Clinical trial NCT03993561: Treatment Summary and Survivorship Care Plans (TSSP)
Official title: Survivorship After Head And Neck Cancer: Validation of Treatment Summary and Survivorship Care Plans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Survivorship
Head and Neck Cancer
Keywords: treatment summary and survivorship care plan
intervention
head and neck cancer survivors
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2019-06-20
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Physician implementation of TSSP
timeFrame: 12 months
Secondary outcomes:
measure: Satisfaction with Care and Communication
timeFrame: baseline and 12 months post-treatment
measure: Patient Self-Efficacy (PEPPI)
timeFrame: baseline and 12 months post-treatment
measure: KATZ Comorbidity Scale
timeFrame: baseline and 12 months post-treatment
measure: 36-Item Short Form Survey Instrument (SF-36)
timeFrame: baseline and 12 months post-treatment
measure: Personal Health Questionnaire Depression Scale (PHQ-8)
timeFrame: baseline and 12 months post-treatment
measure: Knowledge and Preparedness for Survivorship Scale (PLANS scale)
timeFrame: baseline and 12 months post-treatment
measure: Short-Form Patient Satisfaction Questionnaire (PSQ-18)
timeFrame: baseline and 12 months post-treatment
measure: Social support survey
timeFrame: baseline and 12 months post-treatment
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: Western University
name: Danielle MacNeil, MD
role: PRINCIPAL_INVESTIGATOR
References: