Protocol summary

Study aim
Main Objective: To determine the effectiveness of Acceptance and Commitment Therapy (ACT) on experiential avoidance, self-compassion, and fear of cancer recurrence in patients with cancer. Specific Objectives: 1.To determine the effectiveness of Acceptance and Commitment Therapy (ACT) on experiential avoidance in patients with cancer. 2.To determine the effectiveness of Acceptance and Commitment Therapy (ACT) on self-compassion in patients with cancer. 3.To determine the effectiveness of Acceptance and Commitment Therapy (ACT) on fear of cancer recurrence in patients with cancer.
Design
This quasi-experimental study evaluated the effectiveness of an 8-session Acceptance and Commitment Therapy (ACT) intervention on 40 cancer patients. Participants were randomized into either an ACT group or a waitlist control group. Findings suggest that ACT significantly reduces experiential avoidance and fear of cancer recurrence while enhancing self-compassion.
Settings and conduct
The study will include patients from Imam Khomeini Cancer Institute and be conducted at Araman Clinic.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: The inclusion criteria for the study were as follows: A minimum duration of 6 months having elapsed since the confirmed diagnosis of cancer; Providing written informed consent to participate in the study; Absence of diagnosed psychiatric disorders (based on self-report and medical records) requiring psychotropic medication; Absence of other comorbid chronic physical conditions; Being within the age range of 18 to 45 years.
Intervention groups
“Participants will be divided into two groups: the experimental group (who will receive the Acceptance and Commitment Therapy intervention) and the control group (who will receive no therapeutic intervention).”
Main outcome variables
Experiential avoidance, self-compassion, and fear of relapse

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260919071111N1
Registration date: 2026-09-29, 1405/07/07
Registration timing: prospective

Last update: 2026-09-29, 1405/07/07
Update count: 0
Registration date
2026-09-29, 1405/07/07
Registrant information
Name
Amirreza Moradi Samad Abadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 5423 6313
Email address
amirrezaonestar@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-10-02, 1405/07/10
Expected recruitment end date
2026-11-21, 1405/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of acceptance and commitment therapy on experiential avoidance, self-compassion, and fear of recurrence in cancer patients
Public title
The effectiveness of acceptance and commitment therapy on experiential avoidance, self-compassion, and fear of recurrence in cancer patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of cancer Survey to participate in research informed consent Possibility of attending therapy sessions
Exclusion criteria:
Lack of literacy Lack of physical and mental conditions
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University,Tonekabon branch
Street address
No. 11, Yas Dead-end, Gol-e Narges Alley, Shahid Moslemi St., Tonekabon, Iran.
City
Tonekabon
Province
Mazandaran
Postal code
4681743130
Approval date
2026-07-15, 1405/04/24
Ethics committee reference number
IR.IAU.TON.REC.1405.100

Health conditions studied

1

Description of health condition studied
Cancer
ICD-10 code
F54
ICD-10 code description
Psychological and behavioral factors associated with disorders or diseases classified elsewhere

Primary outcomes

1

Description
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.

2

Description
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

3

Description
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

Secondary outcomes

empty

Intervention groups

1

Description
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).
Category
Treatment - Other

2

Description
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.
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Cancer Institute of Imam Khomeini hospital in Tehran
Full name of responsible person
Amirreza Moradi Samad Abadi
Street address
No. 11, Yas Dead-end, Gol-e Narges Alley, Shahid Moslemi St., Tonekabon, Iran.
City
Tonekabon
Province
Mazandaran
Postal code
4681743130
Phone
+98 11 5463 6313
Email
amirrezaonestar@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Masoud Qane
Street address
3rd kilometer of Chalus-Vali Abad road-Tonekabon Islamic Azad University Complex
City
Tonekabon
Province
Mazandaran
Postal code
۴۶۸۴۱۶۱۱۶۷
Phone
+98 11 5427 1105
Email
amirrezaonestar@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Dr. Banafsheh Mohammadi Zeidi
Position
Secretary of Ethics Committee
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
3rd kilometer of Chalus-Vali Abad road-Tonekabon Islamic Azad University Complex
City
Tonekabon
Province
Mazandaran
Postal code
۴۶۸۴۱۶۱۱۶۷
Phone
+98 11 5427 1105
Email
amirrezaonestar@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Amirreza Moradi Samad Abadi
Position
Master of health psychology student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 11, Yas Dead-end, Gol-e Narges Alley, Shahid Moslemi St., Tonekabon, Iran.
City
Tonekabon
Province
Mazandaran
Postal code
4681743130
Phone
+98 11 5427 1105
Email
amirrezaonestar@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Amirreza Moradi Samad Abadi
Position
Master of health psychology student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 11, Yas Dead-end, Gol-e Narges Alley, Shahid Moslemi St., Tonekabon, Iran.
City
Tonekabon
Province
Mazandaran
Postal code
4681743130
Phone
+98 11 5427 1105
Email
amirrezaonestar@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 further information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Loading...