Clinical trial NCT04573088: Acceptance-based Intervention at Colorectal Cancer Patients
Official title: Impact of Perioperative Acceptance-based Intervention on Early Psychological and Fanctional Recovery of Colorectal Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Neoplasms
Acceptance Process
Pain, Procedural
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Taking into account the unavoidable effect of a major oncologic surgery commonly required for colorectal cancer patients and the recognized psychological and functional sequelae of the surgical treatment on their status, we will evaluate the influence of a psychological intervention, known as acceptance-based intervention, offered to those patients at the preoperative setting. Reduction of anxiety and assessmemt of indices of post-intervention psychological and functional recovery will be the primary goals of the study.

Detailed description: Introduction: Uncertainty, fears and anxiety are common reactions to an upcoming colectomy for colorectal cancer patients and are related not only to cancer disease, but also to the inevitable change in colon anatomy, affecting their preoperative psychological and functional condition and their postsurgical recovery.

Purpose: We aim to evaluate the psychological and functional recovery of colorectal cancer patients, who undergo colectomy, after an acceptance-based nursing intervention. The scope of this brief preoperative intervention is to enable patients to cope more efficiently with the upcoming surgery and their health status, as it is expected to reduce anxiety and have positive effect on postsurgical psychological and functional recovery.

Methods: The study includes histologically diagnosed patients with colorectal cancer, regardless of stage, who are scheduled to undergo colectomy. Patients will be divided into two groups-the experimental and the control group-by simple randomization. Both groups are going to complete a set of same questionnaires regarding quality of life, sleep, anxiety, depression and functional status. Patients in the control arm will then receive treatment-as-usual while patients in the experimental arm will also receive an acceptance-based intervention before surgery. Postoperatively, for both groups, apart from the self-reported symptoms, we will assess objective recovery factors, such as postoperative complications

Eligibility criteria: Inclusion Criteria:

* Patients with histologically proven colorectal adenocarcinoma
* Age \> 18 years

Exclusion Criteria:

* Metastasis at time of diagnosis
* Recurrence at time of diagnosis
* History of other malignancies
* Mental retardation
* Deafness
* Illiteracy
* ASA score\>3
* Poor performance status

Primary outcomes:
measure: Postoperative pain as measured by VAS score
timeFrame: Third postoperative day
Secondary outcomes:
measure: Functional status as measured by "Maintain Function" Scale (MFS)
timeFrame: Third postoperative day
measure: Anxiety and depression measured by Brief Illness Perception Questionnaire (Brief IPQ)
timeFrame: Third postoperative day
measure: Anxiety and depression measured by State-Trait Anxiety (STAI) questionnaire
timeFrame: Third postoperative day
Other outcomes:
Locations:
city: Athens
country: Greece
facility: NKUAthens
Study officials:
affiliation: Associate Professor of Surgery
name: George E Theodoropoulos
role: PRINCIPAL_INVESTIGATOR
References: