Accepted for/Published in: JMIR Research Protocols
Date Submitted: Feb 24, 2023
Open Peer Review Period: Feb 24, 2023 - Apr 21, 2023
Date Accepted: Aug 28, 2023
(closed for review but you can still tweet)
Prehabilitation in an integrative medicine day clinic (PRIME-DC) for patients undergoing neoadjuvant treatment: a single-center feasibility pilot study
ABSTRACT
Background:
Cancer patients receiving neoadjuvant treatment prior to surgery are in a very stressful situation. Preparation of these patients for the intervention in terms of prehabilitation has great potential to reduce the burden of postoperative complications and may improve the clinical outcome. A multimodal approach is mandatory to address patients’ diverse needs during this critical period.
Objective:
The aim of the study presented here is to evaluate the feasibility of an integrative prehabilitation day clinic (PRIME-DC) prior to cancer surgery at a major university clinic. PRIME-DC is considered feasible if 80% of enrolled patients are willing and able to complete at least six out of eight weekly meetings, each lasting 6.5 h, at such a clinic.
Methods:
The PRIME-DC intervention combines mind−body medicine (MBM), exercise therapy, nutrition therapy, naturopathic counselling and the application of a yarrow liver compress. Adult cancer patients with a primary tumour in the abdomen (including intraperitoneal cancer, stomach cancer, and extraperitoneal cancers such as pancreatic, bladder, rectal, oesophageal, endometrial, ovarian and cervical cancer) or the breast requiring a neoadjuvant oncological treatment setting are eligible to participate. The addressed cancer entities imply either an extensive surgical intervention with an expected need for prehabilitation (e.g. abdominal surgery) or a neoadjuvant treatment of several months with a high burden of treatment associated side-effects (breast cancer). Adherence to the day-clinic programme is the primary endpoint being defined as presence during the day clinic session. Secondary endpoints are physical assessment and quality of life (QoL), together with a structured assessment of neoadjuvant treatment-associated side effects. Furthermore, to collect qualitative data voluntary participants of the day clinic will be interviewed in a semi-structured way after completion of the day clinic program on each component of the study (mind-body intervention, exercise, nutrition, naturopathic counseling, yarrow liver compression).
Results:
Approval was obtained from the ethics committee of Ulm University, Germany (no. 77/22). The procedures used in this study adhere to the tenets of the Declaration of Helsinki. As of February 2023, we enrolled 23 patients, the dominant cancer entity is breast cancer (18 enrolled patients).
Conclusions:
The presented protocol combines prehabiliation, naturopathic counselling, dietary assistance and naturopathy in an innovative and integrative way. Clinical Trial: DRKS00028126
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Copyright
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