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Effectiveness of a Psychosocial Intervention for Colorectal Cancer (EPIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03258450
Recruitment Status : Recruiting
First Posted : August 23, 2017
Last Update Posted : March 6, 2019
Sponsor:
Collaborator:
Singhealth Foundation
Information provided by (Responsible Party):
Irene Teo, Duke-NUS Graduate Medical School

Brief Summary:
Studies have reported about one-third to half of advanced cancer patients experience psychological distress yet the mental healthcare needs of these patients are not properly assessed and addressed. Patients with advanced colorectal cancer can face unique challenges that are stoma- or bowel-related in addition to other symptom burden such as pain, fatigue, and existential distress that have deleterious consequences on their psychological and social functioning. This pilot study aims to test an intervention for patients specifically with advanced colorectal cancer that incorporates culturally-appropriate topics. Using a randomized selection design, we will investigate the feasibility and acceptability of the intervention and obtain an initial estimate of efficacy of the intervention. This pilot study will yield useful information to inform the preparation of a larger, phase III confirmatory study.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Behavioral: Psycho-behavioural intervention arm (PBI) Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Feasibility and Acceptability of a Psychosocial Intervention for Advanced Colorectal Cancer Patients
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Psycho-behavioural intervention arm (PBI)
Participants will receive 4 sessions(PBI) that lasts approximately 60 mins.
Behavioral: Psycho-behavioural intervention arm (PBI)
The first session introduces the rationale of the intervention and is designed to encourage participants to recognize the autonomous role they can play in their health and well-being. Patients will be trained on breathing as a relaxation technique. The second session focuses on building behavioural skills to manage common symptoms for colorectal cancer patients. The third session focuses on cognitive strategies to address worries and existential distress. The last session focuses on maximizing social support and applying skills learned so far in dealing with loved ones. Participants will be provided an MP3 player that contains the relaxation exercise recording and a folder with summaries of the session content.

No Intervention: Waitlist Control Arm (WLC)
The WLC group receives standard usual care before being offered the same PBI protocol and assessment thereafter.



Primary Outcome Measures :
  1. The feasibility of the intervention will be tested through enrolment rates. [ Time Frame: Up to 8 weeks ]
    Feasibility of the intervention will be assessed through enrolment rates, rejection rates and exclusion rates.

  2. The acceptability of the intervention will be assessed through the Client Satisfaction Questionnaire. [ Time Frame: Up to 8 weeks ]
    Acceptability of the intervention will be assessed through patient's reported satisfaction with the program, There are 12 items measuring the perceived quality of the program, usefulness of the program, satisfaction with the intervention, comfort level in working with a mental healthcare provider, likelihood of recommending the intervention to others. Five-point Likert scales will be used for the measurement.


Secondary Outcome Measures :
  1. Psychological distress will be accessed through The Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Up to 8 weeks ]
    The Hospital Anxiety and Depression Scale (HADS)(Zigmond & Snaith, 1983) will be used to measure psychological distress. There are 7 items measuring anxiety symptoms (HADS-A) and 7 items measuring depressive symptoms (HADS-D). An overall HADS score representing psychological distress will be calculated. This measure has been translated into Singaporean Mandarin and validated for use in Singapore.



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Ages Eligible for Study:   21 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 21 years or older
  2. Diagnosis of stage IV colorectal cancer
  3. Able and willing to attend outpatient therapy appointments
  4. Speak and read English or Chinese language

Exclusion Criteria:

  1. Serious mental illness (e.g., schizophrenia, bipolar disorder) indicated by medical records
  2. Visual, hearing, or cognitive impairment that will interfere with intervention
  3. Unaware they have cancer

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): NCT03258450


Contacts
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Contact: Irene Teo, Ph.D. +65-660-15145 irene.teo@duke-nus.edu.sg

Locations
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Singapore
National Cancer Centre Recruiting
Singapore, Singapore, 169610
Contact: Fang Ting Pan, BS    +6587178928    pan.fang.ting@nccs.com.sg   
Sponsors and Collaborators
Duke-NUS Graduate Medical School
Singhealth Foundation
Investigators
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Principal Investigator: Irene Teo, Ph.D. Duke-NUS Graduate Medical School

Publications:
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Responsible Party: Irene Teo, Clinical Psychologist , Assistant Professor, Duke-NUS Graduate Medical School
ClinicalTrials.gov Identifier: NCT03258450     History of Changes
Other Study ID Numbers: HSRNIG
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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