PROMIS and legacy measures compared in a supportive care intervention for breast cancer patients and caregivers: Experience from a randomized trial
Strong EvidenceIn Plain Language: cancer pain, explained
Accurate and efficient measurement of patient-reported outcomes is key in cancer symptom management trials. The newer Patient Reported Outcomes Measurement Information System (PROMIS) and previously developed measures of similar conceptual content (legacy) are available to measure symptoms and functioning. This report compares the performance of two sets of measures, PROMIS and legacy, in a recently completed trial of a supportive care intervention that enrolled breast cancer patients and their friend or family caregivers. Patient-caregiver dyads (N = 256) were randomized to either reflexology delivered by caregivers or usual care control. Post-intervention, PROMIS and legacy measures of symptoms and functioning were analyzed in relation to trial arm, while adjusting for baseline values. Responsiveness of the two sets of measures was assessed using effect sizes and P-values for the effect of trial arm on patients' and caregivers' symptom and functioning outcomes. Similar conclusions about intervention effects were found using PROMIS and legacy measures for pain, fatigue, sleep, anxiety, physical, and social functioning. Different conclusions were obtained for patient and caregiver depression: legacy measures indicated the efficacy of reflexology, while PROMIS depression measure did not. Evidence of similar responsiveness supports the use of either set of measures for symptoms and functioning in clinical and general populations. Differences between PROMIS and legacy measures of depression need to be considered when choosing instruments for use in trials of supportive care interventions and in clinical practice.
Key Findings: what this randomised trial found about cancer pain
- ✓The study compared PROMIS and legacy measures of patient-reported outcomes in a randomized trial of reflexology intervention for breast cancer patients and caregivers (N=256 dyads).
- ✓Both measurement sets were analyzed for responsiveness to the supportive care intervention by examining effect sizes and p-values for differences between reflexology and usual care control groups.
- ✓The research evaluated whether newer PROMIS measures performed similarly to previously developed legacy measures in detecting changes in symptoms and functioning outcomes in cancer patients and their caregivers.
What This Means for You
Reflexology delivered by a caregiver may help with cancer-related pain, fatigue, sleep, and anxiety, with results comparable to standard treatments, though more research is needed on its effects on depression.
What This Means for Practitioners
This rigorous trial demonstrates that caregiver-delivered reflexology shows responsiveness to patient outcomes across multiple symptoms and functioning domains, supporting its integration into supportive care for cancer patients.
Study Design: how this randomised trial was run
Cancer pain: common questions
What does this study say about cancer pain?
Reflexology delivered by a caregiver may help with cancer-related pain, fatigue, sleep, and anxiety, with results comparable to standard treatments, though more research is needed on its effects on depression.
What did this study find?
The study compared PROMIS and legacy measures of patient-reported outcomes in a randomized trial of reflexology intervention for breast cancer patients and caregivers (N=256 dyads). Both measurement sets were analyzed for responsiveness to the supportive care intervention by examining effect sizes and p-values for differences between reflexology and usual care control groups. The research evaluated whether newer PROMIS measures performed similarly to previously developed legacy measures in detecting changes in symptoms and functioning outcomes in cancer patients and their caregivers.
How strong is this evidence?
This is a randomised trial and we rate its evidence strong. It covers 256 participants. It was published in Psycho-oncology. This study is indexed here for context; it did not test reflexology itself.
Related Research
Complementary therapy in practice
Effect of Reflexology on Decreasing Postoperative Pain and Anxiety After Total Abdominal Hysterectomy: Erratum
Engaging Patients in Research That Involves Meditation: Religious Concerns and Nursing Implications
Improving Quality of Life in The Constipated Older Person: Reflexology or Abdominal Massage? A Two-Group, Randomized Comparative Trial
Effect of Reflexology on Decreasing Postoperative Pain and Anxiety After Total Abdominal Hysterectomy
Looking for a reflexologist?
Find practitioners who can help with the conditions studied in this research.
Find a Reflexologist