NCT02637349

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2 cancer

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 22, 2015

Completed
11 months until next milestone

Study Start

First participant enrolled

November 30, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

November 26, 2019

Status Verified

November 1, 2019

Enrollment Period

2.1 years

First QC Date

December 16, 2015

Last Update Submit

November 22, 2019

Conditions

Cancer

Outcome Measures

Primary Outcomes (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.

    1,3, 6 months after entering the study

Secondary Outcomes (7)

  • Changes in Confidence in Transitioning to Survivorship

    1,3,6 months after entering the study

  • Changes in Depression

    1,3,6 months after entering study

  • Changes in Anxiety

    1,3,6 months after entering study

  • Change in Health care utilization

    6-months after entering the study

  • Change in Patient Satisfaction and Usefulness of SCP

    1,3,6 months after entering the study

  • +2 more secondary outcomes

Study Arms (2)

POST SCP

EXPERIMENTAL

Patient 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.

Behavioral: POST Intervention

POST TAU

ACTIVE COMPARATOR

Patient receives treatment as usual (TAU) after active treatment ends.

Behavioral: POST Treatment as Usual

Interventions

POST InterventionBEHAVIORAL

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 SCP
POST Treatment as UsualBEHAVIORAL

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.

POST TAU

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Massachusetts Medical School-Cancer Center

Worcester, Massachusetts, 01655, United States

Location

Related Publications (1)

  • 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.

    PMID: 34151734DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Aftercare

Intervention Hierarchy (Ancestors)

Continuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesPrimary Health CareComprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Erin O'Hea, PhD

    University of Massachusetts, Worcester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2015

First Posted

December 22, 2015

Study Start

November 30, 2016

Primary Completion

December 31, 2018

Study Completion

August 31, 2019

Last Updated

November 26, 2019

Record last verified: 2019-11

Locations

US(1)