NCT04214912

Personalized Survivor Care Plan for Oral Cancer Patients-Effects on Physical-Psychological Functions and Return-to-Work

Status unknown NA Last updated 2 January 2020

What this trial tests

NA trial testing Personalized Survivor Care Plan (PSCP) in Oral Cancer in 300 participants. Status unknown.

Timeline

1 December 2017

Primary endpoint
31 July 2020

31 July 2020

Quick facts

Lead sponsor	National Taiwan University Hospital
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	supportive care
Enrollment	300
Start date	1 December 2017
Primary completion	31 July 2020
Estimated completion	31 July 2020
Sites	1 location across Taiwan

Drugs / interventions tested

• Personalized Survivor Care Plan (PSCP)

Conditions studied

• Oral Cancer — all drugs for Oral Cancer →

Sponsor

National Taiwan University Hospital

Who can join

Eligibility, any sex, with Oral Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: Due to the complex treatment modalities and long-term side effects, oral cancer (OC) patients might suffer from psychological and physical distress and be unable to return to work (RTW).

Purposes: This is a two-phase study. First, the investigator aims to validate a scale about OC patients' perception of RTW and identify those concerns in RTW. Second, the investigator aims to (1) develop the contents of a "Personalized Survivorship Care Plan- Oral Cavity Cancer (PSCP-OC)" and (2) examine the short and long-term effects of PSCP-OC on patients' physical function (symptoms, muscle strengths, fitness, nutrition status), psychological distress (depression, fear of cancer recurrence) and RTW.

Method: First phase, the investigator will modify and validate the "Illness Perception Questionnaire (IPQ)" with adding the head and neck cancer specific items (modified IPQ-mHN) to assess the barriers of RTW in OC patients. The investigator will recruit 300 subjects in this phase to test the IPQ-mHN psychometrics. The second and third year will develop and test the PSCP-OC intervention. Eligible subjects will be (1) newly diagnosed OC patients with surgery, and (2) who are at work in time of diagnosis. A stratified randomization by cancer stage would be conducted. Both groups will receive baseline assessment before first intervention. PSCP-OC is a 6-month intervention which includes two parts: General module and Personalized module (150 subjects for each group). Ex group will receive the first PSCP-OC before discharge and 3 times face-to-face PSCP-OP once a month in the first three month after discharge and 3 times telephone physical-psycho-education interventions in month 4-6. Control group will receive regular and cancer case manager cares for 6 months. Each group will be followed for 12 months and assess of their outcomes at 6 time points: baseline (pre-discharge) and 1, 3, 6, and 12 months after surgery. Outcomes will be evaluated by physical distress, muscle strength, nutrition status, and length of time of RTW since completion of last major treatment. Results would be analyzed mainly by GEE. IRB approval will be received before the RCT.

Expected Outcome: Expecting to develop a scale to identify those barriers preventing OC patients' RTW and further to test the PSCP. A promising result will further apply into clinical care to prevent or decrease the potential declined physical and psychological functions, increase their strength and help them RTW.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Non-medical interventions to enhance return to work for people with cancer.
   de Boer AG, Tamminga SJ, Boschman JS, Hoving JL. · · 2024 · cited 21× · PMID 38441440 · DOI 10.1002/14651858.cd007569.pub4