The Effect of Acceptance and Commitment Approach-Based Psychoeducation in Cancer Survivors

NCT07205965 | Active Not Recruiting

• 1 other identifier: 8122-GOA
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief Summary

The study is planned to be conducted in a randomised controlled experimental design in accordance with CONSORT. The study is planned to be conducted between September 2025 and December 2026 at X Hospital with individuals who have completed cancer treatment. The randomisation list will be concealed from the participants, and each participant will be informed of which group they have been assigned to after being included in the study. The 'Stratified Randomisation' method will be used to determine which group participants will be assigned to, and participants will be included in the study based on their scores on the HAD scale. They will then be divided into experimental and control groups. To prevent study bias, the assignment of intervention and control groups will be conducted by an expert who has not participated in the study, with the aim of keeping the randomisation information confidential. The experimental group will consist of a total of 16 participants and will receive individual psychoeducation in an internet-based environment for 6 weeks, with each session lasting 30 minutes. No intervention will be made to the control group during the application period, and they will be placed on a waiting list. Participants who complete the psychoeducation will undergo follow-up measurements via an internet-based platform one month, six months, and one year after the psychoeducation, and their scores will be compared with those of the control group. The sample criteria include: having completed cancer treatment, having completed treatment for breast, gynaecological, colon or rectal cancer, having internet access, and being at risk for depression or anxiety in one or both of these sub-dimensions according to the Hospital Anxiety and Depression (HAD) scale. Exclusion criteria include receiving another psychosocial intervention, using psychiatric medication other than antidepressants, being in an advanced stage of cancer, having metastatic cancer, having recurrent cancer, and having started antidepressants in the last three months. Participants will be asked to complete a demographic information form. In addition, anxiety and depression levels will be measured using the Hospital Anxiety and Depression (HAD) scale. Psychological flexibility will be measured using the Acceptance and Action Questionnaire-II, mindfulness will be measured using the Mindfull Attention Awareness Scale, and the level of valuing will be measured using the Valuing Questionnaire. Validity and reliability studies have been conducted for the scales. Ethical committee approval has been obtained. Institutional approval has been obtained from the hospital where the study is being conducted.

Conditions

Cancer Breast; Colon Cancer; Cancer Survivors

Keywords

depression; anxiety; Mindfulness; Values; Acceptance and commitment approach; Psychological flexibility; cancer survivor

Outcome Measures

Primary Outcomes (1)

• Hospital Anxiety and Depression Scale

  The Hospital Anxiety and Depression Scale (HADS) is used to measure participants' anxiety and depression levels. In this scale (HADS), there are seven questions each to measure the dimensions of depression and anxiety. Each subscale consists of seven items with a 4-point ordinal response format. Scores ranges from 0 to 21 in each subscale, with higher scores indicating higher levels of anxious or depressive state. The scale has a four-point Likert-type. The cut-off points for the Turkish form of the HADS Scale are 10 for the anxiety subscale (HAD-A) and 7 for the depression subscale (HAD-D).

  Change from to the end point of the intervention and one month (4 weeks), six months (24 weeks), 12 months (48 weeks) after the intervention.

Secondary Outcomes (3)

• Acceptance and Action Questionnaire-II (AAQ-II)

  Change from baseline psychological flexibility levels to the end point of the intervention and one month (4 weeks), six months (24 weeks), 12 months (48 weeks) after the intervention.

• Mindful Attention Awareness Scale (MAAS)

  Change from baseline mindfulness levels to the end point of the intervention and one month (4 weeks), six months (24 weeks), 12 months (48 weeks) after the intervention.

• The Valuing Questionnaire

  Change from baseline valuing levels to the end point of the intervention and one month (4 weeks), six months (2.4 weeks), 12 months (48 weeks) after the intervention

Study Arms (2)

control

NO INTERVENTION

The control group will not receive any intervention during the application period and will be put on waitlist.

experimental/group

EXPERIMENTAL

The experimental group will consist of 16 participants and the participants will receive internet-based environment psychoeducation for 6 weeks, each session for 30 minutes.

Behavioral: Experimental Group

Interventions

Experimental Group BEHAVIORAL

The experimental group will consist of 16 participants and the participants will receive internet-based environment psychoeducation for 6 weeks, each session for 30 minutes.

experimental/group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• having completed cancer treatment, having completed treatment for breast, gynaecological, colon or rectal cancer, having internet access, and being at risk for depression or anxiety in one or both of these sub-dimensions according to the Hospital Anxiety and Depression (HAD) scale.

You may not qualify if:

• receiving another psychosocial intervention, using psychiatric medication other than antidepressants, being in an advanced stage of cancer, having metastatic cancer, having recurrent cancer, and having started antidepressants in the last three months

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (2)

Dokuz Eylul University

Izmir, 35340, Turkey (Türkiye)

Location

Dokuz Eylul University

Izmir, Turkey (Türkiye)

Location

Related Publications (1)

• Hayes SC. Acceptance and Commitment Therapy, Relational Frame Theory, and the Third Wave of Behavioral and Cognitive Therapies - Republished Article. Behav Ther. 2016 Nov;47(6):869-885. doi: 10.1016/j.beth.2016.11.006. Epub 2016 Nov 10.

  PMID: 27993338 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Colonic Neoplasms; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Elif C Bulut, Msc

  Dokuz Eylul University

  PRINCIPAL INVESTIGATOR

• Elif can Bulut, Msc

  Dokuz Eylul University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: October 3, 2025
• Study Start: November 3, 2025
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 18, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)