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Iervolino, V., Di Costanzo, G., Azzaro, R., Diodato, A.M., Di Macchia, C.A., Di Meo, T., . . . Cacciapuoti, C. (2013). Platelet gel in cutaneous radiation dermatitis. Supportive Care in Cancer, 21, 287–293.  

Study Purpose

To evaluate the effectiveness of an autologous platelet gel dressing in treating chronic skin dermatitis due to radiation therapy

Intervention Characteristics/Basic Study Process

After being prepared in a lab on the same day, the authors detail a \"homemade\" platelet gel made from the patient's blood. This gel patch was applied with the intent of promoting healing and tissue repair. Each gel application was cut to the size of the affected area of chronic dermatitis/ulcer from radiation therapy and applied weekly for 35 days. The area was digitally imaged before, during, and after treatment by unidentified provider type(s) at the transfusional medicine department of the Naples Tumour Institute. Unidentified staff evaluated the condition of the wounds after treatment—immediately after treatment in five patients, six months later in three patients, one year later in one patient, and two years later in another patient.

Sample Characteristics

  • N = 10  
  • AGE = 26–81 years
  • MALES: 90%, FEMALES: 10%
  • KEY DISEASE CHARACTERISTICS: High to moderate grade tumor, limb sarcoma (upper and lower, right and left)
  • OTHER KEY SAMPLE CHARACTERISTICS: Patients received 54–64 Gy radiation therapy post-surgically. Using guidelines and scoring according to the European Pressure Ulcer Advisory Panel (EPUAP) and Common Terminology Criteria for Adverse Events (CTCAE), all patients had developed third and fourth degree chronic skin ulcers. For two months prior to being enrolled in this study, all patients previously had tried other traditional treatments for skin dermatitis (e.g., hydrogels, alginates, polyurethane foams, hydrocolloids). All patients had functional status of ECOG 0–1 and 5. All patients had platelet counts greater than 150,000.

Setting

  • SITE: Single site    
  • SETTING TYPE: Outpatient  
  • LOCATION: Naples Tumour Institute Transfusional Medicine OU (presumed to mean outpatient unit)

Phase of Care and Clinical Applications

  • PHASE OF CARE: Transition phase after active treatment
  • APPLICATIONS: Elder care

Study Design

  • Repeated measures: Digital imaging during weekly change and application of platelet gel

Measurement Instruments/Methods

  • Digital imaging before, during, and after the treatments
  • Authors note that the size of lesion, evolution over time, healing response (complete or partial), and healing time (days) were accounted for.

Results

Seven out of the 10 treated patients showed a complete rate of healing varying from 21–49 days and after a range of three to seven applications of the platelet gel. Two patients' treatments with the gel were held after they had disease progression and metastases. One patient's treatment was discontinued after six applications because of an \"incomplete response.\" Upon follow-up, no patients had recurrence or complications (unclear if this means disease/cancer recurrence or skin reaction recurrence) as a result of the platelet gel, and at five years post-treatment, six of the seven patients who had demonstrated a complete response remained disease-free (unclear if this means cancer-free or radiation dermatitis-free).

Conclusions

In this limited, disease-specific, small population sample, autologous platelet gel application seemed clinically useful and successful at treating third and fourth degree skin reactions. Patients with limb sarcoma who have surgery and then radiation therapy and develop moderate to severe skin reactions or ulcerations may benefit from weekly applications of autologous platelet gel to the affected areas.

Limitations

  • Small sample (<30): N = 10
  • Risk of bias (no control group)
  • Risk of bias (no random assignment)
  • Risk of bias (sample characteristics): This study was limited to patients with limb sarcoma only who had surgery and then radiation therapy and developed moderate to severe skin reactions prior to receiving this treatment.
  • Key sample group differences that could influence results: Patient age and comorbid conditions could affect skin healing (patient age ranged from 26—81 years).
  • Measurement validity/reliability questionable: Digital imaging process and who was reading results is not described. Authors cite \"the state of the wounds was evaluated by a unique medical of Transfusional Medicine OU\" without letting the reader know what qualifications or licensure or experience the unique person(s) had to make the measurement valid or reliable.
  • Findings not generalizable: Due to the limited population (post-surgical, post-radiotherapy patients with limb sarcoma only), it does not appear that the findings could be generalized to any other patient population, such as breast cancer, head and neck squamous cell carcinoma, or skin cancer. It is not clear whether this treatment is as effective as or superior to traditionally used measures in the United States. 
  • Intervention expensive, impractical, or training needs: Unknown whether labs in the United States do this type of harvesting or processing for autologous platelet gel application. Unknown whether patient's insurance would cover this treatment, and, if so, how much out-of-pocket cost would be transferred to the patient.

Nursing Implications

The science of this treatment seems sound, based on the role of platelets in tissue repair and growth factors released by activated platelets. A larger patient sample size, including patients with different types of cancer, might address the effectiveness of autologous platelet gel application in radiation dermatitis post-radiation therapy.

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Iconomou, G., Koutras, A., Karaivazoglou, K., Kalliolas, G.D., Assimakopoulos, K., Argyriou, A.A., . . . & Kalofonos, H.P. (2008). Effect of epoetin alpha therapy on cognitive function in anemic patients with solid tumors undergoing chemotherapy. European Journal of Cancer Care, 17(6), 535–541.

Study Purpose

The study's primary aim was to assess whether erythropoietin (epoetin alfa) would improve cognitive performance in a group of patients with cancer who were anemic and receiving chemotherapy. Its secondary aim was to confirm the positive impact of erythropoietin on hematologic parameters and quality of life.

Intervention Characteristics/Basic Study Process

Participants were treated with 40,000 units of erythropoietin weekly for 12 weeks. After the first four weeks of therapy, if the increase in hemoglobulin (Hgb) was less than 1 g/dL over the baseline value, the dose of erythropoietin was increased to 60,000 units weekly. In patients whose Hgb level exceeded 13.0 g/dL, erythropoietin was withheld until Hgb decreased to less than 12.0 g/dL, and resumed at that point to 75% of the previous dose. All participants also received 200 mg of oral elemental iron daily throughout the study. Questionnaires were administered prior to epoetin alfa therapy and at the study's completion.

Sample Characteristics

  • The number of participants was 55, with 50 completing the study.
  • The average participant age was 58.9 ± 9.9 years.
  • 63.6% of the participants were female and 36.4% were male.
  • 30.8% of the participants had breast cancer, 21.8% had colorectal cancer, 18.2% had lung cancer, 18.2% had genitourinary cancer, and 11.0% had another form of cancer.
  • The average participant years of education attained was 8.7 ± 4.2. 
  • The average participant Hgb level was 10.35 ± 0.50 g/dL.

Setting

This was a single-site study in Greece.

Study Design

The study utilized a prospective, longitudinal, single-arm design. 

Measurement Instruments/Methods

  • The Mini-Mental State Examination (MMSE) measured global cognitive function.
  • The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-30 (EORTC QLQ-C30) measured global and functional quality of life using six subscales (global, physical, role, cognitive, emotional, social functioning) and three symptom scales (for fatigue, pain and nausea/vomiting). Scores range from 0–100, with higher scores indicating higher quality of life for the global and functional scales. The Greek version was employed. 

Results

There were no significant differences in cognitive function between erythropoietin responders and non-responders. Sixteen percent of patients had cognitive impairment at baseline measurement (MMSE score < 24). MMSE mean scores increased from 27.24 at baseline to 27.90 at week 12 (p < 0.016). Change in Hgb levels were associated with the magnitude of improvement in quality-of-life parameters such as fatigue (p < 0.01), social function (p < 0.01), and role function (p < 0.01). MMSE changes were not associated with changes in Hgb levels. 

Conclusions

The study failed to demonstrate a clinical benefit of erythropoietin on cognitive function during treatment.

Limitations

  • The study had a small sample size.
  • There was no control or comparison group.
  • The MMSE is not sensitive enough to detect subtle cognitive changes and has ceiling effects; overall, patients had high baseline scores.
  • There was a lack of alternate forms for repeated administration.
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Hwang, I.G., Kang, J.H., Oh, S.Y., Lee, S., Kim, S.H., Song, K.H., . . . Kim, H.J. (2016). Phase II trial of epidermal growth factor ointment for patients with erlotinib-related skin effects. Supportive Care in Cancer, 24, 301–309.

Study Purpose

To evaluate the effect of epidermal growth factor (EGF) ointment on quality of life (QOL) and erlotinib-related skin effects (ERSEs) in patients with non-small cell lung cancer and pancreatic cancer

Intervention Characteristics/Basic Study Process

EGF ointment containing 1 ppm of nepidermin was applied evenly to skin lesions twice daily for patients with grade 2 or greater lesions.

Sample Characteristics

  • N = 46  
  • MEDIAN AGE = 61 years (40–83); 20 aged younger than 60 years (43%), 26 aged older than 60 years (57%)
  • MALES: 30 (65%), FEMALES: 16 (35%)
  • CURRENT TREATMENT: Targeted therapy (erlotinib)
  • KEY DISEASE CHARACTERISTICS: Non-small cell lung cancer or pancreatic cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: Eastern Cooperative Oncology Group (ECOG) score, number of previous chemotherapy sessions

Setting

  • SITE: Multicenter   
  • SETTING TYPE: Institutes    
  • LOCATION: Korea

Phase of Care and Clinical Applications

PHASE OF CARE: Active treatment

Study Design

Phase II, open-label, noncomparative, multicentered trial

Measurement Instruments/Methods

  • Common Terminology Criteria for Adverse Events (CTCAE), version 3.0, for ERSE grading
  • Skindex-16 for QOL

Results

ERSEs (n = 46): EGF ointment was effective in 36 (69.2%) intention-to-treat patients for treatment of ERSEs. The grading for average CTCAE rating of rash/acne and itching improved:
  • 2.02 (SD = 0.83) to 1.13 (SD = 0.89) (rash/acne) (p < 0.001)
  • 1.52 (SD = 0.84) to 0.67 (SD = 0.9) (itching) (p < 0.001)
QOL (n = 25 patients from two institutions):
  • Medial overall score of 41.25 (SIQR = 14.38)
  • Highest scores were emotion demain (median = 42.86, SIQR = 15.71).
    • Higher than functioning and symptoms domain
  • Medial overall score after treatment was 8.75.
    • Significantly lower than initial median score of 41.25 (p = 0.0019)

Conclusions

EGF ointment was effective for ERSEs regardless of patient gender, age, type of tumor, and dosage of erlotinib and seems to improve all kinds of ERSEs.

Limitations

  • Small sample (< 100)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Findings not generalizable
  • No discussion of nursing education of patients
  • No discussion of training on grading

Nursing Implications

Nursing education, interventions, and additional randomized, controlled studies are needed to elucidate the effectiveness of EGF ointment on ERSEs and QOL in patients with non-small cell lung cancer and pancreatic cancer.

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Hwang, W.Y., Koh, L.P., Ng, H.J., Tan, P.H., Chuah, C.T., Fook, S.C., … Goh, Y.-T. (2004). A randomized trial of amifostine as a cytoprotectant for patients receiving myeloablative therapy for allogeneic hematopoietic stem cell transplantation. Bone Marrow Transplantation, 34, 51–56.

Intervention Characteristics/Basic Study Process

Patients were given 1,000 mg/day IV amifostine (740 mg/m2) once a day or divided (depending on frequency of chemotherapy or total body irradiation [TBI]), rounded to nearest 500 mg, and given over 15 minutes prior to chemotherapy or TBI. 

Sample Characteristics

  • The study reported on 60 patients (30 in the amifostine group and 30 in the control group).
  • Median age was 28 years in the amifostine group and 30 years in the control group. Ages ranged from 15–47 years old.
  • Patients were receiving allogeneic hematopoietic stem cell transplant (HSCT).
  • Treatment regimens were busulfan and cyclophosphamide, cyclophosphamide and TBI, or etoposide.

Setting

This was a single-institution, randomized, open-label trial conducted between August 1998 and October 2003.

Measurement Instruments/Methods

The World Health Organization (WHO) Mucositis grading scale was used daily during the study, followed by the Common Toxicity Criteria in Cancer Therapy Evaluation Program (CTEP).

Results

  • No significant differences were found between the groups in grades of mucositis; however, duration of all grades of mucositis was significantly reduced in the amifostine group. Patients in the amifostine group experienced a shorter overall duration (16 days versus 21 days, p < 0.02). They also had a shorter duration of grade 3 or 4 mucositis (0 days versus 5 days), but this difference was not significant (p = 0.3).
  • Patients who received amifostine had lower incidence of grade 3 or 4 mucositis (41% versus 63%), but this difference was not significant (p = 0.44).
  • Side effects included nausea and vomiting, hypotension, and hypocalcemia.

Limitations

  • The exact dosing of amifostine was difficult to determine when divided doses were given.
  • Only used sibling allogeneic transplants.
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Hwang, J.M., Hwang, J.H., Kim, T.W., Lee, S.Y., Chang, H.J., & Chu, I.H. (2013). Long-term effects of complex decongestive therapy in breast cancer patients with arm lymphedema after axillary dissection. Annals of Rehabilitation Medicine, 37, 690–697. 

Study Purpose

To investigate complex decongestive therapy (CDT) and its long-term effects on reduction of edema in patients with breast cancer-related lymphedema who have undergone axillary lymph node dissection, based on their initial fluid volume

Intervention Characteristics/Basic Study Process

A retrospective review of 57 patients was done. Patients were treated with CDT for two weeks and followed for 24 months, with arm volumes being measured before/immediately after CDT, and at 3, 6, 12, and 24 months. Patients were divided into two groups according to their percent excess volume (PEV).

Sample Characteristics

  • N = 57  
  • AGE = 48.6 (SD = 10.3)
  • MALES: 2%, FEMALES: 98%
  • KEY DISEASE CHARACTERISTICS: Breast cancer-related lymphedema
  • OTHER KEY SAMPLE CHARACTERISTICS: Right-arm lymphedema in 23 patients; left-arm lymphedema in 34 patients.

Setting

LOCATION: Seoul, Korea

Study Design

  • Retrospective review of patients

Measurement Instruments/Methods

  • Independent T-test,
  • Linear mixed model 
  • SPSS®, version 18.0

Results

Group 1 had a mean PEV of 11.4% (SD = 5) before CDT and 14.1% (SD = 10.6) at 24 months after CDT, with no significant difference. Group 2, which had a higher initial PEV of 41.9% (SD = 19.6) showed a significant reduction at 24 months to 28.8% (SD = 15.7).

Conclusions

Patients with a higher initial PEV showed a greater reduction in fluid volume after using CDT. For patients with a lower initial PEV, their lymphedema did not increase in severity.

Limitations

  • Small sample (< 100)

Nursing Implications

Nurses should encourage movement of affected arms to promote lymphatic drainage, especially in patients with a higher PEV.

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Hwang, K.H., Jeong, H.J., Kim, G.C., & Sim, Y.J. (2013). Clinical effectiveness of complex decongestive physiotherapy for malignant lymphedema: A pilot study. Annals of Rehabilitation Medicine, 37, 396–402. 

Study Purpose

To evaluate the effect of complex decongestive physiotherapy on patients with malignant lymphedema, with regard to volume reduction and quality of life (QOL)

Intervention Characteristics/Basic Study Process

There is no comparison/control group. Patients received non-elastic compression therapy, remedial exercise, and skin care.  Manual lymphatic drainage (MLD) was not utilized.

Sample Characteristics

  • N = 22  
  • AGE = 35–80 years (Mean = 60)
  • MALES: 5%         FEMALES: 17%
  • KEY DISEASE CHARACTERISTICS: Cancer survivors diagnosed with malignant lymphedema; selected by one physician in the Department of Rehabilitation at Kosin University Hosptial in Korea.
  • OTHER KEY SAMPLE CHARACTERISTICS: Greater than 2 cm circumference difference between affected upper or lower limb and the ‘normal’ upper or lower limb; diagnosis of lymphedema by lymphoscintigraphy; lymphatic channel or lymph node invasion in axilla, pelvis, lumbar, or inguinalareas diagnosed by imaging; aggressive, or rapidly progressing limb swelling
  • EXCLUSION CRITERIA: Age greater than 80 years, bilateral lymphedema of upper or lower limbs, patients with benign lymphedema before malignant metastasis, patients with induced lymphedema during radiotherapy or chemotherapy, vascular disorders that might cause lymphedema and poor communication skills or low treatment compliance

Setting

  • SITE:  Single site  
  • SETTING TYPE:  Inpatient  
  • LOCATION: Kosin University Hospital, Korea

Phase of Care and Clinical Applications

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

Study Design

  • Pilot study

 

Measurement Instruments/Methods

  • Changes in limb volume via circumferential limb volume measurements
  • Pain intensity via 10-point Visual Analog Scale (VAS)
  • QOL via Short form-36, version 2, questionnaire (SF-36)

Results

The authors report a statistically significant difference in volume change in upper limbs (p = 0.001) and lower limbs (p = 0.001).

Conclusions

Components of complex decongestive physiotherapy (CDPT) are helpful in treating malignant lymphedema for pain and volume reduction, with positive impact on QOL. MLD was not utilized, based on conflicting reports regarding potential for spreading cancer. However, the authors state all components of the CDPT program, except MLD, are helpful when MLD was not utilized or controlled.

Limitations

  • Small sample (< 30)
  • Risk of bias (no control group)
  • Risk of bias (sample characteristics)
  • Unintended interventions or applicable interventions not described that would influence results
  • Selective outcomes reporting 

Nursing Implications

CDPT has a positive effect on QOL and limb volume reduction. This particular study did not utilize MLD, one of the main components of CDT. The reason given was that MLD could potentially spread cancer via the lymphatic channels; however, in fact, malignant lymphedema is a metastatic disease process.

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Hutchison, S.D., Sargeant, H., Morris, B.A., Hawkes, A.L., Clutton, S., & Chambers, S.K. (2011). A community-based approach to cancer counselling for patients and carers: A preliminary study. Psycho-Oncology, 20, 897–901.

Study Purpose

To provide guidance for cancer services by describing intervention strategies, characteristics, psychological concerns, and distress outcomes for patients and their carers that use a community-based cancer counseling service

Intervention Characteristics/Basic Study Process

Clients who accessed a statewide cancer telephone helpline received referral to a free community-based and evidence-based multicomponent cancer counseling service (CCS) that provided brief telephone-delivered psychosocial interventions for individuals struggling to cope with cancer. CCS clients were referred from a statewide cancer helpline that provides individual support and information about cancer. Over a three-year period, 86% of the 1,201 people who received CCS services met the inclusion criteria for the institutional review board–approved study. Qualified psychologists spoke to patients and carers on the phone. Outcomes measures included the Stress Distress Thermometer and a session satisfaction questionnaire. Collection of measures occurred via each telephone interaction between the psychologist and patient or carer upon client referral to CCS and at each counseling session.

Criteria for referral to the CCS included high levels of self-reported cancer-related distress and/or request for counseling. The CCS interventions are multicomponent and include psychoeducational, emotional support, coping skills, cognitive behavior therapy, and other psychological interventions such as mindfulness, acceptance and commitment therapy, communication skills, and partner support. Interventions are short-term, with clients generally receiving five sessions.

Sample Characteristics

  • The sample was comprised of 681 patients with cancer and 520 carers.  
  • Patient mean age was 52.8 years (SD = 11.8; range = 18–84 years); carer mean age was 49.7 years (SD = 13.5; range = 18–86 years).
  • The male sample was 23.3% patient and 12.5% carer; the female sample was 76.7% patient and 87.5% carer.
  • Patients had breast cancer (35.8%), lung cancer (12.5%), bowel cancer (11.3%), prostate cancer (8.5%), hematologic cancer (6.7%), brain cancer (5.6%), melanoma (5.6%), and other cancers (32.9%). 
  • Of the carers, 94% were patient partners or immediate family members.
  • The majority (88%) of patients and carers had an English-speaking background and did not represent ethnically diverse population groups.
  • Approximately 75% of patients and carers had finished secondary or tertiary schooling.
  • More than half of patients were not working, whereas 25.4% of carers worked full-time.
  • More than half (56.7%) of patients had a diagnosis of cancer for six months or less.
  • The number of rural and urban patients and carers was approximately equal.

Setting

  • Multisite
  • Home setting 
  • Queensland, Australia

Phase of Care and Clinical Applications

  • Active treatment
  • First diagnosis; cancer diagnosis and treatment continuum; telephone intervention

Study Design

A repeated measures design was used.

Measurement Instruments/Methods

  • Distress Thermometer: This instrument measured patient and carer distress during the past week. Data were collected at referral and at the beginning of each telephone session. No identified reliability or validity indices were provided.
  • Session satisfaction: Patients and carers provided a single rating of their overall satisfaction with the telephone session. Data were collected at referral and at each counseling session. No identified reliability or validity indices were provided.

Results

There were significant differences (p < 0.001) between patients and carers who identified concerns before the telephone intervention. However, both groups identified adjusting to cancer as the most common presenting problem. Other predominant problems for patients were anxiety, depression, and family relationships. Predominant problems for carers were bereavement, anticipatory grief, and family/intimate relationships. There was no significant difference in the number of telephone sessions for patients and carers. Eighty-six percent completed therapy in five sessions. A t test indicated that the average length of sessions significantly differed for patients and carers (t [4193] = 2.43, p < 0.05). Carers had significantly (p < 0.001) more distress before the telephone intervention and postintervention than patients, although both groups showed a significant decrease in distress by the final intervention (p < 0.001). Almost 70% of patients and carers met “improvement” or “recovery” on the Distress Thermometer assessment postintervention. No significant distress differences were noted between patients and carers referred to further counseling postintervention than those who did not complete therapy. Mean satisfaction ratings for sessions were 9.35 based on a possible 10-point (“just right”) scale.

Conclusions

This study demonstrated the effectiveness of a CCS telephone-delivered intervention to patients with cancer and many of their carers for a wide range of identified problems over the cancer trajectory. The delivery format allows provision of educational and emotional support to both groups despite place of residence, ability to leave the home, and other factors affecting access to the intervention.

Limitations

  • The study did not have a comparison or control group.
  • The study had no randomization to intervention data collection by individuals providing the support sessions immediately before and after each session.
  • The study used brief assessment measures with lack of psychometric data: The study did not isolate whether the CCS  telephone intervention is more effective at certain times of the cancer trajectory or ways standardization of the intervention occurred that would better support outcomes measures. It appears that the patient and carer separately received the intervention, a process that might prevent needed dialogue between the patient and carer on an urgent issue needing their collaboration. It is not clear how psychologists who provided the intervention were trained or how monitoring occurred to ensure intervention integrity. One may question the freedom of the patient or carer to deliver a true oral evaluation of a counseling session over the phone when that psychologist may render future services.

Nursing Implications

Nurses providing oncology care must carefully screen both patients and carers for concerns during the cancer treatment cycle. This screening may need to occur with each individual patient and carer alone to gain accurate information that is useful for individualized teaching and support. Nurse–patient/carer telephone dialogues between clinic or hospital visits may also be valuable in preventing and treating concerns before they become urgent issues needing attention. Healthcare team referral to social workers, spiritual leaders, and others specific to patient or carer concerns may also prove valuable to prevent or treat carer or patient depression or anxiety that affects the ability of the dyad to effectively cope with the cancer experience. Future research also is needed to investigate the effect of the intervention on low literacy and ethnically diverse people with cancer who value a face-to-face encounter as essential to their perception of health provider support during cancer care. 

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Husson, O., Mols, F., & van de Poll-Franse, L.V. (2011). The relation between information provision and health-related quality of life, anxiety and depression among cancer survivors: A systematic review. Annals of Oncology: Official Journal of the European Society for Medical Oncology/ESMO, 22(4), 761–772.

Purpose

To complete a systematic review of available literature regarding the relationship between information provision and health-related quality of life, anxiety, and depression

Search Strategy

  • Databases searched were PubMed and PsycINFO. The search was for original articles published up to February 2010.
  • Search keywords were cancer, information, information provision, information disclosure, information needs, information satisfaction, information level, information barriers, written information, oral information, audiotape information, CDROM, quality of life, health status, well-being, anxiety, depression.
  • A study was included if it was appropriate to the purposes of the analysis, was the original article, was printed in the English language, and was published in a peer-reviewed journal.
  • A study was excluded if it was a care report or a review article, was related to end-stage cancer patients, focused on communication aspects, focused on family members, focused on diagnosis or prognosis, or used a single-item measure of health-related quality of life.

 

Literature Evaluated

  • The initial search found 5,732 articles. In reviewing the abstracts, 37 articles potentially met the study criteria.
  • The study consisted of (1) design: prospective, cross-sectional, (2) study population: size, diagnosis, stage, (3) measuring instruments, (4) types of information provision instruments, (5) results, and (6) overall methodological quality based on a scoring system. The evaluation criteria for methodological quality included the validity of measurements, clearly stated inclusion and exclusion criteria, the inclusion of sociodemographic variables, participation or response rates higher than 75%, sample size, a prospective study design, comparisons of results to other groups or times, and sound data analysis.
  • Other comments on literature evaluated: Investigators did not conduct meta-analysis.
     

Sample Characteristics

  • The final number of studies included in the sample was 25. All the studies had been conducted from 1996 through 2009. After detailed evaluation, three investigators selected 25 of the 37 articles.
  • Sample size across the studies was 30–3,197.
  • Participants were cancer survivors with diverse cancer types at various stages.

Phase of Care and Clinical Applications

  • Phase of care: long-term follow-up
  • Clinical applications: late effects and survivorship

Results

  • No part of the study was evaluated as being of low quality.
  • Prospective studies showed that satisfied patients—that is, patients who reported to receive large amounts of clear information—reported better mental health-related quality of life (HRQoL) and global health-related quality of life. Cross-sectional studies found a positive relation between HRQoL and fulfilled information needs, information satisfaction, information quality or clarity, and fewer information barriers. 
  • Cross-sectional and prospective studies reported that patients with information satisfaction in general had less anxiety and depression.
  • Of eight intervention studies that aimed to improve information provision, only one showed a positive association with better HRQoL. No benefit was found regarding depression or anxiety. Types of interventions and measured construct varied across the studies, making interstudy comparisons difficult. A lack of effect may be associated with the limited surplus value of the additional information given in the experimental conditions, the neutral mode of information provision without patients' active participation, the short duration of some of the interventions, and low compliance.

Nursing Implications

Additional research is needed before making definitive conclusions about information interventions is justified; because of methodological constraints, the results in the studies examined did not reach statistical significance. The fast and recent development of the field of patient-reported outcomes in cancer survivorship will make conducting studies of better quality possible.

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Husebo, A.M., Dyrstad, S.M., Mjaaland, I., Soreide, J.A., & Bru, E. (2014). Effects of scheduled exercise on cancer-related fatigue in women with early breast cancer. The Scientific World Journal, 2014, 271828. 

Study Purpose

To compare the effects of a scheduled, home-based exercise intervention to the effects of advising patients to exercise on fatigue, physical fitness, and physical activity level

Intervention Characteristics/Basic Study Process

Patients who had surgical treatment and were receiving adjuvant chemotherapy for breast cancer were randomly assigned to the scheduled exercise or control comparison groups. The intervention combined resistance and aerobic exercise with resistance bands and strength training three times per week along with 30 minutes of brisk walking daily. Those in the experimental group received motivational phone calls every two weeks. Patients in the control group were advised to continue their regular activity levels and had one follow-up phone call. Study measures were obtained at baseline, prior to chemotherapy, 8–24 weeks at the end of chemotherapy, and about six months after completing chemotherapy.

Sample Characteristics

  • N = 54
  • MEAN AGE = 52.2 years (SD = 9.3 years)
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: 88.4% of patients had stage I or II disease; 80.6% had college-level education;  81% were living with a partner, and about one half were employed full or part-time.

Setting

  • SITE: Single-site  
  • SETTING TYPE: Outpatient  
  • LOCATION: Norway

Phase of Care and Clinical Applications

  • PHASE OF CARE: Multiple phases of care

Study Design

Randomized controlled trial (RCT)

Measurement Instruments/Methods

  • Schwartz Cancer Fatigue Scale (SCFS-6)
  • International Physical Activity Questionnaire (IPAQ)
  • Six-Minute Walk Test (6MWT)
  • Exercise diary

Results

Fatigue scores increased significantly from baseline to the end of chemotherapy for all patients (p = .003) with no difference between groups. Fatigue returned to baseline levels after the end of chemotherapy with no difference between groups. A similar pattern was shown for all patients in physical fitness. There were no differences between groups in mean levels of physical activity per week, though there was a slight trend toward more exercise in the intervention group.

Conclusions

There were no additional effects of a scheduled home exercise program to reduce fatigue compared to individuals who were simply encouraged to maintain appropriate exercise levels.

Limitations

  • Small sample (< 100)
  • Risk of bias (no blinding)
  • Risk of bias (no appropriate attentional control condition)
  • Subject withdrawals ≥ 10%

Nursing Implications

Study findings show a pattern of fatigue such that fatigue increases significantly during chemotherapy and then declines after the end of treatment. Both groups of patients in this study performed exercise at general recommended levels, which likely accounts for the lack of differences in fatigue found. These results suggest that patients do not necessarily need to have scheduled approaches to exercise, and that encouraging patients to maintain at least moderate exercise levels can be effective. Nurses can encourage patients to maintain exercise and choose approaches that they prefer in order to maintain motivation for regular activity.

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Hurlow, A., Bennett, M.I., Robb, K.A., Johnson, M.I., Simpson, K.H., & Oxberry, S.G. (2012). Transcutaneous electric nerve stimulation (TENS) for cancer pain in adults. Cochrane Database of Systematic Reviews, 3, CD006276.

Purpose

To review and summarize the evidence regarding the effect of transcutaneous electric nerve stimulation (TENS) for management of cancer-related pain

The type of study is systematic review.

Search Strategy

Databases searched were MEDLINE, CINAHL, PEDro, AMED, EMBASE, PsycINFO, and the Cochrane Central Register of Controlled Trials.

An extensive listing of search terms per database are provided.

Studies were included in the review if they evaluated TENS-administered monophasic or biphasic pulsed electrical currents, reported on participants 18 years or older, and were randomized controlled trials (RCTs) not involving active treatment control.

Studies reporting on percutaneous interventions were excluded.

Literature Evaluated

The total of four references were retrieved.

The Jadad scale was used for evaluation as well as the Cochrane risk of bias tool.

Sample Characteristics

Three studies were included in the review; two studies were added to prior review of two studies.

Sample range across studies was 15–49, with a total of 68 patients included in the review.

Results

Results were inconclusive due to lack of suitable RCTs for inclusion. One study indicated that bone pain may improve with TENS, but this was not well designed and underpowered. Two studies showed no significant difference with TENS.

Conclusions

No conclusions regarding the effectiveness of TENS can be made.

Limitations

  • The review included few studies with variable quality.
  • Studies were underpowered.

Nursing Implications

There is insufficient evidence to determine whether TENS is effective for management of pain in patients with cancer.

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