Oncotool for Cancer Medications

NCT ID: NCT03952312

Last Updated: 2023-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-15
• Study Completion Date: 2022-11-04

Brief Summary

The purpose of this study is to examine the efficacy of a psychosocial eHealth intervention on the proposed primary outcomes, TKI adherence and health related quality of life (HRQoL), in patients taking TKIs for cancer management.

The intervention components include psychosocial management strategies, cancer medication knowledge and embedded physician reports. The intervention will be delivered via an online application over an 8-week period. Participants in the intervention will complete bi-weekly side effect questionnaires as part of their study involvement, which may trigger an alert to their prescribing physician if they reach a certain threshold. Participants in the control will not complete these questionnaires.

Participants are randomized into either an intervention application (described above) or a control application (health information and general health promotion strategies). Aside from having access to the online application for the recommended 8 weeks, participation in this study includes three assessments: baseline (at the beginning of the research study), post-intervention (8 weeks after baseline) and a 6-month follow-up.

Detailed Description

Molecularly targeted tyrosine kinase inhibitors (TKIs) have improved the overall prognosis of patients with cancer. When properly adhered to, TKIs can extend progression-free survival by decades. Despite the promise of TKIs, nonadherence is problematic and studies report that as little as 23% of patients are fully adherent over time. Poor adherence is of significance as it is associated with disease progression and mortality. Despite the importance of optimal adherence (<90% adherence for TKIs), only a handful of interventions with very limited documented efficacy have targeted adherence to TKIs. This is problematic as the number of patients receiving oral anticancer medications is steadily increasing and patients taking TKIs are required to be adherent for years to impact survival. Furthermore, the limited half-life of TKIs highlights the need to optimize full adherence to these medications.

The few interventions that have sought to improve oral anticancer medication adherence have been limited by: (a) lack of a conceptual model that incorporates modifiable psychosocial factors (e.g., illness perceptions, self-efficacy) known to influence adherence behaviors, (b) lack of patient-centered education and training to manage the chronic and debilitating burden of the medication side effects, and (c) lack of more than one objective method of tracking participants' medication adherence. Strategies that (a) facilitate patient-provider communication about side effects and side effect monitoring, and (b) incorporate evidence-based tools to improve side effect monitoring and management, as well as coping with illness-related stress, may be especially beneficial for aiding patients to optimally adhere to TKI medications. Therefore, the investigators propose that an evidence-based psychosocial intervention that can improve management of oral anticancer medication side effects, and therefore improve quality of life, may also improve adherence.

Previous work elucidating the determinants of adherence to oral anticancer medications and developing web-based symptom monitoring tools and psychosocial interventions for patients with cancer makes the research team uniquely positioned to develop and evaluate the feasibility of an intervention to improve adherence to life-saving TKI medications. Consistent with PA-17-061 (Oral Anticancer Agents), the investigators propose to establish the feasibility of an evidence-based, web-delivered and adaptive program called Oncotool to improve adherence to TKIs. Oncotool is patient centered and grounded in models of health behavior change, self-management and established barriers (e.g., patient, system and treatment factors) to medication adherence. Oncotool will incorporate patient education (e.g., compliance education, medication adherence benefits), track side effects bi-weekly, notify providers of patient-reported side effects, and provide medical and psychosocial management strategies for TKI medication side effects. The purpose of this study is to compare the efficacy of Oncotool to a control program, which will contain general health information such as cancer screening, diet and physical activity. The primary study outcome will be feasibility of Oncotool (i.e., acceptability, demand, practicality). Adherence and health-related quality of life (HRQoL) will be assessed as secondary outcomes over 6 months in Oncotool compared to the control condition.

Conditions

Cancer; Cancer, Treatment-Related; Medication Adherence; Communication; Tyrosine Kinase Inhibitor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

"OncoTool" Intervention

Group Type: EXPERIMENTAL

Oncotool Intervention (symptom reporting + TKI education)

Intervention Type: BEHAVIORAL

OncoTool is a website intended to improve self-management practices for helping cancer patients cope with side effects and improve health-related quality of life. OncoTool provides symptom education and management for dealing with the numerous physical and mental side effects associated with TKIs (e.g., fatigue, nausea, skin toxicity). OncoTool is a website designed to improve TKI adherence by improving quality of life and TKI associated symptom burden, as well as providing a portal for provider-patient communication via a bi-weekly health questionnaire. Both intervention and active comparator conditions are administered to participants for 8 weeks.

"Oncotool" Control

Group Type: ACTIVE_COMPARATOR

Oncotool Control (health information)

Intervention Type: BEHAVIORAL

OncoTool is a health promotion website with health education on subjects like nutrition and exercise specific to cancer patients, as well as general advice on lifestyle choices and prevention. The Oncotool control has similar TKI education content as the experimental content but without the side effect education or physician notification. Both intervention and active comparator conditions are administered to participants for 8 weeks.

Interventions

Oncotool Intervention (symptom reporting + TKI education)

OncoTool is a website intended to improve self-management practices for helping cancer patients cope with side effects and improve health-related quality of life. OncoTool provides symptom education and management for dealing with the numerous physical and mental side effects associated with TKIs (e.g., fatigue, nausea, skin toxicity). OncoTool is a website designed to improve TKI adherence by improving quality of life and TKI associated symptom burden, as well as providing a portal for provider-patient communication via a bi-weekly health questionnaire. Both intervention and active comparator conditions are administered to participants for 8 weeks.

Intervention Type: BEHAVIORAL

Oncotool Control (health information)

OncoTool is a health promotion website with health education on subjects like nutrition and exercise specific to cancer patients, as well as general advice on lifestyle choices and prevention. The Oncotool control has similar TKI education content as the experimental content but without the side effect education or physician notification. Both intervention and active comparator conditions are administered to participants for 8 weeks.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. ≥ 18 years of age

2. medical chart confirmed diagnosis of cancer

3. willingness to be randomized into study

4. have initiated TKIs within the past 18 months, as data in literature indicates that the majority of patients who initiate oral anticancer medications are still adherent within the first few months

5. willing to use a web-based platform on a bi-weekly basis, as well as an email address and access to the internet

6. English speaking, as all material will be in English

Exclusion Criteria

(a) significant cognitive impairment, inpatient psychiatric treatment, or overt signs of severe psychopathology (e.g., psychosis).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Betina Yanez

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Betina Yanez

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University

Chicago, Illinois, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

STU00207397

Identifier Type: -

Identifier Source: org_study_id