A Qualitative Study Into How Patients Deal With Chemother... | NCT01867489

Studies
A Qualitative Study Into How Patients Deal With Chemotherapy-related Side Effects at Home

NCT01867489

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Completed

Last Update Posted

Nov 18, 2014Estimated

Enrollment

28Actual

Phase

Not provided

Conditions

Exploration of How Patients Deal With Side Effects From Chemotherapy

Interventions

No intervention

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2012

Primary Completion Date

Jan 2014Actual

Completion Date

Jan 2014Actual

First Submitted Date

May 19, 2013

First Submission Date that Met QC Criteria

May 29, 2013

First Posted Date

Jun 4, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 17, 2014

Last Update Posted Date

Nov 18, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Annemarie Coolbrandt, Clinical Nurse Specialist Oncology, Universitaire Ziekenhuizen KU LeuvenPrincipal Investigator

Lead Sponsor

Universitaire Ziekenhuizen KU LeuvenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This qualitative study explores how patients deal with the side effects from chemotherapy at their home, what factors and ideas influence their symptom self-management and how professional caregivers contribute to the management of their symptoms at home. Data are collected through semi-structured interviews with adult patients treated with chemotherapy and analysed using a Grounded Theory approach.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Chemotherapy, Cancer		Adult cancer patients (with any type of cancer) being treated with chemotherapy	Other: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other		Chemotherapy, Cancer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
patient's experience		one interview during the course of treatment, i.e. one timepoint between 2 months after the start of chemotherapy and the end of the patient's treatment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult (≥18 years) patients with (any type and any stage of) cancer who were undergoing chemotherapy treatment in an ambulatory setting or during short hospital stays
Dutch speaking
Able to provide informed consent and to participate in an interview

Exclusion Criteria:

Patients who were in the first 2 cycles of treatment
Patients for whom an interview was considered physically, mentally and/or emotionally too burdensome.
Patients who had reported not to experience any side effect from treatment at all

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patients treated with chemotherapy

Sampling Method

Non-Probability Sample