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IRCT20260919071111N1 IRCT 2026-09-29 Islamic Azad University The effectiveness of acceptance and commitment therapy on experiential avoidance, self-compassion, and fear of recurrence in cancer patients The effectiveness of acceptance and commitment therapy on experiential avoidance, self-compassion, and fear of recurrence in cancer patients 2026-10-02 anticipated 40 Recruiting https://irct.ir/trial/93506 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Unit of Randomization: Individual. Method of Randomization: Simple randomization with a 1:1 allocation ratio into intervention and control groups (20 participants per group). Stratification: Stratified randomization was not applied; all participants were randomized within a single stratum. Randomization Tool and Sequence Generation: A standard table of random numbers was used to generate the allocation sequence. From an arbitrarily selected starting coordinate in the table, digits were read sequentially: even numbers were allocated to the intervention group and odd numbers to the control group until the quota of 20 participants per arm was fulfilled. Allocation Concealment: To prevent selection bias, the generated allocation sequence was pre-packaged into sequentially numbered, opaque, sealed envelopes prior to enrollment. The assigned envelope was unsealed strictly after participant enrollment and baseline assessment, managed by an independent individual not involved in participant recruitment, intervention, or outcome evaluation. N/A Cancer. Intervention 1: Intervention group: In the experimental group, following participant sampling and random assignment, the Acceptance and Commitment Therapy (ACT) intervention was conducted over eight 90-minute sessions. Prior to the commencement of the intervention, the “Fear of Progression Questionnaire” and the “Self-Compassion Scale (Neff, 2003)” were administered to the participants as a pretest. Upon completion of the treatment course, a posttest was administered to both groups. Finally, the obtained data were analyzed using descriptive statistics (mean and standard deviation) and inferential statistics (univariate and multivariate analyses of covariance). Intervention 2: Control group: In the control group, no therapeutic intervention was provided during the implementation of the treatment for the experimental group, and participants were placed on a waitlist. Following the completion of the eight intervention sessions in the experimental group, the “Fear of Progression Questionnaire” and the “Self-Compassion Scale (Neff, 2003)” were administered to the participants in the control group without the implementation of any intervention. Furthermore, in adherence to ethical considerations, the Acceptance and Commitment Therapy (ACT) intervention was subsequently provided to the participants of the control group upon the completion of the study. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Dr. Banafsheh Mohammadi Zeidi
3rd kilometer of Chalus-Vali Abad road-Tonekabon Islamic Azad University Complex
Tonekabon Iran (Islamic Republic of) ۴۶۸۴۱۶۱۱۶۷ +98 11 5427 1105 amirrezaonestar@gmail.com Islamic Azad University scientific Amirreza Moradi Samad Abadi
No. 11, Yas Dead-end, Gol-e Narges Alley, Shahid Moslemi St., Tonekabon, Iran.
Tonekabon Iran (Islamic Republic of) 4681743130 +98 11 5427 1105 amirrezaonestar@gmail.com Islamic Azad University Iran (Islamic Republic of) Definitive diagnosis of cancer Survey to participate in research informed consent Possibility of attending therapy sessions no limit no limit Both Lack of literacy Lack of physical and mental conditions F54 Psychological and behavioral factors associated with disorders or diseases classified elsewhere Treatment - Other Diagnosis Intervention group: In the experimental group, following participant sampling and random assignment, the Acceptance and Commitment Therapy (ACT) intervention was conducted over eight 90-minute sessions. Prior to the commencement of the intervention, the “Fear of Progression Questionnaire” and the “Self-Compassion Scale (Neff, 2003)” were administered to the participants as a pretest. Upon completion of the treatment course, a posttest was administered to both groups. Finally, the obtained data were analyzed using descriptive statistics (mean and standard deviation) and inferential statistics (univariate and multivariate analyses of covariance). Control group: In the control group, no therapeutic intervention was provided during the implementation of the treatment for the experimental group, and participants were placed on a waitlist. Following the completion of the eight intervention sessions in the experimental group, the “Fear of Progression Questionnaire” and the “Self-Compassion Scale (Neff, 2003)” were administered to the participants in the control group without the implementation of any intervention. Furthermore, in adherence to ethical considerations, the Acceptance and Commitment Therapy (ACT) intervention was subsequently provided to the participants of the control group upon the completion of the study. Fear of Recurrence: Fear of progression (or fear of recurrence) represents an appropriate and rational response to the real threat of cancer and its medical treatments. However, elevated levels of fear of progression can become dysfunctional, adversely affecting well-being, quality of life, and social functioning. To assess cancer-related fear of progression/recurrence, the 12-item questionnaire developed by Frodl et al. (2018), designed on a 5-point Likert scale, was utilized. Timepoint: We will conduct sessions on the experimental group for 2 months according to the treatment protocol. Method of measurement: 12-question questionnaire by Ferdel et al. Experiential Avoidance: Experiential avoidance is broadly defined as the attempt to avoid thoughts, feelings, memories, physical sensations, and other internal experiences, even when doing so causes long-term harm. To measure experiential avoidance, the 11-item questionnaire developed by Hayes et al. (2004), designed on a 7-point Likert scale, was utilized. Timepoint: We will conduct sessions on the experimental group for 2 months according to the treatment protocol. Method of measurement: Hayes et al. 11-question questionnaire. Self-Compassion: Self-compassion is defined as extending compassion to oneself in instances of perceived inadequacy, failure, or general suffering, which comprises three core components: self-kindness, common humanity, and mindfulness. To measure self-compassion, the 26-item scale developed by Neff (2003), designed on a 5-point Likert scale, was utilized. Timepoint: We will conduct sessions on the experimental group for 2 months according to the treatment protocol. Method of measurement: Neff's 26-question scale. Islamic Azad University Approved 2026-07-15 Ethics committee of Islamic Azad University,Tonekabon branch No. 11, Yas Dead-end, Gol-e Narges Alley, Shahid Moslemi St., Tonekabon, Iran. Tonekabon Mazandaran Iran (Islamic Republic of)