Clinical trial · Interventional
Effectiveness of a Psychosocial Intervention for Colorectal Cancer
The Feasibility and Acceptability of a Psychosocial Intervention for Advanced Colorectal Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Psycho-behavioural intervention arm (PBI) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Psycho-behavioural intervention arm (PBI)
- description
- Participants will receive 4 sessions(PBI) that lasts approximately 60 mins.
- interventionNames
- Behavioral: Psycho-behavioural intervention arm (PBI)
- type
- NO_INTERVENTION
- label
- Waitlist Control Arm (WLC)
- description
- The WLC group receives standard usual care before being offered the same PBI protocol and assessment thereafter.
Primary outcomes (2)
- measure
- The feasibility of the intervention will be tested through enrolment rates.
- timeFrame
- Up to 8 weeks
- description
- Feasibility of the intervention will be assessed through enrolment rates, rejection rates and exclusion rates.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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
References
Publications (4)
- BACKGROUNDCampbell 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
- BACKGROUNDTan 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
- BACKGROUNDZhang 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
- BACKGROUNDSanson-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