## Protocol Section
### Identification Module
**NCT ID:** NCT04896879

**Brief Title:** Experiences and Needs of Patients, Their Informal Caregiver and Healthcare Professionals Regarding LARS

**Official Title:** Rectal Cancer Survivorship, the Struggle of the Low Anterior Resection Syndrome (LARS). Experiences and Needs of Patients, Their Informal Caregiver and Healthcare Professionals

#### Organization Study ID Info
**ID:** EC2016/1016
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Ghent
### Status Module
#### Completion Date
**Date:** 2020-12-31

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-05-21

**Type:** ACTUAL

**Last Update Submit Date:** 2021-05-20

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2020-12-31

**Type:** ACTUAL

#### Start Date
**Date:** 2016-11-22

**Type:** ACTUAL

**Status Verified Date:** 2021-05

#### Study First Post Date
**Date:** 2021-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2020-12-31
**Study First Submit QC Date:** 2021-05-20
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Kom Op Tegen Kanker

**Class:** OTHER

**Name:** AZ Sint-Jan AV

**Class:** OTHER

**Name:** AZ Delta

**Class:** OTHER

**Name:** AZ Sint-Lucas Gent

#### Lead Sponsor

**Class:** OTHER

**Name:** University Hospital, Ghent

#### Responsible Party

**Investigator Affiliation:** University Hospital, Ghent

**Investigator Full Name:** GIHeelkunde

**Investigator Title:** Principal investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Exploration of the experiences and needs of patients with the low anterior resection syndrome, their informal caregiver and health care professionals. This is a qualitative study where semi-structured interviews will be conducted with patients and informal caregivers. next to that focus groups will be performed with healthcare professionals from different professions.

### Conditions Module

**Conditions:**

- Low Anterior Resection Syndrome

- Rectal Cancer

**Keywords:**

- low anterior resection syndrome

### Design Module

#### Design Info

**Observational Model:** OTHER

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 69

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients with major LARS

**Intervention Names:**

- Behavioral: interviews

**Label:** Patients

#### Arm Group 2

**Description:** Informal caregivers of patients with major LARS

**Intervention Names:**

- Behavioral: interviews

**Label:** Informal caregivers

#### Arm Group 3

**Description:** Healthcare professionals taking care for patients with LARS

**Intervention Names:**

- Behavioral: interviews

**Label:** Healthcare professionals

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Healthcare professionals

- Informal caregivers

- Patients

**Description:** semi-structured interviews will be conducted in patients with major LARS and their informal caregiver to explore their experiences and needs. Focus groups will be perfomed with healthcare professionals of several professions.

**Name:** interviews

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** Exploring needs and experiences of patients with major lars and their informal caregiver through individual semistructured interviews

**Measure:** needs and experiences of patients with major lars and their informal caregiver through individual semistructered interviews

**Time Frame:** Interview will last about 60 minutes

**Description:** Exploring needs and experiences of healthcare professionals caring for patients with LARS

**Measure:** Needs and experiences of healthcare professionals caring for patients with LARS through focus groups

**Time Frame:** Focus group will last about 60 minutes

### Eligibility Module

**Eligibility Criteria:** PATIENTS

Inclusion Criteria:

* adult patients (18+)
* confronted with major low anterior resection syndrome after rectal cancer surgery

Exclusion Criteria:

* stoma at time interview
* abdominal perineal resection

INFORMAL CAREGIVERS Inclusion criteria

* Adults (18+)
* Nominated by the participating patient as their principal caregiver Exclusion criteria None

HEALTHCARE PROFESSIONALS inclusion criteria

* Adults (18+)
* Caring for patients with LARS Exclusion criteria None

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** The participants will be patients with major LARS, their informal caregivers and healthcare professionals

### References Module

#### References

**Citation:** Pape E, Decoene E, Debrauwere M, Van Nieuwenhove Y, Pattyn P, Feryn T, Pattyn PRL, Verhaeghe S, Van Hecke A; Belgian LARS collaborative group. Information and counselling needs of patients with major low anterior resection syndrome: A qualitative study. J Clin Nurs. 2023 Apr;32(7-8):1240-1250. doi: 10.1111/jocn.16277. Epub 2022 Mar 6.

**PMID:** 35253296

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004194

- Term: Disease

- ID: D000010335

- Term: Pathologic Processes

- ID: D000015179

- Term: Colorectal Neoplasms

- ID: D000007414

- Term: Intestinal Neoplasms

- ID: D000005770

- Term: Gastrointestinal Neoplasms

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000007410

- Term: Intestinal Diseases

- ID: D000012002

- Term: Rectal Diseases

- ID: D000003108

- Term: Colonic Diseases

- ID: D000011183

- Term: Postoperative Complications

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: BC04

- Name: Neoplasms

### Condition Browse Module - Browse Leaves

- ID: M16355

- Name: Syndrome

- Relevance: HIGH

- As Found: Syndrome

- ID: M3018

- Name: Low Anterior Resection Syndrome

- Relevance: HIGH

- As Found: Low Anterior Resection Syndrome

- ID: M14846

- Name: Rectal Neoplasms

- Relevance: HIGH

- As Found: Rectal Cancer

- ID: M17890

- Name: Colorectal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M10448

- Name: Intestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10444

- Name: Intestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14844

- Name: Rectal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6336

- Name: Colonic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14065

- Name: Postoperative Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000012004

- Term: Rectal Neoplasms

- ID: D000094123

- Term: Low Anterior Resection Syndrome

- ID: D000013577

- Term: Syndrome

### Misc Info Module

- Version Holder: 2024-05-24
