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Small-group, Virtual Program for Improving Symptoms and Distress Related to Hormonal Therapy for Breast Cancer Survivors (STRIDE)

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ClinicalTrials.gov Identifier: NCT03837496
Recruitment Status : Recruiting
First Posted : February 12, 2019
Last Update Posted : February 22, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jamie Jacobs, Massachusetts General Hospital

Brief Summary:
The purpose of this study is to explore the feasibility and acceptability of a brief, virtual, group-based cognitive-behavioral intervention for breast cancer survivors taking hormonal therapy. The intervention (STRIDE) aims to alleviate symptoms related to hormonal therapy or breast cancer, optimize medication-taking (i.e., adherence), and reduce distress.

Condition or disease Intervention/treatment Phase
Breast Cancer Adherence, Medication Other: STRIDE Other: Medication Monitoring Control Not Applicable

Detailed Description:

Background: The majority of breast cancer is hormone sensitive and treated with 10 years of adjuvant endocrine therapy (AET) (i.e., tamoxifen, aromatase inhibitors) to reduce risk of recurrence and improve survival; however, adherence to AET among breast cancer survivors (BCS) is a challenge, with half of women becoming non-adherent within five years. Difficulty coping with symptoms (e.g., sleep problems, hot flashes, weight gain, fatigue) and psychosocial distress (i.e., depression or anxiety symptoms), and other emotional and logistical factors are major barriers to adherence. There is a dearth of efficacious interventions targeting the needs and adherence challenges of BCS prescribed AET.

Objective: To address this gap, the proposed study, funded by the National Cancer Institute, employs a mixed-methods design to develop and test an evidence-based intervention (STRIDE) to enhance adherence to AET, improve symptom management, and reduce distress in breast cancer survivors.

Specific Aims: The primary aims of this study are: 1) to examine the feasibility and acceptability of a tailored, small-group, virtual intervention (STRIDE) compared to a medication monitoring control for survivors of breast cancer taking AET, and 2) to explore the effects of the STRIDE intervention on adherence to AET, symptom distress, and satisfaction with AET.

Study Design: Phase 1 included (1) semi-structured interviews with BCS on AET (n=30) and intervention development with psychologists and oncology clinicians. The intervention is a a brief, virtual, small-group, cognitive-behavioral intervention that aims to alleviate symptoms and side effects related to hormonal therapy or breast cancer, optimize medication-taking, and reduce emotional distress for breast cancer survivors taking hormonal therapy. Phase 2 will entail a run-in phase (n=5) to evaluate acceptability and further refine the intervention, followed by a randomized controlled pilot trial (n=75) to assess the feasibility of comparing the STRIDE intervention to a medication monitoring control with assessments and adherence monitoring over the course of six months. Participants will be recruited at Massachusetts General Hospital Cancer Center and three community satellite sites. Eligible participants will be hormone-receptor positive breast cancer survivors prescribed AET who are experiencing distress related to AET (e.g., adherence difficulties, side effects, etc.). This research study involves completing 3 questionnaire batteries at the time of enrollment, 3 months, and 6 months. The participant will also be asked to store their hormonal therapy pills in a medication bottle provided by the study team throughout the 6-month study period. If the participants are randomized to receive the STRIDE intervention, the participant will have five weekly one-hour virtual (videophone) or in-person sessions in small groups with a trained clinician followed by two 15-minute check-in phone calls later in the study. If the participants are randomized to standard care, the participant will have the option to receive the STRIDE intervention materials after completion of their participation in the study.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: One of the arms will account for the run-in period.
Masking: Single (Outcomes Assessor)
Masking Description: The outcomes assessor will be blinded to the participant's study condition
Primary Purpose: Supportive Care
Official Title: Symptom-Targeted Randomized Intervention for Distress and Adherence to Adjuvant Endocrine Therapy (STRIDE) Among Breast Cancer Survivors: A Pilot Feasibility Trial
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: STRIDE Run-In
  • Stride is delivered as a Five weekly one-hour virtual (videophone) or in-person sessions in small groups with a trained clinician
  • Two 15-minute check-in phone calls later in the study
  • Participants will store hormonal therapy medication in a bottle provided by the study team.
  • Participants will complete questionnaires at enrollment and 3-months post- enrollment
Other: STRIDE
STRIDE is a brief, group-based, virtual (videoconference) cognitive-behavioral intervention. The intervention incorporates adherence problem-solving, cognitive restructuring, relaxation training, symptom management, coping skills training, and mindfulness techniques.

Experimental: STRIDE
  • Stride is delivered as a Five weekly one-hour virtual (videophone) or in-person sessions in small groups with a trained clinician
  • Two 15-minute check-in phone calls later in the study
  • Participants will store hormonal therapy medication in a bottle provided by the study team.
  • Participants will complete questionnaires at enrollment, 3-months, and 6-months post-enrollment
Other: STRIDE
STRIDE is a brief, group-based, virtual (videoconference) cognitive-behavioral intervention. The intervention incorporates adherence problem-solving, cognitive restructuring, relaxation training, symptom management, coping skills training, and mindfulness techniques.

Active Comparator: Medication Monitoring Control
  • Medication monitoring plus standard care
  • Participants will store hormonal therapy medication in a bottle provided by the study team.
  • Participants will complete questionnaires at enrollment, 3-months, and 6-months post-enrollment
Other: Medication Monitoring Control
Care provided as standard by the hospital and medication monitoring




Primary Outcome Measures :
  1. Feasibility and acceptability as measured by participant rates of enrollment [ Time Frame: 2 years ]

    Hypothesis 1: Feasibility will be assessed by recruitment (enrollment rate > 50%), retention (follow-up assessment completion rate > 70% of all participants who complete baseline) and attendance (attendance rate of at least 70% of participants completing at least 3 of 5 sessions [60%]).

    Hypothesis 2: The study will be acceptable demonstrated by >75% of participants reporting average satisfaction scores greater than the scale's mid-point (Client Satisfaction Questionnaire).



Secondary Outcome Measures :
  1. Group Differences in Weekly and/or Monthly Adherence to Adjuvant Endocrine Therapy Across the 6-month Study Period [ Time Frame: Monthly and weekly medication adherence rates across the 6-month study period ]
    Medication Event Monitoring System (MEMS Caps): Participants will store mediation in the MEMS bottles to electronically monitor adjuvant endocrine therapy daily dose and timing of dose administration. Prescribed medication, dose, and timing will be identified in the Electronic Health Record and verified by the patient. Adherence will be calculated as the percentage of medication taken of the total prescribed. Monthly and weekly adherence scores will be calculated to examine different in adherence rates and changes across the 6-month study period between groups.

  2. Changes in Self-Reported Adjuvant Endocrine Therapy Adherence between Groups on the Medication Adherence Report Scale (MARS-5) from baseline to 3- and 6-months post-baseline [ Time Frame: Baseline, post-intervention at 3-months post-baseline, and 6 months post-baseline ]
    Medication Adherence Report Scale (MARS-5): Changes in self-reported adherence to adjuvant endocrine therapy between groups will be explored using the MARS-5 at 3- and 6-months post-baseline. The MARS-5 assesses adherence to treatment and has been used specifically in the context of AET adherence. The scale consists of five items that ask about suboptimal adherence behaviors, such as "I stop taking my adjuvant endocrine therapy medicine for a while." Each item is answered on a scale of 1 (Always) to 5 (Never).

  3. Changes in Satisfaction with Adjuvant Endocrine therapy (AET) between Groups on the Cancer Therapy Satisfaction Questionnaire (CTSQ) from baseline to 3- and 6-months post-baseline [ Time Frame: Baseline, post-intervention at 3-months post-baseline, and 6 months post-baseline ]
    Cancer Therapy Satisfaction Questionnaire (CTSQ): Changes in self-reported satisfaction with AET will be explored between groups at 3 and 6-months post-baseline with the Cancer Therapy Satisfaction Questionnaire (CTSQ). The CTSQ is a previously published 21-item measure that evaluates patients' beliefs about the following aspects of medical care: expectations of the effectiveness of cancer therapy, feelings about side effects, oral cancer therapy adherence, satisfaction with cancer therapy, stopping cancer therapy, and reasons for non-adherence. Each item is scored on a scale of 1 ("Never" or "Very inconvenient") to 5 ("Always" or Very Convenient"). A greater score on this measure indicates greater patient cancer therapy satisfaction.

  4. Changes in Symptom Distress between Groups on the Breast Cancer Prevention Trial Symptom Scale (BCPT) from baseline to 3- and 6-months post-baseline [ Time Frame: Baseline, post-intervention at 3-months post-baseline, and 6 months post-baseline ]
    Breast Cancer Prevention Trial Symptom Scale (BCPT): The investigators will examine changes in self-reported symptom distress on the BCPT between groups at 3- and 6-months post-baseline. The BCPT is a symptom checklist used to document physical and psychological symptoms associated with ET use. The measure includes several clinically-relevant symptom subscales and has been used broadly in previous studies on symptom distress in breast cancer patients. The BCPT asks participants to rate how much they have been bothered by several symptoms over the past week on a scale of 0 (Not at all bothered) to 4 (Extremely bothered).



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female
  • Age 21 or older
  • Diagnosis of early-stage (Stage 0-IIIb), hormone receptor + breast cancer
  • Within 1 week-12 months of starting adjuvant endocrine therapy
  • Ability to read and respond in English
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  • Currently taking adjuvant endocrine therapy (i.e. if took recent break, has taken within the past 2 weeks)
  • Completed primary treatment (i.e., chemotherapy, surgery, and/or radiation) for early-stage breast cancer
  • Indicates a score ≥4 on one of the three NCCN adapted distress thermometer study screening questions

Exclusion Criteria:

  • Uncontrolled psychosis, active suicidal ideation, or psychiatric hospitalization within the past year
  • Cognitive impairment that prohibits participation in the study
  • Enrollment in a different clinical trial for breast cancer
  • Current participation in formal group psychotherapy or other psychosocial intervention trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03837496


Contacts
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Contact: Jamie M. Jacobs, PhD 617-643-1777 jjacobs@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Cancer Center Recruiting
Boston, Massachusetts, United States, 02114
Contact: Jamie M Jacobs, PhD         
Principal Investigator: Jamie M Jacobs, PhD         
Sponsors and Collaborators
Massachusetts General Hospital
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Jamie M. Jacobs, MD Massachusetts General Hospital

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Responsible Party: Jamie Jacobs, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03837496     History of Changes
Other Study ID Numbers: 18-603
K07CA211107 ( U.S. NIH Grant/Contract )
First Posted: February 12, 2019    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data can be shared no earlier than 1 year following the date of publication
Access Criteria: BCH - Contact the Technology & Innovation Development Office at www.childrensinnovations.org or email TIDO@childrens.harvard.edu BIDMC - Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu BWH - Contact the Partners Innovations team at http://www.partners.org/innovation DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu MGH - Contact the Partners Innovations team at http://www.partners.org/innovation

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jamie Jacobs, Massachusetts General Hospital:
Breast Cancer
Endocrine Therapy
Hormonal Therapy
Symptoms
Distress
Survivors

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases