Quality of Life Clinical Trial
Official title:
Fatigue as a Late Effect in Breast Cancer Survivors - is Acupuncture a Treatment Option?
The success of treatment of breast cancer has improved, hence the prevalence of survivors have increased. However, experienced late effects from the cancer itself or from cancer treatment is substantial. Anti-cancer treatment can have a number of side effects including nausea, fatigue, vomiting, anorexia and alopecia. Late effects such as cancer related fatigue (CRF) are very persistent. CRF is a common side effect of cancer therapy, and affects the quality of life of patients and their families. It is important to point out that CRF is a form of fatigue that are different from normal fatigue which everyone can experience every now and then. Acupuncture is increasingly used in cancer centers both in the US and Europe, and that patients are positive to using acupuncture. Albeit the emerging evidence for acupuncture and CRF, acupuncture has neither been offered as a treatment for CRF within a Norwegian hospital nor in general practice. Hence the investigators think there is a need for a large randomized controlled trial (RCT) in a Norwegian health care setting.
Status | Recruiting |
Enrollment | 250 |
Est. completion date | December 1, 2024 |
Est. primary completion date | June 1, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. Breast cancer survivors, aged 18 or older, not receiving any curative cancer treatment 2. On adjuvant treatment of anti-estrogens 3. Sufficient knowledge of Norwegian is necessary for communicating with the acupuncturist and for filling in and understanding all the Norwegian questionnaires within the study. Exclusion Criteria: 1. Any causal pathology related to fatigue or receiving ongoing acupuncture treatment for fatigue. 2. Participants who are pregnant at baseline or planning to get pregnant within the treatment period will be excluded. Reason is that several acupuncture points should be avoided during pregnancy and several of those are related to the treatment of fatigue. 3. Potential participants who are unable to understand, speak, or who find it difficult to communicate in Norwegian will be excluded from the study. |
Country | Name | City | State |
---|---|---|---|
Norway | Kristiania University College | Oslo |
Lead Sponsor | Collaborator |
---|---|
Kristiania University College | Dana-Farber Cancer Institute, Memorial Sloan Kettering Cancer Center, Norwegian Cancer Society, University Hospital, Akershus, University of Bergen, University of Tromso, University of York |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fatigue | Chalders Fatigue questionnaire (FQ) | 12 weeks (treatment completion), Change from baseline registration at 3 and 6 month | |
Primary | Fatigue 2 | Fatigue Severity Scale (FSS) | Change from baseline registration at 3 and 6 month | |
Secondary | Anxiety and depression | Hospital and Anxiety Depression scale (HADS). The HADS questionnaire has seven items each for depression and anxiety subscales. Scoring for each item ranges from zero to three, with three denoting highest anxiety or depression level. Scores are constructed by summation, whereby increasing scores indicate increasing burden. A total subscale score of >8 points out of a possible 21 denotes considerable symptoms of anxiety or depression. | 12 weeks (treatment completion), Change from baseline registration at 3 and 6 months | |
Secondary | Bergen Insomnia Scale | The Bergen Insomnia Scale consist of six items, of which the first three pertain to sleep onset, maintenance, and early morning wakening insomnia, respectively. The last three items refer to not feeling adequately rested, experiencing daytime impairment, and being dissatisfied with current sleep. Each item is rated on an 8-point scale, ranging from 0 to 7 days per week. A total composite score is calculated by adding together the scores for each item, yielding a total score with a possible range of 0 to 42. A high score indicating more severe problems. | 12 weeks (treatment completion), Change from baseline registration | |
Secondary | The Epworth Sleepiness Scale | The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3). The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'. | 12 weeks (treatment completion), Change from baseline registration | |
Secondary | Hot flashes | Self-managed diary reporting the frequency and the severity of hot flashes | 12 weeks (treatment completion), Change from baseline registration | |
Secondary | Quality of Life (QLQ) questionnaire | EORTC QLQ-C30, | 12 weeks (treatment completion), Change from baseline registration | |
Secondary | Quality-adjusted life year - QALY questionnaire | EQ-5D- 5L | Baseline and 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05559255 -
Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI
|
N/A | |
Completed |
NCT06238557 -
Prospective Evaluation of Psychological Consequences and Impact on Long-term Quality of Life
|
||
Recruiting |
NCT05563805 -
Exploring Virtual Reality Adventure Training Exergaming
|
N/A | |
Completed |
NCT05472935 -
Asynchronous Mindfulness Based Stress Reduction to Reduce Burnout in Licensed Clinical Social Workers
|
N/A | |
Recruiting |
NCT04444544 -
Quality of Life and High-Risk Abdominal Cancer Surgery
|
||
Completed |
NCT04281953 -
Impact on Quality of Life of Long-term Ototoxicity in Cancer Survivors
|
||
Active, not recruiting |
NCT04746664 -
Effects of Nutrition Counselling on Old Age People's Nutritional Status and Quality of Life in Bahir Dar City, North West Ethiopia
|
N/A | |
Completed |
NCT05387174 -
Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period
|
N/A | |
Recruiting |
NCT04142827 -
The Effect of Long Term Therapy With High Flow Humidification Compared to Usual Care in Patients With Bronchiectasis (BX)
|
N/A | |
Active, not recruiting |
NCT05903638 -
A Pilot RCT: the Impact of a Virtual MBSR Course on Women With Primary Infertility
|
N/A | |
Completed |
NCT05538455 -
Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases
|
N/A | |
Completed |
NCT06216015 -
Exercise Training and Kidney Transplantation
|
N/A | |
Completed |
NCT03813420 -
Sleep Quality of Physiotherapy Students Quality of Life and Physical Activity Level
|
N/A | |
Recruiting |
NCT05550545 -
Infant RSV Infections and Health-related Quality of Life of Families
|
||
Completed |
NCT05346588 -
THRIVE Feasibility Trial
|
Phase 3 | |
Recruiting |
NCT05233020 -
Robotic Versus Hybrid Assisted Ventral Hernia Repair
|
N/A | |
Terminated |
NCT03304184 -
The Role of Biodentine in Class V Dental Lesions on Oral Health Related Quality of Life
|
Phase 3 | |
Completed |
NCT05063305 -
Probiotics, Immunity, Stress, and QofL
|
N/A | |
Recruiting |
NCT05380856 -
Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction
|
N/A | |
Completed |
NCT05934578 -
Lymphatic Function in Patients With Fontan Circulation: Effect of Physical Training
|
N/A |