Ireland
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Active, not recruiting Not applicable

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

NCT07205965 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2025-11-03
Last updated
2025-12-19

Condition(s) studied

Cancer BreastColon CancerCancer Survivors

Investigational drug(s) / intervention(s)

Experimental Group

Experimental Group: 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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
Inclusion Criteria: * 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: * 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

Primary outcome measure(s)

  • Hospital Anxiety and Depression Scale — 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.
    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).

Trial sites (2)

FacilityCityRegionStatus
Dokuz Eylul University Izmir Turkey (Türkiye)
Dokuz Eylul University Izmir Turkey (Türkiye)
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07205965 on ClinicalTrials.gov ↗ ← All trials in Turkey