Treatment Summary and Survivorship Care Plans (TSSP)

Head and Neck Cancer Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03993561
• Other study ID #: 114194
• Status: Completed
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: January 1, 2023

Study information

• Verified date: November 2023
• Source: Western University, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 1, 2023
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Survivorship

Intervention

Other:
• Treatment summary and survivorship care plan
Individually tailored counselling session will be implemented within 1 month of treatment completion.

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Western University, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physician implementation of TSSP	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	Satisfaction with Care and Communication	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
Secondary	Patient Self-Efficacy (PEPPI)	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
Secondary	KATZ Comorbidity Scale	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
Secondary	36-Item Short Form Survey Instrument (SF-36)	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
Secondary	Personal Health Questionnaire Depression Scale (PHQ-8)	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
Secondary	Knowledge and Preparedness for Survivorship Scale (PLANS scale)	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
Secondary	Short-Form Patient Satisfaction Questionnaire (PSQ-18)	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
Secondary	Social support survey	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