A Manualized Post-Traumatic Growth Intervention for People With Cancer in Greece - IC-Growth

NCT07108517 | Recruiting

• 1 other identifier: ELIDEK_KARAMANIDOU
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Cancer can be a very traumatic experience for the people affected and the majority of the psychological literature focuses on this. Less proliferated and researched is the increasingly recognized fact that as a result of struggling with such traumatic adversities, some people experience what is known as post-traumatic growth (PTG). PTG not only allows them to overcome their trauma (e.g., impact of cancer) and return to pre-diagnosis functioning (e.g., health, wellbeing, employment) but also results in them going over and above their previous state (e.g., increased resilience). This renders PTG an important phenomenon that could be enhanced as part of the support people with cancer receive. IC-Growth has two interconnected paths, namely a research one and another of health policy and best practice recommendations. On the first path, is a sequence of three studies, starting with a systematic review, followed by a cross-sectional study and concludes with a randomized control trial (RCT). The systematic review and close collaboration with experts (e.g., patient associations) will lead to the development of a novel manual to facilitate PTG in groups of people with cancer. The cross-sectional study will explore relationships between variables (e.g., PTG, quality of life, biological variables, illness perceptions, distress, anxiety, depression) in people with cancer (n = 150-180). Lastly, the RCT will evaluate the intervention's effects among three different groups (breast, colorectal, and head and neck cancers, n = 50-60 per group). On the other path, is the development of health policy and best practice recommendations regarding the psychosocial support of people with cancer in Greece. The project's results will be disseminated to stakeholders who provide support to people with cancer (e.g., oncologists, surgeons, psychologists, psychiatrists), through professional associations, a conference on "Psychosocial Support in Oncology", and publications in scientific journals. Overall, IC-Growth is a multidisciplinary project (i.e., psychology, medical, patient organizations, health policy) and joins the clinical, research and policy fields together to workable actions leading to empowering the wider community of people with cancer and improving their care.

Conditions

Breast Cancer; Colon Cancer; Head and Neck Cancers

Keywords

Post-Traumatic Growth (PTG); Cancer Survivorship; Psychosocial Intervention; Acceptance and Commitment Therapy (ACT); Quality of Life (QoL); Biomarkers (Cortisol, CRP); Randomized Controlled Trial (RCT; Oncology Supportive Care; Group Therapy; Breast Cancer; Head and Neck Cancer; Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Post-Traumatic Growth (PTG)

  PTG will be assessed using the Post-Traumatic Growth Inventory (PTGI), a validated 21-item self-report questionnaire measuring positive psychological change following trauma. Higher scores indicate greater post-traumatic growth.

  Baseline and post-intervention (6-8 weeks)

Secondary Outcomes (5)

• Anxiety and Depression

  Measured using the Hospital Anxiety and Depression Scale (HADS), a 14-item validated self-report tool. Higher scores indicate greater levels of anxiety and depression.

• Quality of Life and Spiritual Well-being

  Baseline and post-intervention (6-8 weeks)

• Distress Related to Traumatic Events

  Baseline and post-intervention (6-8 weeks)

• Illness Perceptions

  Baseline and post-intervention (6-8 weeks)

• Salivary Cortisol Levels

  Baseline and post-intervention (6-8 weeks)

Study Arms (2)

1. Group-Based Post-Traumatic Growth (PTG) Intervention

EXPERIMENTAL

Participants receive a manualized, group-based psychosocial intervention designed to enhance post-traumatic growth (PTG). The program is delivered over 6-8 weeks, with weekly 90-minute sessions, and incorporates evidence-based techniques (e.g., Acceptance and Commitment Therapy, mindfulness, cognitive and narrative exercises, and interpersonal support).

Behavioral: IC-Growth ACT-Based Support Program

2. Standard Care (Usual Oncology Follow-Up)

NO INTERVENTION

Participants receive standard oncology follow-up care with no additional psychosocial intervention. They will complete the same assessments as the intervention group at baseline and post-intervention.

Interventions

IC-Growth ACT-Based Support Program BEHAVIORAL

IC-Growth Psychosocial Group Intervention is a structured, manualized program designed to enhance post-traumatic growth (PTG) in adults diagnosed with breast, colorectal, or head and neck cancer. The intervention is delivered in small groups (8-10 participants) over 6-8 weeks, with weekly 90-minute sessions led by trained health psychologists. The program integrates evidence-based therapeutic approaches, including Acceptance and Commitment Therapy (ACT), mindfulness, cognitive restructuring, narrative exercises, and interpersonal support-building, with the goal of improving psychological flexibility, resilience, quality of life, and overall well-being.

Also known as: Experimental, 1

1. Group-Based Post-Traumatic Growth (PTG) Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (≥ 18 years)
• Having a diagnosis of a. Breast Cancer, b. Colorectal Cancer, or c. Head and Neck Cancer.
• Having concluded the planned chemotherapy courses and related hospital admissions
• Having no more than 5 years since the initial diagnosis.

You may not qualify if:

• Being in active psychological or psychiatric treatment
• Having an unmanaged mental health difficulty
• Having a severe cognitive impairment
• Being unable to give informed consent
• Being unable to speak or read Greek
• Having one or more relapses
• Diagnosed with another type of cancer within 5 years prior to recruitment.
• Having less than one-year life expectancy

Sponsors & Collaborators

• Centre for Research and Technology Hellas: lead
• AHEPA University Hospital: collaborator
• Hellenic Cancer Society: collaborator
• Theagenio Cancer Hospital: collaborator

Study Sites (1)

AHEPA University Hospital

Thessaloniki, 54636, Greece

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Colonic Neoplasms; Head and Neck Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Health Psychologist, Researcher, PhD

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 7, 2025
• Study Start: May 1, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 30, 2025
• Last Updated: August 7, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)