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CancerPhase 2POSTNCT02637349

Polaris Oncology Survivor Transition (POST) System

A Phase 2 study testing POST Intervention and POST Treatment as Usual in people with Cancer, run by Polaris Health Directions at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Cancer
What is being tested?
POST Intervention and POST Treatment as Usual
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteUnited States
Study dates
30 Nov 2016to 31 Aug 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Massachusetts Medical School-Cancer Center

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

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:

Read more
  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.

Read the 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.

Conditions
Cancer
Being tested
POST Intervention, POST Treatment as Usual
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • POST InterventionBehavioural

    POST Intervention group will receive a tailored survivorship care plan (SCP) at the end of their active treatment. The SCP will be discussed with them. Patient will be asked about satisfaction with the end of treatment session.

  • POST Treatment as UsualBehavioural

    The POST control group may receive a survivorship care plan (SCP) as part of treatment as usual though it is not a usual procedure. They will be asked about their satisfaction with the end of treatment session.

Study groups in NCT02637349
Study groupRoleWhat they receive
POST SCPExperimentalPatient receives Survivorship Care Plan (SCP) after active treatment ends. It will be discussed with the patient. SCP includes medical and psychosocial history, medical contact information, 5-year follow-up plan and educational materials.
Receives: Behavioral: POST Intervention
POST TAUActive comparatorPatient receives treatment as usual (TAU) after active treatment ends.
Receives: Behavioral: POST Treatment as Usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in Quality of Life

    Quality of life will be measured at baseline and at the follow-ups using the City of Hope Quality of Life measure. Improvement in quality of life is the primary goal of survivorship planning.

    Measured: 1,3, 6 months after entering the study

Secondary outcomes (7)

  1. Changes in Confidence in Transitioning to Survivorship

    National Cancer Institute (NCI) and the Institute of Medicine (IOM) have emphasized that SCPs should help improve patients' feelings of preparedness and confidence in managing and understanding the next steps at the end of treatment. This will be measured at baseline and follow-up sessions using the Confidence in Survivorship Information Questionnaire (CSI).

    Measured: 1,3,6 months after entering the study

  2. Changes in Depression

    Changes in depression will be measured by the Patient Health Questionnaire -9 (PHQ-9).

    Measured: 1,3,6 months after entering study

  3. Changes in Anxiety

    Changes in anxiety will be measured by the General Anxiety Disorder 7-item measure (GAD-7).

    Measured: 1,3,6 months after entering study

  4. Change in Health care utilization

    Participants' medical charts will be reviewed six months after termination of active treatment for frequency and appropriateness of oncology, primary care, and emergency room visits, as well as hospitalizations.

    Measured: 6-months after entering the study

  5. Change in Patient Satisfaction and Usefulness of SCP

    Patients will be asked to assess their satisfaction with the POST program and with the content and quality of the SCP.

    Measured: 1,3,6 months after entering the study

  6. Change in Patient Satisfaction with the POST system

    Patients will be asked to assess their satisfaction with the POST system.

    Measured: 1,3,6 months after entering the study

  7. Change in Provider Satisfaction with the POST system

    Providers will be asked to assess their satisfaction with the POST system.

    Measured: 1,3,6 months after entering the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2015 (estimated)
  2. Study start30 Nov 2016
  3. Primary completion31 Dec 2018
  4. Study completion31 Aug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02637349
Sponsor's protocol ID
2R42CA174048-03
Acronym
POST
Status last verified
Nov 2019
First submitted
16 Dec 2015
Last updated
26 Nov 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 34151734

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing POST Intervention and POST Treatment as Usual in people with Cancer, run by Polaris Health Directions at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Quality of Life (time frame: 1,3, 6 months after entering the study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02637349, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2019.

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