NCT03837496

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 12, 2019

Completed
9 months until next milestone

Study Start

First participant enrolled

October 28, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
12 months until next milestone

Results Posted

Study results publicly available

November 18, 2022

Completed
Last Updated

November 18, 2022

Status Verified

November 1, 2022

Enrollment Period

1.8 years

First QC Date

February 8, 2019

Results QC Date

August 15, 2022

Last Update Submit

November 7, 2022

Conditions

Breast CancerAdherence, Medication

Keywords

Breast CancerEndocrine TherapyHormonal TherapySymptomsDistressSurvivors

Outcome Measures

Primary Outcomes (1)

  • Feasibility and Acceptability

    The investigators will evaluate program feasibility by examining rates of recruitment (enrollment rate \> 50%), retention (follow-up assessment completion rate \> 70% of all participants who complete baseline) and attendance of program sessions (attendance rate of at least 70% of participants completing at least 4 of 6 sessions \[67%\]). The investigators will evaluate program acceptability by examining satisfaction scores on the Client Satisfaction Questionnaire (CSQ). The program will be deemed acceptable if \>75% of participants report average satisfaction scores greater than the CSQ's mid-point. The CSQ is scored on a four-point Likert scale with higher scores indicating higher satisfaction.

    12 weeks

Secondary Outcomes (4)

  • Group Differences in Mean Medication Adherence Rates to Adjuvant Endocrine Therapy Across the 24-week Study Period

    Mean medication adherence rates over 24 weeks

  • Changes in Self-Reported Adjuvant Endocrine Therapy Adherence Between Groups on the Medication Adherence Report Scale (MARS-5) From Baseline to 12-weeks Post-baseline

    Baseline, and post-intervention at 12-weeks post-baseline

  • Changes in Satisfaction With Adjuvant Endocrine Therapy (AET) Between Groups on the Cancer Therapy Satisfaction Questionnaire (CTSQ) From Baseline to 12-weeks Post-baseline.

    Baseline, and post-intervention at 12-weeks post-baseline

  • Changes in Symptom Distress Between Groups on the Breast Cancer Prevention Trial Symptom Scale (BCPT) From Baseline to 12-weeks Post-baseline

    Baseline and post-intervention at 12 weeks post-baseline

Study Arms (3)

STRIDE Run-In

EXPERIMENTAL

* 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

EXPERIMENTAL

* Stride is delivered as six weekly one-hour virtual (videophone) sessions in small groups with a trained clinician (or individually, in the rare instance in which scheduling doesn't allow for groups and the participant is approaching the 12-week assessment window) * 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, 12-weeks, and 24-weeks post-enrollment

Other: STRIDE

Medication Monitoring Control

ACTIVE COMPARATOR

* 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, 12-weeks and 24-weeks post-enrollment

Other: Medication Monitoring Control

Interventions

STRIDEOTHER

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.

STRIDESTRIDE Run-In
Medication Monitoring ControlOTHER

Care provided as standard by the hospital and medication monitoring

Medication Monitoring Control

Eligibility Criteria

Age21 Months+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Female
  • Age 21 or older
  • Diagnosis of early-stage (Stage 0-IIIb), hormone receptor + breast cancer
  • Within 1 week-36 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

You may not qualify if:

  • 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
  • Undergoing primary treatment for other cancer (i.e., advanced stage cancer)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Related Publications (3)

  • Walsh LE, Dunderdale L, Horick N, Temel JS, Greer JA, Jacobs JM. Intervention-Related Changes in Coping Ability Drives Improvements in Mood and Quality of Life for Patients Taking Adjuvant Endocrine Therapy. Psychooncology. 2024 Dec;33(12):e70049. doi: 10.1002/pon.70049.

    PMID: 39706803DERIVED

  • Walsh EA, Post K, Massad K, Horick N, Antoni MH, Penedo FJ, Safren SA, Partridge AH, Peppercorn J, Park ER, Temel JS, Greer JA, Jacobs JM. Identification of patient subgroups who benefit from a behavioral intervention to improve adjuvant endocrine therapy adherence: a randomized-controlled trial. Breast Cancer Res Treat. 2024 Apr;204(3):547-559. doi: 10.1007/s10549-023-07228-z. Epub 2024 Jan 17.

    PMID: 38231313DERIVED

  • Jacobs JM, Rapoport CS, Horenstein A, Clay M, Walsh EA, Peppercorn J, Temel JS, Greer JA. Study protocol for a randomised controlled feasibility trial of a virtual intervention (STRIDE) for symptom management, distress and adherence to adjuvant endocrine therapy after breast cancer. BMJ Open. 2021 Jan 4;11(1):e041626. doi: 10.1136/bmjopen-2020-041626.

    PMID: 33397667DERIVED

MeSH Terms

Conditions

Breast NeoplasmsMedication Adherence

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Limitations and Caveats

Study recruitment paused due to the COVID-19 pandemic from mid-March 2020 through May of 2020.

Results Point of Contact

Title
Jamie Jacobs, PhD
Organization
Massachusetts General Hospital
jjacobs@mgh.harvard.edu
617-643-1777

Study Officials

  • Jamie M. Jacobs, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcomes assessor will be blinded to the participant's study condition
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 8, 2019

First Posted

February 12, 2019

Study Start

October 28, 2019

Primary Completion

August 17, 2021

Study Completion

December 1, 2021

Last Updated

November 18, 2022

Results First Posted

November 18, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, 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

Locations

US(1)