Patient Priorities for Survivorship Care in Older Breast Cancer Survivors

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age65-100
SponsorThe University of Texas Health Science Center, Houston

About this trial

The objective of this study is to adapt the Patient Priorities Care (PPC) framework to breast cancer survivorship via a user-centered approach, through an iterative process in which patients and their physicians help to refine and modify the intervention. A second objective is to evaluate the feasibility and effectiveness of the adapted PPC framework in breast cancer survivorship for older adults.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

able to write and speak English

Stage DCIS/I/II/III breast cancer diagnosis

3 months from active cancer therapy (including first or second-line treatment chemotherapy, radiation and/or surgery, or multimodal treatment) up to 10 years since completing treatment

≥3 documented comorbidities by chart review, or taking ≥10 medications, have ≥ 1 hospitalization over the past year, ≥ 2 emergency department visits over the past year, seen by > 2 specialists over the past year

Disqualifiers

currently on active cancer therapy (including first or second-line treatment chemotherapy, radiation and/or surgery, or multimodal treatment)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Adapted Patient Priorities Care (PPC) approach

    Behavioral

    Step 1 is a PPC facilitation encounter, at which the facilitator will help the participant identify patient priorities, such as clarifying values (what matters most); setting meaningful, specific, and realistic outcome goals; describing healthcare preferences (care that is helpful and/or burdensome) and tradeoffs; and discussing priorities with clinicians. The participant's healthcare priorities are then documented and transmitted to clinicians, in order to facilitate changes in the patient's care plan to align it with his/her priorities. In step 2, the clinician considers patient's priorities and potential healthcare options (options might include starting or stopping treatments; adding or removing medications; ordering more or fewer tests; recommending or removing self-management tasks). In step 3, the clinician discusses care options with the participant, using strategies for aligning care with patient priorities.

  • Usual Care

    Other intervention

    Usual care for breast cancer survivorship includes regular visits with the oncology provider and yearly mammograms for surveillance.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Adapted Patient Priorities Care (PPC) approach plus Usual CareExperimental treatment 2 interventions
Group B: Usual CareActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Treatment burden as assessed by the treatment burden questionnaire (TBQ)

The treatment burden questionnaire (TBQ) measures perceptions of burden of overall care (for example, medication taking, self monitoring, visits to the provider, tests, tasks to access and coordinate care). Total score ranges from 0 to 150, and a higher score indicates greater perceived burden.

Time frame
baseline
2

Treatment burden as assessed by the treatment burden questionnaire (TBQ)

The treatment burden questionnaire (TBQ) measures perceptions of burden of overall care (for example, medication taking, self monitoring, visits to the provider, tests, tasks to access and coordinate care). Total score ranges from 0 to 150, and a higher score indicates greater perceived burden.

Time frame
3 months
3

Treatment burden as assessed by the treatment burden questionnaire (TBQ)

The treatment burden questionnaire (TBQ) measures perceptions of burden of overall care (for example, medication taking, self monitoring, visits to the provider, tests, tasks to access and coordinate care). Total score ranges from 0 to 150, and a higher score indicates greater perceived burden.

Time frame
6 months
4

Health status as assessed by the Functional Assessment of Cancer Therapy - Breast (FACT-B)

The Functional Assessment of Cancer Therapy- Breast (FACT-B) is a standardized approach to objectively evaluate and quantify the overall health status of patients with subscales measuring physical, social, emotional, and functional well-being. Total score ranges from 0 to 148, where a higher score indicates a better outcome.

Time frame
baseline

Secondary outcomes

1

Number of participants who adhere to survivorship basic recommendations

Survivorship basic recommendations for breast cancer survivors, as recommended by the American Society of Clinical Oncology (ASCO) guidelines, include receiving a detailed cancer-related history and physical examination every 3-6 months for the first 3 years and every 6 to 12 months for the next 2 years, as well as having an annual mammogram (unilateral if for unilateral mastectomies or bilateral for patients with lumpectomies or other breast conserving strategies).

Time frame
from baseline to 12 months
2

Number of participants who adhere to priorities-driven survivorship recommendations

Adherence to priorities-driven survivorship recommendations will focus on adherence to medications, self-management tasks, procedures, tests or referrals recommended during survivorship care based on patient's priorities.

Time frame
from baseline to 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Health Science Center, Houston

Lead sponsor

National Center for Advancing Translational Sciences (NCATS)

Collaborator

National Institute on Aging (NIA)

Collaborator