in this study. In general, some evidence supports the benefit of exercise in lymphedema, but whether this type of water-based exercise is effective for actual lymphedema reduction is not clear.
Johannsen, M., O'Connor, M., O'Toole, M.S., Jensen, A.B., Hojris, I., & Zachariae, R. (2016). Efficacy of mindfulness-based cognitive therapy on late post-treatment pain in women treated for primary breast cancer: A randomized controlled trial. Journal of Clinical Oncology, 34, 3390–3399.
To assess the efficacy of mindfulness-based therapy on pain and distress in women treated for breast cancer
After completing baseline questionnaires, patients were randomized to the intervention or waitlist control group. The intervention was adapted from a standard intervention manual to the use of a shorter two-hour session, shorter meditation exercises, more gentle yoga exercises, and the elimination of all day sessions. The intervention was delivered in groups during eight consecutive weeks. All sessions were facilitated by a trained mindfulness instructor. Study measurements were conducted after the intervention and at three and six months after completion.
PHASE OF CARE: Transition phase after active treatment
Randomized, controlled trial with waitlist control
Pain intensity and neuropathic pain declined over time in the intervention group compared to the control group (p = 0.036). No differences in anxiety or depression over time were reported between groups. The average number of sessions attended was five, and the average amount of time spent on homework was 24 minutes per day. A direct correlation between number of sessions attended (p = 0.01) and time spent on practice (p = 0.01) was reported. The dropout rate was 22% across both study groups; only four dropouts were in the control group.
Participation in the mindfulness-based intervention was associated with a reported reduction in pain intensity; however, a large percentage of those allocated to the intervention dropped out of the study or were lost to follow-up, suggesting that the intervention as provided may not be practical to many patients.
Mindfulness-based group therapy may be helpful in the management of long-term pain with breast cancer but was not shown to have an affect on anxiety or depression over time. The strength of findings in this study is limited because of study limitations.
Johanson, J.F., Morton, D., Geenen, J., & Ueno, R. (2008). Multicenter, 4-week, double-blind, randomized, placebo-controlled trial of lubiprostone, a locally-acting type-2 chloride channel activator, in patients with chronic constipation. American Journal of Gastroenterology, 103, 170–177.
To assess the efficacy and safety of lubiprostone 24 mcg BID in patients with chronic constipation.
Patients were randomized to receive either oral lubiprostone 24-mcg capsules or placebo capsules. Patients continued to record information regarding bowel movements (BMs), use of rescue medications, and symptoms on a daily basis. Study drug capsules were counted to assess compliance every two weeks. Rescue medication comprised bisacodyl suppository and fleet enema if the suppository was not effective. Efficacy was defined as the frequency of spontaneous BMs during the first and subsequent study weeks. Patients were followed for four weeks.
This was a double-blind, placebo-controlled randomized trial.
Taking lubiprostone improved frequency of spontaneous BMs and constipation-related symptoms, with low incidence of treatment-related adverse events.
Lubiprostone effectively improved constipation in this study; however, applicability to patients with cancer is not clear. Nausea was the most common side effect, which could limit its use in patients with cancer, who may be on other medications and treatments that also cause nausea. Research involving patients with cancer-related constipation should be considered.
Johansen, N.J., & Hahn, C.H. (2015). Prophylactic antibiotics at the time of tracheotomy lowers the incidence of pneumonia. Danish Medical Journal, 62, A5107. Retrieved from http://www.danmedj.dk/portal/page/portal/danmedj.dk/dmj_forside/PAST_IS…
To estimate the prevalence of pneumonia after tracheotomy in patients with head and neck cancer, and to evaluate the effect of prophylactic antibiotics
Data on patients who underwent tracheotomy were obtained from health records, and patients were grouped according to whether they had been given prophylactic antibiotics. In all cases, tracheotomy was the primary operation. The comparison of ventilator-associated pneumonia was analyzed.
Pneumonia was defined as the clinical suspicion of pneumonia or the postoperative administration of antibiotics.
More patients who did not receive prophylaxis received antibiotics postoperatively (p = 0.04). The hospital stays of those given prophylactic antibiotics were seven days shorter (p < 0.01).
Prophylactic antibiotic administration for patients undergoing tracheotomy may reduce the risk of postprocedure ventilator-associated pneumonia.
Prophylactic antibiotic use in patients undergoing surgical procedures has been shown to reduce postoperative infections. The findings from this study add to that body of evidence, suggesting that this approach prior to tracheostomy provides a similar benefit in preventing ventilator-associated pneumonia.