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Ling, C.C., Lui, L.Y., & So, W.K. (2012). Do educational interventions improve cancer patients' quality of life and reduce pain intensity? Quantitative systematic review. Journal of Advanced Nursing, 68(3), 511–520.

Purpose

To complete a systematic review to evaluate the effect of patient education on the pain intensity, pain interference, and quality of life of patients with cancer 

Search Strategy

  • Databases searched were MEDLINE, CINAHL, PubMed, EMBASE, PsycINFO, and Database of Abstracts of Reviews of Effects (DARE).
  • Search keywords were cancer, malignancy, neoplasm, tumor, nursing, pain, pain management, educational intervention, coaching, training, barriers, mood, well-being, wellness, anxiety, functional ability, patient teaching, patient education, quality of life, and systematic review.
  • Studies were included if they
    • Were randomized controlled trials of pain education for cancer patients
    • Were published in English
    • Involved adults with cancer-related pain and educational intervention in the form of information, instructions, or advice via written or auditory means by a healthcare provider to a patient with cancer
    • Included quality-of-life measures based on functional status, perceived pain control, well-being, anxiety, satisfaction with pain treatment, pain interference, physical functioning, and pain intensity and interference
  • Studies were excluded if they involved only caregivers or family members or if they used measures of quality of life or pain as the only outcome measures.
     

Literature Evaluated

The search retrieved 68 references. Authors considered 23 references. Authors evaluated studies on the basis of methodological quality assessment; two independent reviewers assessed all studies by using the Jadad scoring system. In the event of a discrepancy, a third reviewer evaluated the study. Data were obtained by means of the PICO (participants, interventions, comparison, and outcomes) approach. The study employed six different instruments to measure quality of life across four studies; two instruments were used to evaluate pain (three studies used the Brief Pain Inventory).

 

Sample Characteristics

  • The final number of studies analyzed was four.
  • The sample size, across studies, was 647 patients. The sample range was 97–189 patients.
  • Patients were American or Australian, 55–62 years old, and recruited from outpatient clinics. The sample included various types of pain and cancer diagnoses.

Phase of Care and Clinical Applications

Clinical applications: late effects and survivorship, palliative care

Results

Pain scores decreased as a result of the educational interventions in each study, but effects of education on quality of life were not statistically significant.

Conclusions

A limited number of studies evaluating effects of education on cancer pain and quality of life are available. Based on available studies, education about pain has little effect on quality of life in the specified patient population.

Limitations

  • The studies used different tools to evaluate quality of life
  • Whether authors assessed methodological quality is unclear.
Print

Ling, W., Lui, L.Y.Y., So, W.K.W., & Chan, K. (2014). Effects of acupuncture and acupressure on cancer-related fatigue: A systematic review. Oncology Nursing Forum, 41, 581–592. 

Purpose

STUDY PURPOSE: To critically examine the evidence for acupuncture and acupressure in the management of cancer-related fatigue (CRF) in adult patients with cancer
 
TYPE OF STUDY: Systematic review

Search Strategy

DATABASES USED: AMED, British Nursing Index, CINAHL, Evidence-Based Medicine Reviews, Embase, Journals@Ovid, MEDLINE, Physiotherapy Evidence Database, ProQuest, PubMed, ScienceDirect, SpringerLink, TRIP, Wiley Online Library, China Academic Journals Full-Text Database, and Wanfang Data China Online Journals
 
KEYWORDS: Fatigue, cancer, acupuncture, and acupressure
 
INCLUSION CRITERIA: Randomized, controlled trials (RCTs) of acupuncture and acupressure for CRF in adult patients with cancer regardless of the type of cancer, duration of disease, and type of treatment received. CRF was a key outcome to be clearly measured and reported. Only studies published in English or Chinese were included.
 
EXCLUSION CRITERIA: Articles whose sole target participants were patients with fatigue other than CRF were excluded. Studies using shiatsu or reflexology for therapeutic intervention also were excluded.

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 716
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Two reviewers independently appraised the methodologic quality of the full texts of all potentially eligible articles by means of the standard checklist for RCTs developed by the Scottish Intercollegiate Guidelines Network ([SIGN], 2014). The 10 appraisal criteria for internal validity in the SIGN checklist were equally weighted. Most studies were underpowered or consisted of small sample sizes.

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 11
  • TOTAL PATIENTS INCLUDED IN REVIEW = 731
  • SAMPLE RANGE ACROSS STUDIES: 13–302 patients
  • KEY SAMPLE CHARACTERISTICS: Age range was 20–81 years; average age was 52–59 years; variety of diagnoses but mainly breast cancer

Phase of Care and Clinical Applications

PHASE OF CARE: All phases

Results

Seven out of eight acupuncture studies showed improvement in CRF, but only four reached statistic significance. All four acupressure studies showed significant improvement. The four studies that showed improvement during initial treatment determined that results could be maintained for as many as 12 weeks. However, the maintenance study did not determine any extra benefit. Three studies reported no side effects. In other studies, adverse events were identified as minor and transient. Four studies used acupressure. These showed positive results. However, three studies were underpowered, and the comparability of study groups was questionable.

Conclusions

Acupuncture and acupressure may be helpful in reducing fatigue. However, because of multiple methodologic flaws in studies reviewed, no firm conclusions can be made regarding the effectiveness of these interventions.

Limitations

  • Heterogeneity of the samples, sizes, types of cancer, treatments administered, length, dose, and intensity of treatment
  • Studies had multiple flaws

Nursing Implications

Acupuncture and acupressure appear to be safe and may be effective. Therefore, this intervention may be suggested for patients with CRF. Additional research is needed to confirm their effectiveness.

Print

Lindquist, H., Enblom, A., Dunberger, G., Nyberg, T., & Bergmark, K. (2015). Water exercise compared to land exercise or standard care in female cancer survivors with secondary lymphedema. Lymphology, 48, 64–79. Retrieved from https://journals.uair.arizona.edu/index.php/lymph/article/view/18783

Study Purpose

To determine if water exercise was more effective than land exercise and the current standard of care to reduce limb volume, body mass index (BMI), and perceptions of swelling in female cancer survivors with secondary lymphedema

Intervention Characteristics/Basic Study Process

The water exercise group participated in water training once a week in 25-meter indoor pool that was 140 cm deep. The water temperature was 28–2°C, and exercises were led by a physiotherapist. The 50-minute program included a warm-up exercise (10 minutes), mobility/stretch exercises (10 minutes), movements to increase heart rate (10 minutes), strength training (10 minutes), and slow-down mobility exercises (10 minutes). All participants wore compression sleeves/hosiery.
 
The land exercise group participated in gymnastics once a week. The leader adjusted training if women could not jump, who instead did exercise closer to floor. The 50-minute program included a warm-up exercise (10 minutes), mobility/stretch exercises (10 minutes), movements to increase heart rate (10 minutes), strength training (10 minutes), and slow-down mobility exercises (10 minutes). All participants wore compression sleeves/hosiery.
 
The standard care program group performed self-care/skin care, mobility exercises for their arm or leg, and placed their swollen limb above heart level. Participants self-massaged their arm/leg, wore compression sleeves/hosiery, and performed occasional manual lymphatic drainage (MLD).

Sample Characteristics

  • N = 88   
  • AGE = 58–63 years (SD = 11)
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Breast cancer survivors with secondary arm lymphedema (n = 69), of which 99% underwent surgical nodal dissections during breast cancer surgery (sentinel lymph node biopsy [46%]) and 93% underwent external beam radiation; gynecologic cancer survivors with secondary leg lymphedema (n = 14), of which 60% underwent lymph node dissection with surgery and 100% underwent external beam radiation
  • OTHER KEY SAMPLE CHARACTERISTICS: Self-reported level of physical activity (walking, jogging, strength training, bicycling) and height and weight for calculation of BMI were provided by all participants prior to intervention. Participants reported comorbidities (specifically hypertension, cardiovascular), frequency of MLD prior to intervention, and self-report of relevant medications (diuretics, anti-hypertensives, anticoagulates)
 

 

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Multiple settings    
  • LOCATION: Two hospitals and one primary healthcare unit in the middle, east, and north of Sweden

Phase of Care and Clinical Applications

  • PHASE OF CARE: Late effects and survivorship

Study Design

  • Non-randomized, controlled, clinical intervention study conducted at three different sites comparing water exercise, land exercise, and standard of care

Measurement Instruments/Methods

  • Limb volume = water displacement or circumference with tape measurement
  • Range of motion = goniometry
  • Disability of Arm, Shoulder, and Hand (DASH) questionnaire
  • Hip Osteoarthritis Outcome Score (HOOS) questionnaire
  • Demographic, clinical, and health data = study-specific questionnaire 
  • General well-being = visual digital scale ranged from 1–7
  • Body-image = seven questions from validated body awareness verbal Likert-type scale 
  • Study-specific lymphedema questionnaire (108 questions)
  • Self-report of height and weight were used for the calculation of BMI.

Results

A higher proportion of participants in the water exercise group compared to land the exercise group experienced reduced arm volume (p = 0.029); however, no statistically significant difference in the size of reduction existed between exercise groups after the intervention (p = 0.185). Women with arm lymphedema in the water exercise group experienced reduced arm volume after intervention (p = 0.046), which was not seen in the other groups. For leg lymphedema, no difference in volume following the intervention existed. Only the water exercise group reported a lower frequency of limb swelling after the intervention (p = 0.031). A significant decrease in BMI (p = 0.047) was observed in the water exercise group but not in the other groups after the intervention. After the intervention, participants with arm lymphedema in the land exercise group had improved DASH scores (p = 0.049) and external rotation of shoulder (p = 0.012), with no changes in other groups after the intervention from baseline. The groups with leg lymphedema had no improvement in HOOS scores or joint movement. Well-being was high at baseline for all three groups and remained without any statistically significant differences during the study period.

Conclusions

Physical exercise does not worsen lymphedema and, based on the results from this study, female cancer survivors with secondary arm lymphedema experience decreased volume, BMI, and self-reported frequency of swelling after water exercise compared to land exercise. Conclusions about the value of land or water exercise as an intervention for female cancer survivors with secondary leg lymphedema cannot be drawn from this study because of the small number of subjects in that group.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Risk of bias (sample characteristics)
  • Measurement validity/reliability questionable 
  • Findings not generalizable
  • Subject withdrawals ≥ 10% 
  • Water exercises were performed in colder water (less than 29°C); warmer water often increases mobility, and physiotherapy for lymphedema is performed in warmer water (33–34°C).
  • The study included only one follow-up at end of intervention. 
  • Limb volume was measured either with circumference or water displacement based on the facility/intervention group. 
  • The number of leg lymphedema survivors was too small to draw conclusions.
  • Unclear if HOOS was previously used in same type of study
  • Assignment to intervention group was based on city.
  • Women were asked if they wanted to participate (self-selection bias).
  • Pre-study criteria for compliance rate/participation of at least seven times served as a confounding factor.
  • BMI was based on self-report of height and weight.
  • The number of dropped participants in the text does not mention the standard group of four participants who were lost to follow-up.
  • Almost full adherence to wearing compression
  • Unclear when post-intervention measures were taken
  • Unclear on the use of compression and if some used compression who normally did not
  • The resultant reduction in limb volume may be related to the introduction of a compression garment rather than the exercise program.
 

 

Nursing Implications

Water exercise can be beneficial to female cancer survivors with secondary arm lymphedema. Further interdisciplinary research is needed to design studies that will lead to the development of guidelines/protocols specific to exercise for cancer survivors with secondary arm and leg lymphedema.

Print

Lindemalm, C., Mozaffari, F., Choudhury, A., Granstam-Björneklett, H., Lekander, M., Nilsson, B., . . . Mellstedt, H. (2008). Immune response, depression and fatigue in relation to support intervention in mammary cancer patients. Supportive Care in Cancer, 16, 57–65.

Study Purpose

To examine the effect of a support intervention on immune function and levels of depression, anxiety, and fatigue in patients with breast cancer after completion of surgery and adjuvant treatment

Intervention Characteristics/Basic Study Process

A total of 41 women were chosen from an ongoing prospective randomized study. The first patients in each stratum of treatment were chosen for current study. Twenty-one women received adjuvant combined radio-chemotherapy (CT-RT), and 20 women received radiotherapy (RT). Eleven CT-RT patients and 10 RT patients were randomized to the support group, while 10 CT-RT and 10 RT patients served as controls. The support intervention consisted of educational lectures about cancer etiology, risk factors, treatment, psychological and physical effects, and coping. Exercise, relaxation training, qigong, and art therapy were also included. The intervention was provided for one week and then for another four days two months later. Study measures were obtained at baseline, 2 months, 6 months, and 12 months.

Sample Characteristics

  • The study reported on a sample of 41 patients with breast cancer (100% female).
  • Patient age range was 56–69 years.
  • Most patients were receiving chemotherapy and radiation therapy.

Setting

  • Single site
  • Outpatient setting
  • Vasteras Hospital, Sweden

Phase of Care and Clinical Applications

Patients were in the transition phase after initial treatment.

Study Design

A randomized controlled trial design was used.

Measurement Instruments/Methods

  • Hospital Anxiety and Depression Scale    
  • Norwegian Fatigue Questionnaire
  • Immune Analysis

Results

There was no significant immune effect from the support intervention. More patients in the support group had higher anxiety scores at the start of the intervention compared to the nonsupport group. The mean value anxiety score in the support group was also higher compared to the nonsupport group and improved significantly over time. Low levels of depression were reported in both groups, with no significant difference in depression scores. There was no significant difference in fatigue, but fatigue significantly improved over time in all patients. There were no significant differences in study measures between groups.

Conclusions

The support intervention had no effect on depression or immune parameters. There was no difference in improvement of anxiety and fatigue over time associated with the intervention.

Limitations

  • The study had a small sample, with less than 100 participants.
  • The sample had low depression scores at baseline.
  • It is not clear how the intervention was provided, whether individually, in groups, in the home, or in some other setting. 
  • The study had no blinding.

Nursing Implications

Findings do not support effectiveness of the intervention tested here. Results show that depression, anxiety, and fatigue improved significantly over time.

Print

Lindemalm, C., Mozaffari, F., Choudhury, A., Granstam-Björneklett, H., Lekander, M., Nilsson, B., . . . Mellstedt, H. (2008). Immune response, depression and fatigue in relation to support intervention in mammary cancer patients. Supportive Care in Cancer, 16(1), 57-65.

Study Purpose

To examine the effect of a support intervention on immune function and levels of depression, anxiety, and fatigue in breast cancer patients after completion of surgery and adjuvant treatment  

Intervention Characteristics/Basic Study Process

Authors chose 41 women from an ongoing prospective randomized study. The first patients in each stratum of treatment were chosen for the current study. Of the 41 women, 21 received adjuvant combined radiochemotherapy (CT-RT) and 20 women received radiotherapy (RT). Eleven women (CT-RT) were randomized to the support group, and 10 women (RT) were randomized to the support group. Ten CT-RT and 10 RT patients served as controls. The support intervention consisted of educational lectures about cancer etiology risk factors, treatment, psychological and physical effects, and coping. Exercise, relaxation training, qigong, and art therapy were also included. The intervention was provided for one week and, two months later, for another four days. Study measures were obtained at baseline, 2 months, 6 months, and 12 months.

Sample Characteristics

  • The sample was composed of 41 participants.
  • The range of mean patient age was 56–69 years.
  • Males: 0 %; females: 100%.
  • Participants were patients with breast cancer.
  • Most patients were receiving chemotherapy and radiation therapy.
     

Setting

  • Single site
  • Outpatient
  • Vasteras Hospital, Sweden
     

Phase of Care and Clinical Applications

Phase of care: transition phase after initial treatment

Study Design

Randomized controlled trial

Measurement Instruments/Methods

  • Hospital Anxiety and Depression Scale    
  • Norwegian Fatigue Questionnaire
  • Immune analysis
     

Results

  • Results revealed no significant immune effect from support intervention.
  • More patients in the support group had higher anxiety scores at the start of the intervention than did patients in the nonsupport group.
  • The mean value of anxiety in the support group was higher than that in the nonsupport group, and the value improved significantly over time.
  • Patients in both groups had low levels of depression, with no significant difference in depression scores.
  • Patients in both groups had no significant difference in fatigue. The measure of fatigue decreased over time for all patients.
  • No significant differences in study measures existed between groups.
     

Conclusions

The support intervention had no effect on depression or immune parameters. The intervention did not appear to cause any difference in improvement of anxiety and fatigue over time.

Limitations

  • The  study had a small sample size, with fewer than 100 participants.
  • Participants had low depression scores at baseline.
  • Authors did not specify how the intervention was provided—individually, in groups, in the home, or in some other setting. 
  • The study had a risk of bias due to no blinding.

Nursing Implications

Findings do not support effectiveness of the intervention tested here. Results show that levels of depression, anxiety, and fatigue reduced significantly over time.

Print

Lindemalm, C., Strang, P., & Lekander, M. (2005). Support group for cancer patients. Does it improve their physical and psychological wellbeing? A pilot study. Supportive Care in Cancer, 13, 652–657.

Intervention Characteristics/Basic Study Process

A residential, rehabilitative, psychoeducational intervention was conducted over a six-day period, followed by a four-day follow-up/booster intervention two months after the initial visit. Members of the intervention team included oncologists, social workers, art therapists, massage therapists, and a person trained in qigong and visualization; all had several years of experience and were trained according to the method of Grahn (1993). During the intervention period, patients received information about cancer, risk factors, treatment, psychological effects, and coping mechanisms. Physical exercise, relaxation training, qigong, and art therapy were mixed with educational lectures. Social activities, such as concerts and visits to museums and restaurants, were provided, along with opportunities for peer support. The residential rehabilitation environment was chosen for its beautiful and restful surroundings.

Sample Characteristics

  • Patients (n = 59) were primarily women; only two males participated.
  • Median age was 53 years (range 29–81).
  • Diagnoses included breast cancer (61%), gynecologic cancer (20%), and gastrointestinal malignancy (9%).
  • The median time from the end of treatment to intervention was 1.2 years (range 6 months–3 years).

Setting

The intervention venue was a residential rehabilitation setting selected specifically to deliver the intervention.

Phase of Care and Clinical Applications

Patients were undergoing the long-term follow-up phase of care.

Study Design

The study was uncontrolled—fatigue was evaluated immediately after the first six-day intervention, with follow-up at 3, 6, and 12 months postintervention.

Measurement Instruments/Methods

Norwegian fatigue questionnaire—an 11-item measure with two factors:  physical fatigue and mental fatigue. The total score is created by totaling the 11 items.

Results

At the conclusion of the intervention, there were statistically significant differences in fatigue reflected on most of the single-item scores on the Norwegian fatigue scale, as well as a statistically significant difference in the scores on the physical and mental fatigue factors. Only the improvement in physical fatigue remained statistically significant at three-month follow-up, and there were no significant improvements in fatigue noted at the 6- and 12-month postintervention time points.

Limitations

  • The study lacked a control group.
  • The sample size was not justified by power analysis; it is unknown whether the study was powered to detect an effect.
  • No information was provided relative to the psychometric properties of the fatigue measure.
  • No explanation of the gender bias in study participation and recruitment was offered.
  • Generalization of the study results is limited by the primarily female sample and the overrepresentation among patients of breast and gynecologic malignancies.
  • Costs of residential group treatment were unexplored.

Nursing Implications

The program requires the involvement of several skilled professionals.

Print

Lindemalm, C., Strang, P., & Lekander, M. (2005). Support group for cancer patients. Does it improve their physical and psychological wellbeing? A pilot study. Supportive Care in Cancer, 13, 652–657.

Intervention Characteristics/Basic Study Process

The residential, rehabilitative, psychoeducational intervention was conducted over a six-day period, followed by a four-day follow-up/booster intervention two months after the initial visit. Members of the intervention team included oncologists, social workers, art therapists, massage therapists, and a person trained in qigong and visualization; all had several years of experience and were trained according to the method reported by Grahn (1993). During the intervention period, participants received information about cancer, risk factors, treatment, psychological effects, and coping mechanisms. Physical exercise, relaxation training, qigong, and art therapy were mixed with educational lectures. Social activities, such as concerts and visits to museums and restaurants, were provided, along with opportunities for peer support. The residential rehabilitation environment was chosen for its beautiful and restful surroundings.

Sample Characteristics

  • Participants (n = 59) were primarily women; only two men participated.
  • Median age was 53 years (range 29–81).
  • Diagnoses included breast cancer (61%), gynecologic cancer (20%), and gastrointestinal malignancy (9%).
  • Median time from end of treatment to the intervention was 1.2 years (range 6 months–3 years).

Setting

Residential rehabilitation setting selected specifically for the intervention

Phase of Care and Clinical Applications

Patients were undergoing the long-term follow-up phase of care.

Study Design

This was an uncontrolled study. Fatigue was evaluated immediately after the first six-day intervention, with follow-up at three, six, and 12 months postintervention.

Measurement Instruments/Methods

The Norwegian fatigue questionnaire, an 11-item measure with two factors (physical and mental fatigue), was used. The total score was created by summing the 11 items.

Results

At the conclusion of the intervention, there were statistically significant differences in fatigue reflected on most of the single-item scores on the Norwegian fatigue scale, as well as a statistically significant difference in the scores on the physical fatigue and mental fatigue factors. Only the improvement in physical fatigue remained statistically significant at three-month follow-up, and there were no significant improvements in fatigue at the six- and 12-month postintervention time points.

Limitations

  • No control group was included.
  • The sample size was not justified by power analysis; it was unknown whether the study was powered to detect an effect.
  • No information was provided relative to the psychometric properties of the fatigue measure.
  • No explanation of the gender bias in study participation/recruitment was offered.
  • Generalization of the results was limited by the primarily female sample and the overrepresentation of participants with breast and gynecologic malignancies.
  • Costs of residential group treatment were unexplored.
  • The program required the involvement of several skilled professionals.
Print

Lindblad, K., Bergkvist, L., & Johansson, A.C. (2016). Evaluation of the treatment of chronic chemotherapy-induced peripheral neuropathy using long-wave diathermy and interferential currents: A randomized controlled trial. Supportive Care in Cancer, 24, 2523–2531. 

Study Purpose

To evaluate the effects of interferential therapy and long-wave diathermy at high power (ITH) compared to long-wave diathermy at low power (LDL) on peripheral neuropathy (PN) pain, sensory, and motor symptoms among adults with chronic chemotherapy-induced peripheral neuropathy (CIPN) symptoms in the lower extremities who completed chemotherapy treatment for various cancers

Intervention Characteristics/Basic Study Process

Intervention: Interferential therapy and ITH once per week for 12 weeks. A physical therapist delivered 15 minutes of interferential therapy (Electro Stimulation Device ES 520 and Vacuum Unit) to the lower legs for 15 minutes using four wet sponge–containing vacuum electrodes placed on the medial and lateral sides of the upper and lower portions of the lower leg. The stimulation intensity (0–100 Hz) was adjusted based on when the patient felt a strong but not painful stimulation. Long-wave diathermy (Skanlab 25 Body Wave® apparatus) was delivered at an unspecified high power for six minutes using an electrode and gel lightly applied in circular motions to the sole of the foot. A ground electrode was placed on the middle of the calf.
 
Sham control: LDL once per week for 12 weeks. A physical therapist delivered long-wave diathermy at an unspecified allegedly sub-therapeutic power level in the same manner as for the ITH group (Skanlab 25 Body Wave® apparatus electrode applied to the sole of the foot for six minutes).
 
Timepoints of measurement: Baseline (before randomization and ITH/LDL initiation), 12 weeks (immediately after ITH/LDL treatment completion), and 37 weeks after baseline

Sample Characteristics

  • N = 67   
  • AGE = 64 years (SD = 10.57 years)
  • MALES: 49.3%, FEMALES: 50.7%
  • CURRENT TREATMENT: Other
  • KEY DISEASE CHARACTERISTICS: The medical record charted numbness, tingling, pain, or swelling sensation in the feet/lower legs, and physicians diagnosed chronic CIPN related to platinum-, taxane-, or vinca alkaloid–based chemotherapy completed a mean of 11.49 months (SD = 10.67 months) prior to the study; varied tumor types
  • OTHER KEY SAMPLE CHARACTERISTICS: Participants were excluded if they had type 1 diabetes mellitus, PN related to other nonchemotherapy causes, or ongoing treatment with neurotoxic chemotherapy.

Setting

  • SITE: Single site   
  • SETTING TYPE: Not specified    
  • LOCATION: Sweden

Phase of Care and Clinical Applications

  • PHASE OF CARE: Late effects and survivorship
  • APPLICATIONS: Elder care, palliative care

Study Design

Three-group, sham-controlled, randomized, controlled trial

Measurement Instruments/Methods

Primary outcome: Numeric Rating Scale (NRS) of pain intensity ranging from 0 (no pain) to 100 (worst possible pain)
 
Secondary outcomes: NRS of discomfort (“uncomfortable feeling of not knowing where the feet are in relation to the room” [p. 2,526]) of 0 (no discomfort) to 100 (worst possible discomfort); zones of paresthesia (i.e., the number of zones with sensations of pins and needles, tingling, paresthesia, and numbness sensations [ranging from 0–10] indicated on a lower extremity body map and averaged between the bilateral extremities); Dizziness Handicap Inventory to measure subjective balance (scored 0–60); Tightened Romberg Test with closed eyes in tandem stance (bilateral leg average, best of three attempts, 0–60 seconds); One Leg Stance Test with closed eyes (bilateral leg average, best of three attempts, 0–30 seconds)

Results

There were no significant between-group differences at the 12-week and 37-week follow-ups in all outcomes: self-reported pain, discomfort, paresthesia/numbness, or balance, or in objectively measured balance. At the 12- and 37-week follow-ups, both groups reported significantly improved CIPN discomfort (p < 0.05), zones of paresthesia (p < 0.003), and subjective balance (p ≤ 0.025). Only the LDL group experienced improved pain at 12 weeks (p = 0.017), but neither group had significant improvements in pain at 37 weeks. Only the intervention group demonstrated significantly improved balance at 12 and 37 weeks, based on the objective measures (p ≤ 0.04).

Conclusions

This randomized, controlled trial provides no evidence to support the efficacy of interferential therapy and ITH compared to LDL once per week for 12 weeks for pain, CIPN discomfort, patient-reported balance, and objectively measured balance among participants with physician-diagnosed chronic CIPN.

Limitations

  • Small sample (< 100)
  • Baseline sample/group differences of import
  • Risk of bias (no blinding)
  • Risk of bias (sample characteristics)
  • Unintended interventions or applicable interventions not described that would influence results
  • Measurement validity/reliability questionable
  • Findings not generalizable
  • Questionable protocol fidelity
  • Subject withdrawals ≥ 10%
  • Convenience sampling used in this study increases the risk of sampling bias and decreases the generalizability of the results.
  • The definition of chronic CIPN was not defined, and participants had completed neurotoxic chemotherapy aa mean of 11.49 months (SD = 10.67 months) prior to the study, meaning some participants may have had unstable CIPN that naturally improved over time (i.e., maturation effects were likely responsible for the outcome improvements).
  • The primary outcome was pain, but about one-third of the patients had no pain at baseline. 
  • No measurement or control for key potential influencing factors of CIPN and pain (e.g., concomitant analgesic or psychotropic medication changes during the study; smoking; comorbidities, such as type 2 diabetes, peripheral arterial disease, alcohol dependence, vitamin B deficiency)
  • None of the measurements had sufficient validity and reliability. The NRS has not been validated as a measure of CIPN pain or discomfort, and the authors created the map of paresthesia zones but had not tested it psychometrically. No evidence was provided to support the validity and reliability of the balance measures for patients with CIPN.
  • There was 25.4% attrition by the 37-week follow-up, and no report of how missing values were handled (despite stating that an intent-to-treat analysis was conducted) was provided.

 

Nursing Implications

No evidence supports the efficacy of interferential therapy and long-wave diathermy, and, currently, this intervention should not be recommended to patients with heterogeneous types of painful and nonpainful CIPN. However, evidence shows that CIPN symptoms and balance may recover for some patients by one year after completing treatment with neurotoxic chemotherapy. Additional studies of nursing interventions for CIPN are needed.

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Linardou, H., & Gogas, H. (2016). Toxicity management of immunotherapy for patients with metastatic melanoma. Annals of Translational Medicine, 4, 272.

Purpose & Patient Population

PURPOSE: To review the side effects of checkpoint inhibitors and their management
 
TYPES OF PATIENTS ADDRESSED: Adult patients with melanoma receiving checkpoint inhibitor therapy

Type of Resource/Evidence-Based Process

RESOURCE TYPE: Expert opinion

 

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Guidelines & Recommendations

Skin: Rash reported in about 20% of patients in clinical trials. Suggests topical and/or oral steroid treatment for persistent or recurring grade 2 rash. Antihistamines suggested for pruritis. IV high-dose steroids (methylprednisolone 1–2 mg/kg/day) followed by oral steroids on improvement tapered over four weeks
 
Diarrhea: Most studies report diarrhea in at least 30% commonly presenting at about five weeks. Grade 1: Loperamide, antidiarrheal diet, hydration
 
Grade 2: Oral budesonide or other moderate corticosteroid, tapered over 30 days. 
 
Grade 3: High-dose IV steroids (e.g., methylprednisolone 1–2 mg/kg/day) tapering for at least one month. If no improvement occurs within one week, use anti-TNF inhibitors, remicade, or infliximab.
 

Limitations

Expert opinion level only. The evidence is derived only from initial drug clinical trials.

Nursing Implications

Limited research evidence regarding interventions to prevent and manage side effects of immunotherapies exists, and most relies on corticosteroid treatment with increased dosing according to the severity of the side effects. Nurses need to be aware that diarrhea, in particular, with immunotherapy can lead to severe colitis, which can be life-threatening and require surgical removal of the colon. Patients need to be taught to report side effects promptly, and patients need to be monitored closely for these adverse events, with prompt intervention.

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Lin, L. C., Que, J., Lin, L. K., & Lin, F. C. (2006). Zinc supplementation to improve mucositis and dermatitis in patients after radiotherapy for head-and-neck cancers: a double-blind, randomized study. International Journal of Radiation Oncology, Biology, Physics, 65, 745–750.

Study Purpose

To determine whether zinc supplementation can accelerate the healing of mucositis and dermatitis after radiation therapy (RT).

Intervention Characteristics/Basic Study Process

There were two randomized groups:  the experimental (group A) received 25 mg of zinc three times per day and the control (group B) received the placebo (n = 48).

The principle researcher was blinded. Evaluation and grading of mucositis and dermatitis was performed weekly during treatment andtwo weeks after completion of RT, including the weekends.

Sample Characteristics

  • The sample was comprised of 97 patients (86% male, 14% female).
  • Mean (standard deviation) age was 50 years (11 years) in group A and 51 years (11 years) in group B.
  • Patients had head and neck cancer.
  • The daily fraction was 180 t–200 cGy in five weekly fractions. Interruption was greater than three days.
  • Of the patients, 59% were receiving concurrent chemotherapy.

Setting

Chi-Mei Foundation Medical Center Tainan, Taiwan, China

Study Design

The study was a randomized, double-blind, placebo-controlled trial.

Measurement Instruments/Methods

Radiation Therapy Oncology Group (RTOG) scores for dermatitis

Results

  • Group A had less interruption, and more patients completed treatment. Zinc supplementation use did not show much benefit in the patients who received concurrent chemotherapy.
  • Survival curve analysis showed that grade 2 (p = 0.014) and grade 3 (p = 0.0092) dermatitis was less prevalent and occurred later in patients receiving zinc supplementation.
  • No significant difference was found in the two weeks following treatment completion and resolution of dermatitis.

Conclusions

Oral zinc supplementation may delay the onset and reduce the severity of radiodermatitis.

Limitations

The treatment design for the timing of the study was standard practice; it is not certain if one could correlate the study information to modern treatment delivery.

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