]>
IRCT20231101059926N1 IRCT 2023-11-10 Shahid Beheshti University of Medical Sciences Effectiveness of Mindfulness-based Cancer Recovery in gastrointestinal cancer MBCR Effectiveness of brief Mindfulness-based Cancer Recovery intervention on physical and psychological symptoms of gastrointestinal cancer patients 2023-11-22 anticipated 52 Complete https://irct.ir/trial/73536 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be simple randomization method and the random unit is individuals. 52 patients with gastrointestinal cancer will be divided into intervention and control groups by Microsoft Excel software using Rand function. In this way, a table of random numbers will be prepared and the Randbetween function will be created and the patients will be divided into two groups of 26 people respectively, Blinding description: The outcome assessor in data collection after the intervention and the data analyst will be unaware of the objectives of the study. N/A Gastrointestinal Cancer. Intervention 1: Intervention group: Mindfulness Based Cancer Recovery will be implemented in 4 sessions, as a group and in 90-minute sessions. Intervention 2: Control group: After the follow-up period, Mindfulness Based Cancer Recovery will be implemented in 4 sessions, as a group and in 90-minute sessions. Yes - There is a plan to make this available What will be shared: Participant data will be shared in the SPSS file using the participant code (not using first and last name). When: Access to the data will be after the articles are published To whom: The data will be available only to researchers working in academic and scientific institutions Conditions: Request from the journals where the articles related to this research are going to be published. Where to obtain: By receiving confirmation via email to the main promoter or promoters of the project How to obtain: By sending an email to the main promoter or other project promoters and receiving written confirmation from them Comments:
public Nahid Bahadoriyan Lotf abadi
arabi St, Taleghani Hospital
Tehran Iran (Islamic Republic of) 193954631 +98 21 2243 9872 nahidbahadoriyan@gmail.com Shahid Beheshti University of Medical Sciences scientific Nahid Bahadoriyan Lotf abadi
Arabi St, Taleghani hospital
Tehran Iran (Islamic Republic of) 193954631 +98 21 2243 9770 nahidbahadoriyan@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Age 18 and above Definitive diagnosis of stage 2 and 3 gastrointestinal cancer by an oncologist Having minimum reading and writing literacy to complete the questionnaires Not participating in any yoga and meditation classes or courses in the last 6 months Not participating in any mindfulness intervention at the same time 18 years no limit Both Not continuing mindfulness sessions for more than 2 sessions Disease recurrence or metastasis Failure to complete questionnaires Having a medical illness at the same time having a serious psychiatric disorder such as psychotic spectrum disorders, bipolar disorder, and substance abuse via self-report (C15-C26) Malignant neoplasms of digestive organs Treatment - Other Treatment - Other Intervention group: Mindfulness Based Cancer Recovery will be implemented in 4 sessions, as a group and in 90-minute sessions. Control group: After the follow-up period, Mindfulness Based Cancer Recovery will be implemented in 4 sessions, as a group and in 90-minute sessions. Psychological distress. Timepoint: In the per-intervention and post-intervention stages for 2 and 6 months for follow up. Method of measurement: The Kessler Psychological Distress Scale (K10). Demoralization Syndrome. Timepoint: In the per-intervention and post-intervention stages for 2 and 6 months for follow up. Method of measurement: Demoralization Scale(DS). Pain. Timepoint: In the per-intervention and post-intervention stages for 2 and 6 months for follow up. Method of measurement: Numeric Pain Rating Scale (NPRS). Fatigue. Timepoint: In the per-intervention and post-intervention stages for 2 and 6 months for follow up. Method of measurement: Brief Fatigue Inventory(BFI). Sleep disturbance. Timepoint: In the per-intervention and post-intervention stages for 2 and 6 months for follow up. Method of measurement: Insomnia Severity Index (ISI). Quality of Life. Timepoint: In the per-intervention and post-intervention stages for 2 and 6 months for follow up. Method of measurement: World Health Organization Quality of Life (WHOQOL). Shahid Beheshti University of Medical Sciences Approved 2023-10-28 Ethics committee of Shahid Beheshti University of Medical Sciences Arabi Ave, Daneshjoo Blvd, Velenjak Tehran Tehran Iran (Islamic Republic of)