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Collaborative Network to Take Responsibility for Oral Anticancer Therapy (CONTACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02861209
Recruitment Status : Recruiting
First Posted : August 10, 2016
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Lise-Marie Kinnaer, KU Leuven

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.


Condition or disease Intervention/treatment Phase
Breast Cancer ALL Lung Cancer Melanoma Colorectal Cancer Prostate Cancer Other: Implementation of a care pathway Not Applicable

Detailed Description:

For each hospital, an individual care pathway will be developed following the 7-phase model by Vanhaecht et al., 2011. This methodology aims to offer a systematic approach in 7 phases for the support of an interdisciplinary team in the development of new care pathways or in the improvement of existing ones.

The before-part of the study includes phases 1 to 4 that aim to map current practice in detail and to translate these findings into the development of a care pathway. Current practice will be investigated using mixed methods comprising:

  • surveys evaluating care on the level of the hospital
  • semi-structured interviews with healthcare professionals (HCP) and patients
  • outcome assessments in patients included in the study (self-management, adherence, satisfaction with care, satisfaction with information, quality of life) using validated questionnaires at the start of the therapy, after 1 month and after three months
  • outcome assessments in healthcare professionals at baseline (self-efficacy and perceptions on self-management) using validated questionnaires
  • training and feedback sessions on counseling for HCPs

Based upon these findings, a care pathway in each hospital will be developed by a local project team of different stakeholders from different disciplines.

The after-part of the study includes phase 5-7 in which the care pathway is implemented, evaluated and continuously followed up.

Implementation and evaluation take place at the same time. The evaluation includes:

  • outcome assessments in patients (newly recruited) at the start of the therapy, after 1 month and after three months
  • outcome assessments in HCPs (follow up)
  • evaluation of counseling skills
  • focus group discussions and interviews with HCPs to evaluate the development and implementation of the care pathway.

At the end of the study a comparison of outcomes before and after the implementation will be made to study the impact of the care pathway on the before mentioned aspects (see "Brief Summary").

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 228 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: CONTACT: A Prospective Interventional Multicentre Before-after Study for the Implementation of a Care Pathway to Increase Self-management of Patients With Cancer Who Are Treated With Oral Anticancer Medications
Study Start Date : November 2015
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma

Arm Intervention/treatment
No Intervention: Non-care pathway

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.

Experimental: Care Pathway

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
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.




Primary Outcome Measures :
  1. Change in self-management skills [ Time Frame: at the start of the therapy, after one and three months ]

    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".



Secondary Outcome Measures :
  1. Change in medication Adherence [ Time Frame: after one and three months of therapy ]
  2. Change in patient satisfaction with treatment using the Cancer Therapy Satisfaction Questionnaire (CTSQ) [ Time Frame: after one and three months ]
  3. Change in patient satisfaction with care using Out-patsat 35 [ Time Frame: at the start of the therapy, after one and three months ]
    The outpatsat is a questionnaire for ambulatory cancer patients in which they are asked to rate in different subscales their perceptions on care delivered by doctors, nurses and rate te overall organisation (accessibility of the hospital, ease of reaching the hospital by telephone, ...) during their stay at day hospital of consultations

  4. Health Related Quality of Life [ Time Frame: at the start of the therapy, after one and three months ]
  5. Change in Distress using the Distress Barometer [ Time Frame: at the start of the therapy, after one and three months ]
  6. Efficacy of treatment Using ECOG performance scale and RECIST criteria [ Time Frame: at the start of the therapy, after one and three months ]
  7. Toxicity of treatment [ Time Frame: at the start of the therapy, after one and three months ]
    Summarizing adverse drug events

  8. Cost of care [ Time Frame: at the start of the therapy, after one and three months ]
    Prospective report on health care expenditures (use of healthcare and other services, use of medicines, …)


Other Outcome Measures:
  1. Change in Self-efficacy in HCPs using the Self-efficacy and Performance in Self-management Instrument (SEPSS) [ Time Frame: at baseline (before the implementation of the care pathway) and after 24 months (during implementation) ]
    SEPSS investigates the ability of a HCP to evaluate their own performance in daily practice and caregiving.

  2. Change in perceptions on self-management in HCPs using the Clinician Support for Patient activation measure [ Time Frame: at baseline (before the implementation of the care pathway) and after 24 months (during implementation) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02861209


Contacts
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Contact: Lise-Marie Kinnaer, PharmD 3216328265 lisemarie.kinnaer@kuleuven.be
Contact: Veerle Foulon, Prof. Dr. veerle.foulon@kuleuven.be

Locations
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Belgium
AZ Turnhout Recruiting
Turnhout, Antwerpen, Belgium, 2300
Contact: Lise-Marie Kinnaer, PharmD    16328265 ext 32    lisemarie.kinnaer@kuleuven.be   
Maria Middelares Gent Recruiting
Ghent, Oost-Vlaanderen, Belgium, 9000
Contact: Lise-Marie Kinnaer, PharmD    16328265 ext 32    lisemarie.kinnaer@kuleuven.be   
Imelda Bonheiden Recruiting
Bonheiden, Vlaams-Brabant, Belgium, 2820
Contact: Lise-Marie Kinnaer, PharmD    16328265 ext 32    lisemarie.kinnaer@kuleuven.be   
AZ Groeninge Kortrijk Recruiting
Kortrijk, West-Vlaanderen, Belgium, 8000
Contact: Lise-Marie Kinnaer, PharmD    016328265 ext 32    lisemarie.kinnaer@kuleuven.be   
Contact: Veerle Foulon, Prof. Dr.       veerle.foulon@kuleuven.be   
Sponsors and Collaborators
KU Leuven
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lise-Marie Kinnaer, PharmD, KU Leuven
ClinicalTrials.gov Identifier: NCT02861209    
Other Study ID Numbers: LMK15022016
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Melanoma
Colorectal Neoplasms
Neoplasms by Site
Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases