Collaborative Network to Take Responsibility for Oral Anticancer Therapy

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02861209
• Date of registration: 02/08/2016
• Prospective Registration: No
• Primary sponsor: KU Leuven
• Public title: Collaborative Network to Take Responsibility for Oral Anticancer Therapy CONTACT
• Scientific 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
• Date of first enrolment: November 2015
• Target sample size: 228
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02861209
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Belgium

Contacts

• Name: Lise-Marie Kinnaer, PharmD

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Melanoma

Breast Cancer

Lung Cancer

Prostate Cancer

ALL

Colorectal Cancer

Intervention(s)

Other: Implementation of a care pathway

Primary Outcome(s)

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

Secondary Outcome(s)

Change in patient satisfaction with care using Out-patsat 35 [Time Frame: at the start of the therapy, after one and three months]

Health Related Quality of Life [Time Frame: at the start of the therapy, after one and three months]

Toxicity of treatment [Time Frame: at the start of the therapy, after one and three months]

Efficacy of treatment Using ECOG performance scale and RECIST criteria [Time Frame: at the start of the therapy, after one and three months]

Cost of care [Time Frame: at the start of the therapy, after one and three months]

Change in Distress using the Distress Barometer [Time Frame: at the start of the therapy, after one and three months]

Change in patient satisfaction with treatment using the Cancer Therapy Satisfaction Questionnaire (CTSQ) [Time Frame: after one and three months]

Change in medication Adherence [Time Frame: after one and three months of therapy]

Secondary ID(s)

LMK15022016

Source(s) of Monetary Support

Please refer to primary and secondary sponsors