Collaborative Network to Take Responsibility for Oral Anticancer Therapy

NCT02861209 | Unknown

• 1 other identifier: LMK15022016
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 4

Brief Summary

This study aims to develop, implement and evaluate a care pathway for patients with cancer who are treated with oral anticancer drugs (OACD). The care pathway will be developed in six hospitals in Flanders, and will be adapted to the local setting and situation. The investigators hypothesize that the implementation of a care pathway will increase the quality of the drug therapy, the communication between health care professionals (HCPs) and patients, and will lead to an improved level of self-management and adherence. Moreover, the invesitgators hypothesize that the care pathway will facilitate the communication between HCPs in the hospital setting and in ambulatory care, and will improve counseling skills, self-efficacy and self-confidence of HCPs. At the end of the study, a roadmap for the nation-wide implementation of a similar care pathway will be constructed based on the experiences of the participating hospitals. This roadmap will certainly include an e-learning platform for healthcare professionals.

Conditions

Breast Cancer; ALL; Lung Cancer; Melanoma; Colorectal Cancer; Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Change in self-management skills

  There is no gold standard to define self-management. A definition from Barlow et al., 2002 (2) defines self-management as follows: the ability of an individual to manage the symptoms, treatment, physical and psychosocial consequences and life style changes due to his/her condition. Adequate self-management refers to the ability to monitor one's condition and to effect cognitive, behavioural and emotional responses necessary to maintain a satisfactory quality of life. The studied self-management skills in this project comprise "social integration and support", "health service navigation", "constructive attitudes and approaches", "skill and technique acquisition" and "emotional distress".

  at the start of the therapy, after one and three months

Secondary Outcomes (8)

• Change in medication Adherence

  after one and three months of therapy

• Change in patient satisfaction with treatment using the Cancer Therapy Satisfaction Questionnaire (CTSQ)

  after one and three months

• Change in patient satisfaction with care using Out-patsat 35

  at the start of the therapy, after one and three months

• Health Related Quality of Life

  at the start of the therapy, after one and three months

• Change in Distress using the Distress Barometer

  at the start of the therapy, after one and three months

Other Outcomes (2)

• Change in Self-efficacy in HCPs using the Self-efficacy and Performance in Self-management Instrument (SEPSS)

  at baseline (before the implementation of the care pathway) and after 24 months (during implementation)

• Change in perceptions on self-management in HCPs using the Clinician Support for Patient activation measure

  at baseline (before the implementation of the care pathway) and after 24 months (during implementation)

Study Arms (2)

Non-care pathway

NO INTERVENTION

This arm comprises patients before the implementation of the care pathway. Patients starting with an oral anticancer therapy participate in the current care process. Outcomes are assessed at start of treatment, after 1 and after 3 months. The decision to start with an oral anticancer therapy depends solely on the treating physician.

Care Pathway

EXPERIMENTAL

This arm comprises patients after the implementation of the care pathway. Patients starting with an oral anticancer therapy in this arm, receive care as is described by the novel designed care pathway. Outcomes are again assessed at start of treatment, after 1 and after 3 months. The decision to start with an oral anticancer therapy depends solely on the treating physician.

Other: Implementation of a care pathway

Interventions

Implementation of a care pathway OTHER

The care pathway will consist of procedures of care in the hospital (e.g. consultations with doctors, contact moments with nurses, ...) that describe the initiation of an oral anticancer therapy and the further follow up. The care pathway should describe how care can efficiently be organised.

Care Pathway

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a hematological cancer of solid tumor
• starting an oral anticancer drug for the first time
• able to understand and speak Dutch

You may not qualify if:

• patients following an adjuvant oral anticancer therapy (e.g. tamoxifen)
• patients following a therapy with a study drug

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (4)

AZ Turnhout

Turnhout, Antwerpen, 2300, Belgium

RECRUITING

Maria Middelares Gent

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

Imelda Bonheiden

Bonheiden, Vlaams-Brabant, 2820, Belgium

RECRUITING

AZ Groeninge Kortrijk

Kortrijk, West-Vlaanderen, 8000, Belgium

RECRUITING

Related Publications (1)

• Kinnaer LM, Decoene E, Van Hecke A, Foulon V. Collaborative network to take responsibility for oral anticancer therapy (CONTACT): Study-protocol investigating the impact of a care pathway. J Adv Nurs. 2019 Dec;75(12):3726-3739. doi: 10.1111/jan.14157. Epub 2019 Aug 27.

  PMID: 31310353 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Lung Neoplasms; Melanoma; Colorectal Neoplasms; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Lise-Marie Kinnaer, PharmD

CONTACT

3216328265; lisemarie.kinnaer@kuleuven.be

Veerle Foulon, Prof. Dr.

CONTACT

veerle.foulon@kuleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PharmD

Study Record Dates

• First Submitted: August 2, 2016
• First Posted: August 10, 2016
• Study Start: November 1, 2015
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: April 16, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (4)