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

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 - The YBSR study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON43915

Enrollment

104

Registered

2012-08-21

Start date

2012-11-09

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

moeheid breast cancer mammacarcinoma

Interventions

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 cance

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: *Women with stage I-III breast cancer *Scheduled to receive (neo)adjuvant chemotherapy *Age 18-70 years *Written informed consent *Accessible by phone and internet /email

Exclusion criteria

Exclusion criteria: *Previous treatment with cytostatics *Presence of metastasis or other malignancies *Deafness *Serious psychiatric or cognitive problems *Inability to understand and speak the Dutch language *Participating in other yoga or stress-reduction programs at the time of the intervention *inoperable tumor

Design outcomes

Primary

Measure	Time frame
Mean fatigue symptoms: will be measured at baseline (T=0), 3 months (T=1) and 6 months (T=3) after the start of the intervention using the 20-item Multidimensional Fatigue Inventory (MFI), including questions on physical and mental fatigue and the 18-item Fatigue Quality List (FQL) assessing womens perception and appraisal of experienced fatigue	—

Secondary

Measure	Time frame
Health-related quality of life: will be measured at baseline (T=0), 3 (T=1) and 6 months (T=3) after the start of the intervention using the 30-item European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-C (EORTC-QLQ-C-30) together with the 23-item breast cancer specific module: EORTC QLQ-BR23. Psychological distress will be measured at baseline (T=0), 3 months (T=1) and 6 months (T=3) after the start of the intervention using the 14-item Hospital Anxiety Depression Scale (HADS) and the 22-item Impact of Events Scale (IES). Sense of Coherence: will be measured at baseline (T=0), 3 months (T=1) and 6 months (T=3) after the start of the intervention using the 13-item Sense of Coherence Questionnaire Participants expactations:will be measured at baseline (T=0) and 3 months (T=1)after the start of the intervention using the Participants Expectations Questionnaire Return to work: by means of a semi-structured telephone interview by the research physician. Satisfaction with care: by means of asemi-structured telephone interview by the research physician. Adverse events: It will be noted 3 month after the start of the intervention (T=1) and at the end of the study (T=3) if participants have experienced any side effects from medication or therapies (by means of a telephone interview by the research physician). In addition, It will be noted every standard hospital visit during the study if participants have experienced any side effects from medication or therapies (by means of writing it down in the patient*s file by the oncology nurse or oncology surgeon).	—

Measure

Time frame

*Health-related quality of life: will be measured at baseline (T=0), 3 (T=1) and 6 months (T=3) after the start of the intervention using the 30-item European Organization for Research and Treatment of Cancer, Quality of Life Questionnaire-C (EORTC-QLQ-C-30) together with the 23-item breast cancer specific module: EORTC QLQ-BR23. *Psychological distress will be measured at baseline (T=0), 3 months (T=1) and 6 months (T=3) after the start of the intervention using the 14-item Hospital Anxiety Depression Scale (HADS) and the 22-item Impact of Events Scale (IES). *Sense of Coherence: will be measured at baseline (T=0), 3 months (T=1) and 6 months (T=3) after the start of the intervention using the 13-item Sense of Coherence Questionnaire *Participants expactations:will be measured at baseline (T=0) and 3 months (T=1)after the start of the intervention using the Participants Expectations Questionnaire *Return to work: by means of a semi-structured telephone interview by the research physician. *Satisfaction with care: by means of asemi-structured telephone interview by the research physician. Adverse events: It will be noted 3 month after the start of the intervention (T=1) and at the end of the study (T=3) if participants have experienced any side effects from medication or therapies (by means of a telephone interview by the research physician). In addition, It will be noted every standard hospital visit during the study if participants have experienced any side effects from medication or therapies (by means of writing it down in the patient*s file by the oncology nurse or oncology surgeon).

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)