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IRCT20260108068591N1 IRCT 2026-01-25 Qazvin University of Medical Sciences Investigating The Effect of the Mindfulness on Healing Motivation in Cancer Patients and Illness Uncertainty in patients and Their Care givers With Dyadic Approach Investigating The Effect of the Mindfulness-Based Living training on Healing Motivation in Cancer Patients Undergoing Chemotherapy and Illness Uncertainty in patients and Their Care givers: A Dyadic Patient- Caregiver Approach 2026-02-14 anticipated 76 Complete https://irct.ir/trial/88652 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: The study was designed in a dyadic manner, meaning that the cancer patient and their primary caregiver enter the study as a single unit, both receiving the mindfulness intervention, and the effect of this intervention is then assessed on the outcome variables, Randomization description: In this study, permuted block randomization with block sizes of 2, 4, and 6 will be used. To implement this randomization method, a list of all possible permutations with the specified block sizes is first generated, and then a number of these permutations are randomly selected (with replacement). Based on the order of the selected permutations, participants are assigned to either the intervention or control group. The entire process of selecting permutations and generating the random allocation sequence will be performed using R software and the Blockrand package. N/A Cancer. Intervention 1: The intervention group: An educational intervention based on mindfulness-based life, following the standardized mindfulness-based stress reduction protocol by Jon Kabat-Zinn, as well as the book "Mindfulness-Based Life Skills Program," is designed as an 8-week weekly training program, combining in-person and virtual sessions. Each session lasts between 30 to 90 minutes, with home practice exercises of 10 to 20 minutes per day. These exercises include both formal and informal practices. Formal practices are structured with specific time durations, while informal practices are simpler activities to integrate mindfulness into daily life. In-person sessions will be provided during chemotherapy for patients and their primary caregivers, while virtual sessions will be offline, with pre-recorded videos and guided audio files sent through a messaging app to participants. Session 1: Introduction to mindfulness, its importance in managing illness-related stress, clear explanation of the study objectives (increasing treatment motivation and reducing uncertainty), and the rationale for couple participation. Session 2: Teaching mindful sitting with emphasis on breathing as an "anchor for attention." Explaining how to use breathing during moments of treatment-related anxiety. Session 3: Introducing the concept of separating "pain" from "suffering." Introducing body scan as a method to observe the body without catastrophizing. Session 4: Introducing movement as a form of meditation. Teaching gentle chair yoga and mindful walking with emphasis on being and sensing rather than doing. Session 5: Introducing the "guest house" model for dealing with difficult thoughts and emotions. Teaching self-compassion exercises as an alternative to self-criticism. Session 6: The role of supportive relationships in the treatment process. Teaching loving-kindness memory exercises and the expansion of kindness (toward oneself, loved ones, and all beings).Session 7: Introducing the "three-step breathing space" as an immediate technique. Teaching the "three circles" exercise (threat, motivation, calm) to raise awareness of life balance. Session 8: Review of the seven-week journey, emphasis on small progress. Summarizing how to continue the practices in life. Delivering a final message of hope and acceptance. Expressing appreciation for participation. Intervention 2: Control group: The control group will not receive any training from the researcher and will only receive the usual care and standard education provided by the ward, just like others. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information available
public Zahra Rahmani
No. 7, Sadra 8th Alley, 22 Bahman Northern Street, Takestan, Qazvin
Qazvin Iran (Islamic Republic of) 3481744914 +98 28 3522 7182 zahra438044@gmail.com Qazvin University of Medical Sciences scientific Zahra Rahmani
No. 7, Sadra 8th Alley, 22 Bahman Northern Street, Takestan, Qazvin
Qazvin Iran (Islamic Republic of) 3481744914 +98 28 3522 7182 zahra438044@gmail.com Qazvin University of Medical Sciences Iran (Islamic Republic of) Having satisfaction with participation in the study Scoring above 3 on the Functional Status Scale in cancer patients Being over 18 years of age The patient must have a primary caregiver Not having any mental illnesses Not using any psychiatric medications Not receiving any other forms of psychological interventions Having a smartphone Having access to the internet Having literacy the ability to read and write The caregiver is recognized as the primary caregiver by the patient The caregiver does not receive any payment for providing care to the patient 18 years no limit Both The patient is unwilling to participate in the study The patient scores 3 or lower on the Performance Status Scale for cancer patients C80 Malignant neoplasm without specification of site Lifestyle N/A The intervention group: An educational intervention based on mindfulness-based life, following the standardized mindfulness-based stress reduction protocol by Jon Kabat-Zinn, as well as the book "Mindfulness-Based Life Skills Program," is designed as an 8-week weekly training program, combining in-person and virtual sessions. Each session lasts between 30 to 90 minutes, with home practice exercises of 10 to 20 minutes per day. These exercises include both formal and informal practices. Formal practices are structured with specific time durations, while informal practices are simpler activities to integrate mindfulness into daily life. In-person sessions will be provided during chemotherapy for patients and their primary caregivers, while virtual sessions will be offline, with pre-recorded videos and guided audio files sent through a messaging app to participants. Session 1: Introduction to mindfulness, its importance in managing illness-related stress, clear explanation of the study objectives (increasing treatment motivation and reducing uncertainty), and the rationale for couple participation. Session 2: Teaching mindful sitting with emphasis on breathing as an "anchor for attention." Explaining how to use breathing during moments of treatment-related anxiety. Session 3: Introducing the concept of separating "pain" from "suffering." Introducing body scan as a method to observe the body without catastrophizing. Session 4: Introducing movement as a form of meditation. Teaching gentle chair yoga and mindful walking with emphasis on being and sensing rather than doing. Session 5: Introducing the "guest house" model for dealing with difficult thoughts and emotions. Teaching self-compassion exercises as an alternative to self-criticism. Session 6: The role of supportive relationships in the treatment process. Teaching loving-kindness memory exercises and the expansion of kindness (toward oneself, loved ones, and all beings).Session 7: Introducing the "three-step breathing space" as an immediate technique. Teaching the "three circles" exercise (threat, motivation, calm) to raise awareness of life balance. Session 8: Review of the seven-week journey, emphasis on small progress. Summarizing how to continue the practices in life. Delivering a final message of hope and acceptance. Expressing appreciation for participation. Control group: The control group will not receive any training from the researcher and will only receive the usual care and standard education provided by the ward, just like others. Treatment Motivation: The score that cancer patients receive from the cancer patient motivation scale. The score ranges from 25 to 125, and higher scores indicate higher motivation for recovery. Timepoint: Measurement is conducted at three time points: before the intervention begins, immediately after the intervention ends, and three months after the intervention ends. Method of measurement: Cancer Patients' Treatment Motivation Questionnaire. Uncertainty in illness: Refers to a score that patients and caregivers receive from the Mishel Uncertainty in Illness Scale. The score on this scale ranges from 33 to 165, and higher scores indicate greater uncertainty about the illness. Timepoint: Measurement is conducted at three time points: before the intervention begins, immediately after the intervention ends, and three months after the intervention ends. Method of measurement: Mishel Uncertainty in Illness Scale Questionnaire. Qazvin University of Medical Sciences Approved 2025-12-27 Research Ethics Committees of Qazvin University of Medical Sciences No. 7, Sadra 8th Alley, 22 Bahman Northern Street, Takestan, Qazvin Qazvin Qazvin Iran (Islamic Republic of)