Shaw, E.G., Rosdhal, R., D’Agostino, R.B., Lovato, J. Naughton, M.J., Robbins, M.E., & Rapp, S.R. (2006). Phase II study of donepezil in irradiated brain tumor patients: Effect on cognitive function, mood, and quality of life. Journal of Clinical Oncology, 24(9), 1415–1420.
The study was conducted to determine whether donepezil improved cognitive functioning, mood, and quality of life in patients who had irradiated brain tumors.
All participants received 5 mg/day of donepezil for 6 weeks, then 10 mg/day of donepezil for 18 weeks, followed by a washout period of 6 weeks where no treatment was administered.
This was a prospective, open-label, phase II study.
Significant improvement was noted between the pre-treatment baseline and week 24 on measures of attention/concentration, verbal memory, figural memory, and a trend for verbal fluency (all p < 0.05). Confused mood was also improved from baseline to 24 weeks (p = 0.03). Health-related quality of life improved from baseline to 24 weeks in brain-specific concerns (p = 0.003), emotional functioning (p = 0.04), and social functioning (p = 0.02), with a trend for improvement in total health-related quality of life (p = 0.07).
Ten of 21 participants, or 48% of those who completed the study through the 30-week assessment, chose to go back on donepezil. A total of 63 toxicities ranging from grade 1 to grade 3 were reported.
Mood, health-related quality of life, and cognitive functioning (attention/concentration, verbal memory, and figural memory) were significantly improved following a 24-week course of donepezil.
Shaw, J.M., Young, J.M., Butow, P.N., Badgery-Parker, T., Durcinoska, I., Harrison, J.D., . . . Solomon, M.J. (2015). Improving psychosocial outcomes for caregivers of people with poor prognosis gastrointestinal cancers: A randomized controlled trial (Family Connect). Supportive Care in Cancer, 24, 585–595.
To assess the effectiveness of an intervention using structured telephone interventions for the caregivers of patients diagnosed with gastrointestinal cancer that had a poor prognosis to improve psychosocial outcomes of the patient and caregiver
This intervention was a randomized, controlled trial in which caregivers were assigned to either the family connect (FC) telephone intervention or usual care. The FC group received four standardized telephone calls in the 10 weeks after patient hospital discharge. The caregivers’ quality of life, caregiver burden, unmet supportive needs, and distress were assessed at three and six months.
This study was a parallel-randomized trial with a 1:1 group allocation.
Caregiver QOL scores were similar in both groups. The group that was randomized to receive the intervention reported a greater sense of social support and reduced worry about finances, and they also had fewer rehospitalization and emergency department visits.
This intervention did not demonstrate significant improvements in quality of life or sense of well-being for the caregivers. There were some trends observed through data analysis, which warranted the continued development of meaningful, telephone-based, caregiver-focused supportive care interventions.
This study did demonstrate the potential to improve patient and caregiver QOL. Future nursing research should focus on continuing to educate caregivers with strategies to identify and address patient care needs, which can ultimately reduce the overall cost to healthcare systems.
Sharp, L., Cotton, S., Gray, N., Avis, M., Russell, I., Walker, L., . . . TOMBOLA Group. (2011). Long-term psychosocial impact of alternative management policies in women with low-grade abnormal cervical cytology referred for colposcopy: A randomised controlled trial. British Journal of Cancer, 104, 255-264.
To compare the psychosocial outcomes of two different approaches for management of women undergoing colposcopy: immediate large loop excision versus punch biopsies with recall
In a larger study, women had been randomly assigned to cytological surveillance or colposcopy for low-grade abnormal cervical cytology. Women having colposcopy then were randomly assigned to either immediate large loop excision or to a group having punch biopsies and selective recall. Assessments were done at baseline, at six weeks post-procedure, and at 12,18, 24, and 30 months.
PHASE OF CARE: Diagnostic
Randomized controlled trial
There were no differences between groups in prevalence of significant depression at any study time-point. In all patients, the median POMS score fell significantly from recruitment to 12 months (p < .001) and remained stable thereafter. There were no significant differences in average scores at any time-point. In all patients, anxiety fell significantly from baseline to six weeks post-procedure (p < .001) and remained stable thereafter. There were no significant differences between groups at any time point in the study.
There were no differences in symptoms of anxiety and depression based on the type of management examined here for women undergoing colposcopy. In all patients, anxiety and depression declined significantly shortly after the procedure and then remained stable over the next 24 months. However, the prevalence of significant depression (HADS depression subscale ≥ 8 ) increased from 6% precolcoscopy to 9.6% at 30 months.
Findings suggest that the specific approach to management with colposcopy does not significantly impact anxiety and depression in women with low-risk abnormal cervical cytology. The timing of depression increase seen here might suggest that extended follow-up after colposcopy and treatment may be associated with depression for some women. Which of the strategies examined here offers the best balance between benefits and harms is a matter of continuing debate.
Sharplin, G.R., Jones, S.B., Hancock, B., Knott, V.E., Bowden, J.A., & Whitford, H.S. (2010). Mindfulness-based cognitive therapy: An efficacious community-based group intervention for depression and anxiety in a sample of cancer patients. Medical Journal of Australia, 193(5 Suppl.), S79–82.
To assess the impact of an eight-week mindfulness-based cognitive therapy program on individuals experiencing distress as a consequence of cancer
Participants included people with a history of cancer and those the study defined as carers. Participants were people who called the Cancer Council South Australia Helpline. They were assessed for anxiety and depression before and after a course of mindfulness-based cognitive therapy (MBCT). The MBCT program consisted of eight weekly two-hour sessions facilitated by an experienced counselor. The program sessions included these topics: stepping out of automatic pilot; dealing with barriers; mindfulness of one’s breath; staying present; acceptance; holding, allowing, letting be; thoughts are not facts; how to best take care of oneself; and using learned skills to control future mood. An optional three-hour follow-up session occurred six weeks after program completion, to reinforce mindfulness principles.
Prospective, one-group, pre/post-test design
Poor study design and small sample prevent drawing a valid conclustion about the effect of the intervention.
MBCT may be an effective intervention for cancer survivors and carers who are willing to make a time commitment for sessions and homework. Further research is warranted.
Sharpe, M., Walker, J., Holm Hansen, C., Martin, P., Symeonides, S., Gourley, C., . . . Murray, G. (2014). Integrated collaborative care for comorbid major depression in patients with cancer (SMaRT Oncology-2): A multicentre randomised controlled effectiveness trial. Lancet, 384, 1099–1108.
To compare the effectiveness of an integrated treatment program for major depression in patients with cancer with usual care
This study enrolled patients with major depression from three cancer centers. Patients were randomly assigned in a one-to-one ratio to either the standard care for depression or an intervention group. The intervention consisted of a multicomponent treatment program. This collaborative care model was expanded to include integration with the patients' specialist medical care. Potential participants were identified by the depression screening offered to all patients attending the selected National Health Service clinics in Scotland. A database software program randomized participants to the standard care or intervention groups. In the standard care group, the primary care physician and oncologist were informed of the diagnosis of major depression and asked to treat their patient accordingly. In the intervention group, the physicians were informed of the diagnosis and the participant saw a specially trained nurse under the supervision of a psychiatrist. This program was an intensive, collaborative care-based program specifically designed to be integrated with the patient’s cancer treatment.
Randomized, controlled trial comparing a standard treatment and an intervention
From 2008 to 2011, 253 patients were placed into the intervention group and 247 were placed in the standard of care group. Baseline characteristics did not differ between groups. Rates of antidepressant prescriptions at minimum effective doses and dose adjustments were higher in the intervention group. Very few patients from either group received formal psychological treatment from mental health professionals. The primary outcome of treatment response was achieved by 62% of patients in the intervention group compared to 17% of patients in the standard care group. The odds ratio was eight to five (95% confidence interval, p < .0001). The intervention was better than standard care for all secondary and tertiary outcomes. The mean additional cost per patient of providing depression care was in the 95% confidence interval.
A statistically significant number of patients had a clinical response in the intervention group versus the standard of care. This group also had a much greater improvement in anxiety, pain, fatigue, functional ability, quality of life, and perceived quality of care.
Nurses are able to play a major role in screening for depression and are able to provide (with training) interventions to help patients improve the symptoms of depression. Nurses also can provide longitudinal follow-up in assessing the improvement of depression. Attention to and treatment of depression in patients with cancer is effective. Nurses can advocate for sufficient attention to depression screening and management.
Sharp, L., Finnilä, K., Johansson, H., Abrahamsson, M., Hatschek, T., & Bergenmar, M. (2013). No differences between Calendula cream and aqueous cream in the prevention of acute radiation skin reactions – Results from a randomised blinded trial. European Journal of Oncology Nursing, 17, 429–435.
To compare two topical agents (Calendula Weleda® cream and Essex® cream) in reducing the risk of severe acute radiation skin reactions in women receiving adjuvant radiation therapy for breast cancer
Patients randomly were assigned one of two creams (Calendula or Essex) and applied a thin layer twice daily from the beginning of radiotherapy through two weeks after their final radiation treatment or until the skin reaction healed. The cream was not applied within two hours of the radiation treatment. Patients were advised to wash daily with nonperfumed soap and told not to apply other topicals in the radiation field. Patients completed questionnaires related to quality of life (European Organization for Research and Treatment of Cancer [EORTC]-QLQ C30), sleep (MOS), and symptoms (e.g., pain, tenderness, burning, pulling, itching) related to the radiation field on a visual analog scale.
Researchers found no statistically significant difference in severe acute radiation skin reactions in the group using Calendula cream versus the group using Essex cream (a water-based topical emollient, which is the standard of care in that institution.) Severe acute radiation skin reaction (RTOG/EORTC grade less than or equal to 2) was 23% in the Calendula group versus 19% in the Essex group. There were no differences in patient-reported outcomes in terms of pain, burning, itching, pulling, or tenderness at the radiation site. However, there was a statistically significant difference in patient evaluation of application and absorption of the cream in favor of Essex cream.
There was no difference in severe acute radiation skin reactions in women with breast cancer using Calendula cream or Essex cream during radiation therapy.
Patients with breast cancer undergoing curative radiation therapy may experience a less severe acute radiation skin reaction using twice daily application of Calendula cream or an aqueous-based cream. Future studies could include patients with other types of cancer and different treatment fields to compare benefits of these topical emollients.
Sharp, D.M., Walker, M.B., Chaturvedi, A., Upadhyay, S., Hamid, A., Walker, A.A., … Walker, L.G. (2010). A randomised, controlled trial of the psychological effects of reflexology in early breast cancer. European Journal of Cancer, 46, 312–322.
To evaluate the effects of reflexology compared to the effects of massage or usual care on the cancer-related quality of life, relaxation, mood, and adjustment of women with newly diagnosed early breast cancer
Women were randomized to one of three interventions: reflexology plus self-initiated support (SIS), scalp massage plus SIS, or SIS (treatment-as-usual control group). Patients receiving reflexology or massage received eight one-hour sessions at weekly intervals for eight weeks, beginning seven weeks after surgery. Patients were assessed by a nurse who was blinded to treatment allocation. Assessments occurred before randomization (week 6 after surgery), 18 weeks after surgery, and 24 weeks after surgery.
Phase of care: active treatment
Randomized controlled clinical trial
At the two end points, authors noted no significant differences in depression scores. This indicated that neither intervention had any impact on depression or anxiety.
Findings do not support the effectiveness of reflexology as a means of reducing depression or anxiety.
Sharp, D.M., Walker, M.B., Chaturvedi, A., Upadhyay, S., Hamid, A., Walker, A.A., . . . Walker, L.G. (2010). A randomized, controlled trial of the psychological effects of reflexology in early breast cancer. European Journal of Cancer, 46, 312–322.
To evaluate the effects of reflexology in comparison with two comparator interventions (reflexology and massage) on cancer-related quality of life, relaxation, mood, and adjustment in women with newly diagnosed early-stage breast cancer
Women were randomized to one of three interventions:
Patients receiving reflexology or massage received eight one-hour sessions at weekly intervals for eight weeks, beginning seven weeks after surgery. Patients were assessed by a clinical and research specialist nurse (blinded to treatment allocation) before randomization (week 6 post-surgery), 18 weeks after surgery (primary end point 1), and 24 weeks after surgery (secondary end point). Seventy-five percent of women received all eight sessions of reflexology, and 75.4% received all eight sessions of massage.
Patients were undergoing the active treatment phase of care.
A randomized controlled trial design was used.
There were no significant differences between groups on any measure or demographic variable at baseline. At the primary end point (week 18), TOI scores for the three groups differed significantly: massage patients had significantly higher scores on the TOI (indicating a better quality of life) than those receiving SIS. The difference existed only between massage and SIS. There were no differences among groups in self-reported quality of life as measured by FACT. MRS scores at the primary end point showed that massage and reflexology patients were significantly more relaxed than those randomized to SIS, and total MRS scores for reflexology and massage patients were significantly higher than for SIS patients. At this end point, massage patients were significantly more easygoing than either reflexology or SIS patients. Scores on HADS anxiety and depression did not differ significantly between the three groups. At the second end point (week 24), reflexology patients were significantly more relaxed than SIS patients measured by TOL and MRS. Scores on HADS anxiety and depression did not differ significantly between the three groups.
The authors concluded this was a well-controlled and rigorous study with an adequate sample size. Overall, however, there was low psychiatric morbidity in this sample, and despite the high compliance with the interventions (reflexology and massage), there were really no significant differences in the two end points in the depression scores.
Findings do not support effectiveness of reflexology for reduction of depression or anxiety.
Sharma, S., Rajagopal, M.R., Palat, G., Singh, C., Haji, A.G., & Jain, D. (2009). A phase II pilot study to evaluate use of intravenous lidocaine for opioid-refractory pain in cancer patients. Journal of Pain and Symptom Management, 37, 85–93.
To determine the magnitude and duration of pain relief in patients receiving IV lidocaine and placebo infusions, to explore the efficacy and potential uses of IV lidocaine for pain relief in opioid-refractory cancer pain, and to evaluate the safety profile, specifically acute side effects
Patients received infusions of lidocaine and placebo in random order with 14 days between the two infusions. Patients were to record their average daily pain score for 14 days after each infusion.
This was a single-site study conducted in India.
This was a randomized, double-blind, placebo-controlled, crossover study.
Pain was measured using a numeric analog scale (NAS) ranging from 0–10, with 0 being no pain and 10 being worst imaginable pain.
The average duration of pain relief in this study after a single infusion of lidocaine was 9.34 days.
Further studies are indicated to establish guidelines and investigate the safety profile for the use of IV lidocaine.
Sharma, P., Vatsa, M., & Sharma, A. (2015). Effect of oral cooling on bolus 5-FUFA induced mucositis in cancer patients. International Journal of Nursing Education, 7, 249–255.
To evaluate the effect of oral cooling using ice-rolls on chemotherapy-induced mucositis in patients administered bolus 5-FUFA
Randomized, control trial of 53 patients with gastroinstenal tract cancer receiving 5-fluorouracil (5-FU) in an outpatient clinic either daily for three, four, or five days (n = 22) or weekly (n = 31). The intervention group (n = 27) was asked to do oral cooling using ice-rolls in and out of oral cavity for the following schedule (10 minutes before administration, 5 minutes during administration, and 15 minutes after the administration of 5-FU). Patients used oral cooling for a total of 30 minutes (SD = 5 minutes). Assessment of oral cavity was conducted every week for three weeks.
PHASE OF CARE: Active antitumor treatment
Randomized, controlled trial
A significanct decrease in oral mucositis incidence was noted in the experimental group in week 1 (p = 0.001), week 2 (p = 0.014), and week 3 (p = 0.05) compared to the control group. Descriptive statistics showed only mild oral mucositis in the experimental group, whereas moderate and severe oral mucositis was reported in the control group.
Oral cooling was effective in reducing oral mucositis in patients receiving 5-FU.
Oral cooling was 100% accepted as an intervention to reduce the incidence of oral mucositis induced by chemotherapy. Nurses need education on proper assessment tools for oral mucositis. Educational materials should also be given to patients and their families to enhance the proactivity of preventing mucositis induced by chemotherapy.