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Interactive Care Plan for the Monitoring of Symptoms and Recovery in Patients With Stage 0-III Breast Cancer

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ClinicalTrials.gov Identifier: NCT04693338
Recruitment Status : Recruiting
First Posted : January 5, 2021
Last Update Posted : January 5, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Daniela L. Stan, M.D, Mayo Clinic

Study Description
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Brief Summary:
This phase I trial evaluates how well a mobile device-based breast cancer survivorship interactive care plan works in monitoring symptoms and recovery in patients with stage 0-III breast cancer. The interactive care plan provides patients with individualized, 'just in time' education materials to promote self-management for those reporting difficult to control symptoms, as well as escalations to contact their care team for signs or symptoms concerning for cancer coming back (recurrence). The interactive care plan may help alleviate the symptoms of fatigue, insomnia, hot flashes, and sexual dysfunction; increase physical activity level and improve quality of life in patients with breast cancer.

Condition or disease Intervention/treatment Phase
Anatomic Stage 0 Breast Cancer AJCC v8 Anatomic Stage I Breast Cancer AJCC v8 Anatomic Stage IA Breast Cancer AJCC v8 Anatomic Stage IB Breast Cancer AJCC v8 Anatomic Stage II Breast Cancer AJCC v8 Anatomic Stage IIA Breast Cancer AJCC v8 Anatomic Stage IIB Breast Cancer AJCC v8 Anatomic Stage III Breast Cancer AJCC v8 Anatomic Stage IIIA Breast Cancer AJCC v8 Anatomic Stage IIIB Breast Cancer AJCC v8 Anatomic Stage IIIC Breast Cancer AJCC v8 Prognostic Stage 0 Breast Cancer AJCC v8 Prognostic Stage I Breast Cancer AJCC v8 Prognostic Stage IA Breast Cancer AJCC v8 Prognostic Stage IB Breast Cancer AJCC v8 Prognostic Stage II Breast Cancer AJCC v8 Prognostic Stage IIA Breast Cancer AJCC v8 Prognostic Stage IIB Breast Cancer AJCC v8 Prognostic Stage III Breast Cancer AJCC v8 Prognostic Stage IIIA Breast Cancer AJCC v8 Prognostic Stage IIIB Breast Cancer AJCC v8 Prognostic Stage IIIC Breast Cancer AJCC v8 Other: Quality-of-Life Assessment Other: Questionnaire Administration Other: Supportive Care Phase 1

Detailed Description:

PRIMARY OBJECTIVES:

I. To evaluate the feasibility and usability of the breast cancer (BC) survivorship interactive care plan (ICP) as designed.

II. To determine the behavioral, toxicity symptom burden and quality of life (QOL) changes in patients engaged with the ICP.

III. To assess clinical workflow impact by the introduction of the ICP in the BC survivor practice.

OUTLINE:

Patients completion surveys of 4 common symptoms: fatigue, hot flashes, insomnia, and sexual dysfunction and receive educational material via mobile application (app) to help with bothersome symptoms. Patients also completes Monthly questionnaires dealing with symptoms concerning for cancer recurrence as well as quarterly questionnaires asking about quality of life domains ( physical, emotional, social and functional quality of life).

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Assessing the Usability and Workflow Impact of a Mobile-Based Breast Cancer Survivorship Care Plan in the Oncology Practice
Actual Study Start Date : August 20, 2020
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : November 25, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Supportive care (ICP)
Patients completion surveys of 4 common symptoms: fatigue, hot flashes, insomnia, and sexual dysfunction and receive educational material via mobile app to help with bothersome symptoms. Patients also complete questionnaires.
 Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment

Other: Questionnaire Administration
Ancillary studies

Other: Supportive Care
Receive ICP tasks
Other Names:
  • Supportive Therapy
  • Symptom Management
  • Therapy, Supportive


Outcome Measures
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Primary Outcome Measures :
  1. Symptoms assessment response rate [ Time Frame: 12 months ]
    Will assess the total response rate of all surveys administered over the course of the study. The interaction with the educational materials and reminders will be similarly assessed as a total proportion of interaction with the materials and reminders.


Secondary Outcome Measures :
  1. Change in patient behavior (activity) [ Time Frame: Baseline up to 12 months ]
    Frequency of exercise will be assessed as #days exercising/week/month

  2. Change in toxicity symptom burden [ Time Frame: Baseline up to 12 months ]
    LASA (linear analogue symptom assessment)Single item for fatigue, vasomotor or symptoms, insomnia and sexual dysfunction. Scale 1-10, higher scores are worse.

  3. Change in quality of life (QOL) [ Time Frame: Baseline up to 12 months ]
    Patient-Reported Outcomes Measurement Information System (PROMIS) 29 questionnaire. Higher scores are more favorable 29 includes 7 HRQoL domains (Physical Functioning, Anxiety, Depression, Fatigue, Sleep Disturbance, Social Functioning, and Pain). Each of the 7 domains has four 5-level items (i.e., 16 decrements each). The total scores for each domain ranges from 10-90. Across all symptoms, the thresholds (cut scores) identified to differentiate normal from mildly symptomatic were near a T score of 50. Cut scores differentiating mildly from moderately symptomatic were at or near 60, and those separating moderately from severely symptomatic were at or near 70.

  4. Change in quality of life (QOL) [ Time Frame: Baseline up to 12 months ]
    Patient-Reported Outcomes Measurement Information System (PROMIS) 29 questionnaire. Higher scores are more favorable 29 includes 7 HRQoL domains (Physical Functioning, Anxiety, Depression, Fatigue, Sleep Disturbance, Social Functioning, and Pain). The pain domain has 2 subdomains (interference and intensity). Each of the 7 domains has four 5-level items (i.e., 16 decrements each). In addition to these items, pain intensity is assessed using a single 11-point numeric rating scale anchored between no pain (0) and worse imaginable pain, adding 10 additional decrements. The total scores for each domain ranges from 10-90. Across all symptoms, the thresholds (cut scores) identified to differentiate normal from mildly symptomatic were near a T score of 50. Cut scores differentiating mildly from moderately symptomatic were at or near 60, and those separating moderately from severely symptomatic were at or near 70.

  5. Clinical workflow impact by implementation of the breast cancer survivorship interactive care plan in the practice [ Time Frame: 12 months ]
    number of messages generated to the Care team by escalations generated by symptoms of recurrence and high scores on the anxiety and depression subscales of the PROMIS 29


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Recently diagnosed and treated for breast cancer -- having a biopsy-proven, stage 0-III breast cancer and are within 12 months of completion of loco-regional breast cancer treatment and (as indicated) neoadjuvant and/or adjuvant chemotherapy. Ongoing treatment with adjuvant endocrine, bisphosphonate, and single-agent, HER2-directed therapy during the study period is allowed
  • Willing to install an application (APP) on personal smart device

Exclusion Criteria:

  • Unwilling to return to Mayo Clinic for routine follow-up visits
  • Unwilling to use the Mayo Clinic Mobile App
  • Unable to provide consent
  • Unable to speak or read English
  • Unable to participate in mild activity
Contacts and Locations
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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): NCT04693338


Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Referral Office    855-776-0015    mayocliniccancerstudies@mayo.edu   
Principal Investigator: Daniela L. Stan, MD         
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Daniela L Stan Mayo Clinic in Rochester
More Information
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Responsible Party: Daniela L. Stan, M.D, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04693338    
Other Study ID Numbers: 19-002448
NCI-2020-07744 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
19-002448 ( Other Identifier: Mayo Clinic in Rochester )
P30CA015083 ( U.S. NIH Grant/Contract )
First Posted: January 5, 2021    Key Record Dates
Last Update Posted: January 5, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Breast Carcinoma In Situ
Neoplasms by Site
Neoplasms
Breast Diseases
 Skin Diseases
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type