Mindfulness-Based Reduction Stress Program

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05831293
• Other study ID #: nihann
• Status: Completed
• Phase: N/A
• Start date: January 15, 2023
• Est. completion date: September 15, 2023

Study information

• Verified date: November 2023
• Source: Ataturk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: September 15, 2023
• Est. primary completion date: March 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Caregiver Stress
• Quality of Life

Intervention

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.

Locations

Country	Name	City	State
Turkey	Ataturk University	Erzurum
Turkey	Ataturk University	Erzurum

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 Ugur and Fadiloglu (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
Primary	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