Oncotool for Cancer Medications

NCT03952312 | Completed

• 1 other identifier: STU00207397
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

eHealth; Adherence; Symptom Burden; Health Related Quality of Life

Outcome Measures

Primary Outcomes (4)

• Change in Self Reported Adherence to TKIs will be evaluated with the ARMS questionnaire.

  The ARMS (Adherence to Refills and Medications Scale) survey is a previously validated patient-report measure of barriers to medication adherence and adherence-related behavior.

  Time Frame: T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention)

• Electronically Verified TKI Adherence will be measured using medication event monitoring systems (MEMS)

  A MEMS cap is an electronic bottle cap that tracks when participants open their medication bottle. MEMS cap data will be collected continuously during the duration of participation in the study.

  ime Frame: MEMS data will be collected continuously during study participation from T1 (prior to starting intervention) to T3 (6 months post-intervention)

• Pharmacy reported Adherence to TKIs will be measured using pharmacological records

  Pharmacy data will be pulled once at approximately T3 when a participant finishes the study. This data will inform how frequently patients refill their oral cancer medication (TKIs).

  T3 (6 months post-intervention)

• Change in Health Related Quality of Life will be evaluated with The Functional Assessment of Cancer Therapy (FACT-G7)

  The FACT-G7 is a validated questionnaire that assesses top-rated symptoms and concerns for a broad spectrum of advanced cancers.

  T1 (prior to starting intervention), biweekly during the 8 week intervention, T2 (8 weeks post intervention), T3 (6 months post-intervention)

Secondary Outcomes (7)

• Cancer-Specific Distress will be evaluated using The Impact of Event Scale (IES)

  T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention)

• Stress Management Skills will be evaluated with the Brief COPE Inventory

  T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention)

• Perceived benefits and cost barriers to using oral cancer medications will be assessed using a Beliefs about Medicines scale

  T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention)

• Emotional Social Support is assessed using the emotional subscale portion of the Medical Outcomes Study - Social Support Survey Instrument (MOS-SSS)

  T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention)

• Patient Self-Efficacy in managing side effects is measured using the PROMIS Self Efficacy for Managing Symptoms

  T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention)

Study Arms (2)

"OncoTool" Intervention

EXPERIMENTAL

Behavioral: Oncotool Intervention (symptom reporting + TKI education)

"Oncotool" Control

ACTIVE COMPARATOR

Behavioral: Oncotool Control (health information)

Interventions

Oncotool Intervention (symptom reporting + TKI education) 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" Intervention

Oncotool Control (health information) 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.

"Oncotool" Control

Eligibility Criteria

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

You may qualify if:

• ≥ 18 years of age
• medical chart confirmed diagnosis of cancer
• willingness to be randomized into study
• 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
• willing to use a web-based platform on a bi-weekly basis, as well as an email address and access to the internet
• English speaking, as all material will be in English

You may not qualify if:

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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Neoplasms; Neoplasms, Second Primary; Medication Adherence; Communication

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Betina Yanez

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: May 16, 2019
• Study Start: January 15, 2020
• Primary Completion: August 13, 2022
• Study Completion: November 4, 2022
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)