Clinical trial NCT03952312: Oncotool for Cancer Medications
Official title: Feasibility of OncoTool to Improve Self-Management and Adherence to Oral Anticancer Medications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Cancer, Treatment-Related
Medication Adherence
Communication
Tyrosine Kinase Inhibitor
Keywords: eHealth
Adherence
Symptom Burden
Health Related Quality of Life
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2019-05-16
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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).

Primary outcomes:
measure: Change in Self Reported Adherence to TKIs will be evaluated with the ARMS questionnaire.
timeFrame: Time Frame: T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention)
measure: Electronically Verified TKI Adherence will be measured using medication event monitoring systems (MEMS)
timeFrame: ime Frame: MEMS data will be collected continuously during study participation from T1 (prior to starting intervention) to T3 (6 months post-intervention)
measure: Pharmacy reported Adherence to TKIs will be measured using pharmacological records
timeFrame: T3 (6 months post-intervention)
measure: Change in Health Related Quality of Life will be evaluated with The Functional Assessment of Cancer Therapy (FACT-G7)
timeFrame: T1 (prior to starting intervention), biweekly during the 8 week intervention, T2 (8 weeks post intervention), T3 (6 months post-intervention)
Secondary outcomes:
measure: Cancer-Specific Distress will be evaluated using The Impact of Event Scale (IES)
timeFrame: T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention)
measure: Stress Management Skills will be evaluated with the Brief COPE Inventory
timeFrame: T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention)
measure: Perceived benefits and cost barriers to using oral cancer medications will be assessed using a Beliefs about Medicines scale
timeFrame: T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention)
measure: Emotional Social Support is assessed using the emotional subscale portion of the Medical Outcomes Study - Social Support Survey Instrument (MOS-SSS)
timeFrame: T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention)
measure: Patient Self-Efficacy in managing side effects is measured using the PROMIS Self Efficacy for Managing Symptoms
timeFrame: T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention)
measure: Cancer Related Communication and Attitudinal Self Efficacy will be evaluated using the Communication and Attitudinal Self-Efficacy scale for cancer (CASE-cancer)
timeFrame: T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention)
measure: TKI specific side effects will be evaluated using measures from PRO-CTCAE
timeFrame: T1 (prior to starting intervention), bi-weekly during the 8 week intervention,.T2 (8 weeks post intervention), T3 (6 months post-intervention)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Betina Yanez
role: PRINCIPAL_INVESTIGATOR
References: