Clinical trial NCT06025799: Effect of Mindfulness-based Stress Reduction Intervention on Psychological Distress and Hope Among Female Patients Undergoing Radiotherapy for Breast Cancer
Official title: Effect of Mindfulness-based Stress Reduction Intervention on Psychological Distress and Hope Among Female Patients Undergoing Radiotherapy for Breast Cancer: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Female
Keywords: Mindfulness-based stress reduction
Psychological Distress
Hope
Female patients
Radiotherapy
Breast cancer
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-09-06
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Breast cancer is a significant issue in Egypt, affecting a large number of women and impacting their psychological well-being. Younger patients and those undergoing adjuvant therapy or radiotherapy are particularly susceptible to psychological distress. Psychological counseling and support groups can help improve patients' quality of life and social functioning. Hope plays a crucial role in the treatment process, as it is associated with positive outcomes and serves as a protective mechanism against stress and disease. Mindfulness-Based Stress Reduction (MBSR) is an intervention that can reduce stress and depression in cancer patients. It involves cultivating awareness of the present moment and has positive effects on quality of life. Investigating the impact of MBSR on psychological distress and hope in women undergoing radiotherapy for breast cancer is important for providing effective support during treatment.

The aim of this study is to:

Examine the effect of the Mindfulness-Based Stress reduction intervention on psychological distress and hope among female patients undergoing radiotherapy for breast cancer.

RESEARCH HYPOTHESIS Female patients undergoing radiotherapy for breast cancer who attend Mindfulness-Based Stress reduction intervention sessions exhibit higher levels of hope and lower levels of psychological distress compared to those who receive conventional hospital treatment.


Eligibility criteria: Inclusion Criteria:

* Adult female patients with post-mastectomy (within one to six months).
* Able to communicate verbally.
* Able to read and write.
* Willing to participate in the study.

Exclusion Criteria:

* other associated diseases such as (renal disease, ischemic heart disease, liver disease) will e excluded.

Primary outcomes:
measure: Five Factors Mindfulness Questionnaire (FFMQ)
timeFrame: 9 weeks
measure: Depression Anxiety and Stress Scale 21 (DASS-21)
timeFrame: 9 weeks
measure: The Herth Hope Index (HHI)
timeFrame: 9 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Nursing, Alexandria University
Study officials:
References:
citation: Carlson LE, Ursuliak Z, Goodey E, Angen M, Speca M. The effects of a mindfulness meditation-based stress reduction program on mood and symptoms of stress in cancer outpatients: 6-month follow-up. Support Care Cancer. 2001 Mar;9(2):112-23. doi: 10.1007/s005200000206.