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Clinical Trials/NCT06025799
NCT06025799
Completed
Not Applicable

Effect of Mindfulness-based Stress Reduction Intervention on Psychological Distress and Hope Among Female Patients Undergoing Radiotherapy for Breast Cancer: A Randomized Control Trial

Alexandria University1 site in 1 country100 target enrollmentAugust 24, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer Female
Sponsor
Alexandria University
Enrollment
100
Locations
1
Primary Endpoint
The Herth Hope Index (HHI)
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 24, 2023
End Date
December 6, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Heba Mohamed Abdelaal

Assistant professor at Psychiatric& Mental Health Nursing, Faculty of Nursing

Alexandria University

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.

Outcomes

Primary Outcomes

The Herth Hope Index (HHI)

Time Frame: 9 weeks

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.

Depression Anxiety and Stress Scale 21 (DASS-21)

Time Frame: 9 weeks

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.

Five Factors Mindfulness Questionnaire (FFMQ)

Time Frame: 9 weeks

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.

Study Sites (1)

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