Post-White, J., Kinney, M. E., Savik, K., Gau, J. B., Wilcox, C., & Lerner, I. (2003). Therapeutic massage and healing touch improve symptoms in cancer. Integrative Cancer Therapies, 2, 332–344.
All participants received four weekly 45-minute sessions of therapeutic massage (MT), healing touch (HT), or presence (P) and four weekly sessions of a standard care control. Credentialed practitioners who were also registered nurses delivered MT and HT. The three interventions all included music, a centering message, and a message to focus on breathing and letting go of extraneous thoughts. The order of the conditions was randomized. MT included a written Swedish massage protocol using massage gel. For HT, the protocol developed by Healing Touch International was used, and touch and nontouch techniques were used. Energy techniques used included centering, unruffling, magnetic unruffling, full-body connection, mind clearing, chelation, and lymphatic drain to modulate the energy field. For P, participants lied on a table listening to relaxing music. An MT or HT therapist sat with the participant during the session. The purpose was to be attentive and caring but to avoid therapy or physical intervention. In the control group, symptoms and vital signs were assessed.
Patients were from two outpatient chemotherapy clinics in the Midwest.
Patients were undergoing the active treatment phase of care.
This was a randomized, two-period crossover (between one of the interventions and standard care) study.
Compared to the control group, there was no effect of presence on fatigue. When comparing individual interventions to their matched control periods, the effect of MT on fatigue was close to significance (p = 0.057). HT was found to reduce fatigue (p = 0.028).
There was no clear evidence that one intervention was superior to the other, but MT and HT seemed to be more effective than presence alone or standard care in improving fatigue.
Post-White, J., Kinney, M.E., Savik, K., Gau, J.B., Wilcox, C., & Lerner, I. (2003). Therapeutic massage and healing touch improve symptoms in cancer. Integrative Cancer Therapies, 2, 332–344.
To determine if massage therapy and healing touch were effective in reducing anxiety, mood disturbance, pain, fatigue, and nausea and in improving the relaxation and satisfaction with care of patients receiving chemotherapy treatment
Patients were randomly assigned to one of three groups: therapeutic massage, healing touch, or caring presence. All received four weekly 45-minute sessions of the intervention and four weeks of standard care (control). After four weeks, patients were crossed over to another intervention or the control. Order of the intervention and usual-care control were randomized. Pre- and post-assessments of pain, nausea, and vital signs were done at each session. Assessments of intervention effects were done at the beginning and end of each four-week session. Therapeutic massage was provided in a standardized fashion, using a Swedish massage protocol. Healing touch followed a previously developed protocol incorporating centering, unruffling, magnetic unruffling, full-body connection, mind clearing, chelation, and lymphatic drain. Presence consisted of patients lying down for 45 minutes with relaxing music and the presence of a therapist. The therapist asked patients how they were feeling and if they had any questions. Conversation may or may not have occurred, according to the patient’s preference; the purpose of the therapist was to be attentive but to avoid therapy or physical intervention. The control condition consisted of usual care, which the authors did not describe.
Patients were undergoing the active treatment phase of care.
A randomized, controlled, parallel-group, crossover design was used.
Massage therapy and healing touch were more effective than presence alone or standard care in improving mood, reducing anxiety, pain, and fatigue and in reducing heart rate, blood pressure, and respiratory rate immediately postintervention.
Massage therapy and therapeutic touch can be beneficial to patients because the interventions induce physical relaxation and reduce pain, fatigue, and anxiety. In this study, these interventions were more effective in this regard than was therapeutic presence alone. Massage therapy and therapeutic touch are complementary therapies that nurses can consider and advocate for on behalf of patients who may benefit from them.
Posadzki, P., Moon, T. W., Choi, T. Y., Park, T. Y., Lee, M. S., & Ernst, E. (2013). Acupuncture for cancer-related fatigue: a systematic review of randomized clinical trials. Supportive Care in Cancer, 21, 2067–2073.
To review the evidence regarding acupuncture for cancer-related fatigue (CRF).
Databases searched were PRISMA, AMED, CINAHL, EMBASE, MEDLINE, PsycINFO, Cochrane Collaboration, one Chinese, three Japanese, and four Korean databases.
Search keywords were acupuncture therapy or electroacupuncture, cancer, and fatigue. A full listing of search terms used was provided.
Studies were included in the review if they were randomized, controlled trials (RCTs) investigating the effect of acupuncture treatments on CRF.
The exclusion criteria were not specified.
In total, 2,419 references were retrieved. The Cochrane tool was used to assess research method quality.
Of the seven RCTs found for inclusion, four favored acupuncture and three showed no effect. Most studies had serious limitations and methodological flaws. Of the two studies that were of relatively high quality, one showed no benefit over sham acupuncture and one favored the intervention over sham and wait-list control. Three of the four studies that controlled for placebo effect showed no benefit of acupuncture.
The evidence for acupuncture in the management of CRF is ambiguous, conflicting, and inconclusive.
Findings showed that evidence is lacking in support of acupuncture for the management of CRF.
Porter, L.S., Keefe, F.J., Garst, J., Baucom, D.H., McBride, C.M., McKee, D.C., . . . Scipio, C. (2011). Caregiver-assisted coping skills training for lung cancer: Results of a randomized clinical trial. Journal of Pain and Symptom Management, 41, 1–13.
To assess the efficacy of two variant cognitive skills training (CST) interventions for the caregivers of patients with lung cancer to improve caregiver distress, self-efficacy, and strain
Following a baseline data collection period, participants (patient-caregiver dyads) were randomly assigned to either CST or a cancer education and support group. Trained research assistants blinded to participant treatment groups collected patient and caregiver assessments via telephone calls immediately after each treatment session and at four months post-study. Fourteen 45-minute, telephone-based sessions with individual dyads using speaker phones occurred over an eight-month period. All study patients continued regular healthcare visits informed by including educational information. Trained, registered nurses adhering to detailed and audiotaped treatment outlines received weekly supervision and evaluation from study psychologists. Dyads in the CST group received information about ways to manage disease symptoms, homework assignments, and a CD focused on stress management. The education and support dyad group received lung cancer disease and treatment information, including hospice and palliative care, in a supportive environment without focus on coping skills training.
Randomized, controlled trial with blinding of intervention
No significant demographic or medical variable differences existed between dyads in the CST and education and support groups. Caregiver outcome measures indicated significant main effects over time for the POMS-B anxiety subscale (p = 0.02) and self-efficacy (p = 0.01). Both intervention groups showed decreases in caregiver anxiety and increases in their self-efficacy to manage patient symptoms although no significant time to intervention occurred with hierarchical linear modeling. An exploratory moderator analysis showed the education and support intervention to most benefit the caregivers of patients with stage 1 cancer. The CST intervention most benefited the caregivers of patients with stage 2 or 3 lung cancer.
CST and education and support intervention improved patient and caregiver anxiety and efficacy although the lack of a nontreatment group prevented specific conclusions about either intervention approach. Influences of time and attention may have affected dyadic outcomes. More research on important intervention aspects and their operation for improved lung cancer clinical practice is needed.
Identifying effective caregiver support interventions to aid in the care of patients with lung cancer remains a priority because of high levels of patient and caregiver distress and low self-efficacy. Additional studies need to include diverse participants, structured protocols for data collection and evaluation, a standard care (control) group, and innovative recruitment and retention methods for caregivers to strengthen the clinical practice evidence for this group of caregivers.
Porter, L.S., Keefe, F.J., Baucom, D.H., Hurwitz, H., Moser, B., Patterson, E., & Kim, H.J. (2012). Partner-assisted emotional disclosure for patients with GI cancer: 8-week follow-up and processes associated with change. Supportive Care in Cancer, 20, 1755–1762.
To (a) examine data collected eight weeks following participants’ completion of the intervention to determine whether treatment effects were maintained, and (b) process data to identify factors that might explain variability in response to the intervention
After providing informed consent, participants were administered baseline measures and then randomly assigned to either a partner-assisted emotional disclosure intervention group or an education/support condition group. The partner-assisted emotional disclosure intervention protocol systematically trained couples in skills designed to help patients disclose their feelings and concerns related to the cancer experience.
Individual couples attended four in-person sessions with a master's-level therapist. Sessions included training in communication skills to help patients express their cancer-related thoughts and feelings and partners to encourage patients’ disclosure and communicate understanding and acceptance. The majority of sessions were devoted to couples’ conversations in which patients were given the opportunity to disclose their cancer-related thoughts and feelings to their partners.
Couples in the cancer education/support condition group attended four in-person sessions that centered on presenting information relevant to living with cancer. The therapists and scheduling sessions were the same as for the disclosure intervention. Couples in this condition group did not receive any training in communication skills, and patients were not encouraged to discuss their thoughts and feelings related to the cancer experience with their partners.
A randomized controlled trial design was used.
The study experienced a 27.7% attrition rate due to patient death or declining health or conflicts between study completion and life issues. Analysis occurred according to an intent-to-treat model based on an initial randomized sample of 130 couples. For couples in which the patient initially reported high levels of holding back from discussing cancer-related concerns, the partner-assisted emotional disclosure intervention led to significant improvement in relationship quality (p = 0.002) and intimacy (p = 0.020) over an eight-week follow-up period compared to an education/support control condition. There was no treatment effect on mood. Overall, the benefits of disclosure intervention appeared largest for patients who were high in holding back.
In patients who were more expressive during disclosure sessions, patients and partners were significantly more likely to report increases in relationship quality and intimacy from baseline to post-treatment assessment. When patients reported more negative affect following the disclosure sessions, both patients and partners were significantly more likely to report decreases in psychological distress between baseline and post-treatment assessment.
The intervention showed a positive effect on couples’ relationships over the eight-week follow-up; however, there was no demonstrated effect on affect or mood disturbance for patients or their partners.
Nurses have a role in assessing patient–partner coping during cancer treatment and referring couples to relevant resources to facilitate physical, spiritual, and psychosocial health of couples. Partner-assisted emotional disclosure in a structured supportive environment may benefit couples when patients have difficulty expressing cancer-related concerns.
Portenoy, R.K., Burton, A.W., Gabrail, N., Taylor, D., & Fentanyl Pectin Nasal Spray 043 Study Group. (2010). A multicenter, placebo-controlled, double-blind, multiple-crossover study of Fentanyl Pectin Nasal Spray (FPNS) in the treatment of breakthrough cancer pain. Pain, 151(3), 617–624.
To demonstrate the safety and efficacy of fentanyl-pectin nasal spray (FPNS) in the treatment of breakthrough cancer pain
Consenting patients entered an open label-titration phase for determination of effective dose of FPNS. Effective dose was defined as a dose that achieved successful treatment of two breakthrough episodes. In the titration phase, if pain relief was unacceptable at 30 minutes, the patient was able to take his or her previous rescue medication. Doses were sequentially increased up to 800 mcg. Individuals who achieved an effective dose were eligible to continue in the double-blind stage. Patients received randomly assigned separate bottles, identified by number. Patients were instructed to use the bottles in the order designated. Each breakthrough episode was treated with a single dose. Pain that continued to require treatment after 30 minutes was treated with the patient’s usual rescue medication. Electronic diaries were used for data collection. Patients recorded pain intensity and pain relief at 5, 10, 15, 30, 45, and 60 minutes. Adverse events were recorded throughout the study, and visual nasal assessments were performed by the study physician at baseline and at the end of treatment. Maximum study duration was eight weeks.
Multisite (26 in the United States and 2 in other countries)
Randomized double-blind placebo-controlled crossover study
FPNC is effective and well tolerated for treatment of breakthrough cancer pain.
FPNS is an effective approach to the management of the breakthrough pain of patients with cancer who are taking opiods for relief of background pain. FPNS can be a useful alternative in situations where clinicians want to reduce the number of oral medications. Studies of the use of nasal sprays have been relatively brief, so nurses must remain aware of the need to assess the patient’s nares and related symptoms.
Portenoy, R.K., Raffaeli, W., Torres, L.M., Sitte, T., Deka, A.C., Herrera, I.G., . . . Fentanyl Nasal Spray Study 045 Investigators Group. (2010). Long-term safety, tolerability, and consistency of effect of fentanyl pectin nasal spray for breakthrough cancer pain in opioid-tolerant patients. Journal of Opioid Management, 6(5), 319–328.
To evaluate the safety and tolerance of fentanyl-pectin nasal spray for cancer-related breakthrough pain
Patients completed an open dose-titration phase for dose determination and then entered a 16-week open label treatment phase. Patients were instructed to administer the effective dose from titration for a maximum of four episodes of breakthrough pain per day. If pain relief was inadequate after 30 minutes, patients could take the prestudy rescue medication. Investigators contacted patients at least weekly to review appropriate use of study medication, to discuss the need for dose adjustment and nasal symptoms, and to review use of rescue medication. Patients also rated nasal symptoms by using a 10-point questionnaire. A physician performed graded nasal assessments at baseline, week 8, and week 16.
Open label trial
Fentanyl-pectin nasal spray for cancer-related breakthrough pain appears to be well tolerated over a use period of four months.
The study has a risk of bias due to no appropriate control group.
This study showed that, over a four-month period, patients tolerated the fentanyl-pectin nasal spray well. This study suggests that long-term use is not associated with significant adverse nasal events. Fentanyl-pectin nasal spray used as specified, for the treatment of breakthrough cancer-related pain, was effective for the majority of patients. Fentanyl-pectin nasal spray is a rapidly acting treatment for breakthrough pain that can be particularly helpful to patients who have difficulty with oral intake.
Portenoy, R.K., Thomas, J., Moehl Boatwright, M.L., Tran, D., Galasso, F.L., Stambler, N., . . . Israel, R.J. (2008). Subcutaneous methylnaltrexone for the treatment of opioid-induced constipation in patients with advanced illness: A double-blind, randomized, parallel group, dose-ranging study. Journal of Pain and Symptom Management, 35, 458-468.
To assess the efficacy and safety of subcutaneous methylnaltrexone in patients with advanced illness and opioid-induced constipation (OIC), and to clarify whether a dose-response relationship could be identified.
Methylnaltrexone was administered in doses of 1 mg, 5 mg, or 12.5 mg subcutaneously; patients were randomized to those dose groups in a ratio of 1:1:1. After 22 patients, the dose range was extended to 20 mg; patients were randomized in a ratio of 1:1:3 to 1-mg, 12.5-mg, or 20-mg dose groups. Patients received study medication if they had no bowel movement for at least two days and had a score of 3 or higher on a 5-point scale assessing constipation-related distress. Patients receiving laxatives had to be on a stable regimen for at least four days and remain on regimen during the study.
During the first week of the study, subcutaneous injections were administered on days 1, 3, and 5. Following the first week of double-blind study, patients received the option for open-label study for a maximum of three weeks. The initial dose was 5 mg subcutaneously as often as every other day. The maximum dose was 15 mg in the first 22 patients and 20 mg for the remaining 11 patients. Dose could be increased or decreased by the investigator.
Multi-center
This randomized controlled, parallel-group, repeated-dose, dose-ranging trial included a double-blind phase for one week followed by an open-labeled phase for a maximum of three weeks.
Twenty-two patients completed the blinded phase, and 14 completed the open-label phase.
In the blinded phase, laxation occurred within four hours on day 1 for 1 of 10 patients (10%) in the 1-mg dose group, 3 of 7 patients (43%) in the 5-mg dose group, 6 of 10 patients (60%) in the 12.5-mg dose group, and 2 of 6 patients (33%) in the 20-mg dose group. On day 2, for all dose groups higher than 1 mg, 11 of 23 patients (48%) responded (p = 0.05). There was no dose-response relationship across the three highest doses compared to the 1-mg dose.
The median time to laxation was higher than 48 hours for the 1-mg dose group and 1.72, 0.48, and 6.75 hours in the 5-, 12.5-, and 20-mg dose groups, respectively. The median time to laxation was 1.26 hours for all patients dosed 5 mg or higher, and was statistically significant compared to the 1-mg group (p < 0.0003). The 1-mg dose group required laxative rescue approximately twice as often as other groups. There was no trend in worsening pain control over time.
In the open-label phase, the response rate was from 49% to 64% for patients in dose groups from 5 mg to 12.5 mg. Secondary outcomes were not evaluated because of the small sample size.
Methylnaltrexone doses of 5 mg or higher in patients with advanced illness relieved OIC without decreased analgesia or withdrawal symptoms.
Portenoy, R.K., Ganae-Motan, E.D., Allende, S., Yanagihara, R., Shaiova, L., Weinstein, S., . . . Fallon, M.T. (2012). Nabiximols for opioid-treated cancer patients with poorly-controlled chronic pain: A randomized, placebo-controlled, graded-dose trial. The Journal of Pain: Official Journal of the American Pain Society, 13(5), 438–449.
To obtain information about the dose response for analgesia and safety in a population with medical illness and pain that is inadequately controlled by an opioid
Patients were randomly assigned to different-dose groupings of nabiximol or placebo delivered as an oral spray. Study design included a 5- to 14–day baseline period, five weeks of treatment titration, and a poststudy follow-up after two weeks. Patients received a daily call, from a voice recording system, that asked them to grade average pain. Patients continued the use of scheduled opioids and usual analgesics for the treatment of breakthrough pain. Patients who received at least one dose of the study drug were included in intent-to-treat analysis.
Randomized placebo-controlled, graded-dose trial
Nabiximols can be beneficial in the treatment of the refractory pain of patients with cancer. This study represents a start in regard to discovering the optimum dose effect and safety of nabiximols. In this study, low to medium doses were associated with the greatest effect.
This study affects nursing by providing a potential treatment option for patients with opioid-refractory pain. Nurses should be able to recognize opioid-refractory patients. Nurses should be educated regarding this novel cannabinoid treatment, its administration, and its side effects. Nurses should be able to teach patients how to use nabiximols.
Poppelreuter, M., Weis, J., & Bartsch, H.H. (2009). Effects of specific neuropyschological training programs for breast cancer patients after adjuvant chemotherapy. Journal of Psychosocial Oncology, 27(2), 274–296.
The study was conducted to evaluate the need of patients with breast cancer for neuropsychological rehabilitation after adjuvant chemotherapy. It also sought to determine the effectiveness of differentiated training programs after completion of treatment.
Participants were randomly assigned to one of two intervention groups. Control participants were selected from the “time-out” phase of the study when no training was being offered.
Both intervention groups took part in four one-hour training sessions per week during their inpatient stay. Participants were randomized to one of the following outpatient interventions.
Measures were completed upon admission to the rehabilitation unit (T1), at the end of in-patient rehabilitation (T2), and six months later on an outpatient basis (T3).
The study took place at the Tumor Biology Center Rehabilitation Unit in Freiburg, Germany.
The study utilized a randomized, controlled trial.
No intervention effects were noted in this study. Significant improvement was noted in 11 of 16 neuropsychiatric parameters for all three groups between T1 and T2. Forty participants (44.4%) maintained at least one cognitive deficit at five months; 19 (21.1%) maintained two or more deficits at T3.
Both intervention groups received similar amounts of training sessions. Eighty-four participants (87.5%) had at least one impaired neuropsychological parameter and 54 (56.2%) had two or more at baseline.
No significant differences in cognitive ability between treatment groups were reported.