Treatment Summary and Survivorship Care Plans (TSSP) (SHARE)

November 3, 2023 updated by: Danielle MacNeil, Western University, Canada

Survivorship After Head And Neck Cancer: Validation of Treatment Summary and Survivorship Care Plans

The aim of the study is to establish the highest level of evidence to evaluate treatment summary and survivorship care plans (TSSPs) by piloting the TSSPs on patients with HNC.

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 the investigators 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 the investigators 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Evaluation of TSSP: The investigators 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 receive 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 provide with the TSSP.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6C2R6
        • London Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 years or older
  • willing to provide informed consent
  • diagnosis of stage I-IVA head and neck mucosal cancer (larynx, hypopharynx, oral cavity, oropharynx, nasopharynx)
  • last definitive treatment (surgery, chemotherapy, radiotherapy) at least 1 month but no greater than 3 months from enrollment
  • English speaking

Exclusion Criteria:

  • Second concurrent non-cutaneous malignancy
  • metastatic disease
  • clinically apparent cognitive impairment
  • unable or unwilling to complete questionnaires
  • suspected residual disease after treatment completion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TSSP Group
A one-hour treatment summary and survivorship care plan (TSSP) intervention specifically tailored to the needs of head and neck cancer patients based on the best available evidence and consultation with patients and a multidisciplinary team of head and neck cancer specialists will be provided
Other: Treatment summary and survivorship care plan
Individually tailored counselling session will be implemented within 1 month of treatment completion.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Physician implementation of TSSP
Time Frame: 12 months
Physician implementation of treatment summaries and survivorship care plans (TSSP) recommendations over the course of 12 months, assessed by quarterly patient interviews.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Satisfaction with Care and Communication
Time Frame: baseline and 12 months post-treatment
8-item questionnaire measuring patient level of satisfaction with follow-up care since head and neck cancer treatment ended; 4 questions are ranked using a 6-point Likert scale (1 = Never and 6 = Always), 1 item uses a 5-point likert scale (1 = Definitely yes; 5 = Definitely not); 2 items use a scale of 0-10 (0 = not at all satisfied and 10 = very satisfied); and one item utilized a Yes or No response format. Total scores range from 5 to 50;
baseline and 12 months post-treatment
Patient Self-Efficacy (PEPPI)
Time Frame: baseline and 12 months post-treatment
Five item patient self-efficacy measured on a scale of 0 to 10 (0 = not confident at all, 10 = extremely confident); higher scores indicate better satisfaction with care; Total scores range from 0 to 50;
baseline and 12 months post-treatment
KATZ Comorbidity Scale
Time Frame: baseline and 12 months post-treatment
Patient rated comorbidity scale based on the Charlson Comborbidity index. Thirty-five item scale measures the presence or absence of different health conditions. Each item utilizes a Yes/No format; Yes' are given a point of 1 and No's are scored 0; Higher scores indicate the presence of a greater number of co-morbidities and lower scores; Total scores range from 0 to 35;
baseline and 12 months post-treatment
36-Item Short Form Survey Instrument (SF-36)
Time Frame: baseline and 12 months post-treatment
36 item scale to measure patient health and wellbeing from the patient perspective; Eight subscale scores are generated for the following domains: 1) physical functioning, 2) role-physical, 3) bodily pain, 4) general health, 5) vitality, 6) social functioning, 7) role-emotional, and 8) mental health; Item scales range from 3 to 6 point Likert scales and Yes/No response formats; items are recoded to a scale of 0 to 100; after recoding, averages for each subscale are calculated so that each subscale has a range of 0 to 100 (0 being poor functioning and 100 excellent functioning); higher subscale scores indicate better health.
baseline and 12 months post-treatment
Personal Health Questionnaire Depression Scale (PHQ-8)
Time Frame: baseline and 12 months post-treatment
Eight-item self-reported depression scale; each item is scored using a 4-point likert scale (0 = Not at all, 3 = Nearly every day); Total scores range from 0 to 24; A score of 10 or greater is considered major depression, 20 or more is severe depression;
baseline and 12 months post-treatment
Knowledge and Preparedness for Survivorship Scale (PLANS scale)
Time Frame: baseline and 12 months post-treatment
Sixteen- item knowledge of survivorship issues questionnaire; Items 1-11 use a 4-point scale (1 = Strongly disagree; 4 = Strongly agree) and addresses knowledge of survivorship issues; items 12 to 16 utilize a 10-point scale (1 = Not at all confident; 10 = Extremely Confident) and evaluate patient preparedness for survivorship; Subscale total scores for Knowledge of Survivorship Issues subcale range from 11 to 44 with higher scores indicating better knowledge of survivorship issues; The Preparedness for Survivorship (items 12-16) subscale score ranges from 5 to 50 with higher scores indicating greater level of confidence regarding preparedness for survivorship
baseline and 12 months post-treatment
Short-Form Patient Satisfaction Questionnaire (PSQ-18)
Time Frame: baseline and 12 months post-treatment
Eighteen-item patient satisfaction with care questionnaire using a 5-point Likert scale (1 = Strongly agree; 5 = Strongly disagree); Five subscale scores are generated by calculating averages of items that belong to that particular subscale: General Satisfaction, Technical Quality, Interpersonal Manner, Communication, Financial Aspects, Time Spent with Doctor, Accessibility and Convenience; Each subscale score ranges from 1 to 5 with higher scores reflecting greater level of satisfaction with care;
baseline and 12 months post-treatment
Social support survey
Time Frame: baseline and 12 months post-treatment
Nineteen-item scale measuring social, tangible and emotional support; Each item is ranked on a 5-point likert scale (1 = None of the time and 5 = All of the time); Higher scores indicate greater social support;
baseline and 12 months post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Western University, Canada

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Danielle MacNeil, MD, Western University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 18, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 20, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 8, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 114194

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be made available upon request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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