Treatment Summary and Survivorship Care Plans (TSSP)

NCT03993561 | Completed

• 1 other identifier: 114194
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Survivorship; Head and Neck Cancer

Keywords

treatment summary and survivorship care plan; intervention; head and neck cancer survivors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Satisfaction with Care and Communication

  baseline and 12 months post-treatment

• Patient Self-Efficacy (PEPPI)

  baseline and 12 months post-treatment

• KATZ Comorbidity Scale

  baseline and 12 months post-treatment

• 36-Item Short Form Survey Instrument (SF-36)

  baseline and 12 months post-treatment

• Personal Health Questionnaire Depression Scale (PHQ-8)

  baseline and 12 months post-treatment

Study Arms (1)

TSSP Group

EXPERIMENTAL

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

Interventions

Treatment summary and survivorship care plan OTHER

Individually tailored counselling session will be implemented within 1 month of treatment completion.

TSSP Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6C2R6, Canada

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Danielle MacNeil, MD

  Western University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor - Department of Otolaryngology Head & Neck Surgery

Model Details: A prospective, pilot trial at a single centre with 1 group of 20 adults. The study group will receive 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.

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: June 20, 2019
• Study Start: August 1, 2020
• Primary Completion: March 31, 2021
• Study Completion: January 1, 2023
• Last Updated: November 8, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)