Purpose To determine the effects of a home-based reflexology intervention delivered by a friend/family caregiver compared to 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 4 weekly reflexology sessions or attention control. Caregivers in the intervention group were trained in a 30-minute protocol. During the 4 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=.02) and interference (p<.01) over 11 weeks were found in the reflexology group compared to 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=.02), but controlling for it did not diminish the effect of intervention on symptoms. Significant reductions in symptom severity in the reflexology group compared to 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.

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,

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Aim To evaluate and quantify intervention fidelity of a symptom management protocol through implementation of a scorecard, using an exemplar study of caregiver-delivered reflexology for breast cancer patients. 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 Behavior 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 1 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 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.