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The effects of a yoga-based stress reduction program on fatigue and quality of life in women with adjuvant chemotherapy for breast cancer a mono-centre, pragmatic, randomized clinical study.


- candidate number13790
- NTR NumberNTR3701
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-nov-2012
- Secondary IDsNL41230.028.12 CCMO
- Public TitleThe effects of a yoga-based stress reduction program on fatigue and quality of life in women with adjuvant chemotherapy for breast cancer a mono-centre, pragmatic, randomized clinical study.
- Scientific TitleThe effects of a yoga-based stress reduction program on fatigue and quality of life in women with adjuvant chemotherapy for breast cancer a mono-centre, pragmatic, randomized clinical study.
- ACRONYMYBSR study
- hypothesisThe working hypothesis is that women who receive a postoperative YBSR program added to the standard treatment will report a lower “fatigue symptom score”, lower psychological stress, higher quality of life, less days in return to work and more patient satisfaction than women who receive standard care alone.
- Healt Condition(s) or Problem(s) studiedBreast cancer, Surgery, Neoadjuvant chemotherapy, Fatigue, Quality of life
- Inclusion criteria1. Women with stage I-III breast cancer;
2. Undergone primary surgery;
3. Scheduled to receive adjuvant chemotherapy;
4. Age 18-70 years;
5. Written informed consent;
6. Accessible by phone and internet.
- Exclusion criteria1. Previous treatment with cytostatics;
2. Presence of metastasis or other malignancies;
3. Deafness;
4. Serious psychiatric or cognitive problems;
5. Inability to understand and speak the Dutch language;
6. Participating in other yoga or stress-reduction programs at the time of the intervention.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 5-nov-2012
- planned closingdate1-jun-2015
- Target number of participants86
- InterventionsStandard Medical Treatment is provided according to the hospital guidelines.

Standard Medical Treatment + 12 week Yoga-Based Stress Reduction (YBSR) Program:
In addition to standard care the YBSR program will be followed once a week for a period of 12 weeks. The YBSR program is an innovative behavioral intervention specifically designed and tailored to address patients’ pain, fatigue, and emotional distress. It is a comprehensive program provided by certified yoga teachers, that systematically integrates a broad spectrum of soft movements, breathing- and relaxation techniques. The physical exercises are designed to create body awareness and help patients to improve flexibility in neck, shoulder, arms and back to regain trust in their body. The meditative breathing- and relaxation exercises are directed to reduce stress and fatigue and increase acceptance and emotional well-being.
- Primary outcomeMean fatigue symptoms: Using the 20-item Multidimensional Fatigue Inventory (MFI) and the 28-item Fatigue Quality List (FQL).
- Secondary outcome1. Health-related quality of life: using the 30-item European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-C (EORTC-QLQ-C-30);
2. Psychological distress will be measured using the 14-item Hospital Anxiety Depression Scale (HADS) and the 22-item Impact of Events Scale (IES);
3. Return to work and tpeatment/ patient satisfaction will be measured during a semi-structured interview.
- Timepoints1. Contact 1 (screening): 6-9 days after surgery:
A. Screening;
B. Verbal and written information.
2. Contact 2/ T=0 (intake-baseline): Within 3 weeks after surgery:
A. Informed consent/ medical history/ demographic data/ stage of breast cancer/ type of surgery/ type of adjuvant chemotherapy/ other adjuvant therapies/ instruction for measurements and timelines during the study;
B. Questionnaires (online): MFI, FQL, EORTC-QLQ-C30 + EORTC QLQ-BR23, HADS, IES, SOC, PE.
3. Intervention during 12 weeks: (Standard Care + YBSR-program or Standard Care only according to randomisation);
4. Contact 3, T=1 (3 months after start intervention):
A. Questionnaires (online): MFI, FQL, EORTC-QLQ-C30 + EORTC QLQ-BR23, HADS, IES, SOC, PE;
B. Telephone semi-structured interview: Compliance to the intervention, actual therapies, possible adverse events from intervention, return to work, satisfaction with the provided care.
5. Contact 4, T=2 (4 months after start intervention):
A. General well-being, evaluation treatment + actual medication / therapy, possible adverse events from medications and therapies.
6. Contact 5, T=3 (6 months after start intervention):
A. Questionnaires (online): MFI, FQL, EORTC-QLQ-C30 + EORTC QLQ-BR23, HADS, IES, SOC;
B. Telephone semi-structured interview: Actual therapies, possible adverse events from intervention, return to work, satisfaction with the provided care.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. MD. I. Boers
- CONTACT for SCIENTIFIC QUERIESDrs. MD. I. Boers
- Sponsor/Initiator Louis Bolk Institute
- Funding
(Source(s) of Monetary or Material Support)
Pink Ribbon
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)28-8-2013:
Hypothesis: The working hypothesis is that women undergoing chemotherapy for breast cancer, who receive a postoperative YBSR program added to the standard treatment will report a lower “fatigue symptom score”, lower psychological stress, higher quality of life, less days in return to work and more patient satisfaction than women who receive standard care alone.

Added one Healt Condition(s) or Problem(s) studied: Adjuvant chemotherapy

Inclusion criteria: removed "2. Undergone primary surgery" and added "Scheduled to receive (neo)adjuvant chemotherapy".

Exclusion criteria: added Inoperable tumor.

Standard Medical Treatment + 12 week Yoga-Based Stress Reduction (YBSR) Program: starts 1-2 weeks before the start of chemotherapy

Changes in Timpeoints 1 & 2: 1. Contact 1 (screening): In case of adjuvant chemotherapy: 6-9 days after surgery In case of neoadjuvant chemotherapy: after PA diagnosis A. Screening; B. Verbal and written information. 2. Contact 2/ T=0 (intake-baseline): In case of adjuvant chemotherapy: Within 3 weeks after surgery In case of neoadjuvant chemotherapy: Within 3 weeks after PA diagnosis A. Informed consent/ medical history/ demographic data/ stage of breast cancer/ type of surgery/ type of (neo)adjuvant chemotherapy/ other adjuvant therapies/ instruction for measurements and timelines during the study; B. Questionnaires (online): MFI, FQL, EORTC-QLQ-C30 + EORTC QLQ-BR23, HADS, IES, SOC, PE.

- RECORD13-nov-2012 - 16-sep-2013


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