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Effectiveness of a Psychosocial Intervention for Colorectal Cancer

NCT03258450 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-01-31

No results posted yet for this study

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.

Conditions

  • Colorectal Neoplasms

Interventions

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.

Sponsors & Collaborators

  • Singhealth Foundation

    collaborator OTHER_GOV

  • Duke-NUS Graduate Medical School

    lead OTHER

Principal Investigators

  • Irene Teo, Ph.D. · Duke-NUS Graduate Medical School

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2019-05-31
Completion
2019-08-31

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03258450 on ClinicalTrials.gov