Stress Reduction Through Acupuncture
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorIsabell Xiang Ge
About this trial
This randomized controlled trial evaluates whether eight weeks of weekly acupuncture can reduce psychological distress in breast cancer patients who have recently completed primary therapy compared to standard-of-care wait-list control.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with localized breast cancer having completed primary therapy (operation +/- chemotherapy +/- radiotherapy) in the last 6 months - Distress Thermometer ≥ 5 - Age ≥ 18 years - Signed informed consent for participation of the trial
Prior cancer is allowed
Prior treatment - including chemotherapy - for a prior malignant tumor (including breast cancer) is allowed
Concomitant participation in an experimental therapeutic drug trial is allowed
Disqualifiers
Patients with language or cognitive deficits (including impaired consciousness) that are incompatible with the participation in the study
Severe physical or psychiatric comorbidity that prevents a patient from participating in the study
Patients incapable of giving consent
Pregnancy
Trial design
Design model
Parallel
Treatments tested in this trial
Acupuncture
Procedure/Surgery8 sessions of acupuncture treatment (body and auricular acupuncture) will be given once a week after randomization.
Standard supportive care
Other interventionSupportive care according to local standards will be given which may also include face-to-face psychosocial support or the participation of support groups
Treatment groups
112 Participants
are divided into 2 treatment groupsGroup A: Acupuncture:Experimental treatment 1 intervention
Group B: Wait-listed control groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Distress at 8 weeks of intervention
Distress is assessed after completion of 8 weeks of weekly acupuncture interventions or standard of care (SOC) by the Perceived Stress Scale (PSS-10). PSS-10 is a 10-item questionnaire widely used to assess stress levels in individuals. It measures the degree to which life has been perceived as unpredictable, uncontrollable und overloading over the last month. The responses are rated on a 5-point rating scale with a total score ranging from 0-40 while a higher total score indicating greater stress.
Time frame
Post-intervention (after completion of the 8 week acupuncture therapy or SOC)Secondary outcomes
1
Distress over the course time
Immediate changes in distress before and after the intervention will be assessed over the course of 8 weeks by the Distress Thermometer, a valid and reliable measure developed by the National Comprehensive Cancer Network for screening psychological distress in cancer patients. The German version was adapted by Mehnert et al. A score of 5 or higher at the visual analogue scale. The score ranges from 0-10 while 10 indicates a higher stress level.
Time frame
Before and after each acupuncture session during the the 8 week intervention period2
Quality of life assessment
Quality of life is assessed after completion of the 8 week acupuncture therapy or SOC by 30-items EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30). The score ranges from 0-100 while 100 indicates a higher quality of life.
Time frame
Post-intervention (after completion of the 8 week acupuncture therapy or SOC)3
Anxiety
Anxiety will be measured using the validated questionnaire The Hospital Anxiety and Depression Scale (HADS) for somatically ill patients with good psychometric properties and with satisfactory internal consistency. The scale consists of 14 questions, with each question being assigned a value from 0 to 3. The total score can range from 0 to 21. Scores of 8-10 are considered borderline, 11-15 moderate, and 16 or higher severe anxiety.
Time frame
Post-intervention (after completion of the 8 week acupuncture therapy or SOC)4
Depression
Depression will be measured using the validated questionnaire The Hospital Anxiety and Depression Scale (HADS) for somatically ill patients with good psychometric properties and with satisfactory internal consistency. The scale consists of 14 questions, with each question being assigned a value from 0 to 3. The total score can range from 0 to 21. Scores of 8-10 are considered borderline, 11-15 moderate, and 16 or higher severe depression.
Time frame
Post-intervention (after completion of the 8 week acupuncture therapy or SOC)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Isabell Xiang Ge
Lead sponsor
University Hospital, Basel, Switzerland
Sponsor institution
Swiss GO Trial Group
Collaborator
Source ClinicalTrials.gov