Cancer Clinical Trial
— ARTOfficial title:
A Feasibility Study of Acupuncture to Improve Quality of Life and Fatigue in Cancer Patients Undergoing Radiotherapy Treatment
Verified date | February 2018 |
Source | Royal London Hospital for Integrated Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Feasibility randomized controlled trial of standard care v standard care + acupuncture
administered by specially-trained therapy radiographers in patients undergoing radiotherapy.
It is a feasibility study to investigate all aspects of a future definitive randomized
controlled trial, including statistical power calculation, hence there is no primary outcome
or time point.
Mixed methods: literature review, model validity, training and mentoring of radiographers,
processes, resources, interventions, procedures, patient clinical outcomes, patient and
stakeholder qualitative outcomes
Status | Completed |
Enrollment | 101 |
Est. completion date | October 31, 2016 |
Est. primary completion date | October 31, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Patients due to receive radical (curative) radiotherapy - Patients of either gender and older than 16 years old. - Patients with any cancer diagnosis. - Patients willing to participate in the study and be randomised to one of the two treatment arms. - Patients willing to attend at least 3 acupuncture treatments if assigned to the acupuncture intervention. - Palliative patients. - Patients unwilling to participate (for instance due to needle phobia). - Patients currently receiving acupuncture. - Patients with a platelet count <20 000mm. - Patients with a white blood cell count <1000mm. - Patients with severe clotting dysfunction or who bruise spontaneously. - Patients unable to complete the questionnaires as judged by the investigators. Exclusion Criteria: |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University College London Hospitals Cancer Clinical Trials Unit | London |
Lead Sponsor | Collaborator |
---|---|
Royal London Hospital for Integrated Medicine | University College London Hospitals |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | EORTC QLQC-30 | EORTC QLQC-30: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30. A well-validated quality of life questionnaire for cancer patients focusing on functional assessment. It consists of nine multi-item scales: five functional scales (physical, role, cognitive, emotional, and social); three symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality-of-life scale. High internal consistency and construct validity have been demonstrated. | Change from baseline (T0) to end of radiotherapy (3-8 weeks depending on tumor site and stage) (T2) | |
Secondary | MFI | Multidimensional Fatigue Inventory. A well-validated scale comprising 20 items measuring general fatigue including dimensions of physical and mental fatigue. | Change from baseline (T0) to end of radiotherapy (3-8 weeks depending on tumor site and stage) (T2) | |
Secondary | MSAS | Memorial Symptom Assessment Scale. A multidimensional scale which evaluates 32 physical and psychological symptoms associated with cancer and its treatment. | Change from baseline (T0) to end of radiotherapy (3-8 weeks depending on tumor site and stage) (T2) | |
Secondary | EQ-5D-5L | European Quality of Life 5 Dimensions 5 levels. A well-validated instrument which includes five indices to represent patients' Health Related Quality of Life: mobility; self-care; usual activities; pain/discomfort; anxiety/depression | Change from baseline (T0) to end of radiotherapy (3-8 weeks depending on tumor site and stage) (T2) |
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