Mindfulness-Based Reduction Stress Program

The Effect of Mindfulness Based Stress Reduction Program on Stress and Quality of Life in Family Caregivers of Patients With Cancer: Randomized Controlled Trial

The participants consisted of 1332 caregivers of patients diagnosed with cancer, who applied to Atatürk University Health Research and Application Center, Outpatient Chemotherapy Unit between December 2022 and March 2023. In the power analysis, the sample of the research; According to Cohen, a total of 108 people, 54 of whom were in the experimental group and 54 in the control group, with a medium effect size of 0.5%, an error margin of 0.05% and a confidence interval of 0.95%, were 95% representative of the universe. Against the possibility of data loss, 20% backup sample was included in this number and the study was planned with a total of 124 people, 62 in the experimental group and 62 in the control group. 20 participants were excluded on the basis of inclusion and exclusion criteria. 104 participants formed the sample

Study Overview

• Status: Completed
• Conditions: Quality of Life; Cancer; Caregiver Stress
• Intervention / Treatment: Behavioral: Mindfulness Based Stress Reduction Program

Detailed Description

Pretest measurements (T1) were made to the individuals in the experimental and control groups. 8-week mindfulness-based interventions were administered online to caregivers of cancer patients (Table 1). Before starting the MDI program in the experimental group, visual and written materials about the sessions prepared by the researchers were distributed. The program was implemented 4 days a week, 1 session a day, and each session was implemented in groups of 10-15 people for 60-90 minutes. After the 8-week MDI Program of the experimental group was completed, the data collection forms were re-applied to the individuals in the experimental and control groups, and posttest-1 measurements (T2) were made. 4 weeks after the posttest-1 measurements, the posttest-2 measurements (T3) of the individuals in the experimental and control groups were performed.

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Erzurum, Turkey, 25240
    • Ataturk Unıversity
  • Erzurum, Turkey
    • Ataturk Unıversity

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• No psychiatric problems,
• Over 18,
• literate,
• Having internet access at home,
• Not receiving or planning to receive therapy support during the education process,
• Not having any previous mindfulness experience

Exclusion Criteria:

• Those who want to leave the study,
• Do not accept to participate in the research
• not at a level to answer the questions asked cognitively.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; No intervention will be applied to the control group.
Experimental: Experimental; In each session, three sections were discussed and reviewed: (1) last week's experiences, (2) training, and (3) practice. Each session usually began with mindfulness and meditation exercises, followed by group discussion, review of homework activities, and introduction to new exercises. Participants were asked to complete 15-30 minutes of daily practice each week.	Behavioral: Mindfulness Based Stress Reduction Program; In each session, three sections were discussed and reviewed: (1) last week's experiences, (2) training, and (3) practice. Each session usually began with mindfulness and meditation exercises, followed by group discussion, review of homework activities, and introduction to new exercises. Participants were asked to complete 15-30 minutes of daily practice each week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caregiver Stress Scale	The scale was developed by Robinson (1983) to measure the subjective care burden of caregivers and to quickly identify families with care concerns. Its Turkish adaptation was made by Uğur and Fadıloğlu (2006). The reliability coefficient of the scale was found to be 0.77. The scale consists of 13 items. The scoring of the scale is between 0-1. A score above 7 indicates the burden of care subjectively.	two week
The Caregiver Quality of Life Index Cancer Scale -CQOLC	It was developed by Weitzner et al. to measure the quality of life of caregivers of cancer patients, including physical function, emotional function, family function, and social function. The total score of each sub-dimension and scale in the scale varies between 0 and 140. A higher score indicates a better quality of life.	Two week

Collaborators and Investigators

• Sponsor: Ataturk University
• Investigators: Study Chair: Nihan Türkoğlu, Assist.Prof., Ataturk University

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2023
• Primary Completion (Actual): March 15, 2023
• Study Completion (Actual): September 15, 2023

Study Registration Dates

• First Submitted: April 14, 2023
• First Submitted That Met QC Criteria: April 14, 2023
• First Posted (Actual): April 26, 2023

Study Record Updates

• Last Update Posted (Actual): November 2, 2023
• Last Update Submitted That Met QC Criteria: November 1, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: nihann

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No