This project tests the benefits of a home-based intervention of foot reflexology for improving health- related quality of life (HRQOL) including symptom responses, functioning, and health perceptions in women treated with chemotherapy for advanced breast cancer. Reflexology applies a firm walking-motion during sessions and is based on the premise that the foot has reflexes mirroring organs of the body. Symptom burden is the strongest predictor of HRQOL for cancer patients. This project brings together expertise from nursing, reflexology, communication, statistics, and health economics. The primary specific aims, in a sample of 200 women with advanced breast cancer receiving chemotherapy, are to determine the effects of a 4-week, home-based reflexology intervention delivered by a friend/family provider compared to attention control for improvement of: 1. HRQOL including symptoms, functioning, and health perception at study weeks 5 and 11. We hypothesize that the reflexology group will have better HRQOL (symptoms, functioning, and health perception) than the attention control group at study weeks 5 and 11. 2. Multiple symptom responses and times-to-response as determined by weekly symptom assessments during the 4-week intervention time. We hypothesize that the reflexology group will have a higher proportion of symptoms that respond to the intervention and shorter time-to-symptom-responses than the attention control group. 3. Symptom-related use of unscheduled health services during the11-week study. We hypothesize that fewer unscheduled services will be used for symptom management over the 11- week study period by women receiving reflexology compared to women in the attention control. The exploratory aims are to: 1) Explore differences between trial arms in perceptions of social support due to the family- or friend-delivered reflexology sessions at study weeks 5 and 11;2) Determine if effects of the reflexology intervention on HRQOL are mediated by social support;and 3) Use the newly developed NIH PROMIS standardized symptom and functioning instruments to assess the effects of the reflexology intervention and to compare the responsiveness of PROMIS instruments and existing instruments designed to measure similar constructs. This project has immense potential to make an effective symptom management intervention accessible to patients in their homes via a friend or family home provider. We will not only intervene to enhance HRQOL but also to evaluate social support and costs associated with unscheduled health services. Effective symptom management provides time and cost savings to clinicians, advances the current state-of- the-science, and promotes adherence to medical treatment that may ultimately enhance survival.
This research addresses the public health concerns of the 185,000 women annually diagnosed with breast cancer. Symptom management and quality of life are a primary focus during treatment. This research translates a successful reflexologist-delivered symptom management technique to one delivered by a friend or family member to make it more accessible and cost-effective.
|Holmstrom, Amanda J; Wyatt, Gwen K; Sikorskii, Alla et al. (2016) Dyadic recruitment in complementary therapy studies: experience from a clinical trial of caregiver-delivered reflexology. Appl Nurs Res 29:136-9|