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Obadina, E.T., Dubenske, L.L., McDowell, H.E., Atwood, A.K., Mayer, D.K., Woods, R.W., . . . Burnside, E.S. (2014). Online support: Impact on anxiety in women who experience an abnormal screening mammogram. Breast, 23, 743–748. 

Study Purpose

To evaluate the impact of a computer- and web-based tool on the anxiety of women who had an abnormal mammogram.

Intervention Characteristics/Basic Study Process

Patients were randomized in to a study group and comparison group. The study group received an email with instruction for using the Comprehensive Health Enhancement Support System (CHESS). The comparison group received a list of five credible breast imaging websites. Impact of CHESS evaluated anxiety and breast cancer worry and patient satisfaction with their physician interaction at three time points.

Sample Characteristics

  • N = 130  
  • AGE: Older than aged 21 years
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Recalled after a screening mammography
  • OTHER KEY SAMPLE CHARACTERISTICS: English literate; access to Internet

Setting

  • SITE: Single site    
  • SETTING TYPE: Outpatient    
  • LOCATION: University of Wisconsin Breast Center

Phase of Care and Clinical Applications

  • PHASE OF CARE: Diagnostic
  • APPLICATIONS: Elder care

Study Design

Pilot study; randomized intervention and comparison group

Measurement Instruments/Methods

  • State anxiety (SA) subscale of the State-Trait Anxiety Inventory (STAI)
  • The breast cancer worry subscale of the Lerman Breast Cancer Worry Scale (LBCWS)
  • Patient Satisfaction with Doctor Questionnaire (PSQ-MD)

Results

There was a significant difference in the anxiety scores for the intervention group at the biopsy stage (p = 0.02). There was no difference in the two groups at the diagnostic phase. There was no significant difference in the two groups for breast cancer worry.  Satisfaction with the physician was not analyzed because study participants had difficulty identifying who their physician was during the three time points.

Conclusions

Early CHESS may decrease anxiety in woman recalled for abnormal mammograms when combined with an identifiable care team.

Limitations

  • Risk of bias (no blinding)
  • Risk of bias (no appropriate attentional control condition)  
  • Risk of bias (sample characteristics)
  • Measurement/methods not well described

 

Nursing Implications

Providing resources to women with abnormal mammograms is most effective when a healthcare team interaction is provided to reduce anxiety. Online support system may have some benefit but additional research is needed to determine effectiveness for anxiety and other symptoms, and long-term efficacy needs to be examined.

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O'Toole, M.S., Zachariae, R., Renna, M.E., Mennin, D.S., & Applebaum, A. (2016). Cognitive behavioral therapies for informal caregivers of patients with cancer and cancer survivors: A systematic review and meta-analysis. Psycho-Oncology. Advance online publication. 

Purpose

STUDY PURPOSE: To evaluate the overall effect of interventions using cognitive behavioral therapy (CBT) components and to explore possible moderators of this effect, including trial design, outcomes evaluated, demographic variables, intervention duration and modality of delivery, illness-related variables among patients, and study quality

TYPE OF STUDY: Meta-analysis and systematic review

Search Strategy

DATABASES USED: PsycINFO, Cochrane, CINAHL, and Embase
 
INCLUSION CRITERIA: Peer-reviewed articles and articles that (a) investigated the effect of a CBT for informal caregivers (ICs) of patients with cancer or cancer survivors; (b) employed at least one quantitative measure of psychological, physical, or interpersonal functioning/well-being of the IC both pre- and postintervention; (c) enrolled adult samples aged 18 years or older; (d) reported results that could be converted into an effect size; and (e) were written in English. Articles about CBT if it included at least one of the following components: cognitive restructuring, imaginal or in vivo exposure, coping skills training, problem solving, behavior activation, behavioral experiments, structured homework, acceptance-based strategies, stress and anxiety management through relaxation, or mindfulness
 
EXCLUSION CRITERIA: Nonadult, non-English, after January 2014

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 1,131 retrieved, 163 eligible 
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 36
  • TOTAL PATIENTS INCLUDED IN REVIEW = 3,820 analyzed
  • KEY SAMPLE CHARACTERISTICS: Randomized, controlled trials (RCTs) (K = 27) comparing CBTs with a nonactive control condition (K = 21). Individual (as opposed to group) (K = 28) therapy for couples/dyads (K = 28), and delivered face-to-face (K = 22). Patients with mixed stages of cancer (K = 14). Twelve studies explicitly stated that the intervention adhered to a cognitive behavioral framework. The most commonly employed treatment components (see definition above) were coping skills training (K = 24), problem solving (K = 15), cognitive restructuring (K = 14), structured homework (K =11), and relaxation (K = 10).

Results

A small statistically significant effect of CBTs (Hedges' g = 0.08, p = 0.014) was revealed, which disappeared when RCTs were evaluated alone (Hedges' g = 0.04, p = 0.2). A number of variables were explored as moderators. Only the percentage of female participants was positively associated with the effect size. More specifically, females were more responsive to CBT interventions with an effect on physical health and mastery.

Conclusions

Based on the negligible effect of CBTs across outcomes, future studies should consider moving beyond traditional CBT methods, as these do not appear efficacious. Future interventions should orient toward advances in the basic affective sciences and derived therapies to better understand and treat the emotional struggles experienced by ICs.

Limitations

  • High heterogeneity
  • Low sample sizes
  • Variability in theoretical definition and use of CBT across studies

Nursing Implications

Translating CBT interventions to practice has been a challenge in the nursing discipline. These findings suggest that, although CBT techniques like problem solving could be meaningful, CBT may be one component of a mulitmodual intervention for the best effect for the family caregiver. Nurses should also recognize that gender may influence the possible benefit patients experience from a CBT intervention.

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O'Shaughnessy, J.A. (2007). Management of febrile neutropenia and cardiac toxicity in the adjuvant treatment of breast cancer. Clinical Breast Cancer, 8(Suppl., 1), S11–S21.

Purpose & Patient Population

The purpose of this review was to review guidelines for the supportive treatment of patients undergoing adjuvant breast cancer, and to evaluate strategies that can be used to improve the safety of these regimens.  All of the studies included were with patients receiving chemotherapy for breast cancer.

Type of Resource/Evidence-Based Process

Databases used were not stated.

Key words used include anthracyclines, filgrastim, hematopoietic growth factors, myelosuppression, pegfilgrastim, cost/benefit analysis

Results Provided in the Reference

The number of studies included in the report was 29.

Sample sizes were not reported.

One meta-analysis showed that adding G-CSF prophylactically during the first cycle of chemotherapy in patients being treated for various cancer types helped to decrease the rate of febrile neutropenia from 39% in the control group versus 22.4% in the G-CSF group and made chemotherapy more tolerable, allowing patients to get the appropriate dosages. Another trial compared patients receiving TAC versus FAC initially without G-CSF for either group; researchers did give G-CSF to patients in the TAC group after febrile neutropenia rates soared and rates of febrile neutropenia in the TAC group declined and the rate of trial completion of chemotherapy increased. CALGB9741 also was analyzed and it was discovered that patients receiving the two-week cycle with G-CSF, as compared to the three-week cycle, did remarkably better in declining rates of febrile neutropenia. Another phase III trial showed that patients receiving pegfilgrastim versus placebo had significantly lower rates of febrile neutropenia.

Guidelines & Recommendations

Many of the studies mentioned by the author contributed to the determination that G-CSF should only be given on day 2 due to the elimination period of the drug and that giving it earlier than day 2 may actually increase the risk of febrile neutropenia. The other studies cited in the article were different studies that all showed improvement of febrile neutropenia rates and increase compliance with therapy due to G-CSF.

Nursing Implications

G-CSF decreases the risk of febrile neutropenia in patients with cancer undergoing chemotherapy treatment. Chemotherapeutic regimens that are dose dense also benefits from G-CSF to decrease the risk of febrile neutropenia. These studies also determined that day 2 is the appropriate day to administer G-CSF, as giving it earlier may actually increase the risk of febrile neutropenia.

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O’Shaughnessy, J.A., Vukelja, S.J., Holmes, F.A., Savin, M., Jones, M., Royall, D., . . . & Von Hoff, D. (2005). Feasibility of quantifying the effects of epoetin alpha therapy on cognitive function in women with breast cancer undergoing adjuvant or neoadjuvant chemotherapy. Clinical Breast Cancer, 5(6), 439–446.

Study Purpose

The study's primary aim was to evaluate the effects of erythropoietin (epoetin alfa) on cognitive function and mood in patients with breast cancer. Its secondary aim was to evaluate the effects of erythropoietin on fatigue and quality of life of patients with breast cancer.

Intervention Characteristics/Basic Study Process

At the beginning of 4 weeks of chemotherapy, patients were randomly assigned to receive 40,000 units of epoetin alfa subcutaneously once weekly or a placebo, as administered over 12 weeks.

Sample Characteristics

  • All participants were female and had breast cancer.
  • The number of participants was 94.
  • There were 47 participants in the erythropoietin group and 47 in the placebo group.
  • The average participant age was 53.3 ± 9.7 years in the erythropoietin group and 54.3 ± 12.0 in the placebo group.
  • All participants were scheduled to receive four cycles of anthracycline-based adjuvant or neoadjuvant chemotherapy with or without a taxane.
  • All participants had a Karnofsky performance score of ≥ 70% and an estimated life expectancy of ≥ 1 year.

Setting

The study took place at 13 sites in the United States.

Study Design

The study utilized a longitudinal, exploratory, double-blind, randomized, placebo-controlled design.

Measurement Instruments/Methods

  • The Executive Interview (EXIT-25) measured executive function.
  • The Clock Drawing Task (CLOX) measured executive function.
  • The Functional Assessment of Cancer Therapy (FACT)-Anemia measured cancer-related quality of life specific to the symptom of anemia.
  • The Karnofsky Performance Status scale (KPS) measured general well-being. Scores range from 0 (death) to 100 (perfect health with no complaints or signs of disease).
  • Quality of life was measured by a linear analogue scale assessment.
  • The Profile of Mood States (POMS) was also utilized. 

Results

Although patients in the treatment arm had a greater improvement in executive function between baseline and after completion of the treatment phase, this difference was not significant. The mean change over time in executive function was similar between the two groups at the six month follow-up assessment.

Conclusions

The study was unable to demonstrate an effect of erythropoietin on executive cognitive functioning.

Limitations

  • The number of doses of erythropoietin given in the treatment group was unclear.
  • The authors stated that the CLOX test was found to be an insensitive measure for detecting cognitive changes.
  • There was a lack of alternate forms for repeated administration with the EXIT-25 and CLOX tests.
  • The results were confounded by chemotherapy treatment variations and the eventual administration of epoetin to the placebo group after the initial treatment phase.
Print

O’Shaughnessy, J.A. (2002). Effects of epoetin alfa on cognitive function, mood, asthenia, and quality of life in women with breast cancer undergoing adjuvant chemotherapy. Clinical Breast Cancer, 3(Suppl. 3), S116–S120.

Study Purpose

The study was conducted to assess the feasibility of quantifying the effect of epoetin alfa in patients with breast cancer who were receiving adjuvant chemotherapy on asthenia, executive cognitive functioning, and quality of life. 

Intervention Characteristics/Basic Study Process

Participants were randomized to receive 40,000 units weekly of erythropoietin or a placebo. Erythropoietin or placebo administration began on day 1 of chemotherapy. Both the erythropoietin and placebo were then dose-escalated, with the goal of keeping Hgb levels between 12 g/dL and 14 g/dL. All assessments were administered prior to the start of chemotherapy, one week prior to cycle 4, and 6 months following the completion of chemotherapy.

Sample Characteristics

  • All participants were female and had breast cancer.
  • The number of participants was 100.
  • There were 51 participants in the treatment group and 49 in the control group.
  • The median age of the treatment group was 53 years.
  • All patients were treated with four cycles of doxorubicin and cyclophosphamide.
  • All participants had a Karnofsky performance status of ≥ 70%.
  • Individuals who had packed red blood cell transfusions within 14 days of study entry, clinically significant anemia (not defined), or uncontrolled or severe cardiovascular disease were excluded from the study.

Setting

The study's setting is unknown. 

Study Design

The study utilized a longitudinal, double-blind, randomized, controlled design. 

Measurement Instruments/Methods

  • The Executive Interview (EXIT-25) measured executive function.
  • The Clock Drawing Task (CLOX) measured executive function.
  • The Functional Assessment of Cancer Therapy (FACT)-Anemia measured cancer-related quality of life specific to the symptom of anemia.
  • The Karnofsky Performance Status scale (KPS) measured general well-being. Scores range from 0 (death) to 100 (perfect health with no complaints or signs of disease).
  • Quality of life was measured by a validated linear analogue scale (LASA).
  • The Profile of Mood States (POMS) was also utilized.

Results

A significantly higher mean Hgb level in patients on erythropoietin treatment was reported (p < 0.001). However, there were no significant differences in cognitive function.

Conclusions

The study failed to demonstrate a difference in cognitive functioning between patients in the erythropoietin and placebo groups.

Limitations

  • The number of erythropoietin doses administered to the treatment group was unclear, which could influence study results.
  • The CLOX test was determined to be an insensitive measure for detecting cognitive changes.
  • There was a lack of alternate forms for cognitive tests, so practice effects may have influenced study outcomes.
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O'Hara, R.E., Hull, J.G., Lyons, K.D., Bakitas, M., Hegel, M.T., Li, Z., & Ahles, T.A. (2010). Impact on caregiver burden of a patient-focused palliative care intervention for patients with advanced cancer. Palliative and Supportive Care, 8, 395–404. 

Study Purpose

To assess whether a previously supported patient-directed palliative care intervention would decrease caregiver burden

Intervention Characteristics/Basic Study Process

Patients received a random assignment to either an intervention (palliative care) or usual care group. Intervention patients participated in four weekly telephone sessions focused on communicating with healthcare providers, learning problem-solving skills, managing disease symptoms, and planning for end-of-life care. Patient caregivers received invitations and volunteered to participate in the intervention. Following the intervention, nurses called patients at least once a month to lend support and present additional information. Patients in the usual care group received standard oncology care at the cancer care center. Caregivers and patients completed questionnaires at baseline, one month post-baseline, and every three months until the end of the study. Following patient death during the study period, caregivers were asked to complete the After-Death Bereaved Family Member Interview (ADI).

Sample Characteristics

  • N = 198   
  • MEAN AGE = 59 years
  • MALES: 23%, FEMALES: 77%
  • CURRENT TREATMENT: Other
  • KEY DISEASE CHARACTERISTICS: Patients with advanced cancer receiving outpatient palliative care 
  • OTHER KEY SAMPLE CHARACTERISTICS: Intervention caregivers were significantly more educated than those in usual care group.

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Outpatient    
  • LOCATION: U.S. comprehensive cancer centers in northern New England

Phase of Care and Clinical Applications

  • PHASE OF CARE: End-of-life care
  • APPLICATIONS: Palliative care

Study Design

Randomized, controlled trial

Measurement Instruments/Methods

  • Caregiver burden: 14-item Montgomery Borgatta Caregiver Burden Scale to measure objective burden, stress burden, and demand burden
  • Quality of care: 67-item After-Death Bereaved Family Member Interview (ADI) to measure caregiver perception of patient quality of care four to six months after patient death
  • Patient quality of life: 46-item Functional Assessment of Chronic Illness Therapy-Palliative Care (FACIT-Pal) to measure patient overall end-of-life well-being
  • Physical symptoms: 10-item Edmonton Symptom Assessment Scale (ESAS) to measure patient symptom severity
  • Depressed mood: 20-item Center for Epidemiological Studies-Depression (CES-D) to measure patient and caregiver depression frequency

Results

Patient FACIT-Pal scores correlated negatively and at high levels with ESAS scores and CES-D scores, and ESAS and CES-D scores correlated positively. Fewer and less consistent correlation of caregiver burden scores occurred: caregivers perceiving objective burden sources reported stress but not demand burden (unreasonable patient requests for care). Demand burden was positively correlated with stress burden in caregivers. Patients who identified lower patient quality of life (FACIT-Pal) had caregivers scoring higher on objective and stress burden. Caregivers scored higher on objective burden and stress burden if patients had higher ESAS and CES-D scores (latter evident one month postbaseline). Of 96 caregiver burden correlations, patient well-being, and quality of care, five achieved statistical significance. These included patient spiritual and emotional support concerns associated with patient well-being (p < 0.01) and decreased caregiver stress burden (p < 0.01) at baseline. One month postbaseline, unmet patient needs correlated with caregiver stress burden (p < 0.05), and concerns with patient respectful treatment correlated with increased caregiver demand burden (p < 0.05).

Conclusions

Despite evidence in a previous ENABLE II study supporting the success of a palliative care interventions to decrease patient symptom intensity, depression, and improve quality of life, this study did not support improvement in caregiver burden with a similar methodology.

Limitations

  • Risk of bias (sample characteristics)
  • Unintended interventions or applicable interventions not described that would influence results
  • Findings not generalizable (96% Caucasian , 77% female, and 84% married or living with partner)
  • Subject withdrawals ≥ 10% 
  • Caregiver participation in intervention inconsistent to affect study outcomes
  • High caregiver attrition prevented measurements after four months.
  • ADI reports focused on only patients' quality of care, not caregiver experience.

Nursing Implications

Multiple studies document that minimizing caregiver burden requires specialized interventions focusing on emotional, financial, spiritual, and physical strains but also caregiving benefits gained in a dyadic relationship (patient and caregiver). Well-designed long-term randomized, controlled trials sensitive to documented health interaction outcomes of caregiving dyads may provide clinical direction for improved patient well-being and lower caregiver burden during palliative cancer care.

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O’Grady, N.P., Alexander, M., Burns, L.A., Dellinger, E.P., Garland, J., Heard, S.O., . . . Healthcare Infection Control Practices Advisory Committee (HICPAC). (2011). Guidelines for the prevention of intravascular catheter-related infections, 2011. Retrieved from http://www.cdc.gov/hicpac/pdf/guidelines/bsi-guidelines-2011.pdf

Purpose & Patient Population

To provide evidence-based recommendations for the prevention of intravascular catheter-related infections for healthcare personnel who insert and care for intravascular catheters and for those responsible for surveillance and infection control in hospital, outpatient, and home health settings. Patients addressed in the guidelines were adult and pediatric patients with intravascular catheters.

Type of Resource/Evidence-Based Process

The resource is comprised of evidence-based guidelines. For the development process, evidence was categorized as category 1A to category 2 based on strength of recommendation and support from clinical or epidemiological studies.

Phase of Care and Clinical Applications

  • Patients were undergoing multiple phases of care.
  • The study has clinical applicability for pediatrics. 

Results Provided in the Reference

The results were not summarized.

Guidelines & Recommendations

The guidelines provided extensive recommendations regarding the education and training of staff; selection of catheters and sites, including avoidance of the femoral vein for central venous access and use of the central venous catheter with the minimum number of ports needed; hand hygiene; use of maximal sterile barrier precautions for insertion; skin preparation with alcohol, iodine, or chlorhexidine; use of standard catheter site dressing regimens; specific aspects of care for umbilical and dialysis catheters; and use of piggybacks, stopcocks, and catheter flushing. Guideline recommendations include a bundling of multiple recommendations: antimicrobial-impregnated catheters and cuffs are recommended in patients with long-term use if the organizational central line-associated blood stream infection (CLABSI) rate is not decreasing despite the implementation of comprehensive strategies for improvement. Lower-level (category II) recommendations include the use of prophylactic antimicrobial lock solutions in patients with long-term catheters who have a history of CLABSIs despite optimal aseptic technique as well as daily cleansing of patients in the intensive care unit with 2% chlorhexidine-impregnated washcloths. Recommends changing IV administration sets no more often than every 96 hours unless used for blood products. For needleless components, recommends changing according to administration set timing as above, and states no benefit to changing more than every 72 hours.

Nursing Implications

Provides extensive recommendations for management of all types of intravenous catheters and system components. Nurses should refer to the full set of guidelines for all specific aspects of care.

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O'Connor, J.M., Helmer, S.D., Osland, J.S., Cusick, T.E., & Tenofsky, P.L. (2011). Do topical anesthetics reduce periareolar injectional pain before sentinel lymph node biopsy? American Journal of Surgery, 202(6), 707–711; discussion 711–122.

Study Purpose

 To determine whether lidocaine-prilocaine cream decreases injection pain related to sentinel lymph node biopsy

Intervention Characteristics/Basic Study Process

Eligible subjects were randomized to either the treatment or control group, then provided with a syringe that contained either the study medication (lidocaine-prilocaine cream) or a placebo cream that looked identical to it. Subjects also received instructions on how to apply the cream and a copy of the postprocedure survey, which asked patients to evaluate ease of application as well as level of pain. The subjects were to apply the given cream and then a barrier dressing to the area. Patients went to one of three radiology departments to receive an injection of the Tc sulfur colloid for the sentinel lymph node biopsy. Postoperatively, over the telephone, the patients completed the survey with help from a researcher. 

Sample Characteristics

  • The sample was composed of 39 patients.
  • All patients were older than 18 years.
  • All the patients were female.
  • All the patients had breast cancer
     

Setting

  • Multisite
  • Inpatient and outpatient settings
     

Phase of Care and Clinical Applications

Phase of care: active treatment

 

Study Design

Triple-blinded prospective randomized placebo-controlled trial

Measurement Instruments/Methods

  • Scale measuring ease of cream and dressing application, a five-point Likert-type scale    
  • 10-point pain scale, to measure pain
  • A tool that recorded whether patient would recommend cream (yes/no)
     

Results

Thirty-nine subjects completed the study. Subjects from both groups rated the cream as easy to apply, and both groups responded similarly in regard to dressing retention. Authors reported no significant difference in median injectional pain scores between the treatment and control groups. Authors noted two trends: The treatment group was more likely than the control group to recommend the cream, and the control group was more likely to rate the injection as painful or extremely painful.

Conclusions

The pain scores of subjects who received the lidocaine-prilocaine cream were not significantly lower than those of the control group.

Limitations

  • The study had a small sample size, with fewer than 100 patients.
  • The study comprised variability in injection techniques and volumes.
  • Study design was based on the prediction of a large difference (4) between the two groups on a 10-point Likert scale.  
     

Nursing Implications

This study does not indicate that a topical anesthetic, lidocaine-prilocaine cream, had a significant effect on injectional pain; however, the finding may be a consequence of the study design. Further studies, with larger sample sizes and smaller predicted differences in the study groups, may produce a different result.

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O’Connor, G., Coates, V., & O’Neill, S. (2014). Randomised controlled trial of a tailored information pack for patients undergoing surgery and treatment for rectal cancer. European Journal of Oncology Nursing, 18, 183–191. 

Study Purpose

To evaluate the effects of a tailored information package for patients with rectal cancer on levels of satisfaction with information, anxiety, depression, and readjustment to normal living

Intervention Characteristics/Basic Study Process

This study was conducted at six sites in four healthcare systems in Northern Ireland. A process evaluation of usual standards-of-care established that all patients with rectal cancer were referred to a stoma nurse specialist following diagnosis. A tailored information packet of 14 leaflets dealing with various aspects of disease and treatment was developed based on the theoretical framework of andragogy, developed by Malcolm Knowles, along with a preliminary needs assessment and a literature review. Preparation for the study involved a liaison between stoma-care nurse specialists to determine interest in participation. The researchers then met with the stoma nurse specialists to discuss the study protocol and provide consistent training regarding the use of the information packet. Data were collected using a researcher-administered set of scales at three time points in structured interviews. These were preintervention, postintervention, after surgery, prior to hospital discharge, and six months after surgery.

Sample Characteristics

  • N = 43 (intervention group), 33 (control group)  
  • AGE RANGE = 42–76+ years
  • MALES: 64.5%, FEMALES: 35.5%
  • KEY DISEASE CHARACTERISTICS: Sixty-eight out of 76 patients were considered a B or C in Duke’s staging system. The majority of patients (40) had low anterior resections with loop ileostomies, and 27 patients had abdominoperineal resections (permanent colostomies).
  • OTHER KEY SAMPLE CHARACTERISTICS: Thirty-two patients received short-course radiation prior to surgery. Ten of these patients also had adjuvant chemotherapy. Nine patients had long-course preoperative chemotherapy/radiation, and nine patients had adjuvant chemotherapy only.

Setting

  • SITE: Multi-site    
  • SETTING TYPE: Multiple settings  
  • LOCATION: Northern Ireland

Phase of Care and Clinical Applications

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

Study Design

Randomized, controlled trial

Measurement Instruments/Methods

The Patient Satisfaction with Cancer Treatment Education (PSCaTE) questionnaire was used. It consists of 14 items. Each item has a scale from 1 (strongly disagree) to 5 (strongly agree). The Hospital Anxiety and Depression Scale (HADS), which contains seven intermingled items answered on a four-point scale, and the Reintegration to Normal Living Index (RNLI), which consists of 11 items on scales of 1–10, also were used. Data analysis was carried out using SPSS software.

Results

There was a statistically significant difference in levels of satisfaction with information between the intervention and control groups. Patients who received the tailored information packet were more satisfied with their information than the control group. There were no differences in depression scores between the intervention and control groups at any time. Females were shown to have significantly higher anxiety and depression scores at the preintervention assessment. All participants with high depression scores also had elevated anxiety scores. Anxiety and depression scores showed medium to large negative associations with adjustment levels as measured by the RNLI scores at all three time points.

Conclusions

Patients who received the tailored information packets were significantly more satisfied than those in the control group at the second and third time points.

Limitations

  • Small sample (< 100)
  • Baseline sample/group differences of import
  • Risk of bias (no blinding)
  • Risk of bias (sample characteristics)
  • Key sample group differences that could influence results
  • Other limitations/explanation: This study only assessed satisfaction up to six months following surgery. Caregivers were not included in the study. This study focused predominantly on paper-based literature as an intervention. The Pearson coefficient was used in the analysis to assess for satisfaction; although this is appropriate, it is not as robust in terms of statistical significance.

Nursing Implications

Nurse experts such as stoma-care specialists are in a position to provide effective information to assist patients in adjusting to major life changes. Nurses have the opportunity to provide patient information that will help alleviate the anxiety and depression that come with these life changes.
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Bantum, E.O.C., Albright, C.L., White, K.K., Berenberg, J.L., Layi, G., Ritter, P.L., . . . Lorig, K. (2014). Surviving and thriving with cancer using a Web-based health behavior change intervention: Randomized controlled trial. Journal of Medical Internet Research, 16(2).

Study Purpose

To test the effectiveness of a six-week, web-based, multiple health behavior change program called Surviving and Thriving With Cancer (STC) for adult cancer survivors

Intervention Characteristics/Basic Study Process

STC was a six-week online patient education course with modules on nutrition, changes in body, sleep, and other side effects associated with cancer treatment recovery. Nine online cohorts consisted of 20–25 survivors. Sessions had 30–35 webpages of material geared toward skills building with specific content to build self-efficacy. Each week, users identified a health behavior to change and were guided to set realistic, achievable goals. Action plans were posted in a discussion center where two trained cancer survivor facilitators provided feedback and help. Participants were prompted at the middle and end of the week via an automated message to update progress and give feedback to other participants. The website contained components called \"Discussion Center,\" \"My Tools,\" \"Post Office,\" and \"Help.\" The discussion center facilitated social networking through four threaded bulletin boards: action planning, problem solving, difficult emotions, and celebrations. Randomization occurred by groups of 40–50 participants after the completion of baseline a questionnaire. Half were assigned to treatment and half to a wait-list control group. Data collection occurred at baseline and after six months during follow-up.

Sample Characteristics

  • N = 352  
  • MEAN AGE = 49.3 years (control); 52.4 years (intervention)
  • MALES: 16% (control); 20% (intervention), FEMALES: 84% (control); 80% (intervention)
  • KEY DISEASE CHARACTERISTICS: Adult cancer survivors recruited online, though referrals, or by mailings; 18 years of age or older; after completion of primary cancer treatment at least four weeks prior but not more than five years before joining the study; diagnosis with only one cancer and no recurrence; access to the Internet; ability to read English
  • OTHER KEY SAMPLE CHARACTERISTICS: 85%–89% Caucasian; 83%–84% breast cancer (early stage); majority were healthy; highly educated and well-adjusted

Setting

  • SITE: Multi-site
  • SETTING TYPE: Other
  • LOCATION: Recruited from oncology clinics, a tumor registry, and online mechanisms such as Facebook and the Association of Cancer Online Resources

Phase of Care and Clinical Applications

  • PHASE OF CARE: Late effects and survivorship

Study Design

Randomized, controlled, delayed-treatment design

Measurement Instruments/Methods

  • Demographic and clinical information
  • Brief Fatigue Inventory (BFI)
  • Women’s Health Initiative Insomnia Rating Scale (WHIIRS)
  • Godin Exercise Questionnaire
  • The Block Food Frequency Questionnaire (number of servings of fruits and vegetables per week)
  • Patient Health Questionnaire (PHQ-8)

Results

In total, 303 survivors completed the follow-up survey (six months after completion of the baseline survey), and participants in the intervention arm reported significantly greater reductions in insomnia and greater increases in minutes per week of vigorous exercise and stretching compared to patients in the control arm. Compared to the control group, the intervention group experienced an improvement in insomnia from baseline to six months 9.6–9.2 versus 9.6–10.1 (p = 0.03). There were no significant changes in fruit and vegetable consumption or other outcomes.

Conclusions

The intervention affected insomnia and exercise; however, the majority of the sample met or exceeded national recommendations for health behaviors and were not suffering from depression or fatigue at baseline. Participants’ ability to make substantial health behavior changes may have been limited.

Limitations

  • Baseline sample/group differences of import
  • Risk of bias (no blinding)
  • Risk of bias (sample characteristics)
  • Measurement validity/reliability questionable
  • Findings not generalizable
  • Subject withdrawals ≥ 10%
  • Other limitations/explanation: Roughly 14% of participants who were randomized did not provide any data at six months (but groups did not differ). Sixty percent of the interested participants were highly educated and were recruited from online social networking sites, suggesting that participants were active on the Internet. Therefore, the sample characteristics may bias the results. Overall, the participants were healthy and well-adjusted with little to no need for significant changes in their health behaviors. The majority of participants were Caucasian (87.2%) and female (82.1%), limiting generalizability. A significant difference in age was found among the treatment and wait-list groups. The mean number of sessions logged on at least once was 5.3 (SD = 1.28, range = 0–6), and 67% of participants attended all six sessions, which may have affected the outcomes. Health behaviors were self-reported, and there may have been over- and underestimation of exercise and fruit and vegetable intake because of social desirability or recall bias. The significance level was not adjusted for the multiple comparisons of numerous outcomes.

Nursing Implications

Web-based interventions are relevant for people who are not near facilities that could offer face-to-face interventions. Health behavior change interventions are relevant for cancer survivors, so continuing to test and refine interventions is imperative in the area of cancer survivorship.

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