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Survivorship After Head And Neck Cancer: Patient Care and Adherence to Follow-up (SHARE)

2019-06-27 04:14:28 | BioPortfolio

Summary

The aim of the study is to establish the highest level of evidence to evaluate treatment summary and survivorship care plans (TSSPs) by comparing patients who receive a TSSP to those who receive usual care.

Hypothesis: HNC patients who receive the intervention of the TSSP will have an increased rate of implementation of recommendations for their needs, greater adherence with follow-up schedules, improved quality of life and improved satisfaction with post-treatment care.

Aim 1 (Validation of TSSP): To validate a treatment summary and survivorship care plan (TSSP) intervention specifically tailored to the needs of HNC patients based on the best available evidence.

Approach: In the first phase of the project we will pilot the London Heath Sciences Centre TSSP with head and neck cancer survivors and then have the TSSP extensively reviewed and modified by our multidisciplinary head and neck oncology treatment team.

Aim 2 (Evaluation of TSSP): To evaluate the implementation of a TSSP in survivors of head and neck cancer compared to usual treatment in a randomized fashion to determine whether TSSPs result in improved implementation of recommendations for HNC survivors and improved quality of life and satisfaction.

Approach: In the second phase of the project we will conduct a randomized controlled trial to compare patient reported outcomes in HNC patients who have received the TSSP to patients who have not received the TSSP.

Description

Validation of TSSP: We have performed an extensive literature review to create a comprehensive draft TSSP specifically tailored for HNC patients. We will pilot this study among 20 head and neck cancer survivors. Once we have the feedback from the pilot patients, we will conduct a focus group with the members of our head and neck multidisciplinary group to gain input on the TSSP.

Evaluation of TSSP: This part of the study is a randomized controlled trial.We will recruit head and neck cancer survivors with curable stage I-IVA head and neck mucosal cancer at a tertiary level cancer center in Ontario. Patients will be randomly assigned to either usual treatment or a survivorship care plan (TSSPs) intervention. The intervention will consist of a survivorship care nurse or radiation therapist counseling session coupled with the provision of individualized TSSPs to patients and their health care providers. After a baseline telephone or in-person interview, eligible participants will be randomly assigned to intervention or usual care groups. A randomization schedule has been created using SAS software and will be accessible only to the statistician, who will create sealed, opaque sequenced envelopes for randomization. If all the documentation is in order, the study coordinator will open the next envelope in sequence. Blinding is not possible as the treatment rendered will be obvious to both the patient and the observers. This is a source of bias, which could potentially affect patient self reported questionnaire scores.

The primary outcome will be physician implementation of TSSP care recommendations over the course of 12 months, assessed by quarterly patient interviews. Secondary outcomes will include adherence to recommended follow-up schedules, quality of life using validated measures and patient satisfaction with care.

Study Design

Conditions

Survivorship

Intervention

Treatment summary and survivorship care plan

Location

London Health Sciences Centre
London
Ontario
Canada
N6C2R6

Status

Not yet recruiting

Source

Western University, Canada

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-06-27T04:14:28-0400

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