Ludwig, G., Krenz, S., Zdrojewski, C., Bot, M., Rousselle, I., Stagno, D., . . . Stiefel, F. (2014). Psychodynamic interventions in cancer care I: Psychometric results of a randomized controlled trial. Psycho-Oncology, 23, 65–74.
To evaluate the effects of a psychodynamic-oriented intervention in patients with cancer
Patients who consented were randomized to an immediate intervention group or a waitlist controlled group. Patients who did not want to participate were assigned to an observation group, and they agreed to complete study measurements. The intervention involved an immediate phase of four sessions during which the therapist aimed to link the patients’ biographical information with current responses to disease. The authors noted that this intervention was not considered psychotherapy, but it was designed as psychological support. After the initial sessions, subjects were able to participate in 12 additional sessions if they chose to. Study questionnaires were completed by patients in the home at baseline and at four, eight, and 12 months.
Randomized, controlled trial
Only four patients in the immediate intervention group demonstrated improvements in total HADS scores (defined as a 50% improvement in score). Only 31.5% of those initially entered in the study had data for follow-ups, and the number of drop-outs in the waitlist controlled group was higher. There were no significant differences in study outcome measures between groups, and at some time points, control group scores were better. Only 50% of participants were interested in additional sessions of the intervention.
This study did not show any effects for the tested intervention. Multiple study flaws could have contributed to these results.
This study did not show any effects of the supportive psychodynamic intervention examined. These results need to be viewed with caution because of the multiple flaws and limitations of the study. This report points to the difficulty of getting sustained patient participation in this type of therapy or research. It is not clear if drop-outs were caused by competing issues such as transportation for sessions, problems encountered during cancer treatment, a lack of patient interest, or sense of benefit. Supportive interventions for patients with cancer need to be practical in their implementation for both providers and patients.
Ludman, E.J., McCorkle, R., Bowles, E.A., Rutter, C.M., Chubak, J., Tuzzio, L., . . . Wagner, E.H. (2015). Do depressed newly diagnosed cancer patients differentially benefit from nurse navigation? General Hospital Psychiatry, 37, 236–239.
To evaluate effects of nurse navigation on depression among patients newly diagnosed with cancer
The nurse navigation intervention was designed to address care delays, care coordination, information needs, and help in patient decision-making and lack of emotional and social supports for patients. Patients randomized to receive the intervention had weekly nurse navigator contacts for 16 weeks. Nurses used a distress thermometer to identify problems and monitor progress. Those with high distress scores and suspected to have depression were referred for further assessment and treatment. Outcomes were evaluated in a four month follow-up telephone interview.
PHASE OF CARE: Active antitumor treatment
Most patients did not have depression at baseline. For those with higher baseline PHQ-9 scores, nurse navigation patients had higher PACIC scores; however, differences were not statistically significant.
Findings did not show that nurse navigation was of greater benefit for patients with depressive symptoms or had an impact on depression scores.
Findings of this study did not show that nurse navigation affected depressive symptoms or was of greater benefit to patients with depression among those newly diagnosed with cancer.
Luctkar-Flude, M., & Groll, D. (2015). A systematic review of the safety and effect of neurofeedback on fatigue and cognition. Integrative Cancer Therapies, 14, 318–340.
PHASE OF CARE: Late effects and survivorship
Improvements were noted in fatigue in eight of 17 studies, and improvement was noted in cognition in 14 of the 17 studies reviewed. Neurofeedback interventions were well tolerated with only three studies reporting any side effects.
Insufficient evidence was presented to suggest that these complementary and alternative medicine therapies (neurofeedback) are useful in the management of cancer-related fatigue or cognition.
Additional research needs to be done before this type of therapy can be recommended.
Lucchese, A., Matarese, G., Ghislanzoni, L.H., Gastaldi, G., Manuelli, M., & Gherlone, E. (2016). Efficacy and effects of palifermin for the treatment of oral mucositis in patients affected by acute lymphoblastic leukemia. Leukemia and Lymphoma, 57, 820–827.
To study the efficacy of palifermin for prophylaxis of OM in pediatric patients undergoing hematopoetic cell transplant (HCT)
Patients were randomly assigned to receive either IV palifermin 60 mcg/kg per day starting three days prior to transplant conditioning chemotherapy or placebo. All patients received basic oral hygiene and invasive nutrition as needed. All other aspects of care were essentially the same between groups. OM was assessed daily from 7 days prior to transplantation to 28 days after transplantation. Assessment was conducted by the same clinician.
Significantly fewer patients in the palifermin group developed grade 2 (p = 0.038) and grade 4 (p = 0.006) mucositis compared to the placebo group. Grade 4 was seen in 11% of patients in the palifermin group and 59% of patients in the control group. Fewer patients in the palifermin group had any grade mucositis, but not all differences in grades were statistically significant. The duration of grade 3 and 4 OM in patients in the palifermin group was three days compared to eight days in the control group (p < 0.001). The only adverse reactions reported were rashes and altered taste, lasting for 48–72 hours. The cumulative morphine daily dose per body weight was lower in the palifermin group (p = 0.04).
Palifermin was shown to effectively reduce the severity, prevalence, and duration of OM among pediatric patients undergoing HCT and was not associated with any significant adverse effects.
Palifermin was shown to be beneficial to pediatric patients undergoing HCT for primary prophylaxis for OM. OM is one of the most painful and debilitating effects of high-dose myeloablative chemotherapy. Nurses can advocate for the consideration of palifermin in these patients. Additional research in support of these findings is warranted, and research regarding the potential role of palifermin in other types of chemotherapy regimens associated with OM is needed.
Lu, W., Matulonis, U.A., Doherty-Gilman, A., Lee, H., Dean-Clower, E., Rosulek, A., . . . Penson, R.T. (2009). Acupuncture for chemotherapy-induced neutropenia in patients with gynecologic malignancies: A pilot randomized, sham-controlled clinical trial. Journal of Alternative and Complementary Medicine, 15, 745–753.
The purpose of the study is to investigate the use of acupuncture during chemotherapy on white blood cell count, absolute neutrophil count, and endogenous G-CSF level.
Patients were randomly assigned to receive acupuncture or sham acupuncture sessions 2–3 times weekly beginning one week prior to chemotherapy cycle 2 and ending at the beginning of cycle 3 of chemotherapy. A standard acupuncture protocol was administered by five different experienced providers. An electroacupuncture machine was connected to needles and a heat lamp was placed above the feet of the patient. Lab work was obtained at baseline, the nadir of cycle 1 and then every seven days during the study period.
Multiple sites in New England
Active antitumor treatment
Double-blind, randomized, placebo-controlled trial
Five patients withdrew from the trial due to disease progression, side effects of chemotherapy, or time commitment. After patients received six acupuncture sessions, there was a significant different in white blood cell counts between groups in favor of acupuncture (p = 0.04). These differences remained at nadir and the second recovery day. Average absolute neutrophil counts (ANCs) were higher in the acupuncture group at several time points, but this difference was not statistically significant. G-CSF levels in the acupuncture group were about four times higher; however, this difference between groups was not statistically significant.
Acupuncture may be helpful in in patients receiving myelosuppressive chemotherapy in reducing neutropenia and associated problems. More definitive study in this area is needed to better evaluate the clinical efficacy of acupuncture in this area
Study findings suggest some promise for use of acupuncture among strategies for the prevention of infection; however, due to the very small sample size, no firm conclusions can be drawn. Issues seen in this study point to the problem of time and frequent travel for patients involved in cancer treatment to participate in this type of intervention. Further research in the use of acupuncture with larger trials is needed for further evaluation of efficacy.
Lu, Q., Zheng, D., Young, L., Kagawa-Singer, M., & Loh, A. (2012). A pilot study of expressive writing intervention among Chinese-speaking breast cancer survivors. Health Psychology, 31, 548–551.
To test the feasibility, cultural sensitivity, and effect of an expressive writing intervention.
Patients completed baseline assessments by mail and received three envelopes that were to be opened according to labels for study week. They were asked to write about their deepest feelings about having cancer and about the strategies they used for coping. They were to write for 20 minutes each week. After the last writing assignment and three and six months later they completed study questionnaires by mail. Focus group interviews were also conducted.
The study used a quasiexperimental, pre-/post repeated measures design.
At three months, the change in fatigue showed a partial eta2 of 0.066, and eta2 for posttraumatic stress was 0.208. There was 100% compliance in completing writing assignments. Patients commented that the activity was meaningful for Chinese women.
Findings suggested that expressive writing is a feasible and acceptable intervention for Chinese American women.
Expressive writing appeared to be an acceptable intervention for these women. The study design and sample size did not allow for any firm conclusions about effects to be drawn.
Low, C. A., Stanton, A. L., Bower, J. E., & Gyllenhammer, L. (2010). A randomized controlled trial of emotionally expressive writing for women with metastatic breast cancer. Health Psychology, 29, 460–466.
To test the effect of emotionally expressive writing in a randomized, controlled trial of patients with metastatic breast cancer (MBC) and to determine whether the effects of the intervention varied as a function of perceived social support or time since metastatic diagnosis.
The sample was recruited from several sources; all contact occurred via telephone, mail, or email. Patients were randomized to either an emotional or control writing condition and were mailed a packet of sealed envelopes. Trained research assistants telephoned women at the beginning of each of the four writing sessions within a three-week interval to read instructions and called back 20 minutes later to ask the women to stop writing. The women mailed the essays to the research office at the end of each session for analysis. Outcomes were measured three months after the final writing.
The study was a randomized, controlled trial.
No significant differences existed between the two experimental conditions on demographic/medical variables, depression, intrusive thoughts, or sleep disturbances. There were no main effects for the experimental condition to predict intrusive thoughts. Perceived emotional support at study entry interacted with the experimental condition to predict IES-Intrusion (F [1, 56] = 11.61; p = 0.001). For women with a decreased level of emotional support at entry, the effect of the experimental condition was significant (p = 0.002). There was no effect on sleep in newly diagnosed patients but increased sleep disturbances for women who had been diagnosed more than 4.7 years.
Contrary to the hypothesis, expressive writing did not reduce psychological distress or improve physical health as quantified by fewer sleep disturbances and somatic symptoms.
Expressive writing may be helpful for a subset of patients with MBC (those with low levels of social support and recently diagnosed) and contraindicated for others (those living longer with the diagnosis). Further studies should explore alternative writing topics, such as perceived benefits of the cancer experience.
Low, C.A., Stanton, A.L., Bower, J.E., & Gyllenhammer, L. (2010). A randomized controlled trial of emotionally expressive writing for women with metastatic breast cancer. Health Psychology, 29(4), 460–466.
To test the effects of emotionally expressive writing versus disease-related writing on patients with metastatic breast cancer; to determine whether the effects of expressive writing vary as a function of perceived social support or time since diagnosis of metastasis
Investigators used three sources of recruitment: a larger study, flyers, and advertising on a website and Listserv. All contact with patients was via telephone, postal mail, or email. Participants completed baseline assessments, which gathered data about demographics and emotional support. Investigators collected saliva samples. Patients were randomized to either the emotional or control writing condition, and patients received information about the exercises. Patients were scheduled to participate in four 20-minute sessions that occurred at patients' convenience within a three-week interval. A research assistant monitored compliance. After each session, a patient mailed her writing to the research office. At study entry and three months after the final writing session, a by-mail questionnaire measured outcomes according to stated instruments.
Randomized controlled trial
Expressive writing did not produce reduction in psychological distress or improvement in physical health. The intervention may be beneficial for a subset of patients with metastasis and contraindicated for other patients.
Expressive writing may be of benefit to a certain subset of patients. The intervention is cost-effective and an activity that patients with low levels of social support can do. Future study should apply the expressive-writing approach to vulnerable, underserved, and understudied populations and offer broader topics for expressive writing (e.g., benefits of the cancer experience, a topic unrelated to cancer). Investigators should provide writing supplies. Future research should consider privacy protections (possibly from family members), especially in cultures that place great value on the privacy of written material.
Lower, E. E., Fleishman, S., Cooper, A., Zeldis, J., Faleck, H., Yu, Z., & Manning, D. (2009). Efficacy of dexmethylphenidate for the treatment of fatigue after cancer chemotherapy: a randomized clinical trial. Journal of Pain and Symptom Management, 38, 650–662.
To test the hypothesis that d-methylphenidate (d-MPH) would produce a significant reduction in fatigue compared to placebo.
Patients were randomized to receive the study drug or an identical appearing placebo; packaging and labeling were done by a pharmacist not involved in other aspects of the study. Patients received 5 mg of the drug twice daily by mouth. Measures were performed at baseline and at weeks 1 and 8, which was the end of the double-blind treatment phase. Weekly dose modifications were performed at the investigators' discretion based on the magnitude and duration of response assessed weekly by Clinical Global Improvement–Impression (CGI-I) scores. The maximum allowable total daily dosage was 50 mg/day in two to three doses per day.
This was a double-blind, randomized, controlled study.
D-MPH–treated patients had lower ECOG performance status scores than placebo-treated patients (p = 0.03), indicating better performance. The mean highest dose achieved in d-MPH–treated patients was 27.7 mg/day (range 10–70). A significantly greater improvement in FACIT scores from baseline was seen in patients who received d-MPH compared to placebo at week 8 (p = 0.02). In the study group, there was a mean 10.5-point score reduction in the d-MPH group. Reduction in fatigue was seen at an average dose of 27.7 mg/day of the study drug. All patients had reduction in CGI scores, indicating decreased severity of symptoms from baseline to week 8. Improvement in these scores was seen in a significantly greater percentage of those given d-MPH (p = 0.02). The most frequent adverse events were headache, nausea, and dry mouth in the treatment group and headache, diarrhea, and insomnia in the placebo group. There was a higher rate of adverse events in the d-MPH group. Eleven percent of the treatment group experienced serious adverse events that led to study discontinuation. Events that led to discontinuation were nausea, vomiting, feeling jittery, and abnormal electrocardiogram.
D-MPH treatment in an individualized dosing regimen based on therapeutic response and side effects was associated with a significant improvement in fatigue.
Future studies need to be performed that address a broader range of patient types. The effectiveness of d-MPH in combination with other interventions, such as exercise, should be examined.
Lower, E. E., Fleishman, S., Cooper, A., Zeldis, J., Faleck, H., Yu, Z., & Manning, D. (2009). Efficacy of dexmethylphenidate for the treatment of fatigue after cancer chemotherapy: A randomized clinical trial. Journal of Pain and Symptom Management, 38(5), 650–662.
The study's primary aim was to evaluate the potential therapeutic effect and safety of dexmethylphenidate (d-MPH) in the treatment of patients with chemotherapy-related fatigue. Its secondary aim was to examine the impact of d-MPH on cognitive functioning.
Participants were randomized to a placebo group or an intervention group receiving 5 mg of d-MPH twice daily (10 mg/day total).
The study took place across 24 academic and community-based cancer centers.
This was a randomized, double-blind, placebo-controlled, parallel-group study.
Cognitive measures were taken with the
Other measures were taken with the
The primary outcome of focus was fatigue. Participants treated with d-MPH had significant improvement in fatigue symptoms at week 8 on the FACIT-F (p = 0.02) and on the CGI-S (p = 0.02). The d-MPH treatment group had higher drug-related events (63% vs. 28%) and greater discontinuation of medication (11% vs. 1.3%) than the placebo group. Cognitive function was not significantly improved.
d-MPH can be of benefit in the treatment of fatigue. However, results do not support d-MPH-mediated reduction in cognitive impairment in adult patients with cancer after chemotherapy.