A Guided Written Disclosure Intervention to Promote Post-traumatic Growth in Cancer Patients GUIDED WRITTEN DISCLOSURE

NCT02824484 | Completed

• 1 other identifier: 2015/0024360
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the efficacy of Guided Written Disclosure Protocol (GWDP) in promoting post-traumatic growth through a process of meaning reconstruction in cancer patients at the end of chemotherapy. Also, the intervention (GWDP) intends to reduce distress symptoms (i.e. intrusive thoughts, avoidance, depression and anxiety).

Conditions

Breast Cancer; Colorectal Cancer

Keywords

Guided written disclosure protocol; Emotional disclosure; Meaning; Post-Traumatic Growth; Cancer

Outcome Measures

Primary Outcomes (1)

• Change in post-traumatic growth from baseline to post-intervention assessment and at 6 months follow-up. Post-Traumatic Growth Inventory (PTGI) will be used to assess this outcome

  21-item questionnaire

  Baseline (T0): before randomization. Post-intervention (T1): three months (plus or minus 15 days) from (T1). Follow-up (T2): six months after T1.

Secondary Outcomes (3)

• Change in constructed meaning from baseline to post-intervention assessment and at 6 monts follow-up. Constructed Meaning Scale (CMS) will be used to assess this outcome

  Baseline (T0): before randomization. Post-intervention (T1): three months (plus or minus 15 days) from (T1). Follow-up (T2): six months after T1.

• Change in intrusive thoughts and avoidance from baseline to post-intervention assessment and at 6 months follow-up. Impact of Event Scale (IES) will be used to assess this outcome

  Baseline (T0): before randomization. Post-intervention (T1): three months (plus or minus 15 days) from (T1). Follow-up (T2): six months after T1.

• Change in anxiety and depression from baseline to post-intervention assessment and at 6 months follow-up. Hospital Anxiety and Depression Scale (HADS) will be used to assess this outcome

  Baseline (T0): before randomization. Post-intervention (T1): three months (plus or minus 15 days) from (T1). Follow-up (T2): six months after T1.

Other Outcomes (1)

• Expectancy about change in personal growth as a result of the intervention (Treatment Expectancy, TE)

  baseline (T0)

Study Arms (2)

Guided Written Disclosure Protocol

EXPERIMENTAL

GWDP consists of three 20-minutes writing sessions. Participants write every two weeks at home following the specific instructions for each session.

Behavioral: GWDP

Control

PLACEBO COMPARATOR

Control condition consists of three 20-minutes writing sessions. Participants write every two weeks at home following the instructions. Their task is constructed to be emotionally neutral.

Behavioral: Control

Interventions

GWDP BEHAVIORAL

In each writing session participants are asked to: 1. Describe memories concerning cancer illness in a chronological order, with an objective and detached attitude 2. Describe: (a) thoughts and emotions perceived during the illness experience; (b) the impact of illness on their daily lives, and how it has changed their attitudes toward life. 3. Focus on their actual situation, think about the entire illness experience, and report on the following aspects: -Their present thoughts and feelings, and how those differ from the ones felt during the illness experience. -To what extent they have come to terms with, understand and appreciate themselves to have dealt successfully with the illness.

Also known as: Guided Written Disclosure Protocol

Guided Written Disclosure Protocol

Control BEHAVIORAL

Participants are requested to write about events of their daily routine happened during the past week; they are also asked to focus on facts, with an objective and detached attitude.

Control

Eligibility Criteria

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

You may qualify if:

• A histologically-confirmed stage I-III breast or colon cancer
• Adjuvant chemotherapy completed by no more than eight months
• Disease free (no evidence of metastatic disease) according to what reported by the oncologist during the follow-up oncological consultation
• Aged 18 years or over
• Property of written and spoken Italian language

You may not qualify if:

• Having received a structured psychological intervention performed by a psychologist or by a psychiatrist, for at least six months during the last three years
• Having received a psychopharmacological treatment for a codified psychiatric disorder (according to the DSM-V) during the last three years

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead
• European University of Rome: collaborator

Study Sites (1)

Arcispedale S. Maria Nuova-IRCCS

Reggio Emilia, 42123, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms; Colorectal Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; 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: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2016
• First Posted: July 6, 2016
• Study Start: November 1, 2015
• Primary Completion: November 18, 2019
• Study Completion: December 31, 2021
• Last Updated: June 25, 2025

Record last verified: 2025-06

Locations

IT (1)