Breast Cancer Female Clinical Trial
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
Verified date | December 2023 |
Source | Alexandria University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | December 6, 2023 |
Est. primary completion date | December 1, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Nursing, Alexandria University | Alexandria |
Lead Sponsor | Collaborator |
---|---|
Alexandria University |
Egypt,
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/s00 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Five Factors Mindfulness Questionnaire (FFMQ) | The Baer et al. (2006) scale is a 39-item questionnaire designed to measure different aspects of mindfulness. It uses a five-point Likert scale, with responses ranging from 1 (never or very rarely true) to 5 (very often or always true). The scale consists of five subscales: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience.
Observing subscale: Measures the tendency to notice or attend to internal and external phenomena. Describing subscale: Assesses the ability to label observed phenomena, such as thoughts and emotions. Acting with awareness subscale: Reflects the extent to which individuals engage with full awareness in their current experience or activity. Non-judging subscale: Assesses nonjudgmental awareness of current experience without evaluation. Non-reactivity subscale: Measures the ability to notice internal phenomena without reacting to them. |
9 weeks | |
Primary | Depression Anxiety and Stress Scale 21 (DASS-21) | It is a self-reported scale developed by Lovibond, & Lovibond, (1995). The three subscales of the DASS 21 measure the negative emotional states of depression, anxiety, and stress (i.e., nervous tension and irritability, which are factorially distinct from depression and anxiety). Participants scored questions such as "I thought that as a person I wasn't worth much" (from "0" =did not apply to me at all to "3" =applied very much to me or most of the time). A total score out of 21 was determined for each subscale and then multiplied by 2 to be equivalent to the full-scale DASS scores. At least 10 (depression), 8 (anxiety), and 15 (stress) ratings indicated psychological distress levels for each item. Distress severity was categorized as mild, moderate, severe, and very severe. | 9 weeks | |
Primary | The Herth Hope Index (HHI) | The Herth Hope Index (HHI) is a clinical-setting adaptation form of the Herth Hope Scale (HHS). This scale was developed by Herth, at Minnesota State in the USA (Herth, 1992). It is composed of 12 items, which are rated on a four points Likert scale. The responses ranged from 1 (strongly disagree) to 4 (strongly agree). Items 3 and 6 are reversed in their score. The twelve items are summed to obtain a total score that ranges from 12 to 48, with a higher score equating to a higher level of hope. The instrument contains three factors, namely temporality & future, positive readiness & expectancy, and finally interconnectedness with self and others. | 9 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03080623 -
Ultrasound-based Diagnostic Model for Differentiating Malignant Breast Lesion From Benign Lesion
|
||
Completed |
NCT05527769 -
Pain and Functional Recovery After Mastectomy and IBR by Implant: Prepectoral Versus Subpectoral Technique
|
||
Completed |
NCT06376578 -
Exercise Interventions for Improving Health in Breast Cancer Survivors
|
N/A | |
Completed |
NCT03004534 -
A Study to Evaluate Changes in Human Breast Cancer Tissue Following Short-Term Use of Darolutamide
|
Early Phase 1 | |
Recruiting |
NCT05020574 -
Microbiome and Association With Implant Infections
|
Phase 2 | |
Active, not recruiting |
NCT06277141 -
The Vitality Mammography Messaging Study
|
N/A | |
Completed |
NCT03270111 -
High Physical Activity During a Weight Loss Intervention for Breast Cancer Survivors and High Risk Women
|
N/A | |
Completed |
NCT03555227 -
USG PECS vs LIA for Breast Cancer Surgery
|
N/A | |
Active, not recruiting |
NCT03917082 -
Limited Adjuvant Endocrine Therapy for Low Risk Breast Cancer
|
Phase 2 | |
Recruiting |
NCT05561842 -
Tablet-based Mobile Health Ultrasound for Point-of-care Breast Cancer Diagnosis in Nigeria (Mobile Health: Technology and Outcomes in Low and Middle-Income Countries)
|
||
Completed |
NCT04554056 -
Trial to Compare the Efficacy and Safety Of MW05 and PEG-rhG-CSF
|
Phase 2/Phase 3 | |
Active, not recruiting |
NCT03127995 -
Hypofractionated vs Standard Radiotherapy in Breast Cancer With an Indication for Regional Lymph Node Irradiation About Lymphedema Occurrence
|
N/A | |
Active, not recruiting |
NCT02237469 -
Prone Breast Radiotherapy Treatment Planning Observational Study
|
||
Completed |
NCT01204125 -
Two Regimens of SAR240550/Weekly Paclitaxel and Paclitaxel Alone as Neoadjuvant Therapy in Triple Negative Breast Cancer Patients
|
Phase 2 | |
Recruiting |
NCT04565054 -
Adjuvant Therapy With Abemaciclib + SOC ET vs. SOC ET in Clinical or Genomic High Risk, HR+/HER2- EBC
|
Phase 3 | |
Not yet recruiting |
NCT06412133 -
Conversations in Light and Shadow: Assessing Phototherapy's Impact on Breast Cancer Patients
|
N/A | |
Recruiting |
NCT03956641 -
Evolution of the Physical Condition in Treated Cancer Patients
|
N/A | |
Recruiting |
NCT06087120 -
Investigate the Prognostic and Predictive Value of ctDNA During Neoadjuvant Chemotherapy for Breast Cancer.
|
||
Recruiting |
NCT06058936 -
Exercises Using Virtual Reality on Cancer Patients
|
N/A | |
Completed |
NCT03470935 -
Non-interventional Study Evaluating Gynecological Impact of Diagnosis and Treatment of Breast Cancer in Patients Younger
|