Mindfulness-Based Reduction Stress Program

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

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Key information

Conditions

Cancer Behavior Behavioral Symptoms Caregiver Burden Caregiver Stress Neoplasms Quality of Life Stress, Psychological

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ataturk Unıversity, Erzurum, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mindfulness based stress reduction program

Behavioral

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.

Primary outcomes

Caregiver Stress Scale

Time frame: two week

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.
The Caregiver Quality of Life Index Cancer Scale -CQOLC

Time frame: Two week

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.

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study 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

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2023
First posted: Apr 26, 2023
Registry last updated: Nov 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed