A Web-Based Tool to Improve Breast Cancer Survivorship

NCT03849573 | Completed DMC

• 1 other identifier: STU00206180
• Study Type: interventional
• Target: 84
• 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, hormone therapy adherence and health related quality of life (HRQoL), in breast cancer survivors. The intervention components include mindfulness-based stress reduction, breast cancer knowledge, stress awareness and management, social support, and enhanced communication. The intervention will be delivered via an online application over an 8-week period. 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 with weekly online focus groups, participation in this study includes four assessments: baseline (at the beginning of the research study), post-intervention (8 weeks after baseline), a 6-month follow-up and a 12-month follow-up.

Conditions

Breast Cancer; Hormone Dependent Neoplasms; Adherence to Hormone Therapy

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Change in Self Reported Adherence to Hormone Therapy 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.

  T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention), T4 (12 months post intervention)

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

  The FACT-ES has been used extensively to measure HRQoL. It assesses participant's wellbeing in physical, emotional, social, functional, and concerns specific to endocrine therapy in the last seven days using a five-point response scale.

  T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention), T4 (12 months post intervention)

• Electronically Verified Hormone Therapy 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.

  MEMS data will be collected continuously during study participation from T1 (prior to starting intervention) to T4 (12 months post-intervention)

• Pharmacy reported Adherence to Hormone Therapy will be measured using pharmacological records

  Pharmacy data will be pulled once at approximately T4 when a participant finishes the study. This data will inform how frequently patients refill their hormone therapy medication.

  T4 (12 months post intervention)

Secondary Outcomes (10)

• 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), T4 (12 months post intervention)

• Breast Cancer Related Knowledge will be evaluated with the Knowledge about Breast Cancer Questionnaire

  T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention), T4 (12 months post intervention)

• Breast Cancer Related Communication and Attitudinal Self Efficacy will be evaluated using the Communication and Attitudinal Self-Efficacy scale for cancer (CASE-cancer)

  T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention), T4 (12 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), T4 (12 months post intervention)

• Perceived benefits and cost barriers to using hormone therapy will be assessed using a Beliefs about Medicines scale

  T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention), T4 (12 months post intervention)

Study Arms (2)

Mindfulness-based stress reduction + Hormone Therapy Education

EXPERIMENTAL

Behavioral: "OncoTool" Intervention (MBSR + HT education)

Hormone Therapy Education + Overall Health Education

ACTIVE COMPARATOR

Behavioral: "Oncotool" Control (health +HT education)

Interventions

"OncoTool" Intervention (MBSR + HT education) BEHAVIORAL

OncoTool is a website intended to improve self-management practices for helping cancer patients cope with stress and improve health-related quality of life. OncoTool provides mindfulness-based education and management for dealing with the numerous physical and mental side effects associated with hormone therapy (e.g., muscle and joint pain, vaginal dryness, depressive symptoms). OncoTool is a website designed to improve hormone therapy adherence by improving quality of life, and hormone therapy associated symptom burden. Both intervention and active comparator conditions are administered to participants for 8 weeks.

Mindfulness-based stress reduction + Hormone Therapy Education

"Oncotool" Control (health +HT education) BEHAVIORAL

OncoTool is a health promotion website with health education on subjects like nutrition and exercise specific to breast cancer survivors, as well as general advice on lifestyle choices and prevention. The Oncotool control has similar HT education content as the experimental content but without the CBT and MBSR state. Both intervention and active comparator conditions are administered to participants for 8 weeks.

Hormone Therapy Education + Overall Health Education

Eligibility Criteria

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

You may qualify if:

• ≥ 18 years of age
• English-speaking (6th grade reading level) as required to complete assessments
• medical chart confirmed diagnosis of hormone-receptor positive non-metastatic breast cancer
• Stages I-IIIa
• completion of any combination of surgical, radiation, and chemotherapy treatment
• willingness to be randomized into study
• have initiated HT within the past 6 months as data in literature indicates that the overwhelming majority of women who initiated HT are still adherent within the first 4 months
• first-time diagnosis of breast cancer
• access to a computer or tablet with Internet capabilities

You may not qualify if:

• Visual, hearing, voice, or motor impairment that would prevent completion of study procedures
• diagnosis of an unmanaged psychotic or psychiatric disorder (e.g., clinical depression, anxiety, or PTSD), bipolar disorder, dissociative disorder, or other diagnosis for which participation in this trial is either inappropriate or dangerous - this includes patients who have life-threatening illness (e.g., end-stage kidney disease) or diagnosis of a chronic disease that is associated with a major functional impairment (e.g., chronic severe pain, fibromyalgia)
• Alzheimer's, dementia or history of stroke

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms, Hormone-Dependent

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Betina Yanez, PhD

  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: February 13, 2019
• First Posted: February 21, 2019
• Study Start: May 29, 2019
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: July 5, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)