Condition category
Cancer
Date applied
15/10/2017
Date assigned
17/10/2017
Last edited
05/09/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The aim of this study is to examine the effects of a 6-month Survivorship Care Plan (SCP) on the physical status, caregiver burden, emotional distress, social support, quality of life, and resilience of primary caregivers of patients with advanced oral cavity (mouth) cancer during the first 6 months of the survival period. The study also compares the gender differences of the effects of SCP.

Who can participate?
Primary caregivers of patients with oral cavity cancer

What does the study involve?
Participants are randomly allocated to either the control group or the experimental group. The control group receive routine hospital care. The experimental group receive the 6-month SCP. Physical status, caregiver burden, emotional distress, social support, quality of life and resilience are assessed at the start of the study and at 1, 3, and 6 months after first receiving the SCP.

What are the possible benefits and risks of participating?
If the SCP is useful and effective, a scientific program will be developed, based on the SCP intervention, to improve caregiver burden and enhance the resilience of primary caregivers of patients with advanced oral cavity cancer in Taiwan.

Where is the study run from?
Linkou Chang Gung Hospital (Taiwan)

When is the study starting and how long is it expected to run for?
August 2015 to December 2018

Who is funding the study?
Ministry of Science and Technology (Taiwan)

Who is the main contact?
Prof. Shu-Ching Chen
shuching@gw.cgust.edu.tw

Trial website

Contact information

Type

Scientific

Primary contact

Prof Shu-Ching Chen

ORCID ID

Contact details

261
Wen-Hua 1st Road
Kweishan
Taoyuan
33303
Taiwan
+886 (0)3 2118999 Ext. 3436
shuching@gw.cgust.edu.tw

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effect of a survivorship care plan on resilience in a multi-cultural population of female primary caregivers of patients with advanced oral cavity cancer

Acronym

SCP

Study hypothesis

SCP significantly helps caregivers cope with adverse events, lower feelings of distress, and increase resilience.

Ethics approval

Chang Gung Institutional Review Board, Taiwan, 03/12/2015, ref: 103-7644B

Study design

Prospective randomized controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Primary caregivers of oral cavity cancer

Intervention

Eligible participants will be recruited from the time patients first complete treatment for six months and randomized into a control group (patients receive routine hospital care) and an experimental group (patients receive the 6-month SCP). Subjective and objective measures will be collected at four timepoints: at baseline (before the SCP, T0) and at 1, 3, and 6 months after first receiving the SCP (T1, T2, and T3, respectively). The GEE will be used to analyze the data. The plan is to recruit 40 patient-caregiver dyads for each group.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Resilience, measured using the Resilience Scale (RS) at baseline (before the SCP, T0) and at 1, 3, and 6 months after first receiving the SCP (T1, T2, and T3, respectively)

Secondary outcome measures

1. Physical status, measured using Karnofsky’s Performance Status Index (KPS)
2. Caregiving burden measured using the Caregiver Reaction Assessment (CRA)
3. Distress, measured using the Distress Thermometer (DT)
4. Social support, measured using by Medical Outcomes Study Social Support Survey-modified (MOS SS-m)
5. Health-related quality of life, measured using by the Medical Outcomes Study Short Form SF-12 (MOS SF-12)

Measured at baseline (before the SCP, T0) and at 1, 3, and 6 months after first receiving the SCP (T1, T2, and T3, respectively)

Overall trial start date

01/08/2015

Overall trial end date

31/07/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Primary caregivers:
1. Pathologic confirmation that the patient has oral cavity squamous cell carcinoma (OSCC)
2. New diagnosis of oral cavity cancer with cancer stage on III and IV; receipt of surgery and RT or CCRT; and completion of treatment within the previous 6 months
3. Disease free survivor (i.e., patient shows no apparent signs of cancer)
4. Female (male) primary caregivers aged 20-70 years
5. Female (male) primary caregiver provides uncompensated care or assistance to a patient and is identified by the patient as the primary family caregiver
6. RS score <145 and DT score >4
7. Agreement to participate in the study after explanation of its purposes and procedures

Participant type

Carer

Age group

Adult

Gender

Female

Target number of participants

80

Participant exclusion criteria

1. Oral cavity cancer patient with any prior surgery, RT, or chemotherapy;
2. Female primary caregiver with any unstable systemic disease (heart disease, hypertension, active infection, or other underlying disease)
3. Female primary caregiver with any condition likely to cause discomfort during the research interview

Recruitment start date

01/08/2016

Recruitment end date

31/12/2018

Locations

Countries of recruitment

Taiwan

Trial participating centre

Linkou Chang Gung Hospital, Taiwan
#5, Fu-Hsing St. Kweshain
Taoyuan
333
Taiwan

Sponsor information

Organisation

Ministry of Science and Technology, Taiwan

Sponsor details

#106
Ho-Ping Eastern Road
Taipei
106
Taiwan
+886 (0)2 27377992
llchen@most.gov.tw

Sponsor type

Government

Website

http://www.most.gov.tw

Funders

Funder type

Government

Funder name

Ministry of Science and Technology, Taiwan

Alternative name(s)

Ministry of Science and Technology of Taiwan, MOST

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Taiwan

Results and Publications

Publication and dissemination plan

The results will be published in a cancer journal.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Shu-Ching Chen (shuching@gw.cgust.edu.tw).

Intention to publish date

01/08/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

05/09/2018: The following changes were made to the trial record: 1. The recruitment end date was changed from 31/07/2018 to 31/12/2018. 2. The overall trial end date was changed from 31/12/2018 to 31/07/2019. 3. The intention to publish date was changed from 01/12/2018 to 01/08/2019.