A Web-Based Tool to Improve Breast Cancer Survivorship

Not Applicable

Completed

• Conditions: Adherence to Hormone Therapy; Breast Cancer; Hormone Dependent Neoplasms
• Interventions: Behavioral: "Oncotool" Control (health +HT education); Behavioral: "OncoTool" Intervention (MBSR + HT education)

• Registration Number: NCT03849573
• Lead Sponsor: Northwestern University

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.

Detailed Description

Breast cancer is the most commonly diagnosed cancer among women in the U.S. Approximately 75% to 80% of breast cancer survivors are prescribed HT (hormone therapy) medication for 5 to 10 years following primary treatment. Five years of adjuvant HT among women with non-metastatic cancer reduces the risk of recurrences by 50%. Adherence to HT is also an independent predictor of breast cancer mortality, reducing the risk by up to 28%. HT-side effects, however, are not only a major source of distress but also among the most robust predictors of non-adherence to HT. Therefore, effective management and ability to reduce the burden of these side effects are critically important to achieve optimal HT adherence. Because HT side effects may persist for years and are not easily managed, MBSR's mind-body approach and emphasis on non-judgmental attitudes, acceptance, and uncertainty tolerance may be an especially beneficial approach to helping cancer survivors cope with the burdensome medication-related side effects, thus improving adherence to medication. The investigators propose that a mindfulness-based stress reduction (MBSR) intervention that has been efficacious in reducing HT side effects and improving HRQoL in cancer patients may also prove beneficial in improving HT adherence. After developing a web-based MBSR intervention and refining it via a usability trial, this study will establish the feasibility of a web-delivered, group based MBSR intervention to improve HT medication adherence and HRQoL in patients being treated for breast cancer. It is hypothesized that participants assigned to the MBSR intervention will have better primary outcomes than participants in the control group, which receives standard health information.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-02-13
• Study First Submitted QC: 2019-02-19
• Study First Posted: 2019-02-21
• Study Start: 2019-05-29
• Primary Completion: 2022-05-01
• Study Completion: 2022-05-01
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-01
• Last Update Posted: 2022-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 84

Inclusion Criteria

1. ≥ 18 years of age
2. English-speaking (6th grade reading level) as required to complete assessments
3. medical chart confirmed diagnosis of hormone-receptor positive non-metastatic breast cancer
4. Stages I-IIIa
5. completion of any combination of surgical, radiation, and chemotherapy treatment
6. willingness to be randomized into study
7. 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
8. first-time diagnosis of breast cancer
9. access to a computer or tablet with Internet capabilities

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Exclusion Criteria

1. Visual, hearing, voice, or motor impairment that would prevent completion of study procedures
2. 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)
3. Alzheimer's, dementia or history of stroke

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hormone Therapy Education + Overall Health Education	"Oncotool" Control (health +HT education)	-
Mindfulness-based stress reduction + Hormone Therapy Education	"OncoTool" Intervention (MBSR + HT education)	-

Primary Outcome Measures

Name	Time	Method
Change in Health Related Quality of Life will be evaluated with The Functional Assessment of Cancer Therapy-Endocrine (FACT-ES)	T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention), T4 (12 months post intervention)	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.
Electronically Verified Hormone Therapy Adherence will be measured using medication event monitoring systems (MEMS)	MEMS data will be collected continuously during study participation from T1 (prior to starting intervention) to T4 (12 months post-intervention)	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.
Pharmacy reported Adherence to Hormone Therapy will be measured using pharmacological records	T4 (12 months post intervention)	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.
Change in Self Reported Adherence to Hormone Therapy will be evaluated with the ARMS questionnaire.	T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention), T4 (12 months post intervention)	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.

Secondary Outcome Measures

Name	Time	Method
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)	This questionnaire has been tested and validated with breast cancer patients. It is made up of 16 true and false questions regarding general breast cancer knowledge.
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)	The CASE-cancer questionnaire is made up various subscales measuring breast cancer related communication and attitudinal self-efficacy. Each question asks participants to use a four-point response scale to agree or disagree with statements regarding their level of confidence with different skills.
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), T4 (12 months post intervention)	The PROMIS Self Efficacy for Managing Symptoms survey is a validated, computer adaptive survey to assess how confident participants are in their ability to manage their symptoms and side effects
Mindfulness will be assessed using questionnaires tailored to MBSR treatment	T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention), T4 (12 months post intervention)	The Intolerance of Uncertainty, Rumination and Reassure Me survey assesses participants' development in MBSR intervention targets, which will help isolate and assess the effect of MBSR treatment
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)	The Brief COPE is made up of various subscales measuring different ways of coping. Each question as participants to rate how often they have used each coping mechanism in response to their breast cancer experience.
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)	The 11 point Beliefs about Medicines questionnaire assesses patients' beliefs about the efficacy of their treatment as well as their beliefs about how the benefits and side affects of hormone therapy affect their life.
Self-Reported Negative Mood is measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression questionnaire	T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention), T4 (12 months post intervention)	The PROMIS Depression questionnaire is a computer adaptive assessment that measures patients' self-reported level of negative mood within the past 7 days.
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)	The IES is made up of two subscales measuring the frequency of intrusion and avoidance experiences after a stressful event. The IES has been widely used among patients diagnosed with cancer.
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), T4 (12 months post intervention)	The 8 question MOS-SSS scale was developed by RAND Healthcare to assess the degree of companionship, assistance, or other types of social support that participants have access to. This study will use the 8 question emotional-informational support subsection.
Concerns about cancer recurrence will be measured using the Concerns about Recurrence scale	T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention), T4 (12 months post intervention)	The Concerns about Recurrence scale is a 4 question scale that assesses the frequency and intensity of patients' concerns about cancer recurrence.

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States