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Mak, S.S., Molassiotis, A., Wan, W.-M., Lee, I.Y.M., & Chan, E.S.J. (2000). The effects of hydrocolloid dressing and gentian violet on radiation-induced moist desquamation wound healing. Cancer Nursing, 23, 220–229.

Study Purpose

To examine effectiveness of hydrocolloid dressing in the management of moist desquamation after radiation therapy is complete

Intervention Characteristics/Basic Study Process

Patients with moist desquamation were randomly assigned to one of two arms: hydrocolloid dressing (experimental group) or gentian violet (GV) (control group). Chemotherapy was used in stratifying patients for subgroup analysis.

Sample Characteristics

  • The study sample (N = 39) was comprised of male (n = 22) and female (n = 17) patients with neck, chest, axilla, or perineal area cancer.
  • Mean age was 52.06 years for the hydrogel group (SD = 11.56 years) and 51.07 years for the GV group (SD = 10.41 years).
  • Of patients in the sample, 30% also received chemotherapy.

Setting

The study took place at a hospital authority of Hong Kong.

Study Design

The study used a randomized controlled trial design.

Measurement Instruments/Methods

  • Sites were documented initially and monitored using a tracing method for moist desquamation wounds.
  • Healing time was indicated in days before skin integrity returned (re-epithelialization with absence of moist desquamation and burning).
  • The wound area was traced on alternating days.
  • Incidence of infection assessed erythema and edema, increased drainage, change in drainage, increase tenderness, fever, or leukocytosis.
  • Pain was evaluated using a frequency scale of 1–3 intensity with Wong Baker faces.

Results

  • Chemotherapy showed worse effect on wound healing that was statistically significant (f = 4.4, p < 0.01)
  • Wound size in assessments was smaller in the GV arm and trend of healing seen from second visit onward.
  • Pain level was higher in hydrocolloid group.
  • There was no statistically significant difference in wound healing time between groups.
  • Wound size decreased quicker in the GV group.
  • Patients had a higher satisfaction with hydrocolloid dressing for appearance and comfort.

 

Conclusions

GV was more effective in healing of moist desquamation but hydrocolloid was more comforting and pleasing.

Limitations

  • The study had a small sample size, with less than 50 participants.
  • The experimental group had a larger percentage with use of chemotherapy in addition to radiation, and some patients with comorbid conditions that could have affected healing
  • Assessment of the GV group relied on self-report.
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Majithia, N., Smith, T.J., Coyne, P.J., Abdi, S., Pachman, D.R., Lachance, D., . . . O’Neill, C. (2016). Scrambler therapy for the management of chronic pain. Supportive Care in Cancer, 24, 2807–2814.

Purpose

STUDY PURPOSE: To evaluate what is known about mechanisms of scramble therapy and investigate preliminary evidence regarding efficacy

TYPE OF STUDY: General review/semi-systematic review

Search Strategy

DATABASES USED: PubMed, SCOPUS, EMBASE, Google Scholar
 
INCLUSION CRITERIA: Studies and reports involving scrambler therapy or Calmare
 
EXCLUSION CRITERIA: Not specified

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 20
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Three studies were randomized, controlled trials, one of which was open-label

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 20
  • TOTAL PATIENTS INCLUDED IN REVIEW = 1,200
  • SAMPLE RANGE ACROSS STUDIES: 3–226 patients
  • KEY SAMPLE CHARACTERISTICS: Four reports involved patients with chemotherapy-induced peripheral neuropathy; seven studies included patients with cancer

Phase of Care and Clinical Applications

PHASE OF CARE: Not specified or not applicable

Results

Most reports showed positive results for pain reduction for various pain syndromes. One double-blind, randomized trial showed no difference between controls and those receiving scrambler therapy for chemotherapy-related peripheral neuropathy.

Conclusions

Scramble therapy may have benefit for management of chronic pain and symptoms of peripheral neuropathy; however, current evidence is limited and weak.

Limitations

  • Limited number of studies included
  • No quality evaluation
  • Mostly low quality/high risk of bias studies
  • Low sample sizes

Nursing Implications

Scrambler therapy, a neuromodulator approach to pain relief, may have some benefit in the management of chronic pain and peripheral neuropathy; however, current evidence is limited, and study designs have high risk of bias. Given the promising findings with scrambler therapy, additional well-designed research is warranted.

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Maiya, G., Sagar, M., & Fernandes, D. (2006). Effect of low level helium-neon (He-Ne) laser therapy in the prevention and treatment of radiation induced mucositis in head and neck cancer patients. Indian Journal of Medical Research, 124(4), 399–402.
 

Intervention Characteristics/Basic Study Process

He-Ne wavelength 632.8 nm and output of 10 mW was administered for three minutes five days a week until completion of radiation.
Control group received  oral analgesics, anesthetics, 0.9% saline, and ovidine wash.

Physician was blinded to the type of treatment.
 

Sample Characteristics

Patients with cancer of the oral cavity stages 2–4 receiving radiation 66 Gy in 33 fractions over six weeks

Computer randomization; 25 patients receiving laser treatment, 25 patients in the control group
 
Mean age of study group was 54 years (+/– 1 year); mean age of the control group was 53 years (+/–1 year).
 
Ratio of men to women was 2:1.
 

Measurement Instruments/Methods

WHO mucosiis

VAS for pain

Recorded weekly
 

Results

At the end of week 6 of RT, pain rank in the study group significantly decreased (p < 0.001) as compared to the control group (13 versus 38).

Mean pain score in the study group was 2.6 (+/– 0.64); the control group score was 6.68 (+/– 1.44) (p < 0.001).

At the end of radiation,  mucositis grade in the study group was 1.72 (+/–  0.67); the grade was 3.32 (+/–0.09) in the control group  (p < 0.001).

18 patients in the study group had grade 1, and 7 had grade 2 mucositis;
14 patients in the control group had grade 3, and 11 had grade 4.
 

Limitations

Small sample size, but findings were significant at the end of radiation.

Did not report data during treatment
 

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Maiti, P.K., Ray, A., Mitra, T.N., Jana, U., Bhattacharya, J., & Ganguly, S. (2012). The effect of honey on mucositis induced by chemoradiation in head and neck cancer. Journal of the Indian Medical Association, 110, 453–456.

Study Purpose

To evaluate the use of natural honey for treatment of radiation mucositis

Intervention Characteristics/Basic Study Process

Patients were randomly assigned to the honey treatment or control group. Patients in the intervention group were instructed to take 20 ml of honey 15 minutes before radiation therapy, 15 minutes after radiation therapy, and at bedtime. On days when they had no radiation treatment, they were to take the same amount of honey 3 times per day. Patients were evaluated at baseline, weekly during treatment, and at 3 and 6 weeks after completion of radiation therapy.

Sample Characteristics

  • The study reported on 55 patients with head and neck cancer.
  • The mean age of patients was 47.5 years with a range of 35–65 years.
  • The sample was 78% male and 22% female.

Setting

The study was conducted at a single outpatient site in India.

Phase of Care and Clinical Applications

Patients were undergoing the active antitumor treatment phase of care.

Study Design

This was a randomized controlled trial.

Measurement Instruments/Methods

  • The World Health Organization (WHO) mucositis scale was used.
  • Body weight was recorded.

Results

The authors reported that honey delayed the onset of severe mucositis in about 80% of the intervention group, while 63% of the control group developed severe mucositis.  Grade 3 mucositis developed in 11 patients in the control group and 5 patients in the study group. No statistical analysis was done.

Conclusions

This study suggests that honey may help to delay the onset of mucositis in patients with head and neck cancer during radiation therapy; however, multiple limitations in this report make it impossible to draw firm conclusions.

Limitations

  • The sample size was small with fewer than 100 patients.
  • A risk of bias exists because of the lack of blinding and an appropriate attentional control condition.
  • Although the authors reported that patients were receiving chemotherapy and radiation therapy, no information was provided regarding the chemotherapy agents used, any treatment delays, or radiation dose at which mucositis developed. 
  • No statistical analysis was done.

Nursing Implications

 Findings as reported from this study are inconclusive regarding any effect of honey on the development of mucositis.

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Maione, L., Vinci, V., Caviggioli, F., Klinger, F., Banzatti, B., Catania, B., . . . Klinger, M. (2014). Autologous fat graft in postmastectomy pain syndrome following breast conservative surgery and radiotherapy. Aesthetic Plastic Surgery, 38, 528–532. 

Study Purpose

To evaluate the effectiveness of autologous fat grafting to control pain in patients with persistent postmastectomy pain syndrome (PMPS)

Intervention Characteristics/Basic Study Process

Patients who received lumpectomies and radiation therapy and had severe scar retraction, radiodystrophy, and chronic pain met the definition of PMPS and were considered for the study. Patients who had fat grafting underwent liposuction of the subumbilical area, and the obtained fat was processed and purified. The fat was then injected into the scar area. Study data were obtained at baseline and at one year after the procedure. Patients who had the fat graft procedure were compared to patients who did not receive the procedure.

Sample Characteristics

  • N = 92  
  • MEAN AGE = 52.5 years (range = 33–68 years)
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Patients with breast cancer and PMPS; none had chemotherapy, local recurrence, or previous breast surgery other than the initial lumpectomy

Setting

  • SITE: Single site  
  • SETTING TYPE: Outpatient    
  • LOCATION: Italy

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

Prospective trial

Measurement Instruments/Methods

  • Visual Analog Scale (VAS) for pain

Results

Among those who had the fat graft procedure, there was a mean reduction of 3.1 points for pain compared to a mean reduction of 0.9 points in the comparison group (p ≤ 0.005).

Conclusions

Autologous fat grafting may have reduced PMPS.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Measurement/methods not well described
  • Other limitations/explanation: It was not clear if the VAS measurement was of worst pain, average pain, etc., or over what time period it was considered.

Nursing Implications

Persistent pain as a consequence of surgical treatment for breast cancer is a clinical problem for which the general treatment is pain medication. Nurses need to be aware of this syndrome and educate patients about alternative approaches that may be available for management. Additional well-designed research regarding the efficacy of fat grafting for this population is needed.

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Maiche, A.G., Grohn, P., & Maki-Hokkonen, H. (1991). Effect of chamomile cream and almond ointment on acute radiation skin reaction. Acta Oncologica (Stockholm, Sweden), 30(3), 395–396.

Study Purpose

To evaluate the tolerability and activity of Kamillosan (chamomile cream) as compared to almond ointment in patients receiving radiation therapy

Intervention Characteristics/Basic Study Process

Patients were assigned to use one product above and the other product below their scar. The physician who evaluated the skin was blinded to which product was used on which side of the scar. The skin product was applied twice a day with the first 30 minutes before external beam radiation therapy and again at bed time. Reactions were noted after every 10 Gy and at two weeks and three months following completion.
 

Sample Characteristics

  • The study sample (N = 48) was comprised of female patients with breast cancer.
  • Mean age of the sample was 56 years, with a range of 30–79 years.
  • Patients received 2 Gy per fraction five times per week to 50 Gy (no break).

 

Setting

The study took place at Helsinki University Central Hospital in Helsinki, Finland.

Study Design

The study used a quasi-experimental single-blinded design. Patients were used as their own controls

Measurement Instruments/Methods

Adverse skin effects were graded on a four-point rating scale, with 0 being no change, 1 light erythema, 2 dark erythema, and 3 moist desquamation. Subjective evaluation was also performed, including symptoms such as pain and itching.
 

Results

Skin changes seemed to appear later in the Kamillosan group; however, a higher proportion of the Kamillosan group developed grade 3 reactions. Overall, differences between groups were not significant. The subjective symptoms, such as itching and pain, were equally uncommon in the two groups. Most patients preferred Kamillosan because of convenience and hygienic preference.
 

Conclusions

Neither of the two agents prevented a skin reaction and every patient developed grade 1 erythema.

Limitations

  • Patients were able to decide which product went above or below the incision, leaving room for error.
  • The skin grading scale is not one commonly used, and reliability or sensitivity is unknown.
  • The sample size was small, with less than 50 patients.
  • Since both products were used on all patients, there was no complete control and the effectiveness of either product could not be determined.
     
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Maiche, A., Isokangas, O.P., & Gröhn, P. (1994). Skin protection by sucralfate cream during electron beam therapy. Acta Oncologica, 33, 201–203.

 

Study Purpose

To compare the efficacy of sucralfate cream to a control base cream in women receiving postoperative electron beam therapy to their chest wall

Intervention Characteristics/Basic Study Process

Patients were randomized to apply sucralfate containing 7% micronized sucrose sulfate or equivalent base cream on either side of the scar.

Sample Characteristics

N = 44

AGE RANGE = 33–84 years

MEAN AGE = 60 years

FEMALES: 100%

KEY DISEASE CHARACTERISTICS: Breast cancer of the chest wall

OTHER KEY SAMPLE CHARACTERISTICS: 6 MeV electron beam total dose 50 Gy—10 Gy weekly in five fractions. Surface area varied from 11 cm × 11cm–20 cm × 20 cm. The scar was situated horizontally in the middle of the portal image.

Setting

  • SITE: Single
  • LOCATION: Helsinki, Finland

Study Design

  • Quasi-experimental, double-blind design
    • Patients used as own controls

Measurement Instruments/Methods

  • Adverse effects were graded on a five-point rating scale (0 = no reaction; 1 = light erythema; 2 = dark erythema, area painful; 3 = wet desquamation; 4 = necrosis of the skin).
  • Patients were interviewed for their preference of cream.

Results

Grade 1 and 2 reactions appeared later on the areas treated with sucralfate cream. Grade 2 reactions in the entire sample were observed more often at four weeks (p = 0.01) and at five weeks (p > 0.01 but < 0.05). Recovery time of radiation-induced reactions was faster and, after finishing radiation therapy, the grade of skin reaction remained lower with the sucralfate cream than the base cream (p = 0.05).

 

Conclusions

Sucralfate may be of benefit in reducing severity of radiation dermatitis.

Limitations

  • No information is provided regarding patient compliance.
  • What the total dose was when checked weekly is unclear.
  • Where the rating scale came from is unclear.
  • Small sample size
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Mahigir, F., Khanehkeshi, A., & Karimi, A. (2012). Psychological treatment for pain among cancer patients by rational-emotive behavior therapy—efficacy in both India and Iran. Asian Pacific Journal of Cancer Prevention, 13, 4561–4565.

Study Purpose

To find out the influence of rational emotive behavior therapy (REBT) on pain intensity among patients with cancer in India and Iran

Intervention Characteristics/Basic Study Process

The intervention included eight two-hour sessions of REBT characterized as cognitive techniques, imagery techniques, and behavioral techniques. The intervention was given to the experimental group for 45 days (10 sessions), and at the end of the intervention, pain of patients was evaluated again. Empathy, warmth, respect, relationship building, and family dynamics were covered in the first session; personal experience assessment was covered in the second session; counseling and REBT approach were covered in the third session; REBT was covered in the fourth through seventh sessions; and coping with stress was covered in the final session. Workbooks, worksheets, and practice exercises were included in the program. What the intervention actually entailed is not clear.

Sample Characteristics

  • N = 88
  • AGE = 21–52 years
  • MALES, FEMALES: Not described
  • KEY DISEASE CHARACTERISTICS: Patients with cancer (no information about disease site or stage)
  • OTHER KEY SAMPLE CHARACTERISTICS: None described

Setting

  • SITE: Multi-site
  • SETTING TYPE: Hospital
  • LOCATION: India and Iran

Phase of Care and Clinical Applications

  • PHASE OF CARE: Multiple phases of care

Study Design

  • RCT

Measurement Instruments/Methods

  • McGill Pain Questionnaire

Results

Because of errors in the tables, interpreting the findings is difficult. Data in the table are transposed from the information included in the narrative text; this makes interpretation of the information uncertain. The overall reliability of the data is in question.

Conclusions

The authors have asserted that an intervention resulted in reduction in pain perception, as measured by the McGill Pain Questionnaire, in an experimental group receiving REBT when compared with a control group. However, discrepancies in the article make interpretation difficult.

Limitations

  • Small sample (less than 100)
  • Measurement validity/reliability questionable
  • Other limitations/explanation: Rigor of scientific reporting is questionable.

Nursing Implications

Nurses are well aware that psychoeducational interventions can affect pain control. This study aims to support that contention. This study does not provide additional strong support in this area because of multiple study limitations.

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Maher, J., Refshauge, K., Ward, L., Paterson, R., & Kilbreath, S. (2012). Change in extracellular fluid and arm volumes as a consequence of a single session of lymphatic massage followed by rest with or without compression. Supportive Care in Cancer, 20, 3079–3086.

Study Purpose

To evaluate the effects of massage and compression in women with and without arm lymphedema secondary to breast cancer  

Intervention Characteristics/Basic Study Process

Women with clinically diagnosed lymphedema secondary to breast cancer and a convenience sample of women without breast cancer or lymphedema were recruited. Women who wore a compression garment removed it two hours before measurement and massage.  Measurements were taken prior to, mid way through, and at the completion of massage. Women received a therapeutic massage for one hour using the Foldi method of lymphatic drainage provided by a single trained therapist.

Sample Characteristics

  • The study reported on 30 female patients.
  • The mean age of patients in the breast cancer group was 60 years. The mean age of patients in the nonbreast cancer group was 46 years.
  • All patients with breast cancer were at least three months post-completion of any treatment. All of these patients had an interarm volume difference of at least 200 ml by perometry or bioimpedance interarm ratio greater than the standard cutoff for lymphedema.

Setting

This was a single-site study conducted in the outpatient setting in Australia.

Study Design

The study used a pre/post design.

Measurement Instruments/Methods

Perometry and bioimpedance techniques were used.

Results

No statistically or clinically significant effect was found between the use of massage and limb volume with either study group.

Conclusions

A single session of lymphatic massage did not reduce lymphedema.

Limitations

The sample size was small, with fewer than 30 participants.

Nursing Implications

 Findings suggest that a single session of lymphatic massage does not have any effect on arm volume in women with or without lymphedema.

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Mahendran, R., Lim, H.A., Tan, J.Y.S., Hui, Y.N., Chua, J., Siew, E.L., . . . Kua, E.H. (2017). Evaluation of a brief pilot psychoeducational support group intervention for family caregivers of cancer patients: A quasi-experimental mixed-methods study. Health and Quality of Life Outcomes, 15, 1–8. 

Study Purpose

To evaluate the effects of a psychoeducational program (COPE) on caregivers of patients with cancer

Intervention Characteristics/Basic Study Process

The COPE (Caregivers of Cancer Outpatients' Psycho-Education Support Group Therapy) intervention was provided to caregivers during four weeks. The program included didactic content and supportive interventions in group sessions. Study measures were obtained before and after the intervention. A subgroup was invited to participate in semistructured interviews. Caregivers were placed in one of two groups, one of which was wait-listed and used as a control in the analysis.

Sample Characteristics

  • N = 97   
  • AGE = 21 years and older
  • MALES: 35.1%, FEMALES: 64.9%
  • CURRENT TREATMENT: Chemotherapy, radiation 
  • KEY DISEASE CHARACTERISTICS: Patients had varied tumor types, and most had advanced disease.
  • OTHER KEY SAMPLE CHARACTERISTICS: The majority had provided caregiving for 0–6 months.

Setting

  • SITE: Single site   
  • SETTING TYPE: Outpatient    
  • LOCATION: Singapore

Phase of Care and Clinical Applications

PHASE OF CARE: Multiple phases of care

Study Design

Nonrandomized, prospective, parallel group

Measurement Instruments/Methods

  • Caregiver Quality of Life scale
  • Hospital Anxiety and Depression Scale (HADS)

Results

No significant differences existed between study groups in postintervention caregiver quality of life overall or burden subscale scores. Those in the wait-list control group had much better quality of life scores at baseline.

Conclusions

The intervention studied here did not demonstrate an effect on caregiver burden or quality of life.

Limitations

  • Small sample (< 100)
  • Baseline sample/group differences of import
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment) 
  • Risk of bias (no appropriate attentional control condition)
  • Risk of bias (sample characteristics)
  • Key sample group differences that could influence results
  • Substantial differences between study groups existed at baseline for quality of life and burden.

Nursing Implications

The specific psychoeducational program examined here did not demonstrate an effect on caregivers. Several limitations existed.

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