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Completed

NCT Number: NCT05549687

E-Health Support Program (PACK Health Program) in Supporting Patient Reported Symptoms in Newly Diagnosed Patients With Breast Cancer

This trial studies how well an electronic (e)-health support program, called the PACK Health Program, supports patient reported symptoms in newly diagnosed patients with breast cancer. PACK Health offers a symptom management program involving both interpersonal interaction, as well as e-modules for patients diagnosed with cancer to better manage pain, fatigue, depression, anxiety, and to navigate care more effectively through e-health coaching and tools. Participating in the PACK Health Program may support breast cancer patients' reported side effects and experience of care during chemotherapy treatment and may ultimately improve overall health.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

PRIMARY OBJECTIVE:

I. To examine the impact of an e-health support program on patient reported outcomes.

SECONDARY OBJECTIVES:

I. To evaluate the effect of e-health support program in comparison with standard of care support services, on the symptom experience of patients receiving chemotherapy in the ambulatory setting.

II. To evaluate the effect of e-health support program in comparison with standard of care support services, on the satisfaction of patients receiving chemotherapy in the ambulatory setting.

III. To evaluate the effect of e-health support program, in comparison with standard of care support services, on the frequency of emergency room visits and hospital admissions for patients receiving chemotherapy in the ambulatory setting.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients participate in the PACK Health Program which includes up to 60 scheduled touch points via phone, text, email and a mobile application, as well as weekly interaction with a health coach over 3 months. Patients also have access to standard of care support services at MD Anderson including a telephone triage line 5 days a week between 8 a.m. and 5 p.m.

GROUP II: Patients receive standard of care support services with a telephone triage line available 5 days a week between 8 a.m. and 5 p.m.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • English speaking.
  • Newly diagnosed women with a breast cancer diagnosis preparing to undergo chemotherapy for the first time.
  • All chemotherapy treatment to be completed at the study institution.
  • Access to electronic resources, defined for the purposes of this study as a mobile phone, a landline phone, a computer, or another device with the capacity to receive calls, texts, or e-mails.

Exclusion criteria

  • Patients who have received previous chemotherapy treatment for cancer.
  • Patients who are unable to verbalize (e.g. due to tracheostomy).
  • Patients enrolled on Protocol 2016-0300, as these patients will be receiving proactive triage calls from nurses that could skew their symptom reporting.

Treatment and study plan

Questionnaire Administration

Other

Ancillary studies

Supportive Care

Procedure

Participate in Pack Health, an electronic support program

Primary outcomes

  1. Impact of electronic (e)-health support program on patient reported outcomes

    Time frame: Baseline up to 3 months

    Measured with the National Institutes of Health Patient Reported Outcomes Measurement Information System (PROMIS) Global Health Scale. Summary statistics and box plots will be used to describe PROMIS scores by intervention arm and assessment time. A 2-sample t-test will be used to compare PROMIS scores at 3 months between intervention groups. Linear mixed effects models (LMMs) will be used to assess PROMIS scores over time. The models will include assessment time, intervention and baseline score as fixed effects and intercept as a random effect. Additional models will be created to include possible confounding covariates.

    PROMIS instrument scores will be reviewed and patients referred to the primary medical team if they score 1 on items 1-6, and 9, indicating poor health state and 4 or greater on items 8 and 10, indicating potential emotional distress or moderate to severe fatigue.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Randomized Control Trial of the Effect of an E-Health Support Program on Patient Reported Outcomes of Women Newly Diagnosed With Breast Cancer

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Sep 22, 2022
Registry last updated
Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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