Effects Of Mindfulness-Based Yoga And Meditation Colorectal Cancer

NCT05215899 | Unknown

• 1 other identifier: 95961207604010164779
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

In many systematic reviews, it has also been emphasized that different cancer groups and a large number of applications are needed in order to obtain definitive conclusions about the effect of various interventions applied to these patients (Smith et al, 2004: Mosher et al, 2017: Fieke, 2015). In addition, in the joint results of these studies, it was stated that there are very few studies supporting the effectiveness of psychosocial interventions for CRC patients, and these studies have a limited evidence base, and specifically due to the lack of strong evidence regarding the physiological and psychological difficulties of cancer treatment in the CRC patient group and the practices performed. The level of evidence needs to be strengthened with further studies. Based on these reasons, the various difficulties experienced by CRC survivors and the lack of strong evidence in the systematic analyzes led us to conduct this study.

Conditions

Quality of Life

Keywords

Yoga, Meditation, Colorectal Cancer, sleep, Quality of Life

Outcome Measures

Primary Outcomes (3)

• Mindfulness-based yoga and meditation intervention may improve sleep quality of colorectal cancer patients

  Mindfulness-based yoga and meditation intervention may improve sleep quality of colorectal cancer patients

  8 WEEKS

• Mindfulness-based yoga and meditation intervention may improve the quality of life of colorectal cancer patients

  Mindfulness-based yoga and meditation intervention may improve the quality of life of colorectal cancer patients

  8 WEEKS

• Mindfulness-based yoga and meditation intervention may reduce fatigue level of colorectal cancer patients

  Mindfulness-based yoga and meditation intervention may reduce fatigue level of colorectal cancer patients

  8 WEEKS

Study Arms (2)

MINDFULNESS-BASED YOGA AND MEDITATION INTERVENTION

EXPERIMENTAL

MINDFULNESS-BASED YOGA AND MEDITATION INTERVENTION

Other: MINDFULNESS-BASED YOGA AND MEDITATION

Comparison group

EXPERIMENTAL

Patients in the comparison group will not be subjected to any intervention other than the tests specified in the method. Comparison group patients will continue their standard treatment and care. Questionnaires and scales will be applied to this group again before the application starts and after the application is finished.

Other: MINDFULNESS-BASED YOGA AND MEDITATION

Interventions

MINDFULNESS-BASED YOGA AND MEDITATION OTHER

The application was carried out by the researcher who had completed mindfulness-based yoga and meditation training.

Also known as: Comparison group: Comparison group patients will continue their standard treatment and care.

Comparison group; MINDFULNESS-BASED YOGA AND MEDITATION INTERVENTION

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants' consent for their physicians to participate in the study
• Being a stage 1-4 patient diagnosed with colorectal cancer,
• Being between the ages of 20-70,
• Being receiving outpatient treatment,
• At least 1 month has passed after the operation

You may not qualify if:

• Conditions that will hinder physical activity (Hemoglobin value less than 10mg/Dl, Platelet value less than 50,000)
• Cognitive disability

Sponsors & Collaborators

• Koç University: lead

Study Sites (1)

Tuba Sengul

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Meditation

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Tuba Sengul, PhD

  Koç University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Comparison group Intervention group:

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: January 31, 2022
• Study Start: October 1, 2021
• Primary Completion: January 28, 2022
• Study Completion: March 30, 2022
• Last Updated: January 31, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Outcomes will be shared with other researchers during the completion of the initiatives.
• Access Criteria: Outcomes will be shared with other researchers during the completion of the initiatives.

Locations

TU (1)