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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorCentre for Research and Technology Hellas

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Being in active psychological or psychiatric treatment

Having an unmanaged mental health difficulty

Having a severe cognitive impairment

Being unable to give informed consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: 1. Group-Based Post-Traumatic Growth (PTG) InterventionExperimental treatment 1 intervention
Group B: 2. Standard Care (Usual Oncology Follow-Up)No intervention 0 interventions

Trial outcomes

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.

Time frame
Baseline and post-intervention (6-8 weeks)

Secondary outcomes

1

Anxiety and Depression

Baseline and post-intervention (6-8 weeks)

Time frame
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.
2

Quality of Life and Spiritual Well-being

Measured using the Functional Assessment of Chronic Illness Therapy - Spiritual Well-being (FACIT-Sp) and cancer-type specific scales (e.g., FACT-B, FACT-H\&N, FACT-C). Higher scores reflect better perceived quality of life and spiritual well-being.

Time frame
Baseline and post-intervention (6-8 weeks)
3

Distress Related to Traumatic Events

Measured using the Impact of Event Scale-Revised (IES-R), a 22-item self-report instrument assessing subjective distress related to a specific traumatic event. Higher scores indicate greater distress.

Time frame
Baseline and post-intervention (6-8 weeks)
4

Illness Perceptions

Assessed using the Brief Illness Perceptions Questionnaire (BIPQ), which measures cognitive and emotional representations of illness. Higher scores on relevant subscales indicate more negative or threatening illness perceptions.

Time frame
Baseline and post-intervention (6-8 weeks)

Other outcomes

Sponsors and contacts

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Centre for Research and Technology Hellas

Lead sponsor

AHEPA University Hospital

Collaborator

Hellenic Cancer Society

Collaborator

Theagenio Cancer Hospital

Collaborator