Clinical trial NCT05831293: Mindfulness-Based Reduction Stress Program
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Caregiver Stress
Quality of Life
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2023-04-26
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Caregiver Stress Scale
timeFrame: two week
measure: The Caregiver Quality of Life Index Cancer Scale -CQOLC
timeFrame: Two week
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk Unıversity
city: Erzurum
country: Turkey
facility: Ataturk Unıversity
Study officials:
affiliation: Ataturk University
name: Nihan Türkoğlu, Assist.Prof.
role: STUDY_CHAIR
References: