Effectiveness of a Psychosocial Intervention for Colorectal Cancer

NCT03258450 | Completed

• 1 other identifier: HSRNIG
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Neoplasms

Outcome Measures

Primary Outcomes (2)

• The feasibility of the intervention will be tested through enrolment rates.

  Feasibility of the intervention will be assessed through enrolment rates, rejection rates and exclusion rates.

  Up to 8 weeks

• The acceptability of the intervention will be assessed through the Client Satisfaction Questionnaire.

  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.

  Up to 8 weeks

Secondary Outcomes (1)

• Psychological distress will be accessed through The Hospital Anxiety and Depression Scale (HADS)

  Up to 8 weeks

Study Arms (2)

Psycho-behavioural intervention arm (PBI)

EXPERIMENTAL

Participants will receive 4 sessions(PBI) that lasts approximately 60 mins.

Behavioral: Psycho-behavioural intervention arm (PBI)

Waitlist Control Arm (WLC)

NO INTERVENTION

The WLC group receives standard usual care before being offered the same PBI protocol and assessment thereafter.

Interventions

Psycho-behavioural intervention arm (PBI) BEHAVIORAL

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.

Psycho-behavioural intervention arm (PBI)

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Duke-NUS Graduate Medical School: lead
• Singhealth Foundation: collaborator

Study Sites (1)

National Cancer Centre

Singapore, 169610, Singapore

Location

Related Publications (4)

• Campbell CL, Campbell LC. A systematic review of cognitive behavioral interventions in advanced cancer. Patient Educ Couns. 2012 Oct;89(1):15-24. doi: 10.1016/j.pec.2012.06.019. Epub 2012 Jul 12.

  PMID: 22796302 BACKGROUND

• Tan PY, Tien Tau LC, Lai Meng OY. Living With Cancer Alone? The Experiences of Singles Diagnosed With Colorectal Cancer. J Psychosoc Oncol. 2015;33(4):354-76. doi: 10.1080/07347332.2015.1045678.

  PMID: 25996668 BACKGROUND

• Zhang M, Chan SW, You L, Wen Y, Peng L, Liu W, Zheng M. The effectiveness of a self-efficacy-enhancing intervention for Chinese patients with colorectal cancer: a randomized controlled trial with 6-month follow up. Int J Nurs Stud. 2014 Aug;51(8):1083-92. doi: 10.1016/j.ijnurstu.2013.12.005. Epub 2013 Dec 17.

  PMID: 24406033 BACKGROUND

• Sanson-Fisher R, Girgis A, Boyes A, Bonevski B, Burton L, Cook P. The unmet supportive care needs of patients with cancer. Supportive Care Review Group. Cancer. 2000 Jan 1;88(1):226-37. doi: 10.1002/(sici)1097-0142(20000101)88:13.3.co;2-g.

  PMID: 10618627 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Irene Teo, Ph.D.

  Duke-NUS Graduate Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychologist , Assistant Professor

Study Record Dates

• First Submitted: August 21, 2017
• First Posted: August 23, 2017
• Study Start: November 1, 2017
• Primary Completion: May 31, 2019
• Study Completion: August 31, 2019
• Last Updated: January 31, 2020

Record last verified: 2020-01

Locations

SG (1)