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

Western University, Canada

Status: Completed

Conditions: Survivorship; Head and Neck Cancer

Treatments: Other: Treatment summary and survivorship care plan

Study type: Interventional

Funder types: Other

Identifiers

NCT03993561

114194

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

18 participants in 1 patient group

TSSP Group

Experimental group

Description:

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

Treatment:

Other: Treatment summary and survivorship care plan