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

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ClinicalTrials.gov Identifier: NCT02824484
Recruitment Status : Unknown
Verified April 2016 by Arcispedale Santa Maria Nuova-IRCCS.
Recruitment status was:  Recruiting
First Posted : July 6, 2016
Last Update Posted : July 6, 2016
Sponsor:
Collaborator:
European University of Rome
Information provided by (Responsible Party):
Arcispedale Santa Maria Nuova-IRCCS

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).

Condition or disease Intervention/treatment Phase
Breast Cancer Colorectal Cancer Behavioral: GWDP Behavioral: Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Promoting Post-traumatic Growth in Cancer Patients: a Study Protocol for a Randomized Controlled Trial of Guided Written Disclosure
Study Start Date : November 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Guided Written Disclosure Protocol
GWDP consists of three 20-minutes writing sessions. Participants write every two weeks at home following the specific instructions for each session.
Behavioral: GWDP

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.
Other Name: Guided Written Disclosure Protocol

Placebo Comparator: Control
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
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.




Primary Outcome Measures :
  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 [ Time Frame: Baseline (T0): before randomization. Post-intervention (T1): three months (plus or minus 15 days) from (T1). Follow-up (T2): six months after T1. ]
    21-item questionnaire


Secondary Outcome Measures :
  1. 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 [ Time Frame: Baseline (T0): before randomization. Post-intervention (T1): three months (plus or minus 15 days) from (T1). Follow-up (T2): six months after T1. ]
    8-item questionnaire

  2. 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 [ Time Frame: Baseline (T0): before randomization. Post-intervention (T1): three months (plus or minus 15 days) from (T1). Follow-up (T2): six months after T1. ]
    15-item questionnaire

  3. 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 [ Time Frame: Baseline (T0): before randomization. Post-intervention (T1): three months (plus or minus 15 days) from (T1). Follow-up (T2): six months after T1. ]
    14.item questionnaire


Other Outcome Measures:
  1. Expectancy about change in personal growth as a result of the intervention (Treatment Expectancy, TE) [ Time Frame: baseline (T0) ]
    1 item asking patients to what extent they expect improvement in personal growth after the intervention



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02824484


Contacts
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Contact: Silvia Di Leo, Psych 0039 0522 295369 silvia.dileo@asmn.re.it
Contact: Elisa Rabitti, PhD 0039 0522 295369 elisa.rabitti@ausl.re.it

Locations
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Italy
Arcispedale S. Maria Nuova-IRCCS Recruiting
Reggio Emilia, Italy, 42123
Contact: Silvia Di Leo, Psych    0039 0522 295369    silvia.dileo@asmn.re.it   
Contact: Elisa Rabitti, PhD    0039 0522 295369    elisa.rabitti@ausl.re.it   
Sponsors and Collaborators
Arcispedale Santa Maria Nuova-IRCCS
European University of Rome
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Responsible Party: Arcispedale Santa Maria Nuova-IRCCS
ClinicalTrials.gov Identifier: NCT02824484    
Other Study ID Numbers: 2015/0024360
First Posted: July 6, 2016    Key Record Dates
Last Update Posted: July 6, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Arcispedale Santa Maria Nuova-IRCCS:
Guided written disclosure protocol
Emotional disclosure
Meaning
Post-Traumatic Growth
Cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases