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Not Yet RecruitingNCT07132034

Stress Reduction Through Acupuncture

Study Protocol: Stress Reduction in Breast Cancer Patients During Transition Into Survivorship Using Acupuncture - a Randomized Wait-list-controlled Intervention Study

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
112 (estimated)
Sponsor
University Hospital, Basel, Switzerland · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

Background Psychological distress is common in cancer patients-affecting roughly one-third with diagnosable mental health disorders and about half with significant psychosocial distress. This distress often spikes during diagnosis and treatment, decreases during therapy, but rises again after treatment ends. The transition from active treatment to aftercare is a particularly vulnerable phase, marked by loss of routine medical contact, fear of recurrence, ongoing side effects, and feelings of isolation. In breast cancer survivors, 20-40% experience clinically relevant distress, with many reporting unmet needs for psychological support. Chronic stress in cancer patients is linked to lower quality of life, worse treatment adherence, higher symptom burden, and poorer prognosis. Acupuncture, a method from traditional Chinese medicine, has shown potential to reduce stress through modulation of the autonomic nervous system-reducing sympathetic overactivation and enhancing parasympathetic activity. It has been shown to improve symptoms such as pain, fatigue, and hot flushes in cancer patients, and to lower stress in other populations. However, there is almost no research on acupuncture's effect on post-treatment stress in breast cancer patients, especially in the critical early aftercare phase. Whether acupuncture can also improve resilience and treatment adherence in this context remains unknown. Aim of the Study The study aims to investigate whether acupuncture reduces psychological distress in breast cancer patients who have recently completed primary therapy. Specifically, it tests whether the patients receiving acupuncture will have significantly lower perceived stress after eight weeks compared to a wait-list control group. Secondary objectives include exploring the effects of acupuncture on quality of life, fatigue, cognitive function, anxiety, depression, resilience, and therapy adherence, as well as documenting any adverse events.

Conditions

Interventions

TypeNameDescription
PROCEDUREAcupuncture8 sessions of acupuncture treatment (body and auricular acupuncture) will be given once a week after randomization.
OTHERStandard supportive careSupportive care according to local standards will be given which may also include face-to-face psychosocial support or the participation of support groups

Timeline

Start date
2026-02-01
Primary completion
2027-11-01
Completion
2028-09-01
First posted
2025-08-20
Last updated
2026-01-14

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT07132034. Inclusion in this directory is not an endorsement.