A Manualized Post-Traumatic Growth Intervention for People With Cancer in Greece - IC-Growth. The Overarching Aim of IC-Growth is to Promote Psychosocial Care and Support for People With Cancer Using Acceptance and Committment Therapy.
Phase: NA
Conditions: Breast Cancer, Colon Cancer, Head and Neck Cancers
Sponsor: Centre for Research and Technology Hellas

ClinicalTrials.gov Protocol Document 
Official Title: IC-Growth: Enhancing Post-Traumatic Growth in Cancer Survivors Through 
Group-Based Psychosocial Intervention 
NCT Number: NCTXXXXXXXX 
Ethical Committee Approval: March 20th, 2024 
Document Date: July 31st, 2025 
 
 

Study Protocol 
Study Design 
IC-Growth is a multi-phase, non-pharmacological, randomized controlled trial (RCT) aimed 
at enhancing post-traumatic growth (PTG) among cancer survivors. The study includes an 
intervention group and a control group, with participants randomly assigned to either 
condition. The trial targets three cancer populations: breast, colorectal, and head & neck 
cancer. The intervention is a structured, manualized group program informed by 
Acceptance and Commitment Therapy (ACT) principles. 
 
The study is conducted in three phases: 
1. Preparation Phase: A literature review and expert consultation will inform the 
development of a novel PTG intervention manual. The manual will be co-developed with 
academic experts and patient organizations and revised based on feedback. 
2. Implementation Phase: Participants will be randomly assigned to either the intervention 
or control group. The intervention will be delivered in small, cancer-specific groups (8–10 
participants) over 6–8 weekly sessions lasting 90 minutes each. Control group participants 
will receive standard oncology follow-up without psychosocial intervention. Due to the 
nature of the study, it will be open-label (no blinding). Baseline and post-intervention data 
will be collected. 
3. Synthesis Phase: Based on study results and stakeholder feedback, recommendations for 
integrating psychosocial support into oncology care in Greece will be developed. A policy 
brief will address potential implementation barriers and outline practical solutions. 
Participants 
Participants will be recruited from two oncology hospitals in Thessaloniki, Greece: 
Theageneio Cancer Hospital and AHEPA University General Hospital. Eligible participants 
must: 
- Be adults (≥18 years old) 
- Have completed scheduled chemotherapy and hospitalization 
- Have a diagnosis of breast, colorectal, or head & neck cancer within the past five years 
 
Exclusion criteria include: 
- Current psychiatric treatment 
- Untreated mental health conditions 
- Cognitive impairments 
- Inability to consent or communicate in Greek 
- Cancer recurrence 
- Diagnosis of a different cancer in the past 5 years 
- Life expectancy <12 months 
 
Randomization will be performed via specialized software developed by the Centre for 
Research and Technology Hellas (CERTH), ensuring strict allocation concealment. 

Intervention 
The intervention will focus on promoting PTG using structured sessions grounded in ACT. 
Topics include psychological flexibility, mindfulness, narrative reconstruction, meaning-
making, and value-based goal setting. Sessions will be led by a trained facilitator and a co-
facilitator as needed. Participant feedback will be gathered post-intervention. 
Statistical Analysis Plan 
Software 
All analyses will be conducted using SPSS version 23. 
Preliminary Data Handling 
- Outliers and data normality will be examined. 
- Reliability of all instruments will be assessed using Cronbach’s alpha. 
- Demographic and clinical data will be reported using descriptive statistics. 
Primary Analysis 
The primary outcome—Post-Traumatic Growth (PTG)—will be analyzed using: 
- Paired t-tests within groups (pre- vs. post-intervention) 
- Independent t-tests or ANCOVA to compare intervention and control groups, adjusting for 
baseline PTG scores. 
Secondary Outcomes 
Secondary outcomes will be analyzed similarly: 
- Quality of Life and Spiritual Well-being (FACIT-Sp, FACT subscales) 
- Anxiety and Depression (HADS) 
- Trauma-Related Distress (IES-R) 
- Illness Perceptions (BIPQ) 
- Salivary Cortisol (biomarker analysis) 
 
Group comparisons will use independent t-tests or ANOVA for continuous variables, chi-
square tests for categorical variables, and non-parametric tests as appropriate. 
Multivariate and Predictive Analysis 
- Multiple regression analyses will explore baseline predictors of PTG and intervention 
response. 
- Factor analysis will examine the structure of PTG domains within the Greek population. 
- Exploratory network analysis may identify interactions among psychological and 
biological variables. 
Sample Size Estimation 
Power calculations (via G*Power 3) determined a minimum of 70–80 participants per 
group, totaling 140–160 participants, to detect moderate effect sizes with adequate power 

(β = 0.80) and α = 0.05. Power analysis was informed by Robson & McCartan (2016) to 
reduce the risk of Type I and II errors.