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

Abstract

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.

PROMIS and legacy measures compared in a supportive care intervention for breast cancer patients and caregivers: Experience from a randomized trial

“…The primary aim of the parent study focused on the patient outcome of summed severity index of cancer‐and treatment‐related symptoms from the MDASI legacy instrument. The results of the primary analysis are reported elsewhere . An exploratory aim of the parent trial used a different set of measures for patient and caregiver symptoms and functioning to contribute to the growing evidence of psychometric properties of PROMIS measures by comparing their responsiveness to that of legacy measures.…”

Using SMART design to improve symptom management among cancer patients: A study protocol

“…Solid tumors were selected because fatigue is prevalent during their treatment (Sikorskii et al, ; Sikorskii, Given, You, Jeon, & Given, ; Wyatt, Sikorskii, Rahbar, Victorson, & You, ). Emerging evidence supports the potential efficacy of reflexology and meditative practices for fatigue management (Haller et al, ; Lehto, Wyatt, Sikorskii, Tesnjak, & Kaufman, ; Wyatt et al, , ). The cut‐off of >3 indicates a moderate level of fatigue based on established interference‐based cut‐points (Given et al, ).…”

“…Patients of all cancer stages are eligible for the study if they are receiving treatment at intake, and disease progression after consent does not preclude continued participation. In the team's past studies with late‐stage breast cancer patients (Wyatt et al, , ), many patients continued to participate even if they decided to stop treatment due to disease progression. Also, the team's extensive past experience with the two therapies, reflexology and meditative practices (Lehto et al, ; Wyatt et al, , ), ensures that caregivers are successfully trained in these therapies, and fidelity is maintained.…”

“…In the team's past studies with late‐stage breast cancer patients (Wyatt et al, , ), many patients continued to participate even if they decided to stop treatment due to disease progression. Also, the team's extensive past experience with the two therapies, reflexology and meditative practices (Lehto et al, ; Wyatt et al, , ), ensures that caregivers are successfully trained in these therapies, and fidelity is maintained. The fidelity scorecard (Frambes et al, ) allows for quantitative evaluation of fidelity of the caregiver‐delivered reflexology intervention.…”

“…The sample size determination started at the right end of the schematic in Figure (the second randomization) and moved from right to left to determine the needed number of consenting patients. To power the comparisons for the value added by reflexology or meditative practices, the effect size of .45 was used, the smallest seen in preliminary work (Lehto et al, ; Wyatt et al, ) to conservatively estimate sample size requirements. The effect size of .45 corresponded to two repeated measures in past work, and the design of this study includes four repeated measures at each phase.…”