Fidelity scorecard: evaluation of a caregiver-delivered symptom management intervention.

AIM: To evaluate and quantify the intervention fidelity of a symptom management protocol through implementation of a scorecard, using an exemplar study of caregiver-delivered reflexology for people with breast cancer. BACKGROUND: Studies on caregiver-delivered symptom management interventions seldom include adequate information on protocol fidelity, contributing to potentially suboptimal provision of the therapeutic intervention, hindering reproducibility and generalizability of the results. DESIGN: Fidelity assessment of a 4-week intervention protocol in a randomized controlled trial (RCT) with data collection between 2012 - 2016. METHODS: The National Institutes of Health Behaviour Change Consortium (NIH-BCC) conceptual model for intervention fidelity guided the study. The five NIH-BCC fidelity elements are: (1) dose; (2) provider training; (3) intervention delivery; (4) intervention receipt; and (5) enactment. To illustrate the elements, an intervention protocol was deconstructed and each element quantified using a newly developed fidelity scorecard. RESULTS: Mean scores and frequency distributions were derived for the scorecard elements. For dose, the mean number of sessions was 4·4, 96% used the correct intervention duration and 29% had 4 weeks with at least one session. Provider training was achieved at 80% of the maximum score, intervention delivery was 96%, intervention receipt was 99% and enactment indicated moderate adoption at 3·8 sessions per patient. The sample mean score was 15·4 out of 16, indicating the high overall fidelity. CONCLUSION: Research findings that include description of how fidelity is both addressed and evaluated are necessary for clinical translation. Clinicians can confidently recommend symptom management strategies to patients and caregivers when fidelity standards are explicitly reported and measured.

Self-administered Acupressure for Persistent Cancer-related Fatigue: Fidelity Considerations.

CONTEXT: Complementary therapies are frequently used by breast cancer patients for symptom management; however, documentation of the components of intervention fidelity for studies is not widely available. OBJECTIVE: This report examines the components of intervention fidelity, as put forth by the Treatment Fidelity Workgroup of the Behavior Change Consortium at the National Institutes for Health (NIH-BCC Workgroup), within an ongoing acupressure study of breast cancer survivors with persistent cancer-related fatigue (PCRF). DESIGN: For the acupressure study, the research team designed a randomized, controlled trial (RCT) with 3 parallel groups: (1) stimulating acupressure (intervention group); (2) relaxing acupressure (intervention group); and (3) standard care (control group). SETTING: At baseline and at wk 3 and wk 6 of the study, women in the acupressure study attended sessions for training and data collection at clinics in the counties of Michigan where they lived. The self-administration of acupressure occurred in participants' homes. PARTICIPANTS: Targeted enrollment for the acupressure study is 300 breast cancer survivors who had experienced moderate-to-severe PCRF lasting longer than 1 y beyond treatment. The women are being recruited from 5 counties in Michigan, using the Michigan Tumor Registry to identify potential participants. The subsample report includes 183 participants who have completed all 10 wk of the acupressure study. Most participants in the acupressure study are Caucasian, are married, and have some college education. INTERVENTION: The acupressure study's educators teach participants in the intervention groups to self-administer either relaxing or stimulating acupressure for a 30-min period on a daily basis for 6 wk. All 3 groups receive the usual care for breast cancer survivors. OUTCOME MEASURES: For the acupressure study, the participants log the frequency of the self-administered acupressure sessions and their fatigue levels. Symptom assessments are made for all groups by telephone in the acupressure study at wk 2 through wk 5 to assess fatigue. A competency checklist is used at each session of training and retraining of both acupressure educators and participants. For this report, the 5 recommended fidelity components for interventions are (1) dose, (2) training, (3) intervention delivery, (4) intervention receipt, and (5) enactment of the intervention. RESULTS: The ongoing RCT incorporated all 5 components of fidelity and can serve as a model for future work in this area. CONCLUSIONS: Research protocols that address intervention fidelity can provide results that support internal and external validity. Clinicians should consider recommending complementary interventions that have incorporated fidelity components into their efficacy testing.

Informal Caregivers of Cancer Patients: Review of Interventions, Care Activities, and Outcomes.

Family and friends are important resources for patients during cancer treatment and warrant an expanded review of not only what they contribute to patient care but also the support they need and the personal consequences of caregiving. A review of 14 randomized controlled trials published between 2009 and 2016 was completed utilizing the Preferred Reporting Items for Systematic Reviews and Meta-Analyses. The results of this review expand the scope of what is known regarding relationships among supportive interventions for caregivers, activities performed to care for cancer patients, caregiver characteristics, and health outcomes of caregivers. Specific results include (a) updated synthesis of literature associated with variables important to caregiving, (b) attention to interventions designed to support caregivers,

Effect of Physical Activity Interventions for Girls on Objectively Measured Outcomes: A Systematic Review of Randomized Controlled Trials.

INTRODUCTION: Most girls are not meeting physical activity (PA) guidelines, and 30% are overweight or obese. The purpose of this systematic review was to evaluate the evidence for PA intervention effects on accelerometer-measured PA, body mass index (BMI), and percent body fat (% BF) among girls. METHODS: The Cumulative Index of Nursing and Allied Health Literature, PubMed, PsychInfo, and SportDISCUS databases were searched for randomized controlled trials published from 1985-2014. Studies with a PA intervention and outcomes of accelerometer-measured PA, BMI, or % BF were included. RESULTS: Fifteen studies were reviewed. PA, BMI, and % BF were measured in 5, 15, and 10 studies, respectively. Effect sizes (ES) were highly variable. In one intervention, PA increased (ES = -0.17 to 0.08); in two interventions, BMI was reduced (ES = -0.11 to 0.62); and in five interventions, % BF was lowered (ES = 0.12 to 0.93). DISCUSSION: Future research should involve preadolescent girls, improve methods for handling missing data, include objective measures of PA, and increase intervention attendance rates.

Caregiver-Reported Health Outcomes: Effects of Providing Reflexology for Symptom Management to Women With Advanced Breast Cancer.

PURPOSE/OBJECTIVES: To determine the effects of delivering a reflexology intervention on health outcomes of informal caregivers, and to explore whether intervention effects are moderated by caregiver characteristics. 
. DESIGN: Two-group, randomized clinical trial.
. SETTING: Eight oncology clinics in urban and rural regions of Michigan and Illinois.
. SAMPLE: 180 informal caregivers of patients with advanced breast cancer.
. METHODS: Caregivers were randomized to provide reflexology to individuals with cancer during a four-week period or to attention control. Data collection occurred at baseline and at weeks 5 and 11. Linear mixed-effects modeling was used to test intervention effects among all participants and the effects of the number of sessions delivered in the reflexology group.
. MAIN RESEARCH VARIABLES: Caregiver characteristics; psychological, physical, and social outcomes.
. FINDINGS: Caregiver fatigue in the reflexology group was reduced compared to controls at weeks 5 (p = 0.02) and 11 (p = 0.05). No differences were found for anxiety, depression, pain, physical function, sleep disturbance, satisfaction with participation in social roles, and pain interference between caregivers who delivered reflexology and those who did not.
. CONCLUSIONS: Informal caregivers who provided reflexology to individuals with cancer did not have negative psychological, physical, or social outcomes. Fatigue levels were lower among caregivers who provided reflexology. 
. IMPLICATIONS FOR NURSING: Clinicians need to be aware that providing supportive care interventions, such as reflexology, to reduce symptom burden does not increase negative outcomes on informal caregivers who provide this care, and it may even lead to reduced fatigue.

A Randomized Clinical Trial of Caregiver-Delivered Reflexology for Symptom Management During Breast Cancer Treatment.

PURPOSE: The objective of this study was to determine the effects of a home-based reflexology intervention delivered by a friend/family caregiver compared with attention control on health-related quality of life of women with advanced breast cancer undergoing chemotherapy, targeted and/or hormonal therapy. METHODS: Patient-caregiver dyads (N = 256) were randomized to four weekly reflexology sessions or attention control. Caregivers in the intervention group were trained in a 30-minute protocol. During the four weeks, both groups had telephone symptom assessments, and intervention group had fidelity assessments. The intervention effects were assessed using linear mixed-effects models at weeks 5 and 11 for symptom severity and interference with daily activities, functioning, social support, quality of patient-caregiver relationship, and satisfaction with life. RESULTS: Significant reductions in average symptom severity (P = 0.02) and interference (P < 0.01) over 11 weeks were found in the reflexology group compared with control, with no group differences in functioning, social support, quality of relationship, or satisfaction with life at weeks 5 and 11. Stronger quality of relationship was associated with lower symptom interference in the entire sample (P = 0.02), but controlling for it did not diminish the effect of intervention on symptoms. Significant reductions in symptom severity in the reflexology group compared with attention control were seen during weeks 2-5 but were reduced at Week 11. DISCUSSION: Efficacy findings of caregiver-delivered reflexology with respect to symptom reduction open a new evidence-based avenue for home-based symptom management.