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Koul, R., Dufan, T., Russell, C., Guenther, W., Nugent, Z., Sun, X., & Cooke, L. (2007). Efficacy of complete decongestive therapy and manual lymphatic drainage on treatment-related lymphedema in breast cancer. International Journal of Radiation Oncology, Biology, Physics, 67(3), 841–846.

Intervention Characteristics/Basic Study Process

Researchers analyzed the medical records for 250 patients referred for lymphedema treatment during the first two years of the program and included 138 in the final analysis. Patients were included if their affected arms were larger than their unaffected arms at baseline and one-year follow-up measurements were available. Pre- and postvolumetric measurements were compared. The correlation with age, body mass index, and type of surgery, chemotherapy, and radiotherapy was determined. Treatment was stratified on the basis of the treatment modality used for breast cancer management. The therapy could include all four components of complete decongestive therapy (CDT) or only some components were omitted at the discretion of the therapists. Fifty-five percent of patients received all four components and 32% manual lymph drainage (MLD) alone. Thirteen percent with mild lymphedema received instructions and counseling for the home program, which included self-administered lymph drainage and exercises. All patients received compression wraps during the intensive phase.

Sample Characteristics

The mean age of patients in the sample was 54.3 years.

Setting

The study was conducted at an outpatient lymphedema clinic staffed by two certified Vodder therapists in Winnipeg.

Measurement Instruments/Methods

Circumference was measured from the wrist to axilla.  

Results

CDT and MLD with exercises were associated with a significant reduction in lymphedema volume. The mean affected arm pretreatment volume was 2,929 ml (range 1,474–5,879). The normal arm volume range was (1,320–4,299) with a mean volume of 2,531 ml. The mean difference at baseline was 398 ml. The number of MLD or CDT sessions was related to mastectomy (versus lumpectomy) and chemotherapy. After one year, absolute volume was reduced by 188 ml to 2,741 ml.

Conclusions

The study examines CDT and its components for a variety of patient needs and supports modifications of components of CDT and individualization of care.

Limitations

  • The study was not randomized. 
  • No control group was provided for the study.
  • Research relied on retrospective studies. 
  • The components could not be qualified.

Nursing Implications

Evidence supports a need for expert therapists.

Print

Koukourakis, G.V., Kelekis, N., Kouvaris, J., Beli, I.K., & Kouloulias, V.E. (2010). Therapeutics interventions with anti-inflammatory creams in post radiation acute skin reactions: A systematic review of most important clinical trials. Recent Patents on Inflammation & Allergy Drug Discovery, 4(2), 149–158.

Purpose

To investigate through a systematic review what topical treatments are currently advocated to manage acute skin reactions, including creams, ointments, and dressings, and what evidence there is to support the use of these treatments

Search Strategy

Databases used were  MEDLINE and Cochrane Central Register of Controlled Trials. Keywords searched radiation therapy, epidermis, acute skin reactions, and therapy. Studies were included if they

  • Were written in the English language
  • Were controlled trials
  • Provided information about the post-radiation acute skin reactions
  • Had patients who were eligible for treatment.

No exclusion criteria were identified in the article.

Literature Evaluated

Total references retrieved, evaluation method, and comments on the literature used were not reported.
 

Sample Characteristics

  • The final number of studies included in the review was 17, 15 studies in which an agent was used and 2 studies with washing only.
  • The total sample size across studies was 1,968 participants, with a range of 10–194 participants in one arm and 39–366 participants in an entire study.
  • Radiation sites included breast, head and neck, pelvic, chest, and abdomen.

Phase of Care and Clinical Applications

Patients were undergoing active treatment.

Results

  • Washing: Significant decrease in itching, erythema, and desquamation was found in the group that washed with soap and water. A higher incidence of moist desquamation was found in the no washing group (33%) as compared to the washing with soap and water group (14%). 
  • Aloe vera: One study showed a benefit at higher cumulative doses. Another showed no difference in maximum severity or time to onset of grade 2 radiodermatitis. Still another showed a detriment in that dry desquamation was higher in the aloe vera arm (70%) as compared to topical aqueous cream (41%). 
  • Biafine (trolamine): Two studies showed no significant decrease in skin reaction when comparing no treatment, Aquaphor, Lipiderm, and Biafine. A third study showed a decrease in grade 2 or greater skin reaction, pain, and treatment interruptions. 
  • Hyaluronic acid: Two studies showed a significant benefit (i.e., decreased severity and delayed onset of radiodermatitis) among patients receiving hyaluronic acid as compared to a placebo or unidentified control. 
  • Corticosteroids: Of two randomized, double-blinded studies using corticosteroid cream as a prophylaxis, the study by Bostrom et al. found a 25% compared to 60% incidence of grade IV radiation dermatitis (corticosteroid vs. emollient). The second study did not find significant results in favor of corticosteroid. Another study showed no significant difference between a corticosteroid cream and a placebo. Still another study showed a significant difference between a corticosteroid cream and clobetasone, but most of the patients in both arms experienced moderate-to-maximum skin reactions. 
  • Sulcrafate: A randomized study in head and neck cancer found no difference in erythema, but found a higher incidence of moist desquamation in the topical sulcrafate prophylaxis group. A large (N = 357) randomized study in head and neck (n = 107), breast (n = 229), and anorectal (n = 30) cancer by found no significant difference among the topical sulcrafate, topical aqueous cream, and no cream groups. Another study (N = 44) found a significant reduction in grade 2 radiodermatitis and more rapid healing in the topical sulcrafate group among patients with breast cancer. A different study (N = 39) compared topical sorbolene and sorbolene plus sulcrafate to manage grade 3 or greater skin toxicity and found no differences between the two groups. Another study showed no benefit of using oral sulcrafate as a prophylactic agent for late reaction in prostate cancer. A final study showed no benefit of using oral sulcrafate as a prophylactic agent in preventing skin reactions in head and neck cancer. 
  • Barrier film: A study compared No-Sting barrier film to topical sorbolene as prophylaxis for moist desquamation among patients with breast cancer, showed a significant benefit. Another study  (N = 50 ) examined the use of Dermofilm in reducing pain and irritation. “Favorable” results were reported, but a larger study was recommended.
  • Anti-microbials: No study results were found. The authors cautioned against using antimicrobials as a prophylactic agent related to our knowledge of drug resistance. 
  • Dressings: One study examined healing after radiation treatment among 18 patients and found the mean healing time was 13 days. There was no comparison arm. Another study compared the use of sliver leaf nylon dressings applied to the perineum of 15 patients with anal or gynecologic cancers to historic controls. Patients who received the silver leaf nylon dressings had significantly reduced incidence of grade 3 and 4 reactions. A different study (N = 60) showed a higher incidence of radiodermatitis in the sulcrafate arm among patients with head and neck cancer.  Another study (N = 44) showed a significant benefit to breast cancer patients. One very small study (N = 15) showed a benefit of using sliver leaf nylon dressings to reduce grade 3 and 4 radiodermatitis of the perineum among anal and gynecologic cancers.

Conclusions

Washing with soap and water consistently demonstrated a benefit. The evidence for the use of aloe vera is mixed with one study showing harm. Biafine did not demonstrate a benefit nor a harm. Hyaluronic acid showed a benefit. Corticosteroid showed mixed results, with one study showing favorable results, two showing no increased benefit, and one study showing mixed results. Most of the evidence on topical sulcrafate shows no increased benefit in preventing and managing radiodermatitis. Dermofilm, a barrier film, showed a significant benefit in reducing moist desquamation among patients with breast cancer in one small study.

Nursing Implications

Additional studies with a larger sample and a blinded randomized controlled design are needed.

Print

Kottschade, L.A., Sloan, J.A., Mazurczak, M.A., Johnson, D.B., Murphy, B.P., Rowland, K.M., . . . Loprinzi, C.L. (2011). The use of vitamin E for the prevention of chemotherapy-induced peripheral neuropathy: Results of a randomized phase III clinical trial. Supportive Care in Cancer, 19, 1769–1777.

Study Purpose

The aim of the study was to evaluate the efficacy of Vitamin E for the prevention of chemotherapy-induced peripheral neuropathy.

Intervention Characteristics/Basic Study Process

Patients who were to receive taxane or platinum-based chemotherapy were randomized to receive placebo or vitamin E 300 mg by mouth twice daily. Treatment was begun within four days of the first chemotherapy treatment and continued throughout treatment and for one month beyond completion of chemotherapy. Patient assessments were conducted at baseline, prior to each chemotherapy treatment, and at one and six months after chemotherapy.

Sample Characteristics

  • The total sample consisted of 189 participants, 82% female and 18% male.
  • Sixty-one percent of the total sample were older than age 50 years.
  • Participants had multiple tumor types. Breast cancer was most common (61%).
  • Ninety-four percent were Caucasian. 
  • Fifty-eight percent were receiving taxane and the rest were receiving a platinum-based compound.
  • Patients were excluded if anticoagulatns, opiods, anticonvulsants, or other treatments were used for neuropathic pain.
     

Setting

The study was conducted at multiple outpatient locations that were part of the North Central Cancer Treatment Group.

Phase of Care and Clinical Applications

Phase of care

  • Active antitumor treatment

Study Design

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

Measurement Instruments/Methods

  • NCI-CTCAE, version 3.0
  • Symptom experience diary
  • Neuropathic-specific questions
     

Results

 No significant differences were noted between groups regarding study outcomes.

Conclusions

The findings do not demonstrate an effect of Vitamin E oral supplements on peripheral neuropathy from chemotherapy.

Limitations

  • Measurement and methods were not well described.
  • Measurement validity and reliability was questionable.
  • Use and frequency of the patient diary are not well described.
  • There were no objective measures of neuropathy. 
  • No recognized self-report questionnaire was used.

Nursing Implications

 Findings do not support the use of Vitamin E to prevent chemotherapy-induced peripheral neuropathy. Nurses can guide patients regarding the evidence in this area.

Print

Kosugi, T., Hamada, S., Takigawa, C., Shinozaki, K., Kunikane, H., Goto, F., . . . Eguchi, K. (2014). A randomized, double-blind, placebo-controlled study of fentanyl buccal tablets for breakthrough pain: Efficacy and safety in Japanese cancer patients. Journal of Pain and Symptom Management, 47, 990–1000. 

Study Purpose

To examine the efficacy and safety of fentanyl buccal tablets (FBT) for treating breakthrough pain in patients with cancer

Intervention Characteristics/Basic Study Process

A dose titration of FBT was administered a maximum of four times. If ineffective, FBT was titrated to the next dose. In this double-blind study, nine tablets were prescribed, six being BTP and three a placebo. One tablet was taken per episode of breakthrough pain.

Sample Characteristics

  • N = 136  
  • AGE = 20 years or older
  • KEY DISEASE CHARACTERISTICS: Cancer-related pain
  • OTHER KEY SAMPLE CHARACTERISTICS: Japanese study

Setting

  • SITE: Multi-site    
  • SETTING TYPE: Inpatient    
  • LOCATION: Hospitals in Japan

Phase of Care and Clinical Applications

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

Study Design

Double-blinded, placebo-controlled study

Measurement Instruments/Methods

  • Self-recorded pain diary using an 11-point Numeric Rating Scale (NRS)
  • Questionnaire of subjects' impression of FBT

Results

A significant difference was observed between the treatment groups and the primary endpoint. The mean was 2.4 for FBT treatment and 2 for the placebo. Regarding the effectiveness of FBT in the questioner survey, 22 and 56 subjects responded that analgesic onset of FBT occurred within 15 or within 15–30 minutes postadministraion.

Conclusions

In this study, FBT was well-tolerated in patients with cancer and was shown to relieve breakthrough pain in patients receiving around-the-clock opioids.

Limitations

  • Among the subjects who started effective dose titration, no effective dose was identified for 28 if the subjects, and 10 subjects did not receive a sufficient effect for breakthrough pain.
  • Patients who did not complete the diary were still included.

Nursing Implications

FBT may be useful in cancer-related breakthrough pain with around-the-clock dosing of opioids.

Print

Kosaka, Y., Rai, Y., Masuda, N., Takano, T., Saeki, T., Nakamura, S., . . . Tamura, K. (2015). Phase III placebo-controlled, double-blind, randomized trial of pegfilgrastim to reduce the risk of febrile neutropenia in breast cancer patients receiving docetaxel/cyclophosphamide chemotherapy. Supportive Care in Cancer, 23, 1137–1143. 

Study Purpose

To determine the extent to which pegfilgrastim reduces the risk of febrile neutropenia (FN) in Japanese women with early-stage breast cancer receiving docetaxel and cyclophosphamide (DC) chemotherapy

Intervention Characteristics/Basic Study Process

Pegfilgrastim at 3.6 mg or a placebo was administered subcutaneously on day 2 (at least 24 hours after DC chemotherapy) of a 21-day cycle. The study compared the incidence of FN between the pegfilgrastim and placebo cohorts. The incidence of FN during the first cycle of chemotherapy, incidence of hospitalization related to FN, incidence of grade 4 neutropenia, and percentage of patients who received antibiotics as a result of FN also were tracked.

Sample Characteristics

  • N = 346
  • MEDIAN AGE = 50–51 years (range = 26–69 years)
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Stages I–III primary invasive breast cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: Not applicable

Setting

  • SITE: Multi-site  
  • SETTING TYPE: Not specified  
  • LOCATION: Japan

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

Randomized, double-blinded, controlled trial using pegfilgrastim versus a placebo

Measurement Instruments/Methods

FN was defined as an absolute neutrophil count < 500 and an axillary temperature at or above 37.5°C on the same day or the following day. Complete blood counts were checked on days 1, 2, 8, 11, and 15 during cycle 1 and on days 1, 2, 8, and 11 of subsequent cycles. Axillary body temperature was measured daily.

Results

Patients treated with pegfilgrastim experienced a significantly lower incidence of FN (1.2%) compared to those who received a placebo (68.8%; p < 0.001). The measurement of secondary endpoints also revealed significant differences between the two groups. None of the patients in the pegfilgrastim group required hospitalization for FN whereas 6.9% of the placebo group did (p < 0.001). Patients who received pegfilgrastim were significantly less likely to require antibiotics to treat FN (0.6%) than those in the control group (56.6%; p < 0.001). During the first chemotherapy cycle, only one patient (0.6%) in the pegfilgrastim cohort developed FN compared to greater than half (57.8%) of the placebo group (p < 0.001). Only 4% of the pegfilgrastim group developed grade 4 neutropenia during chemotherapy whereas all of the placebo group developed this grade (p < 0.001).

Conclusions

Previous studies demonstrated the value of pegfilgrastim in significantly reducing FN in European and North American patients with breast cancer receiving chemotherapy with docetaxel. This study confirmed the efficacy of pegfilgrastim (using a dose of 3.6 mg) for use in Japanese female patients with breast cancer receiving DC chemotherapy. These results suggest that additional studies should be designed to determine if the lower pegfilgrastim dose of 3.6 mg is not inferior to the standard 6 mg dose.

Limitations

  • Findings not generalizable
  • Other limitations/explanation: This study used pegfilgrastim at 3.6 mg, not the 6 mg that is the standard dose in the United States and Europe. The authors chose 3.6 mg for their study population because this dose has been demonstrated to be effective in reducing the incidence of FN following docetaxel, doxorubicin, and cyclophosphamide chemotherapy in Japanese patients.

Nursing Implications

The focus of this study was to demonstrate pegfilgrastim's efficacy in female Japanese patients with breast cancer, and it used a smaller pegfilgrastim dose than is commonly prescribed in the United States or Europe. Additional study is warranted to determine the appropriate dosage of pegfilgrastim for this particular population.

Print

Kosaka, Y., Tanino, H., Sengoku, N., Minatani, N., Kikuchi, M., Nishimiya, H., . . . Watanabe, M. (2015). Phase II randomized, controlled trial of 1 day versus 3 days of dexamethasone combined with palonosetron and aprepitant to prevent nausea and vomiting in Japanese breast cancer patients receiving anthracycline-based chemotherapy. Supportive Care in Cancer, 24, 1405–1411.

Study Purpose

To investigate if the use of a second-generation 5-HT3 receptor antagonist (palonosetron) and a NK1 receptor agonist (aprepitant) could allow a decreased dose of dexamethasone based on nausea and vomiting in patients with breast cancer receiving highly emetogenic chemotherapy

Intervention Characteristics/Basic Study Process

Randomization was to Group A: palonosetron IV plus dexamethasone IV with oral aprepitant on day 1 followed by 8 mg dexamethasone IV and 80 mg aprepitant PO on days 2 and 3. Group B received a placebo instead of dexamethasone on days 2 and 3. Patients were treated in the hospital.

Sample Characteristics

  • N = 80   
  • MEAN AGE = Group A: 53.5 years, Group B: 52.6 years
  • AGE RANGE = 35–76 years
  • FEMALES: 100%
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Chemotherapy naïve patients with breast cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: Six patients who were included had metastatic disease. Patients were chemotherapy naïve with confirmed breast cancer and older than 19 years. Patients received chemotherapy that included an anthracycline-cyclophosphamide combination.

Setting

  • SITE: Single site   
  • SETTING TYPE: Inpatient    
  • LOCATION: Japan

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment
  • APPLICATIONS: Elder care, palliative care 

Study Design

Phase-II, single-center, single-blind, placebo-controlled, parallel, randomized trial. Randomization was done on a one to one ratio using a minimization method.

Measurement Instruments/Methods

  • Self-report diary of nausea and vomiting
  • Chart extractions measuring emetic episodes and use of rescue medications
  • Adverse events were classified according to the Common Terminology Criteria of Adverse Events (CTCAE), version 4.0.
  • Patients were classified as having complete control if they used no rescue medications and had no emetic episodes and only mild nausea.
  • Complete response (CR) was defined as no emetic episodes and no rescue medication.  
  • Nausea was measured as none, mild, moderate, or severe, based on subjective patient reports.

Results

This study showed that complete control and CR revealed equivalent findings in acute and delayed chemotherapy-induced nausea and vomiting (CINV) with 1 day or 3 days of dexamethasone. No statistical differences were noted between both groups. Subgroup analysis looked at patients younger than 50 years. This also did not show any differences.

Conclusions

Using one dose of dexamethasone is feasible in treating CINV.

Limitations

  • Small sample (< 100)
  • Measurement validity/reliability questionable
  • Findings not generalizable
  • Uncertainty as to how patients were hospitalized for the duration of the study, but this certainly added to purer date 
  • The researchers relied on self-reports of nausea and vomiting and medical records of emesis, which can lead to underestimation if the nausea and/or vomiting was not documented.

Nursing Implications

Reducing the use of dexamethasone may be possible in treating CINV prospectively. This may be critical in uncontrolled diabetics.

Print

Korstjens, I., Mesters, I., van der Peet, E., Gijsen, B., & van den Borne, B. (2006). Quality of life of cancer survivors after physical and psychosocial rehabilitation. European Journal of Cancer Prevention, 15, 541–547.

Intervention Characteristics/Basic Study Process

This was a twelve-week outpatient rehabilitation program combining physical exercise and psycho-education and delivered in a group setting (12–16 participants per group). Physical training was led by two physiotherapists for two hours twice a week. Sessions aims included improving movement skills, improving strength and endurance, coping with fatigue, enhancing feelings of control, and reducing stress. Each session consisted of individual strength and endurance training (one hour) or a group sports activity (one hour), paired with 30 minutes of aqua aerobics. Each session of the group sports activity had a central theme (i.e., capability and cooperation, coordination, throwing and catching, social contact, winning and losing, relaxation). Psychoeducation sessions were led by oncology health professionals and aimed at providing support in coping with cancer and enhancing self-confidence and autonomy. Participants were provided with information on cancer-related subjects and encouraged to share their experiences as cancer survivors. Patient outcomes were assessed at baseline, week 6, and week 12.

Sample Characteristics

  • N = 658
  • MEAN AGE =50.6 years
  • AGE RANGE = 18–75 years
  • FEMALES: 77.8%
  • KEY DISEASE CHARACTERISTICS: Participants with mixed solid tumors and hematologic malignancies. Approximately 50% of the sample had the diagnosis of breast cancer.
  • OTHER KEY SAMPLE CHARACTERISTICS: The majority was married or lived together (77.7%), most had children (76.9%), about half were employed at the time of diagnosis (48.3%). At the start of rehabilitation, only one-fifth (15.8%) was actually at work. The sample was a mean of 1.3 years from the conclusion of treatment, with a range of 0–14 years following treatment.
  • EXCLUSION CRITERIA: Physically at risk owing to cancer or serious comorbidity, serious cognitive disturbances, restricting side effects of medication, or if needing more complex rehabilitation

Study Design

  • Longitudinal single-arm cohort design
    • No comparison group

Measurement Instruments/Methods

  • EORTC QLQ-C30

Results

After six weeks, participants in the intervention group experienced a significant decline in fatigue (p < 0.001) in comparison to baseline measurements. After 12 weeks, participants experienced an even greater decline in fatigue (p < 0.0001) in comparison to baseline measurements.

Limitations

  • Unable to determine the benefits of exercise and psychoeducation components of intervention separately
  • Lack of a neutral comparison group; therefore, unable to determine whether improvements in quality of life were a direct result of the rehabilitative program
  • Long-term effects were not assessed in the study

Nursing Implications

Future research should incorporate objective physical strength and endurance tests and validated measurement instruments for more specific psychosocial parameters.

Print

Korstjens, I., Mesters, I., van der Peet, E., Gijsen, B., & van den Borne, B. (2006). Quality of life of cancer survivors after physical and psychosocial rehabiliation. European Journal of Cancer Prevention, 15(6), 541–547.

Study Purpose

This 12-week physical fitness and psychoeducational rehabilitation program was conducted to enhance quality of life and recovery among cancer survivors of all types of cancer. Its physical fitness component was aimed at improving movement skills, strength, and endurance; helping participants cope with physical complaints (e.g., fatigue); and enhancing feelings of control and stress reduction. Its psychoeducational component was aimed at providing support in coping with cancer and enhancing self-confidence and autonomy.

Intervention Characteristics/Basic Study Process

 The intervention had three components.  

1. A physical fitness program involving two hours of training twice weekly with guidance from two expert physiotherapists. Each session consisted of

  • One hour of individual training for endurance and strength or one hour of group sports and games
  • 30 minutes of aqua-aerobics in an indoor pool.

2. A psychoeducational program consisting of seven two-hour sessions aimed at providing support in coping with cancer and enhancing self-confidence and autonomy.

3. Information on cancer-related subjects.

Subjective measures were completed prior to the intervention, 6 weeks into the intervention, and at 12 weeks at the intervention's end. 

Sample Characteristics

  • The number of enrolled participants was 665. Of the enrolled participants, 658 initiated the program, 634 completed 6 weeks of the program, and 579 completed the program's full 12 weeks. 
  • The average age of the participants was 50.6 ± 9.5 years, with a range of 18–75 years.
  • 54% of the participants had breast cancer. Other cancers included were lymphoma, digestive tract, gynecologic, and lung cancer.
  • 77.8% of the participants were female and 21% were male. Gender was unknown for 1.2% of the participants. 
  • The average time since diagnosis was 2.1 years, with a range of 0–25 years.
  • The average time since end of treatment was 1.3 years, with a range 0–14 years.

Setting

This was a single-site study. 

Study Design

This was a prospective trial. 

Measurement Instruments/Methods

The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-30 (EORTC QLQ-C30) was used to measured global and functional quality of life using 6 subscales (global, physical, role, cognitive, emotional, social functioning) and one symptom scale on fatigue. Scores range from 0–100, with higher scores indicating higher quality of life for the global and functional scales. Higher symptom scores indicate greater fatigue.

The Tampa Kinesophobia Scale was used to measure excessive, irrational and debilitating fear of physical movement and activity resulting from a feeling of vulnerability to painful injury or re-injury. Two subscales were used to measure avoidance of activities (7 items) and pathologic somatic focus (4 items).

Results

As measured by two items on the EORTC QLQ–C30, cognitive function improved at 12 weeks, but not at 6 weeks. There were significant improvements for all quality-of-life domains and fatigue for all cancer patients after 12 weeks (p < 0.05).

Conclusions

The authors suggest that exercise may improve cognitive functioning as well as other quality-of-life domains.

Limitations

  • Although subjective cognitive function improved over 12 weeks, this finding was not confirmed by objective cognitive-specific measures.
  • A wide range of ages was included in the sample, but no age breakdown was recorded for the two cohorts; ge-related changes in cognitive function may influence the results between the two cohorts.
  • The authors were unable to determine whether changes in quality of life were a result of the exercise versus the psychoeducational intervention or the combination of both.
  • There was no control group as a comparison. 
Print

Korstjens, I., Mesters, I., May, A.M., van Weert, E., van den Hout, J.H., Ros, W., . . . van den Borne, B. (2011). Effects of cancer rehabilitation on problem-solving, anxiety and depression: A RCT comparing physical and cognitive-behavioural training versus physical training. Psychology and Health, 26(Suppl. 1), 63–82.

Study Purpose

To examine the effects of physical therapy (PT) versus physical therapy plus cognitive behavioral therapy (CBT) interventions on problem solving, anxiety, and depression in patients with cancer

Intervention Characteristics/Basic Study Process

Consecutive groups of patients referred to rehabilitation centers were randomly assigned to receive either PT or PT and CBT programs for 12 weeks. PT consisted of twice weekly two-hour sessions of aerobic training, muscle-strength training, and group sports and games. CBT sessions were provided in a group format in which participants learned to apply self-management skills in striving for personal goals. Psychologists gathered self-evaluations regarding the extent to which patients adhered to the intervention protocol, and the process was evaluated via case records. Study measures were obtained at baseline, 12 weeks postrehabilitation, and three and nine months postintervention. After week 6, patients started a home-based walking program.

Sample Characteristics

  • A total of 147 participants were analyzed, with 132 completing rehabilitation.
  • Mean age of participants was 48.8 ± 10.9.
  • The sample was 16.3% male and 83.7% female.
  • Of the sample, 55.8% had breast cancer, all had completed treatment at least three months prior to inclusion, and the average time since treatment was 1.7 years.
  • Nearly 71% were married and living with a spouse, and 86.4% had middle to high levels of education. 
  • At baseline, less than one-third had anxiety or depression scores indicating clinically relevant symptoms.

Setting

  • Multisite
  • Setting unspecified
  • Dutch rehabilitation centers

Phase of Care and Clinical Applications

  • Transition phase after initial treatment
  • Late effects and survivorship

Study Design

Prospective, single-blinded, randomized, two-group trial design

Measurement Instruments/Methods

  • Social Problem-Solving Inventory–Revised    
  • Hospital Anxiety and Depression Scale (HADS)

Results

Overall baseline anxiety and depression scores of participants were significantly higher than those in the general Dutch population (p < 0.001). Immediately after the 12-week program, both groups showed small to moderate effect-size reduction in anxiety (0.45–0.55 [p < 0.001]) and depression (0.44–0.59 [p < 0.001]). At three and nine months, average effects, as measured by HADS score, continued to be lower than baseline, with effect sizes ranging from 0.24 to 0.4. Participants in both groups showed comparable changes in problem solving, anxiety, and depression. Subgroup analysis between those with initially higher and lower levels of distress showed no difference in changes in problem solving. Patients with higher distress, in both intervention groups, showed significant reduction in anxiety (p < 0.01) and depression (p < 0.01) at all study time points. At all measurement points, patients with lower distress at baseline showed levels of distress in keeping with those of the general population.

Conclusions

Study findings did not show that the addition of CBT to PT resulted in effects on problem solving, anxiety, or depression that were greater than the effects of PT alone. Findings did not support the hypothesis that the addition of CBT would be of greater benefit for individuals who had higher distress levels initially. Study findings show beneficial effects of PT on anxiety and depression.

Limitations

  • The study had no appropriate control group.
  • Subgroup analysis was done according to overall distress levels, then compared to outcomes regarding anxiety and depression. These are different concepts and patient experiences. Subgroup analysis would have been more relevant if researchers had compared actual anxiety and depression levels to each other, respectively. 
  • The study provides no information about attendance rates for sessions, the amount of exercise continued after the initial 12-week session, or adherence to the home-based walking intervention.

Nursing Implications

Findings if this study support other findings regarding beneficial effects of physical activity in a supervised group setting. Findings of this study suggest that the addition of specific CBT interventions may not increase these effects. Analysis of results in those who had high versus low levels of distress demonstrates that those with low distress do not show a benefit.

Print

Koopmans-Klein, G., Wagemans, M.F., Wartenberg, H.C., Van Megen, Y.J., & Huygen, F.J. (2015). The efficacy of standard laxative use for the prevention and treatment of opioid induced constipation during oxycodone use: A small Dutch observational pilot study. Expert Review of Gastroenterology and Hepatology, 10, 547–553. 

Study Purpose

To explore the effectiveness of standard laxative treatment in the prevention of oxycodone-induced constipation

Intervention Characteristics/Basic Study Process

From July 2013 to October 2013, standard laxative treatment consisting of polyethylene glycol (PEG) with electrolytes was started at the same time as opioid intake on day 1. Bisacodyl was prescribed, and patients took this as needed. Patients prescribed oxycodone at least 20 mg slow-release tables were started on the standard laxative treatment and followed for 28 days.

Sample Characteristics

  • N = 21  
  • MEDIAN AGE = 65 years
  • RANGE = 39-92 years
  • MALES: 42%, FEMALES: 58%
  • KEY DISEASE CHARACTERISTICS: There were chronic 23 with non-malignant pain and 1 patient with malignant pain.

Setting

  • SITE: Multi-site    
  • SETTING TYPE: Not specified    
  • LOCATION: Netherlands

Phase of Care and Clinical Applications

  • PHASE OF CARE: Multiple phases of care
  • APPLICATIONS: Elder care and palliative care

Study Design

  • Prospective, observational, pilot study

Measurement Instruments/Methods

  • Bowel Function Index (BFI), measured at the start and end of study
  • Bristol stool form scale (BSF), indicates type of stool, numerical pain score, laxative, and a responder analysis using the following criteria: decrease of BFI by 12 points or patient did not develop constipation AND patient did not develop diarrhea AND patient did not discontinue laxative treatment due to adverse events

Results

The dose of PEG and electrolytes varied between 0-3 sachets, and the bisacodyl dose varied from 5 mg-20 mg. Based on responder analysis criteria, 43% of patients (9 of 21) who were prescribed a standard laxative therapy regimen did not respond.

Conclusions

A standard laxative therapy regimen may not be effective in all patients given the type of opioid they may be prescribed and what their bowel function is at the start of opioid therapy.

Limitations

  • Small sample (less than 30)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Measurement/methods not well described
  • Findings not generalizable
  • Pilot study
  • Observational study

Nursing Implications

Response to prophylactic PEG plus electrolytes is patients taking oxycodone SR is variable.

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