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Dyadic recruitment in complementary therapy studies: experience from a clinical trial of caregiver-delivered reflexology

Authors: Holmstrom Amanda J, Wyatt Gwen K, Sikorskii Alla, Musatics Catherine, Stolz Emily, Havener NealaJournal: Applied nursing research : ANRPublished: February 1, 2016DOI: 10.1016/j.apnr.2015.05.019
Q2 JournalSJR: 0.55h-index: 65
Moderate EvidenceRandomized Controlled Trialn=551 participants

In Plain Language: reflexology for cancer pain, explained

As home-based care continues to be a growing trend in health care, involvement of friend and family caregivers in the management of illness becomes essential. However, before nurses can prepare caregivers to engage in various types of care, an evidence base needs to be established via randomized controlled trials (RCTs). Research suggests that recruiting cancer patients and their friend or family caregivers into RCTs presents challenges. The purpose of this paper is to illustrate the barriers to recruitment of patient-caregiver dyads into a RCT of caregiver-delivered reflexology and to recommend strategies to address such barriers. This paper reports on a nurse-directed RCT that involved recruitment efforts unique to a caregiver-delivered reflexology protocol for advanced-stage breast cancer patients. Ineligibility due to caregiver-related reasons, consent among eligible patients (out of 551 approached patients), and reasons for refusal were analyzed. Almost one-third of patients were found to be ineligible due to the lack of a caregiver to participate with them and provide this form of social support. Among eligible patients, the consent rate for this dyadic study is much lower than that of previous RCTs of reflexologist-delivered reflexology that enrolled just patients, not dyads. Implications for nursing practice and research include addressing the need for greater social support for patients and strategies for problem-solving refusal reasons during study enrollment.

Key Findings: what this randomised trial found about cancer pain

  • ✓Almost one-third of approached patients were ineligible due to caregiver-related reasons, representing a significant barrier to recruitment in dyadic intervention studies.
  • ✓Recruiting patient-caregiver dyads into randomized controlled trials presents distinct challenges compared to recruiting individual patients, requiring tailored recruitment strategies.
  • ✓Establishing an evidence base for caregiver-delivered complementary therapies like reflexology requires overcoming recruitment barriers specific to involving both patients and their informal caregivers in clinical trials.

What This Means for You

If you're interested in reflexology as part of your cancer care, involving a family member or close friend may be important, but it can be harder to find studies that include both you and a caregiver.

What This Means for Practitioners

When promoting caregiver-delivered reflexology, be aware that the requirement for a caregiver partner significantly limits who can participate, and consider strategies to help patients identify and engage potential caregiver support.

Study Design: how this randomised trial was run

Sample Size
551 participants
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Reflexology for cancer pain: common questions

Does reflexology help with cancer pain?

If you're interested in reflexology as part of your cancer care, involving a family member or close friend may be important, but it can be harder to find studies that include both you and a caregiver.

What did this study find?

Almost one-third of approached patients were ineligible due to caregiver-related reasons, representing a significant barrier to recruitment in dyadic intervention studies. Recruiting patient-caregiver dyads into randomized controlled trials presents distinct challenges compared to recruiting individual patients, requiring tailored recruitment strategies. Establishing an evidence base for caregiver-delivered complementary therapies like reflexology requires overcoming recruitment barriers specific to involving both patients and their informal caregivers in clinical trials.

How strong is this evidence?

This is a randomised trial and we rate its evidence moderate. It covers 551 participants. It was published in Applied nursing research : ANR, a Q2 journal. Reflexology is a complementary therapy, not a replacement for medical treatment.

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