Trial reportTrials2015
A complex nursing intervention of complementary and alternative medicine (CAM) to increase quality of life in patients with breast and gynecologic cancer undergoing chemotherapy: study protocol for a partially randomized patient preference trial.
Trial report in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
13 citing papers in PubMed, 32 citations in OpenAlex.
- Enhancing patient activation: a controlled implementation study of an interprofessional evidence-based counseling program for complementary and integrative healthcare in cancer patients ('CCC-Integrativ').Frontiers of medicine · 2024Article
- Breast Cancer: How Hippotherapy Bridges the Gap between Healing and Recovery-A Randomized Controlled Clinical Trial.Cancers · 2023Article
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- Influence of Nursing Intervention Based on Risk Assessment Model on Self-Efficacy and Postoperative Rehabilitation of Surgical Patients.Journal of healthcare engineering · 2022Article
- Clinical efficacy of anesthesia with intensive care nursing in attenuating postoperative complications in patients with breast cancer.The Journal of international medical research · 2020Article
- Validation of a German version of the Caregiver Quality of Life Index-Cancer (CQOLC) in a sample of significant others of breast and gynaecologic cancer patients.Psicologia, reflexao e critica : revista semestral do Departamento de Psicologia da UFRGS · 2020Article
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- The Effect of Acupressure on Pain in Cancer Patients With Bone Metastasis: A Nonrandomized Controlled Trial.Integrative cancer therapies · 2018Article
- Dermal carotenoid measurement is inversely related to anxiety in patients with breast cancer.Journal of investigative medicine : the official publication of the American Federation for Clinical Research · 2018Article
- Psychometric assessment of the Chinese version of the MASCC Antiemesis Tool (MAT) for measuring chemotherapy-induced nausea and vomiting.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2016Article
- Recent perspectives on the anticancer properties of aqueous extracts of NigerianBotanics : targets and therapyArticle
- Psychoeducational Nursing Intervention for Symptom Management in Cancer Patients: A Randomized Clinical Trial.Asia-Pacific journal of oncology nursingArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundHealth-related quality of life (HRQoL) is most adversely affected in cancer patients between diagnosis and the end of chemotherapy. The aim of the Complementary Nursing in Gynecologic Oncology (CONGO) study is to assess the effectiveness of a complex nursing care intervention of CAM to increase HRQoL in cancer patients undergoing chemotherapy. METHODS/
designCONGO is a prospective partially randomized patient preference (PRPP) trial including adult women diagnosed with breast and gynecologic cancer starting a new chemotherapy regimen. Patients without strong preferences for CAM will be randomized to usual nursing care or complex nursing care; those patients with strong preferences will be allowed their choice. The intervention consists of three interacting and intertwined elements: CAM nursing intervention packet, counseling on CAM using a resource-oriented approach and evidence-based informational material on CAM. Primary outcome data on participants' HRQoL will be collected from baseline until the end of treatment and long-term follow-up using the EORTC-QLQ-C30. Secondary outcomes include nausea, fatigue, pain, anxiety/depression, social support, self-efficacy, patient competence, spiritual wellbeing, and satisfaction with care. Accompanying research on economic outcomes as well as a mixed-methods process evaluation will be conducted. A total of 590 patients (236 patients in the randomized part of the study and 354 patients in the observational part of the study) will be recruited in the two outpatient clinics. The first analysis step will be the intention-to-treat (ITT) analysis of the randomized part of the trial. A linear mixed model will be used to compare the continuous primary endpoint between the intervention and control arm of the randomized group. The observational part of the trial will be analyzed descriptively. External validity will be assessed by comparing randomized with nonrandomized patients. DISCUSSION: Cancer patients are increasingly using CAM as supportive cancer care, however, a patient-centered model of care that includes CAM for the patient during chemotherapy still needs to be evaluated. This protocol has been designed to test if the effects of the intervention go beyond potential benefits in quality-of-life outcomes.
trial registrationGerman Clinical Trials Register (DRKS), DRKS00006056 (15 April 2014).
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.