Effectiveness of a Psychosocial Intervention for Colorectal Cancer (EPIC)
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|ClinicalTrials.gov Identifier: NCT03258450|
Recruitment Status : Recruiting
First Posted : August 23, 2017
Last Update Posted : March 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Neoplasms||Behavioral: Psycho-behavioural intervention arm (PBI)||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|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|
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.
- 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.
- 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.
- 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.
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
|Contact: Irene Teo, Ph.D.||+firstname.lastname@example.org|
|National Cancer Centre||Recruiting|
|Singapore, Singapore, 169610|
|Contact: Fang Ting Pan, BS +6587178928 email@example.com|
|Principal Investigator:||Irene Teo, Ph.D.||Duke-NUS Graduate Medical School|