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

Breast cancer is the most common cancer diagnosed in women with an expected
rise over the coming years. As survival increases, a better management of
cancer related symptoms is important to reduce suffering in breast cancer
survivors. Persistent fatigue and high levels of distress are the most
frequently reported symptoms.Despite the high prevalence of cancer-related
fatigue, few evidence-based interventions are currently available to manage
this symptom. There is growing evidence that behavioural interventions such a
physical exercise may have positive effects on fatigue. However, cancer
survivors are often unable or unwilling to participate in standard exercise
interventions in relation to their severe fatigue condition. Recent (pilot)
studies have shown promising beneficial effects of yoga in breast cancer
survivors, including reduction of persistent fatigue. However, results of yoga
studies have not been entirely consistent, most likely due to methodological
limitations Additional randomized controlled studies with yoga-based
interventions are thus necessary to confirm its effectiveness.

To investigate whether an adjunctive YBSR program added to standard care
compared to standard care alone, can reduce:
1.fatigue symptoms (primary objective)
2.psychological distress

and improve:
3.health-related quality of life
4.sense of coherence
5.reintegration to work
6.satisfaction with care

A mono-centre pragmatic, randomized controlled prospective study with two
parallel groups.

Standard Care:
Standard care is provided according to the hospital guidelines. Women attend
the breast cancer department *mamma poli*, which provides all necessary
research to diagnose breast cancer in one day, with the biopsy result 2two days
later. After the pathoanatomical diagnosis therapy options are discussed.
Either neoadjuvant or adjuvant chemotherapy could be opted. In the case of
neoadjuvant chemotherapy the start of chemotherapy will be planned within 5
weeks after diagnosis. In the case of primary sSurgery, surgery will be is
planned within 3 weeks after diagnosis. Pathology reports are delivered within
6-9 days after surgery and consultants see every case by videoconferencing to
give an expert opinion as to the aftercare and adjuvant therapy (chemotherapy,
radiotherapy and /or immunotherapy). Women will attend at certain times to an
oncology nurse and a mamma-care nurse during these adjuvant therapies. In case
of severe psychological problems a psychologist or psychiater is consulted. The
oncology nurse is the first contact for care, explanation, support and
appointments.

Standard Care + 12 week 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 a behavioral intervention
specifically designed and tailored to address womens* fatigue, pain 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 women 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.

The risk to participate with the YBSR program is judged as minimal. The extra
time burden due to questionnaires, telephone interviews and the contacts with
the oncology nurse will where desirable and possible integrated in the regular
care.
Next tot this the lessons of the YBSR program itself will be combined if
desirable with other hospital appointments. so the extra burden for the
participating women will be minimal.

Further development and research after possibilities of stress reduction and
exercise aprograms are justified. We expect that the benefits for the women
will exceed the possible burdens . If the study confirms the efficacy of YBSR
in the reduction of fatigue and improvement of quality of life in breast cancer
survivors, the YBSR program will be taken up in the standard care program of
the St. Jansdal hospital for adjuvant therapies of women after breast cancer
surgery, specifically those who receive chemotherapy. This way, breast cancer
survivors can be relieved with an intervention that is highly acces