A Survivorship Care Plan and Embedded Navigation Tool (ASCENT)

Duke University

Status: Completed

Conditions: Prostate Cancer

Treatments: Behavioral: ASCENT

Study type: Interventional

Funder types: Other

Identifiers

NCT03424837

Pro00088754

Details and patient eligibility

About

This is a parallel group, multisite prospective clinical study. The purpose of this study is to evaluate whether ASCENT enables patients to adhere to the survivorship guidelines and improves coordination of care to address patient needs.

Enrollment: 77 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed diagnosis of prostate adenocarcinoma

• Age ≥18 years

• Receiving curative intent radiotherapy for prostate cancer (Note: post-operative radiotherapy [i.e., "adjuvant" or "salvage radiotherapy subsequent to prostatectomy] is allowed.)

• Subjects will be enrolled within two weeks prior to and two weeks after the final fraction of radiotherapy.

• Receiving androgen deprivation therapy (ADT) for a duration of ≥3 consecutive months as follows:

  • GnRH agonist or antagonist (medical castration), with or without an anti-androgen (i.e., bicalutamide, flutamide, nilutamide, etc.), OR
  • Bilateral orchiectomy (surgical castration)

• Technology requirement: candidates must have access to the internet

• Able to understand and willing to sign a written informed consent document.

• Able to speak and understand English, in the opinion of the treating physician.

Exclusion criteria

• Significant concurrent medical or psychiatric condition that would interfere with the patient's ability to abide by the study protocol or cooperate fully with the protocol requirements, including completion of survey and assessment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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77 participants in 2 patient groups

Intervention Arm: SoC (standard of care) and ASCENT

Experimental group

Description:

Health care per institutional standard plus ASCENT via the TrueNTH website.

Treatment:

Behavioral: ASCENT

Control Arm: SoC and TrueNRH

No Intervention group

Description:

Health care per institutional standard, plus access to the public information on the TrueNTH website; such as the symptom tracker, exercise \& diet, and lived experiences modules.