Clinical trial NCT02637349: Polaris Oncology Survivor Transition (POST) System
Official title: Polaris Oncology Survivor Transition (POST) System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cancer
Lead sponsor: Polaris Health Directions
Sponsor class: INDUSTRY
Collaborators: name: University of Massachusetts, Worcester
First posted: 2015-12-22
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The POST's public health impact is likely to be substantial because it will improve cancer survivorship planning, which is currently an important deficiency in cancer care recognized by the Institute of Medicine and the American College of Surgeons.

The POST may have many potential benefits for patients such as:

1. improved long-term health outcomes;
2. improved psychosocial outcomes and quality of life;
3. smoother transitions back into old and new life roles; and
4. improved continuity and coordination of care between providers.

Most importantly, the POST's influence may reach beyond the patients it directly serves as it could help scientists and health care providers understand the potential benefits of cancer survivorship planning and how to best design and implement survivorship planning when patients are ending treatment for cancer.

Detailed description: By January 2015, oncology care providers will be expected to craft Survivorship Care Plans (SCPs) for all individuals ending active treatment for cancer; however, there is a lack of systematic study of the impact survivorship planning has on patients, providers, or healthcare systems. The Polaris Oncology Survivorship Transition (POST) program is a web-based system that incorporates recommendations from the Institute of Medicine (IOM) and American College of Surgeons (ACS) to assist with cancer survivorship planning. It is a patient-centered approach that integrates input from both the treating oncology team and the patient. Phase 1 built and iteratively modified (N=25) the POST system and Phase 2 will test whether the SCPs impact patient and provider outcomes using a single blind, randomized controlled trial (RCT). Breast cancer patients (n=230) transitioning out of active treatment will be recruited and randomly assigned to receive Treatment as Usual (n=115) or the POST (n=115). All participants will be assessed at 1, 3, and 6 months by a research assistant blind to baseline status and group assignment. Primary outcomes will include quality of life, mechanisms of action such as confidence in entering survivorship, and other outcomes such as (1) depression and anxiety, (2) adherence to medical and behavioral health recommendations, (3) health care utilization, and (4) patient and provider satisfaction with the POST system.The POST will innovate the clinical setting through being the first system to produce computer generated tailored survivorship plans fully reflecting IOM recommendations and the new ACS 2015 requirements; incorporating information from both the oncology provider and the patient; featuring readily available "plug in" for two-way electronic health record integration; providing dynamic, electronic referrals for specialized support services; and facilitating care coordination between the oncologist and PCP. This study's impact will be significant. If hypotheses are confirmed, clear scientific evidence will exist for supporting survivorship care planning into oncology clinical practice. If hypotheses are disconfirmed, important lessons will guide future directions for care planning, including whether failure to affect outcomes was due to failure to impact several hypothesized mechanisms of action.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Confirmed diagnosis of breast cancer (not metastatic)
* A final active treatment appointment scheduled with oncology team
* Able to read or understand English at a 6th grade level

Exclusion Criteria:

* Altered mental status (e.g., psychosis, delirium, disorientation)
* Visual problems preventing them from reading the assessment and reports
* Severe illness that would preclude conversation or interface with a computer (e.g.,persistent nausea/vomiting, severe pain)
* Unable to read or understand English at a 6th grade level
* Characteristics that would prevent adequate follow-up (e.g., lack of a telephone)

Primary outcomes:
measure: Changes in Quality of Life
timeFrame: 1,3, 6 months after entering the study
Secondary outcomes:
measure: Changes in Confidence in Transitioning to Survivorship
timeFrame: 1,3,6 months after entering the study
measure: Changes in Depression
timeFrame: 1,3,6 months after entering study
measure: Changes in Anxiety
timeFrame: 1,3,6 months after entering study
measure: Change in Health care utilization
timeFrame: 6-months after entering the study
measure: Change in Patient Satisfaction and Usefulness of SCP
timeFrame: 1,3,6 months after entering the study
measure: Change in Patient Satisfaction with the POST system
timeFrame: 1,3,6 months after entering the study
measure: Change in Provider Satisfaction with the POST system
timeFrame: 1,3,6 months after entering the study
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts Medical School-Cancer Center
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester
name: Erin O'Hea, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: O'Hea EL, Creamer S, Flahive JM, Keating BA, Crocker CR, Williamson SR, Edmiston KL, Harralson T, Boudreaux ED. Survivorship care planning, quality of life, and confidence to transition to survivorship: A randomized controlled trial with women ending treatment for breast cancer. J Psychosoc Oncol. 2022;40(5):574-594. doi: 10.1080/07347332.2021.1936336. Epub 2021 Jun 20.