NCT05741255

Brief Summary

The present study aims to: Determine the effect of acceptance and commitment therapy-based interventions on mental health and cognitive impairment for patients with advanced colorectal cancer. Research Hypothesis: Cancer patients who receive acceptance and commitment therapy-based interventions will exhibit better mental health and lower cognitive impairments than those who didn't receive it.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2022

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2023

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 23, 2023

Completed
Last Updated

February 23, 2023

Status Verified

February 1, 2023

Enrollment Period

Same day

First QC Date

February 14, 2023

Last Update Submit

February 14, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Mental Health Continuum-Short Form

    The original 14-item Mental Health Continuum-Short was developed by (Keyes \& psychology, 2004) in response to demands for a brief self-rating assessment tool that combined the three components of wellbeing: emotional, social, and psychological.

    2 weeks

  • Montreal Cognitive Assessment

    The one-page Montreal Cognitive Assessment (MoCA) was used to assess the eight cognitive domains of attention (6 points), visuospatial/executive functions (5 points), short-term memory (5 points), naming (3 points), language (3 points), orientation (6 points), and abstraction (2 points).

    2 weeks

Study Arms (2)

STUDY GROUP

EXPERIMENTAL

After random sampling and dividing patients into two groups of study and control. Patients from the study and control groups will be interviewed individually by the researcher to apply the study tools. Acceptance and Commitment Therapy will be carried out for patients in the study group

Behavioral: Acceptance and Commitment Therapy

Control group

ACTIVE COMPARATOR

Those in the control group will be left without any intervention to undergo the usual unit routine care.

Behavioral: Acceptance and Commitment Therapy

Interventions

type of mindful psychotherapy that helps you stay focused on the present moment and accept thoughts and feelings without judgment. It aims to help you move forward through difficult emotions so you can put your energy into healing instead of dwelling on the negative.

Control groupSTUDY GROUP

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Are not participating in any type of psychotherapy, score high in the cognitive impairment questionnaire.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Nursing

Alexandria, Egypt

Location

MeSH Terms

Conditions

Psychological Well-BeingCognitive DysfunctionColorectal Neoplasms

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorCognition DisordersNeurocognitive DisordersMental DisordersIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

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
Lecturer

Study Record Dates

First Submitted

February 14, 2023

First Posted

February 23, 2023

Study Start

January 5, 2022

Primary Completion

January 5, 2022

Study Completion

February 5, 2023

Last Updated

February 23, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations