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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

Protocol summary

Study aim
Determining the effect of mindfulness-based life skills training on treatment motivation in cancer patients undergoing chemotherapy and on illness uncertainty in patients and their primary caregivers, using a patient–caregiver dyadic approach.
Design
This study is a randomized, parallel-group, open-label clinical trial with a control group, involving 76 patient–caregiver dyads, using permuted block randomization implemented in R software.
Settings and conduct
This study is conducted in the chemotherapy ward of Velayat Hospital in Qazvin Province on cancer patients and their primary caregivers. Eligible participants are randomly assigned to the intervention or control group. Questionnaires are completed by both groups at baseline, immediately after the intervention, and three months thereafter, and the data are analyzed. The intervention group receives mindfulness-based life program training, while the control group does not receive this training
Participants/Inclusion and exclusion criteria
Participants over 18 years of age with informed consent, having a primary caregiver identified by the patient, a score higher than 3 on the cancer performance status scale, no psychiatric disorders or psychiatric medications, not receiving other psychological interventions, literate, and with access to the internet and a smartphone are eligible. Individuals who do not provide consent or who score ≤3 are not included in the study
Intervention groups
The intervention group participates in an 8-session mindfulness-based life skills training program, with weekly sessions lasting 30 to 90 minutes delivered in a blended in-person and virtual format. The control group does not receive additional training and continues only with the routine care and education provided by the ward
Main outcome variables
Treatment motivation in cancer patients, illness uncertainty in the patient and their primary caregiver

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260108068591N1
Registration date: 2026-01-25, 1404/11/05
Registration timing: prospective

Last update: 2026-01-25, 1404/11/05
Update count: 0
Registration date
2026-01-25, 1404/11/05
Registrant information
Name
Zahra Rahmani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3522 7182
Email address
za.rahmani@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-02-14, 1404/11/25
Expected recruitment end date
2026-07-21, 1405/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Investigating The Effect of the Mindfulness on Healing Motivation in Cancer Patients and Illness Uncertainty in patients and Their Care givers With Dyadic Approach
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
The patient is unwilling to participate in the study The patient scores 3 or lower on the Performance Status Scale for cancer patients
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 76
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
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

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Qazvin University of Medical Sciences
Street address
No. 7, Sadra 8th Alley, 22 Bahman Northern Street, Takestan, Qazvin
City
Qazvin
Province
Qazvin
Postal code
3481744914
Approval date
2025-12-27, 1404/10/06
Ethics committee reference number
IR.QUMS.REC.1404.381

Health conditions studied

1

Description of health condition studied
Cancer
ICD-10 code
C80
ICD-10 code description
Malignant neoplasm without specification of site

Primary outcomes

1

Description
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

2

Description
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

Secondary outcomes

empty

Intervention groups

1

Description
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.
Category
Lifestyle

2

Description
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.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Velayat Educational and Treatment Hospital of Qazvin
Full name of responsible person
Ali Akbar Karami
Street address
Cooperation Square, 22 Bahman Boulevard, Elahie Quarter, Minuder Settlement
City
Qazvin
Province
Qazvin
Postal code
34719 76161
Phone
+98 28 3379 0620
Email
info@hosvelayat.qums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mehdi Mirhashemi
Street address
No. 7, Sadra 8th Alley, 22 Bahman Northern Street, Takestan, Qazvin
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3333 6001
Email
info@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Zahra Rahmani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 7, Sadra 8th Alley, 22 Bahman Northern Street, Takestan, Qazvin
City
Qazvin
Province
Qazvin
Postal code
3481744914
Phone
+98 28 3522 7182
Email
zahra438044@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Zahra Rahmani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 7, Sadra 8th Alley, 22 Bahman Northern Street, Takestan, Qazvin
City
Qazvin
Province
Qazvin
Postal code
3481744914
Phone
+98 28 3522 7182
Email
zahra438044@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Zahra Rahmani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 7, Sadra 8th Alley, 22 Bahman Northern Street, Takestan, Qazvin
City
Qazvin
Province
Qazvin
Postal code
3481744914
Phone
+98 28 3522 7182
Email
zahra438044@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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