Ensuring model validity in a feasibility study of acupuncture to improve quality of life in cancer patients undergoing radiotherapy treatment

Hughes, John; Cummings, Mike; Filshie, Jacqueline; Kassab, Sosie; Leng, G.; Mackereth, Peter; MacPherson, Hugh; Valois, Beverley de; Fisher, Peter

doi:10.1016/j.eujim.2018.06.010

Cited by 5 publications

(3 citation statements)

References 8 publications

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“…Furthermore, our acupuncture intervention reflected clinical practice by being pragmatically designed, where acupuncturists conducted a typical syndrome diagnosis and selected acupuncture points according to this diagnosis. Model validity in complex interventions such as acupuncture is critical to ensure accurate findings in a clinical trial — when model validity is low this may result in “false negative” findings due to suboptimal treatment [ 39 ].…”

Section: Discussionmentioning

confidence: 99%

Acupuncture for the treatment of the pain-fatigue-sleep disturbance-numbness/tingling symptom cluster in breast cancer survivors: a feasibility trial

Kwon,

Lacey,

Kerin-Ayres

et al. 2024

Support Care Cancer

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Purpose Breast cancer survivors following disease-modifying treatment frequently experience multiple-concurrent symptoms (Jansana et al. in Int J Cancer 149(10):1755 1767, 2021), negatively impacting their quality of life and increasing the risk of polypharmacy (Alwhaibi et al. in J Oncol Pharm Pract 26(5):1052 1059, 2020). This study evaluates the feasibility and acceptability of acupuncture for the management of the pain-fatigue-sleep disturbance-numbness/tingling symptom cluster in breast cancer survivors, and investigates relationships between the symptom cluster and Traditional Chinese Medicine (TCM) syndrome diagnosis. Methods This was a single-arm, pre-test/post-test feasibility trial conducted at Chris O’Brien Lifehouse Hospital, Australia. Breast cancer survivors who completed treatment and experienced clinically significant levels of two or more symptoms (pain, fatigue, sleep disturbance, numbness/tingling) were eligible to participate in the individualized, pragmatic 6-week acupuncture intervention. The primary outcome was feasibility and acceptability. Effectiveness was explored using a symptom cluster mean score. Results Twenty women enrolled in the study over an 11-week period and 90% completed the study. Most women agreed or completely agreed that acupuncture was feasible (85%), acceptable (90%), and appropriate (90%). Both mean and composite symptom cluster scores were significantly reduced (p < 0.001), as were individual symptom scores in fatigue (p < 0.001), sleep disturbance (p = 0.04), and numbness/tingling (p = 0.01). TCM syndromes most closely associated with this symptom cluster were Spleen qi deficiency and Heart fire. No adverse events were reported. Conclusion This study demonstrated that acupuncture was safe and feasible, justifying a powered randomized control trial. Preliminary findings suggest beneficial effects of acupuncture for the management of the pain-fatigue-sleep disturbance-numbness/tingling symptom cluster for women with breast cancer. TCM syndromes identified in this trial may be used to guide acupuncture treatment protocols. Clinical trial registration: This trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12622000590763) on 21 April 2022.

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Section: Discussionmentioning

confidence: 99%

Acupuncture for the treatment of the pain-fatigue-sleep disturbance-numbness/tingling symptom cluster in breast cancer survivors: a feasibility trial

Kwon,

Lacey,

Kerin-Ayres

et al. 2024

Support Care Cancer

View full text Add to dashboard Cite

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“…Although the trial acupuncture intervention was designed by an expert panel, and employed a rigorous methodological approach to its design [14], data from the feasibility study reveal a number of ways in which the intervention could have been improved for participants. Qualitative data revealed that some participants perceived the effects of acupuncture as diminishing over a few days, and it is possible that twice weekly treatments may have improved effects.…”

Section: Discussionmentioning

confidence: 99%

“…Informed by the systematic review and their clinical expertise the expert panel devised and agreed the trial acupuncture intervention. Details of the process of designing the intervention have been published elsewhere [14].…”

Section: Art Acupuncture Interventionmentioning

confidence: 99%

A feasibility trial of acupuncture in cancer patients undergoing radiotherapy treatment

Hughes

Carballo

Plant

et al. 2021

European Journal of Integrative Medicine

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The Effect of Religious Psychotherapy Emphasizing the Importance of Prayers on Mental Health and Pain in Cancer Patients

et al. 2018

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The religious aspect is the most important aspect of the human nature that helps the human achieve the meaning and purpose of life as well as playing a very important role in the health of patients. This study aimed to determine the effect of religious psychotherapy emphasizing the importance of prayers on mental health and pain in cancer patients. This study is a clinical trial that was conducted in 2017 in Yasuj, Iran. According to the purpose of the study, the patients were randomly assigned into two experimental and control groups. Prayers 15 and 23 of the SahifehSajjadiyeh book were read at the beginning of the treatment sessions, and the patients were asked to pay attention to the meaning of prayer. The data were analyzed using SPSS 16 software. Before implementing the intervention, the mean and standard deviation of mental health score of the patients in the experimental and control groups were equal to 16.40 (2.21) and 16.56 (1.56). But after implementing the intervention, the mean and standard deviation of mental health score were equal to 11.24 (2.93) and 16.82 (1.83) which illustrates a significant statistical increase. Implementing the supportive spiritual intervention has been tested to enhance the mental health and reduce the pain of patients in the experimental group. Regarding this improvement, it is suggested a religious intervention be implemented to increase these patients' health in a participatory way.

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Ensuring model validity in a feasibility study of acupuncture to improve quality of life in cancer patients undergoing radiotherapy treatment

Cited by 5 publications

References 8 publications

Acupuncture for the treatment of the pain-fatigue-sleep disturbance-numbness/tingling symptom cluster in breast cancer survivors: a feasibility trial

Acupuncture for the treatment of the pain-fatigue-sleep disturbance-numbness/tingling symptom cluster in breast cancer survivors: a feasibility trial

A feasibility trial of acupuncture in cancer patients undergoing radiotherapy treatment

The Effect of Religious Psychotherapy Emphasizing the Importance of Prayers on Mental Health and Pain in Cancer Patients

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