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Bragard, I., Etienne, A.M., Faymonville, M.E., Coucke, P., Lifrange, E., Schroeder, H., . . . Jerusalem, G. (2017). A nonrandomized comparison study of self-hypnosis, yoga, and cognitive-behavioral therapy to reduce emotional distress in breast cancer patients. International Journal of Clinical and Experimental Hypnosis, 65, 189–209.

Study Purpose

To compare the effects of self hypnosis, yoga, and cognitive-based therapy (CBT) on psychological and sleep patient outcomes

Intervention Characteristics/Basic Study Process

Women with non-metastatic breast cancer selected whether they wanted to participate in groups receiving CBT, self hypnosis, or yoga interventions. CBT included six weekly 90 minute group sessions led by trained psychologists. The yoga intervention included six weekly 90 minute group sessions of Hatha yoga and a DVD for use in home practice. Self-hypnosis sessions were 2 hours every two weeks for 12 weeks in small groups. The intervention included tasks and discussions inspired by CBT, with a 15 minute hypnosis exercise at the end of the session. They also received a CD with hypnosis exercises and homework assignments between sessions.

Sample Characteristics

  • N = 99   
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: All had breast cancer, about 33% participated during treatment with chemotherapy
  • OTHER KEY SAMPLE CHARACTERISTICS: On average, all had at least a high school education

Setting

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

Phase of Care and Clinical Applications

PHASE OF CARE: Multiple phases of care

Study Design

Prospective, non-random, three-group trial

Measurement Instruments/Methods

  • Hospital Anxiety and Depression Scale
  • EORTC-QLQ-C30
  • Mental adjustment to cancer scale
  • Insomnia Severity Index
  • Self-report of frequency of practice of interventions provided

Results

The majority of patient selected the hypnosis intervention. Anxiety and depression declined significantly in the yoga and hypnosis groups (p < 0.05). Fatigue and insomnia declined in the hypnosis group (p < 0.05). Most attended at least five sessions and practiced at least weekly at home. All three interventions showed medium effect sizes for change in anxiety (Cohen’s d range = 0.57-0.77).

Conclusions

Yoga and self-hypnosis group sessions were associated with decline in anxiety and depression. Self-hypnosis was also associated with improvement in sleep and fatigue scores.

Limitations

  • Small sample (< 100)
  • Baseline sample/group differences of import         
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Risk of bias (no appropriate attentional control condition)
  • Key sample group differences that could influence results
  • Intervention expensive, impractical, or training needs
  • Other limitations/explanation:  Only the CBT group did not have any material for home practice.  Sizes of the sample groups were vastly different, with only 10 people in the CBT group.  Though not statistically significant, the effect size for CBT was moderate, suggesting lack of significance was due to the small sample.  There was no differentiation between women currently in treatment and those not in treatment which could influence results -The hypnosis intervention included elements of CBT, so it is difficult to determine to what extent this versus the self hypnosis approach had effectiveness.  Provision of self hypnosis requires availability of appropriately trained providers.

Nursing Implications

Findings suggest that self hypnosis can be helpful to reduce anxiety, depression and insomnia in women with breast cancer.  If relevant resources are available to clinicians this could be a low risk and beneficial activity for symptom management.

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Bozcuk, H., Ozcan, K., Erdogan, C., Mutlu, H., Demir, M., & Coskun, S. (2017). A comparative study of art therapy in cancer patients receiving chemotherapy and improvement in quality of life by watercolor painting. Complementary Therapies in Medicine, 30, 67–72.

Study Purpose

To test the effect of painting art therapy, provided by a dedicated professional artist, on quality of life and anxiety and depression levels in patients receiving chemotherapy

Intervention Characteristics/Basic Study Process

Patients receiving treatment at an outpatient chemotherapy unit were recruited into the study for 12 weeks. Patients were classified by their exposure to the Painting Art Therapy Program (PATP). One group had prior exposure the the second did not. The third group were patients who declined participation and they were considered the control group. The study investigator who is an experienced art therapist conducted the therapy. Patients participated in watercolor painting and a discussion about the symbolic nature of the paintings, feelings, and thoughts. The investigator artist provided introduction to watercolor. During the chemotherapy infusion, the patient made watercolor paintings. After completions of the painting, patients discussed the meaning and subject of their painting. Patients in the intervention group were also given painting materials for home practice.

Sample Characteristics

  • N = 97 (65 in the PATP group and 32 in the control group)    
  • AGE: Mean = 50.6 years (range = 22-73)
  • MALES: 35%  
  • FEMALES: 56%
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: 54% metastatic cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: In the intervention group, 26 had prior exposure to PATP and 22 did not. The authors did not define what "prior expose" included.

Setting

  • SITE: Single site   
  • SETTING TYPE: Outpatient    
  • LOCATION: Antalya, Turkey

Phase of Care and Clinical Applications

PHASE OF CARE: Active anti-tumor treatment

Study Design

Comparative prospective study

Measurement Instruments/Methods

  • EORTC-QLQ-C30 questionnaire
  • Anxiety and depression scores (HADS)
  • Analysis of variance (ANOVA) with Bonferroni correction
  • Number of paintings finished by a patient (proxy motivation indicator)

Results

All patients reported liking the PATP to some extent. Change in global quality of life and depression scores differed significantly among the three groups (F = 7.87, p = 0.001; and F = 7.8, p = 0.001).  Correlates of change in depression were participation in PATP (F = 7.75, p < 0.001) and baseline depression scores (F = 17.71, p < 0.001). Predictors of the magnitude of change and change in depression were participation in PATP. Patients who had poorer well being showed better improvements by participating in PATP.  Previous exposure to PATP appeared to diminish the benefit obtained by PATP.

Conclusions

The authors showed improved quality of life and relief from depression in patients with the utilization of PATP. They authors demonstrated that watercolor can be an important form of art therapy in maintaining quality of life in patients with cancer. The application is feasible in the outpatient clinic. Patients demonstrated benefit of PATP in close relationship with basal global quality of life and depression scores. Because art is subjective, other forms of art therapy may target different patients more specifically.

Limitations

  • Small sample (< 100)
  • Baseline sample/group differences of import
  • Risk of bias (no random assignment)
  • Unintended interventions or applicable interventions not described that would influence results

Nursing Implications

Art therapy can be an important and feasible intervention for patients on active treatment. Participation in art therapy while receiving chemotherapy treatment can improve quality of life and contribute to decreased depression.

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Altay, N., Kilicarslan-Toruner, E., & Sari, Ç. (2017). The effect of drawing and writing technique on the anxiety level of children undergoing cancer treatment. European Journal of Oncology Nursing, 28, 1-6.

Study Purpose

To determine the effect of drawing and writing technique on the anxiety level of children treated for cancer during hospitalization.

Intervention Characteristics/Basic Study Process

A five-day therapeutic program to reduce anxiety of children in treatment for cancer was implemented to understand the effect of continuous therapeutic play. Drawing, writing, and mutual storytelling techniques were pre-arranged in the child’s room. Drawing supplies were given to the children. The State Anxiety Inventory was administered on the first day. Drawing was implemented on the first and third days. Children were asked to draw a picture of a child in the hospital and to write a self-created story with a beginning, a middle, and an end about his or her drawing. Mutual storytelling was implemented on the second and fourth days. While listening to the story of the child, the researcher analyzes the themes and psychological meaning for the child. The researcher responds with a story that is similar but has a more positive ending. On the fifth day, the State Anxiety Inventory is administered for the second time.

Sample Characteristics

  • N = 30   
  • AGE: Mean = 12.56 years (range = 9-16)
  • MALES: 7 (23%)  
  • FEMALES: 23 (77%)
  • CURRENT TREATMENT: Chemotherapy, combination radiation therapy and chemotherapy
  • KEY DISEASE CHARACTERISTICS: Leukemia, solid tumor, lymphoma
  • OTHER KEY SAMPLE CHARACTERISTICS: Had received two or more courses of chemotherapy; child and parent consent to participation

Setting

  • SITE: Single site   
  • SETTING TYPE: Inpatient    
  • LOCATION: Gazi University, Ankara, Turkey

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active anti-tumor treatment
  • APPLICATIONS: Pediatrics

Study Design

Quasi-experimental (pre- and postintervention evaluations of a single group)

Measurement Instruments/Methods

  • Descriptive data collection
  • State Anxiety Inventory
  • Wilcoxon test

Results

The five-day program was evaluated on the first and fifth day. The State Anxiety Inventory mean score (38.63 [SD = 4.38]) for children after the intervention decreased when compared to the mean beginning score (42.63 [SD = 4.64])  (Z = -4.57, p < 0.05). Only 2 of the 30 children wanted to keep the drawings after the intervention.

Conclusions

Drawing and writing and mutual storytelling techniques can be used to reduce the anxiety levels of children in treatment for cancer. The five-day program time interval and intervention could be implemented in future research.

Limitations

  • Small sample (< 30)
  • Risk of bias (no control group)
  • Risk of bias (no random assignment)
  • Unintended interventions or applicable interventions not described that would influence results
  • Other limitations/explanation: No information was provided on who implemented the writing and drawing program, although there is a mention of nursing staff or the "researcher" doing this but it was not made clear who this was and what training he or she had.

Nursing Implications

Writing and drawing can enable children to express their emotions and fears in an artistic format. Nurses should use these techniques to help uncover the hospitalized child’s anxiety. Training for interpretation and projective techniques in therapeutic communication with children would be helpful in hospital settings.

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Eyigor, S., Uslu, R., Apaydın, S., Caramat, I., & Yesil, H. (2018). Can yoga have any effect on shoulder and arm pain and quality of life in patients with breast cancer? A randomized, controlled, single-blind trial. Complementary Therapies in Clinical Practice, 32, 40–45.

Study Purpose

To examine the effects of yoga on shoulder and arm pain, quality of life (QOL), depression, and physical performance in patients with breast cancer

Intervention Characteristics/Basic Study Process

A 10-week Hatha yoga program was evaluated in this study. Hatha yoga is a mind-body exercise program of breathing exercises, flexibility, and relaxation components. The program in this study was supervised by a certified trainer and the session was taught at a beginner level. Sessions lasted one hour and were offered two days per week. All study participants (intervention and control) received education about cancer, lymphedema, and coping with ADLs. This included a booklet with information on exercises to stimulate lymph circulation. All participants were asked to practice these exercises twice a day.

Sample Characteristics

  • N = 42   
  • AGE: Mean age = 51.9 years
  • FEMALES: 100%
  • CURRENT TREATMENT: Not applicable
  • KEY DISEASE CHARACTERISTICS: Study participants had completed breast cancer treatment and had no evidence of disease. 
  • OTHER KEY SAMPLE CHARACTERISTICS: Study participants had not participated in a regular exercise program in the past six months.

Setting

  • SITE: Single site   
  • SETTING TYPE: Outpatient    
  • LOCATION: An academic medical center in Turkey

Phase of Care and Clinical Applications

PHASE OF CARE: Transition phase after active treatment

Study Design

Randomized controlled trial (RCT) with a usual care control group. Study outcomes were assessed by personnel blinded to the study assignment.

Measurement Instruments/Methods

Visual analog scale for pain, European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) questionnaire, Beck Depression Inventory, 6-minute walk test, and evaluation of lymphedema. Measures were completed pre- and post-treatment. Study measures were also completed at 2.5 months post-treatment, but because most of the control group did not show up for their follow-up visit, data for the control group were not included in the analysis.

Results

The two study groups did not differ significantly on demographic characteristics, types of breast cancer treatment, and baseline study measure scores. The yoga group demonstrated a significant improvement in pain severity from baseline to post-treatment for shoulder (p = 0.01) and arm (p = 0.01) pain; however, there was no significant difference between the yoga and control groups in regard to pre- and post-treatment pain. The yoga group’s improvement in pain severity was maintained at 2.5 months post-treatment (p = 0.01). There was no difference in depression, 6-minute walk, and QOL scores between groups from baseline to post-treatment. The yoga group demonstrated significantly improved QOL from baseline to 2.5 months post-treatment for functional (p = 0.01) and symptom (p = 0.03) scores, and improvement in their 6-minute walk time (p = 0.04). No evidence of worsening of lymphedema was found in either study group.

Conclusions

It is unclear if the yoga intervention truly relieved the shoulder and arm pain of the women with breast cancer since the control group also experienced a decrease in pain severity from baseline to 10 weeks. Shoulder and arm pain may normally decrease over time for this patient population. However, the Hatha yoga program appears to be a safe intervention which could be recommended if patients are interested in pursuing it.

Limitations

  • Small sample (< 100)
  • Other limitations/explanation: The control group did not complete the 2.5 month follow-up questionnaires, so there is no comparison group for the yoga group findings at this time point.
     

Nursing Implications

Although Hatha yoga was not found to be more effective than usual care in relieving shoulder and arm pain, it appears to be a safe form of exercise. In addition, women in this study liked it as evident by the 95.5% adherence rate. Nurses should have an understanding of Hatha yoga so, if patients ask about it, they can explain that it is a safe form of exercise but its effectiveness in relieving pain needs to be studied further.

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Oh, T., Kim, J., Eom, W., Lee, S., Kim, D., Yim, J., . . . Kim, D.H. (2017). Effects of preoperative ultrasound-guided transversus abdominis plane block on pain after laparoscopic surgery for colorectal cancer: A double-blind randomized controlled trial. Surgical Endoscopy, 31, 127–134.

Study Purpose

To determine whether performing a preoperative ultrasound-guided transversus abdominis plane block is an effective pain control measure for laparoscopic surgery for colorectal cancer.

Intervention Characteristics/Basic Study Process

After anesthesia induction, the patient received 0.5 ml/kg of either 0.25% bupivacaine or normal saline, depending on their predetermined group assignment. Pain was assessed at rest and when coughing 1 hour after surgery, on post-op day 1, post-op day 2, and post-op day 3.

Sample Characteristics

  • N = 55   
  • AGE: 20-80 years old
  • MALES: 67%  
  • FEMALES: 33%
  • CURRENT TREATMENT: Not applicable
  • KEY DISEASE CHARACTERISTICS: Colorectal cancer 
  • OTHER KEY SAMPLE CHARACTERISTICS: Laparoscopic surgery for colorectal cancer pain

Setting

  • SITE: Single site   
  • SETTING TYPE: Inpatient    
  • LOCATION: National Cancer Center, Korea

Phase of Care and Clinical Applications

  • PHASE OF CARE: Diagnostic
  • APPLICATIONS:  Elder care, palliative care

Study Design

Randomized, double-blind, placebo-controlled trial

Measurement Instruments/Methods

Pain was measured using the numeric rating scale (NRS). Cumulative opioid use was recorded from post-anesthesia recovery, post-op day 1, post-op day 2, and post-op 3.

Results

Insignificant differences between the treatment group and control group exists when comparing post-op pain and opioid use.

Conclusions

When comparing the treatment group and control group, the differences in the postoperative pain assessments was not significant enough to support that receiving a transversus abdominis plane (TAP) block provides superior benefits.

Limitations

Small sample (< 100)

Nursing Implications

The purpose of this study was to determine whether performing a preoperative ultrasound-guided transversus abdominis plane block is an effective pain control measure for laparoscopic surgery for colorectal cancer. No differences were seen between the treatment and control group. Based on this study a transversus abdominis plane block requires additional research prior to being recommended in this indication.

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Mohamed, S.A.B., Abdel-Ghaffar, H.S., Kamal, S.M., Fares, K.M., & Hamza, H.M. (2016). Effect of topical morphine on acute and chronic postmastectomy pain: What is the optimum dose? Regional Anesthesia and Pain Medicine, 41, 704–710.

Study Purpose

To determine if using a different morphine amount in a morphine/bupivacaine combination would be more effective in pain management in patients after a radical mastectomy for breast cancer.

Intervention Characteristics/Basic Study Process

Registered clinical trial with 90 patients allocated to receive 10 ml plain bupivacaine 0.5% plus either 5, 10, or 15 mg morphine diluted with saline 0.9% to 20 ml and topically to mastectomy site prior to closing. The three groups were compared for the following: time to first postoperative analgesia; IV patient-controlled analgesia (PCA) morphine consumption; pain scores; hemodynamics; sedation; adverse events in first postoperative 48 hours; and Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) scores in first and third postoperative months. Each patient participated in two study phases: an initial two-day treatment phase (48 hours post-op), phase 1, followed by a one- and three-month follow-up, phase 2. All clinical staff and patients were blinded to treatment group assignment.

Sample Characteristics

  • N = 90   
  • AGE: Mean = 50.8 years (SD = 7.73) (morphine 5 mg: 50.43, SD = 7.84; morphine 10 mg: 49.83, SD = 7.78; morphine 15 mg: 52.13, SD = 7.65)
  • FEMALES: 100%
  • CURRENT TREATMENT: Not applicable
  • KEY DISEASE CHARACTERISTICS: Patients with breast cancer

Setting

  • SITE: Single site   
  • SETTING TYPE: Multiple settings    
  • LOCATION: Assiut University, Assiut, Egypt

Phase of Care and Clinical Applications

PHASE OF CARE: Active anti-tumor treatment

Study Design

Prospective, randomized, double-blind comparative study.

Measurement Instruments/Methods

Visual analog scale (VAS), analgesia time, cumulative morphine consumption in first 48 hours, LANSS pain scale

Results

There was a significant difference in analgesia-free time between the three groups. Morphine 15 mg had no patients requiring postoperative analgesics in the first 48 hours compared to 8 patients (27%) in the morphine 10 mg group and 19 patients (63%) in the morphine 5 mg group (p < 0.002). Regarding the time to analgesia use, the morphine 5 mg group was 7.31 hours (SD = 3.12) versus 14 hours (SD = 3.54) in the morphine 10 mg group (p < 0.000).

The morphine 15 mg group had the lowest LANSS recorded score in the first postoperative month when compared to the morphine 5 mg and 10 mg groups (1.1 [SD = 0.37] versus 5.76 [SD = 3.26] versus 4.73 [SD = 2.87], respectively) (p < 0.0001).

Conclusions

The increase in topical morphine (specifically up to 15 mg) in combination with bupivacaine, when compared to lower doses of morphine, has shown a decrease in postmastectomy pain through the reduction of analgesic use within 48 hours after surgery as well as lower LANSS scores within the first postoperative month.

Limitations

  • Small sample (< 100)
  • Risk of bias (no control group)

Nursing Implications

15 mg topical morphine with bupivacaine may decrease postoperative pain and reduce the rate of PMPS.

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Hagen, N.A., Cantin, L., Constant, J., Haller, T., Blaise, G., Ong-Lam, M., . . . Lapointe, B. (2017). Tetrodotoxin for moderate to severe cancer-related pain: A multicentre, randomized, double-blind, placebo-controlled, parallel-design trial. Pain Research and Management, 2017, 7212713.

Study Purpose

To compare the efficacy of tetrodotoxin (TTX) to placebo in patients with pain secondary to advanced cancer or treatment related to treatment of advanced cancer.

Intervention Characteristics/Basic Study Process

Patients with moderate to severe cancer pain for at least two weeks or longer were randomized to receive a dose of TTX 30 µg or placebo twice daily at least six hours apart for four consecutive days. Participants were then seen on days 5, 8, and 15 in clinic for safety and efficacy evaluations and then on a weekly basis for evaluation by phone or in clinic until pain returned to baseline level.

Sample Characteristics

  • N = 165 (intent to treat, N = 149)
  • AGE: 25-84 years
  • MALES: 43%  
  • FEMALES: 57%
  • CURRENT TREATMENT: Not applicable, other
  • KEY DISEASE CHARACTERISTICS: Any diagnosis of cancer; wide range of solid and other tumors
  • OTHER KEY SAMPLE CHARACTERISTICS: Aged 18 years or older, stable baseline pain score greater or equal to 4/10 (worst pain in past 24 hours based on BPI, no greater than a three-point differed between highest and lowest scores, and no greater than 50% change in opioid analgesic use without addition of new analgesic), and all had a history or analgesics and maintained the regimens of opioids and co-analgesics. Exclusions: Clinically relevant hypoxia or history of CO2 retention, severe renal impairment, prolonged QTc, plan for initiation of a new anticancer therapy, and female with positive pregnancy test.

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Multiple settings    
  • LOCATION: Full-service hospital or private clinic in Canada, Australia, or New Zealand

Phase of Care and Clinical Applications

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

Study Design

Multi-center, randomized, double-blind, placebo-controlled, parallel-design trial

Measurement Instruments/Methods

Brief Pain Inventory form completed, patient diary

Results

Clinical benefit of TTX over placebo with estimate effect size of 16.2% (p = 0.046) after adjustment with Holm method, p value was nominally significant for two primary endpoints but not at the prespecified two-side 5% level.  Average analgesic response was 57.6 days with TTX compared to placebo at 9.9 days; however, when pain was combined with QOL, there was not a statistically significant difference between those treated with TTX and those with placebo.

Conclusions

TTX administration provides a potential option for uncontrolled moderate to severe cancer pain in patients with advanced cancer that is a non-opioid. TTX provides a different approach to pain via the mechanism of action. However, this drug does not come without side effects/potential adverse effects and, while clinical significance has been demonstrated, this is a modest benefit. The pain reduction was only nominally statistically significant and because of statistical penalties for multiplicity, the study is not considered statistically positive. Therefore, additional study is needed to determine the usefulness of TTX for clinical practice, particularly in those who require high doses of opioids to manage their pain.

Limitations

Other limitations/explanation: Conflict of interest: funded by Wex Pharmaceuticals; several doctors received operational funding, Dr. Hagen received honorarium, and some of the authors are employees or consultants for Wex Pharmaceuticals. Patients could be on existing pain regimens, unsure if fixed dosing or not

Nursing Implications

Patients would have to receive via subcutaneous injection. In the study, there were no fatalities and seemed to have a favorable benefit/risk profile. Non-opioid option, although mishandling could cause devastating consequences (TTX can cause paralysis and be fatal in high doses). Patients on high doses of opioids are poor candidates for TTX.

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