Dolbeault, S., Cayrou, S., Bredart, A., Viala, A.L., Desclaux, B., Saltel, P., . . . Dickes, P. (2009). The effectiveness of a psycho-educational group after early-stage breast cancer treatment: Results of a randomized French study. Psycho-Oncology, 18, 647–656.
To determine effect of a cognitive behavioral type of intervention on anxiety
The intervention involved eight weeks of group-based cognitive behavioral training that included cognitive restructuring techniques, relaxation, peer exchange, communication, and general medical information.
A randomized controlled trial design was used.
The treatment group showed a greater reduction in anxiety over time compared to the control group (p = 0.001).
Structured psychoeducational group interventions in patients with early-stage breast cancer in remission can have a positive effect on emotional states, especially in reducing anxiety.
The practicality of conducting two-hour group sessions weekly for eight weeks may be questionable. Furthermore, the study was funded and the intervention was provided free of charge—this may not be routinely possible.
Doi, H., Fujiwara, M., Suzuki, H., Niwa, Y., Nakayama, M., Shikata, T., . . . Hirota, S. (2015). Polaprezinc reduces the severity of radiation-induced mucositis in head and neck cancer patients. Molecular and Clinical Oncology, 3, 381–386.
To evaluate the feasibility and efficacy of polaprezinc (PZ) for the prevention of oral mucositis (OM) in patients with head and neck cancer receiving radiation therapy
PZ was prepared as an oral rinse (10 ml) and was administered four times per day while patients underwent radiation therapy. The solution was rinsed in the mouth and spat out. Patients were instructed to withhold all food and drink for 30 minutes after rinsing.
Nonrandomized, prospective study with a comparative analysis to a case-matched cohort that underwent a retrospective review
Overall, 93.8% of patients reported no difficulty with the PZ rinse. Two patients withdrew because of nontolerability. There was no statistic significance between groups for grade 3 mucositis. Some clinical significance in increased ability to take oral nutrition was reported. Quality of life increased, but no measurement of quality of life was provided. There was no difference in survival outcomes.
The use of a PZ oral solution was feasible and may lessen adverse clinical symptoms in regard to OM for patients with head and neck cancer receiving radiation therapy.
PZ oral solution, which is a zinc-containing compound, might be helpful in reducing OM and increasing patients’ ability to take oral nutrition. However, more research needs to be completed.
Dodin, S., Blanchet, C., Marc, I., Ernst, E., Wu, T., Vaillancourt, C., . . . Maunsell, E. (2013). Acupuncture for menopausal hot flushes. The Cochrane Database of Systematic Reviews, 7, CD007410.
STUDY PURPOSE: To determine whether acupuncture is effective and safe for reducing hot flashes and improving the quality of life of menopausal women with vasomotor symptoms
PHASE OF CARE: Multiple phases of care
Studies that compared acupuncture versus sham acupuncture did not provide sufficient evidence to show whether acupuncture is an effective treatment for vasomotor symptoms. A debate exists about whether sham acupuncture is a placebo intervention or possesses an active effect related to peripheral sensory stimulation. Currently, insufficient evidence exists to determine whether acupuncture is effective as a treatment for hot flashes. Data on adverse effects were not included. Further high-quality studies are needed to determine the effect of acupuncture on vasomotor symptoms. An exclusion of the one study with breast cancer survivors comparing acupuncture with sham acupuncture had shown no difference related to hot flush severity.
The evidence was of low or very low quality, and the studies comparing acupuncture versus no treatment or hormone therapy were not controlled with sham acupuncture or placebo hormone therapy. Most had small sample sizes and questionable methodological quality. Many had an inadequate level of blinding and no intention-to-treat analysis.
This review included menopausal women and women with breast cancer. Risk of infection should be considered in immunosuppressed patients. Studies with larger sample sizes of women with breast cancer are needed to determine the effectiveness of acupuncture for treating hot flashes in this group.
Dodd, M.J., Miaskowski, C., Greenspan, D., MacPhail, L., Shih, A., Shiba, G., … Paul, S.M. (2003). Radiation-induced mucositis: A randomized clinical trial of micronized sucralfate versus salt and soda mouthwashes. Cancer Investigation, 21, 21–33.
Patients with head and neck cancer receiving radiation therapy (RT) were instructed to use the PRO_SELF Mouth Aware (PSMA) Program, an oral hygiene protocol, throughout RT. Those who developed RT-induced oral mucositis (OM) were randomized to either 1 gm carafate or normal saline (NS) mouthwash. Patients were instructed to rinse with the mouthwash four times per day. Nurses who were trained in the intervention, PSMA, and oral assessment phoned the patients twice weekly until one month after RT. One month after RT completion, oral assessment was done.
The study reported on 30 adult patients with head and neck cancer receiving RT with or without chemotherapy. The mean age of the sample was 55.2 years.
This was a randomized, double-blind, clinical trial.
The MacDibbs Mouth Assessment was used to measure the severity of OM. Patients also recorded pain when swallowing. Healing, weight loss, tube feeds, breaks in RT, hospital admissions, and Karnofsky Performance Status Scale scores were recorded. The investigators used t-tests and chi-square analysis.
No significant differences were found in the two groups in terms of average worst severity rating (p = 0.85), severe pain (p = 0.54), MacDibbs scores at the end of RT (p = 0.61), average pain at the end of RT (p = 0.51), MacDibbs scores at the follow-up visit (p = 0.24), pain at the follow-up visit (p = 0.41), or days to heal (p = 0.19).
No significant differences were found for any of the other variables as well (e.g., weight loss, tube feeds, breaks in RT).
Dodd, M.J., Dibble, S.L., Miaskowski, C., MacPhail, L., Greenspan, D., Paul, S.M., et al. (2000). Randomized clinical trial of the effectiveness of 3 commonly used mouthwashes to treat chemotherapy-induced mucositis. Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology, and Endodontics, 90(1), 39–47.
Test the effectiveness of three mouthwashes used to treat chemo-induced OM. Compared: salt/soda, (1 t each/pint of water) chlorhexidine and magic mouthwash (lidocaine, benadryl Maalox).
Also used the Pro-Self program for all patients. Nurses presented the Pro-Self Mouth Aware program to patients and provided them with mouthwash. This program incorporates good oral hygiene, new toothbrush, daily flossing, regular oral assessments, and instruction of oral conditions that the patient must bring attention to the nurse.
Oral assessment and oral protocol 4x/day. Swished MW for 20 sec and then discard. The MW bottles were collected after their sx subsided or after 12 days supply. Measured amount remaining in bottles.
The mean age was 59.05 years.
Chemo- not RT to head and neck or leukemia
23 outpatient/office settings, 202 patients (142 final pts)
Randomized, double-blind trial to 1 of 3 mouthwashes.
Forty-seven patients dropped out, 11 took > 12 days to report a cessation of s/s.
No significance in three groups of demographics, disease-related variables. No significant difference in the time to reported cessation of the signs and symptoms from chemo-induced mucositis among the three groups (p = 0.59).
The average pain scores did not differ significantly (p = 0.79).
Patient reports, no clinician assessment during mucositis
Limitation of OAG tool – this guide addresses information of oral cavity changes and not strictly mucositis
Structure of oral care program may have been the greatest effect on mucositis.
Findings support use of NS/baking soda over chlorhexidine and magic mouthwash – especially with established oral care program.
Dodd, M.J., Dibble, S.L., Miaskowski, C., MacPhail, L., Greenspan, D., Paul, S.M., . . . Larson, P. (2000). Randomized clinical trial of the effectiveness of 3 commonly used mouthwashes to treat chemotherapy-induced mucositis. Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology, and Endodonology, 90, 39–47.
To determine the efficacy of three different mouthwashes in the treatment of chemotherapy-related mucositis
All patients received the PRO-SELF Mouth Aware (PSMA) educational program from a nurse who was blinded to the intervention treatment. The program included didactic information, the development of self-care strategies, and nurse support in the treatment setting. Good oral hygiene was an emphasis of the program, and patients were provided with specific oral hygiene practices to follow during chemotherapy. Nurses contacted the patients via telephone every other day. Patients were randomly assigned to receive one of three possible intervention treatments that were given to the patient in 1-pint opaque plastic bottles. The interventions were either salt and soda, chlorhexidine, or magic mouthwash. Nurses received training in the PSMA program every six months. Patients used the mouthwash four times per day until symptoms resolved or for 12 days. Patients swished 20 mL of their intervention mouthwash for 20 seconds and spit. Mouthwash bottles were collected when symptoms resolved or on day 12, whichever came first, and remaining medication was measured to gauge patient compliance. Oral assessments began upon enrollment, and the first assessment was conducted by a physician or nurse. Patient-directed oral assessments continued thereafter, four times per day, or until mucositis resolved or for 12 days, whichever came first.
Randomized, double-blinded clinical trial
There were no differences between any of the groups in the time to cessation of mucositis symptoms (F2,141 = .52, p = .59). The mean number of days to cessation of symptoms was 6.59 days in the chlorhexidine group, 7 days in the salt and soda group, and 7.17 days in the magic mouthwash group.
Although clinicians regularly use chlorhexidine mouthwash, this study demonstrates that there is no difference between treatments of salt and soda rinses and magic mouthwash as part of a treatment protocol for chemotherapy-induced oral mucositis. Participants in the magic mouthwash group reported the highest mean number of days to cessation of symptoms, indicating this is the least effective treatment of the three.
Educating patients about proper oral hygiene while receiving chemotherapy is important. Nurses should be aware, however, that there is no difference between chlorhexidine mouthwash, salt and soda rinses, and magic mouthwash, the three mouthwashes traditionally used in the clinical setting. As the least effective of the mouthwashes in terms of mean days to cessation of symptoms, magic mouthwash does not appear to be an effective intervention in the treatment of chemotherapy-induced oral mucositis.
Dodd, M. J., Cho, M. H., Miaskowski, C., Painter, P. L., Paul, S. M., Cooper, B. A., . . . Bank, K. A. (2010). A randomized controlled trial of home-based exercise for cancer-related fatigue in women during and after chemotherapy with or without radiation therapy. Cancer Nursing, 33, 245–257.
The primary aim was to evaluate the effectiveness of a home-based exercise training intervention called the Pro-self: Fatigue Control Program on the management of cancer-related fatigue (CRF). The secondary aim was to study the effects of the intervention on sleep disturbance, depression, and pain.
Patients were randomized to one of three groups. Two groups received a home-based prescription for exercise called the Pro-self: Fatigue Control Program (during and after cancer treatment). One of these groups had follow-up. The third group received usual care. All patients completed four valid and reliable tools at baseline, the week before the second chemotherapy treatment, at the end of cancer treatment, and at the end of the study (about one year after the start of the study). The tools measured fatigue, sleep disturbance, depression, and pain and were analyzed to compare how fatigue and other study variables had changed over time and by groups. It was a randomized, single-blind, three-arm, controlled trial design.
The study was a randomized, controlled trial (RCT).
Change in fatigue did not change over time. No significant change in fatigue occurred among groups.
The home-based exercise intervention had no effect on fatigue or related symptoms associated with cancer treatment. The optimal timing of exercise remains to be determined.
When the study was conducted, the benefits of exercise were being reported in the literature and patients could not be asked to stop their regular exercise. The PFS was administered only three times a year, which might not be frequent enough to capture the true effect of exercise on CRF. The self-report of exercise behaviors was obtained with no objective measures.
CRF is a common problem. Some physical activity is better than none, and there is no harm in exercise as tolerated during cancer treatment. More frequent assessments of fatigue, sleep disturbance, depression, and pain may capture the effect of exercise.
Dockham, B., Schafenacker, A., Yoon, H., Ronis, D.L., Kershaw, T., Titler, M., & Northouse, L. (2015). Implementation of a psychoeducational program for cancer survivors and family caregivers at a Cancer Support Community affiliate: A pilot effectiveness study. Cancer Nursing. Advance online publication.
To examine the effectiveness and feasibility of the Family involvement, Optimistic attitude, Coping effectiveness, Uncertainty reduction and Symptom management (FOCUS) program on the quality of life (QOL), benefits of illness and caregiving, communication, and support of cancer survivors and their caregivers in a cancer support community (CSC) site using a small group format
Researchers modified the FOCUS program (a nurse-delivered, home-based intervention for patient/caregiver dyads) for use and administration by social workers at a CSC site to cancer survivors and their caregivers. The program was administered in six sessions over six weeks to three to four dyads in a small-group format.
Pre- and postintervention study with no control group
The intervention effect was assessed by dyadic scores (survivors and caregivers were treated as a unit). Dyadic QOL (physical, emotional, and functional) was significantly improved from preintervention to postintervention, but there was no improvement in social QOL. Dyadic perception of illness and self-efficacy also were significantly improved, but dyadic communication and support were not. The dyadic main effect size ranged from small to moderate for different outcomes. Effect sizes were larger for survivors than for caregivers. For feasibility, the enrollment rate was 60%, retention was 92%, and the intervention fidelity was 94%. Caregivers and survivors were highly satisfied with the intervention.
The modified FOCUS program was feasible and effective when administered to small groups of survivor/caregiver dyads. However, the assessment of improvement in outcomes considering the dyad a unit may lead to confusion in interpreting the outcomes of specific participants (survivors versus caregivers).
Tailored interventions to assist caregivers are effective. Collaborations with community settings that allow for the administration of evidence-based programs assisting caregivers may make such interventions more feasible and available to larger numbers of patients and caregivers. Careful attention to intervention fidelity is essential when programs are translated on a larger scale.
Dobrila-Dintinjana, R., Trivanovic, D., Zelic, M., Radic, M., Dintinjana, M., Petranovic, D., . . . Matijasic, N. (2013). Nutritional support in patients with colorectal cancer during chemotherapy: Does it work? Hepato-Gastroenterology, 60, 475–480.
To determine if dietary counseling, oral nutrition, and megestrol acetate affect nutritional status and survival in patients with advanced cancer
Consecutive patients were given nutritional counseling, 400 mg per day megestrol, oral supplements of 600 kcal per day, and a product containing eicosapentaenoic acid with an additional 600 kcal. Prospective patients were then compared to historical controls when nutritional supplements were not available in the country. Patients were followed for up to 24 weeks.
Prospective and observational with a historical control comparison
This study reports a higher prevalence of diarrhea and water retention in patients receiving nutritional intervention. It reports a lower prevalence of loss of appetite at 12 weeks in those given the intervention compared to historical controls (p = .0046) and improvement of appetite by 12 weeks in the intervention group (p = .0046). Survival curve analysis showed improved survival among those who received the intervention (p = .022)
Oral dietary supplements and nutritional counseling may benefit patients with advanced colorectal cancer.
Dietary counseling and provision of oral nutritional supplements may be of benefit to patients.
Doan, T.N., Kirkpatrick, C.M., Walker, P., Slavin, M.A., Ananda-Rajah, M.R., Morrissey, C.O., . . . Kong, D.C. (2016). Primary antifungal prophylaxis in adult patients with acute lymphoblastic leukaemia: A multicentre audit. The Journal of Antimicrobial Chemotherapy, 71, 497–505.
To investigate practices for antifungal prophylaxis and incidence of invasive fungal disease (IFD)
A retrospective chart review was conducted to collect data on patients from beginning of induction to completion of consolidation regarding the use of antifungal prophylaxis and IFD outcomes. Cost analysis was included.
PHASE OF CARE: Active antitumor treatment
Retrospective
European Organization for Research and Treatment of Cancer (EORTC) criteria for proven, possible, or probable IFD
Ninety-eight percent had neutropenia ranging from 18–45 days in duration. Prophylactic antifungal agents were given to 85% of patients. The only significant difference between those who developed IFD and those who did not was the use of antifungal prophylaxis. Those receiving prophylaxis had a lower incidence of proven or probable IFD (2.6%) than others (21.4%) (p = 0.024). IFD incidence was highest in patients receiving BFM95 treatment (hyper-CVAD: hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone). Cost of care for those with IFD was significantly higher from hospitalization, diagnostic testing, and antifungal treatment costs (p < 0.001).
The use of antifungal prophylaxis was associated with a lower incidence of IFD and associated healthcare costs.
Antifungal prophylaxis in at-risk patients was shown to be effective in reducing the incidence of IFD and associated healthcare costs.