Griffiths, R.R., Johnson, M.W., Carducci, M.A., Umbricht, A., Richards, W.A., Richards, B.D., . . . Klinedinst, M.A. (2016). Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial. Journal of Psychopharmacology, 30, 1181–1197.
Study Purpose
To examine the effect of two psilocybin doses on symptoms of anxiety and depression among patients with advanced cancer
Intervention Characteristics/Basic Study Process
Participants were assigned to two groups: one received low-dose psyilocybin in the first session and high-dose psyilocybin in a second session. The other group received psilocybin doses in reverse order. The first session was done about one month after study entry, and the second session was five weeks later. Study measures were obtained at baseline, during, and at the end of each session, and approximately six months later. Session monitors met with patients prior to sessions to establish rapport and prepare the patient for the sessions. Drug session were done in a living room-like environment with two monitors present.
Sample Characteristics
- N: 56 (46 at 6 months)
- MEAN AGE: 56.3 years (SD = 1.4)
- MALES: 51%
- FEMALES: 49%
- CURRENT TREATMENT: Not applicable
- KEY DISEASE CHARACTERISTICS: All had life-threatening cancer diagnoses and DSM-IV diagnoses of anxiety or mood symptoms Various tumor types
- OTHER KEY SAMPLE CHARACTERISTICS: 69% married, 47% used cannabinoids, 51% had prior medication for anxiety or depression. Almost all had at least a college education
Setting
- SITE: Single site
- SETTING TYPE: Outpatient
- LOCATION: Johns Hopkins, Maryland
Phase of Care and Clinical Applications
- PHASE OF CARE: End-of-life care
- APPLICATIONS: Palliative care
Study Design
Crossover, double blind, randomized study
Measurement Instruments/Methods
- Cardiovascular monitoring during sessions
- Session monitor ratings of participant behaviors and mood throughout session
- Hallucinogen Rating Scale
- 5 Dimension Altered States of Consciousness
- Mysticism Scale
- States of Consciousness Questionnaire
- Mystical Experience Questionnaire
- GRID-HAM-D-17 (for depression)
- HAM_A (for anxiety)
- Beck Depression Inventory
- Hospital Anxiety and Depression Scale
- POMS
- Spiritual Religious Outcomes Scale
- STAI State trait anxiety
Results
There were no serious adverse effects of the intervention. There were transient moderate increases in blood pressure after psilocybin. Transient psychological distress was seen in some patients with high-dose psilocybin. All measures of depression, anxiety, and total mood disturbance showed significant improvement with high dose (p < 0.001). Death acceptance and optimism also were increased with high-dose intervention (p < 0.01). These changes were maintained at 6 months.
Conclusions
High-dose psilocybin under supportive conditions was shown to decrease symptoms of depression and anxiety, and improve mood, optimism, acceptance of death and spirituality. These effects were generally maintained for months after drug use.
Limitations
- Small sample (< 100)
- Risk of bias (no control group)
- Measurement validity/reliability questionable
- Intervention expensive, impractical, or training needs
- Other limitations/explanation: Subjects took a large battery of tests repeatedly raising the question of possible testing affect and subject fatigue. The intervention was provided in a controlled supportive environment
Nursing Implications
Administration of psilocybin under controlled supportive conditions was shown to have multiple benefits for patients with terminal cancers. Further confirmatory research is warranted, and research comparing outcomes with psilocybin to other appropriate interventions would be helpful.
Gregoire, C., Bragard, I., Jerusalem, G., Etienne, A.M., Coucke, P., Dupuis, G., . . . Faymonville, M.E. (2017). Group interventions to reduce emotional distress and fatigue in breast cancer patients: A 9-month follow-up pragmatic trial. British Journal of Cancer, 117, 1442–1449.
Study Purpose
To determine the long-term (nine months) effectiveness of three different group interventions compared to usual care for patients with breast cancer
Intervention Characteristics/Basic Study Process
Participants were allowed to select one of three groups to receive either cognitive behavioral therapy, yoga, and self-hypnosis. People who declined to participate were in a control group. Measurements were taken T0 through T3 to include before and after the short-term interventions, at month 3, and at month 9 follow-up.
Sample Characteristics
- N =123 total; 21 yoga, 67 self-hypnosis (after dropouts and one who died), 10 CBT, 24 control group
- AGE: 27-73 across all groups
- FEMALES: 100%
- CURRENT TREATMENT: Not applicable; mixed numbers of patients who had surgery, chemotherapy, radiation therapy, and hormonal therapy
- KEY DISEASE CHARACTERISTICS: Non-metastatic breast cancer; 18 months postdiagnosis
- OTHER KEY SAMPLE CHARACTERISTICS: Inclusion criteria were at least 18 years old and can read, speak, and write French
Setting
- SITE: Not stated/unknown
- SETTING TYPE: Not specified
- LOCATION: Belgium
Phase of Care and Clinical Applications
PHASE OF CARE: Multiple phases of care
Study Design
Three group intervention self-selection; testing at T0, T1, T2 (month 3), T3 (month 9)
Measurement Instruments/Methods
Demographics; medical history; Hospital Anxiety Depression Scale (anxiety and depression emotional distress); Quality of Life 30-item questionnaire (fatigue); Insomnia Severity Index (sleep quality)
Results
Only results from baseline (T0) and the month 9 follow-up (T3) were reported using MANOVA with repeated analysis and post-hoc analysis.
Post-hoc comparisons of time T0-T1: hypnosis group showed significant decreases in anxiety (p = 0.000), depression (p = 0.004), and fatigue (p = 0.045). Yoga group showed significant decrease in anxiety (p = 0.01).
Post-hoc comparisons of time at T3: hypnosis group showed decreases in anxiety (p = 0.000), depression (p = 0.000), and fatigue (p = 0.002); yoga group showed decrease in anxiety (p = 0.024).
Conclusions
Self-hypnosis led to improvements in anxiety, depression, and fatigue. Anxiety improved in the yoga group. There were no improvements in the CBT or control groups.
Limitations
- Small sample (< 100)
- Risk of bias (no random assignment)
- Other limitations/explanation: Control group included some of the non-consenters
Nursing Implications
Two of the three interventions may be helpful in reducing anxiety, depression, or fatigue when measured at nine months. Self-hypnosis may help patients improve emotional distress such as depression and anxiety, and may also reduce fatigue; yoga may also help improve anxiety. Larger samples and longer follow-up studies are needed.
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Aromatherapy - Sleep-Wake Disturbances
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Acupuncture/Electroacupuncture - Cognitive Impairment
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Cognitive Training - Cognitive Impairment
Rogers, L.Q., Courneya, K.S., Anton, P.M., Verhulst, S., Vicari, S.K., Robbs, R.S., & McAuley, E. (2017). Effects of a multicomponent physical activity behavior change intervention on fatigue, anxiety, and depressive symptomatology in breast cancer survivors: Randomized trial. Psycho-Oncology, 26, 1901-1906.
Study Purpose
To determine the effectiveness of a three-month intervention which includes a multicomponent physical activity change intervention on the symptoms of fatigue, depressive symptoms, and anxiety
Intervention Characteristics/Basic Study Process
Better Exercise Adherence after Treatment for Cancer (BEAT Cancer). Twelve supervised exercise sessions with an exercise specialist that were tapered over the first six weeks to an exclusively unsupervised home-based program. Face-to-face update counseling session with exercise specialist every two weeks during the final six weeks. Exercise and heart rate monitor sheets were provided to those who were randomized to the intervention. Group sessions for the participants. Those randomized to control received care as usual, which included handouts and publicly available printed materials.
Sample Characteristics
- N = 222
- MEAN AGE: 54.4 years
- FEMALES: 100%
- CURRENT TREATMENT: Radiation, Other
- KEY DISEASE CHARACTERISTICS: Breast cancer, finished with adjuvant therapy except for adjuvant hormonal therapy
- OTHER KEY SAMPLE CHARACTERISTICS: 98% non-Hispanic, 84% White, 11% DCIS, 42% stage I, 35% stage II, 12% stage III, 54 mean months since cancer diagnosis, 58% had chemotherapy, 68% had radiation therapy, 50% were on adjuvant hormonal therapy.
Setting
- SITE: Multi-site
- SETTING TYPE: Outpatient
- LOCATION: Two midwestern and one southeastern academic institutions
Phase of Care and Clinical Applications
PHASE OF CARE: Late effects and survivorship
Study Design
Randomized control trial
Measurement Instruments/Methods
Measurements happened at baseline, immediately postintervention, month 3, 3 months after intervention completion, and month 6. Instruments used were the Fatigue Symptom Inventory and the 14-item Hospital Anxiety and Depression Scale
Results
Adjusted linear mixed‐model analyses demonstrated significant effects of BEAT Cancer versus usual care on fatigue intensity (month 3 mean between group difference [M] = −0.6; 95% confidence interval [CI] [−1, −0.2]; effect size [d] = −0.32; p = 0.004), fatigue interference (month 3 M = −0.8; CI [−1.3, −0.4]; d = −0.4; p < 0.001), depressive symptomatology (month 3 M = −1.3; CI [−2, −0.6]; d = −0.38; p < 0.001), and anxiety (month 3 M = −1.3; CI [−2, −0.5]; d = −0.33; p < 0.001). BEAT Cancer effects remained significant at month 6 for all outcomes.
Conclusions
This intervention reduced fatigue, depressive symptomatology, and anxiety up to three months postintervention compared to treatment as usual.
Limitations
Intervention expensive, impractical, or training needs
Nursing Implications
Nurses can safely recommend exercise as tolerated to breast cancer survivors who have completed adjuvant treatment. There are several exercise programs widely available, including Livestrong and STARS Cancer rehabilitation programs.
Packel, L., Fang, C.Y., Handorf, E., & Rodoletz, M. (2017). A 12-week exercise and stress management pilot program from theory through implementation and assessment. Rehabilitation Oncology, 35, 172–180.
Study Purpose
The purpose of the study was to assess the response of an exercise, education, and stress management program (12 weeks) on fatigue levels of community-dwelling cancer survivors.
Intervention Characteristics/Basic Study Process
12-week program that consisted of 10 weeks of supervised moderate-intensity aerobic and strength training combined with 2 unsupervised weeks of home exercise. Supervised weeks included 1 in-person and 2 at-home sessions. Participants also received education on nutrition, stress management (mindfulness), and sleep.
Sample Characteristics
- N = 16
- MEAN AGE: 68.5 years
- MALES: 38%
- FEMALES: 62%
- CURRENT TREATMENT: Not applicable
- KEY DISEASE CHARACTERISTICS: Some patients were receiving active treatment and some were in survivorship
- OTHER KEY SAMPLE CHARACTERISTICS: 24% of patients had breast cancer
Setting
- SITE: Single site
- SETTING TYPE: Outpatient
- LOCATION: Philadelphia area
Phase of Care and Clinical Applications
PHASE OF CARE: Late effects and survivorship
Study Design
Single arm, pre-/post-test design
Measurement Instruments/Methods
FACT-Fatigue, HADS, NCCN Distress Thermometer, 6-Minute Walk Test, and Sit-to-Stand Test
Results
Significant improvements were noted in fatigue (p = 0.008), physical well-being (p = 0.004), and in the anxiety subscale scores of the HADS (p = 0.047). Increases in 6MWT distance (p = 0.002) and Sit-to-Stand Test score (p = 0.018) were also observed. Significant reductions in psychological distress were found (p = 0.003); however, no significant changes were observed in emotional well-being (p = 0.855), social well-being (p = 0.327), or depression (p = 0.221).
Conclusions
The program had some barriers to recruitment and retention but was able to identify a statistically significant improvement in fatigue, physical well-being, and anxiety as well as increased in the 6MWT distance and Sit-to-Stand Test score.
Limitations
- Small sample (< 30)
- 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)
Nursing Implications
Exercise, stress management, and behavior change are moderately feasible and may have an impact on cancer-related fatigue and anxiety. Larger studies are needed to confirm these results.
Cobeanu, O., & David, D. (2018). Alleviation of side effects and distress in breast cancer patients by cognitive-behavioral interventions: A systematic review and meta-analysis. Journal of Clinical Psychology in Medical Settings, 25, 335–355.
Purpose
- STUDY PURPOSE: Ascertain the effect of cognitive-behavioral interventions (CBI) in patients with breast cancer during active treatment for breast cancer; determine effect sizes on side effects of treatment, distress, and quality of life; determine moderators of effect size.
- TYPE OF STUDY: Meta-analysis and systematic review
Search Strategy
- DATABASES USED: PsycINFO and MEDLINE
- YEARS INCLUDED: 1996-2012
- INCLUSION CRITERIA: Randomized control trial to assess the efficacy of CBI in side effect management of breast cancer during treatment. Interventions studied were started upon treatment initiation or before completion of treatment. The study must have included a control group, was in English, and publications were from a peer-reviewed journal. Paper must have sufficient data to compute an effect size
- EXCLUSION CRITERIA: Studies that focused on alleviation of surgical side effects; studies that investigated CBI use in physical symptoms not associated with treatment side effects.
Literature Evaluated
- TOTAL REFERENCES RETRIEVED: 786
- EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Criteria applied for inclusion in meta-analysis were listed in publication. There was no method to assess the risk of bias in individual studies and no report of the quality of studies included.
Sample Characteristics
- FINAL NUMBER STUDIES INCLUDED: 19
- TOTAL PATIENTS INCLUDED IN REVIEW: 2,220
- SAMPLE RANGE ACROSS STUDIES: 34-303
- KEY SAMPLE CHARACTERISTICS: Patients with breast cancer receiving neo-adjuvant or adjuvant treatment.
Phase of Care and Clinical Applications
PHASE OF CARE: Active anti-tumor treatment
Results
Overall, results demonstrated a modest but statistically significant effect on side effect improvement (p = 0.005) with CBI. More specifically, CBI was associated with statistically significant improvements in nausea and vomiting (p < 0.001), overall distress (anxiety and depression, mood, stress, hostility) (p < 0.001), anxiety (p = 0.001), and quality of life (p < 0.001). The review results found non-significant effects on fatigue (p = 0.63), sleep disturbance (p = 0.314), pain (p = 0.854), and depression (p = 0.063). The authors hypothesized that this lack of significance could be due to low power of analysis across the studies on fatigue, sleep, and pain, as well as lack of tailored interventions specific to those symptoms. Lack of significance for CBI on depression could be due to failure to pre-screen participants for depression prior to beginning the intervention.
Conclusions
CBI is effective in reduction of many physical and psychological distress symptoms, including nausea and vomiting, anxiety, and quality of life. Additional research are studies with larger sample sizes are needed to further validate findings. In addition, further research is needed to examine which CBI protocols are most effective for specific symptoms, as well as greater uniformity in the reporting of CBI interventions.
Limitations
- Limited number of studies included
- No quality evaluation
- High heterogeneity
- Inconsistency in reporting of intervention descriptors such as length of treatment and types of professionals administering the intervention
Nursing Implications
CBI has efficacy in improving some physical and psychological symptoms and quality of life in breast cancer patients undergoing active therapy. It is important for nursing to assess and advocate for patients who may benefit from CBI and facilitate access to such interventions as part of the overall treatment plan.
Computerized Cognitive Rehabilitation
Cognitive rehabilitation involves behaviorally-oriented interventions designed to improve performance in cognitive and functional areas (Bray et al., 2017; Levine et al., 2000). Computerized cognitive rehabilitation is the provision of such practice via a computer program.
Transversus Abdominis Plane (TAP) Block
Transversus abdominis plane (TAP) block refers to the infiltration of local anesthetics into the fascial plane between the internal oblique and transversus abdominis muscles (Oh et al., 2017).