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

Primary Purpose

Breast Cancer Female

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Mindfulness-based stress reduction intervention
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer Female focused on measuring Mindfulness-based stress reduction, Psychological Distress, Hope, Female patients, Radiotherapy, Breast cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Nursing, Alexandria UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

"Mindfulness-based stress reduction intervention"

" routine hospital care"

Arm Description

patients who will be under routine hospital care as well as Mindfulness-Based Stress Reduction (MBSR) program The Mindfulness-Based Stress Reduction (MBSR) program consists of eight sessions focusing on reducing stress and improving well-being. Participants learn and practice mindfulness techniques such as mindful eating, breathing, body scan, and meditation. The program emphasizes self-responsibility, developing coping strategies, and applying mindfulness daily. Participants engage in formal mindfulness practices, reflect on their experiences, and receive guidance on continuing their mindfulness journey after the program. The goal is to cultivate resilience, enhance well-being, and reduce stress.

Female cancer patients who will be under routine hospital care

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 30, 2023
Last Updated
September 24, 2023
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT06025799
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 24, 2023 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Female
Keywords
Mindfulness-based stress reduction, Psychological Distress, Hope, Female patients, Radiotherapy, Breast cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
"Mindfulness-based stress reduction intervention"
Arm Type
Experimental
Arm Description
patients who will be under routine hospital care as well as Mindfulness-Based Stress Reduction (MBSR) program The Mindfulness-Based Stress Reduction (MBSR) program consists of eight sessions focusing on reducing stress and improving well-being. Participants learn and practice mindfulness techniques such as mindful eating, breathing, body scan, and meditation. The program emphasizes self-responsibility, developing coping strategies, and applying mindfulness daily. Participants engage in formal mindfulness practices, reflect on their experiences, and receive guidance on continuing their mindfulness journey after the program. The goal is to cultivate resilience, enhance well-being, and reduce stress.
Arm Title
" routine hospital care"
Arm Type
No Intervention
Arm Description
Female cancer patients who will be under routine hospital care
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-based stress reduction intervention
Intervention Description
The Mindfulness-Based Stress Reduction (MBSR) program consists of eight sessions focusing on reducing stress and improving well-being. Participants learn and practice mindfulness techniques such as mindful eating, breathing, body scan, and meditation. The program emphasizes self-responsibility, developing coping strategies, and applying mindfulness daily. Participants engage in formal mindfulness practices, reflect on their experiences, and receive guidance on continuing their mindfulness journey after the program. The goal is to cultivate resilience, enhance well-being, and reduce stress.
Primary Outcome Measure Information:
Title
Five Factors Mindfulness Questionnaire (FFMQ)
Description
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.
Time Frame
9 weeks
Title
Depression Anxiety and Stress Scale 21 (DASS-21)
Description
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.
Time Frame
9 weeks
Title
The Herth Hope Index (HHI)
Description
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.
Time Frame
9 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Adult female patients with post-mastectomy to decrease the confounding factors.
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Faculty of Nursing, Alexandria University
City
Alexandria
ZIP/Postal Code
002
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Faculty of Nursing Faculty of Nursing, PHD
Phone
4291578-4291336-4291344
Ext
203
Email
alexnuring@alexu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11305069
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.
Results Reference
result

Learn more about this trial

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

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