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
Prof Shu-Ching Chen
Wen-Hua 1st Road
+886 (0)3 2118999 Ext. 3436
Effect of a survivorship care plan on resilience in a multi-cultural population of female primary caregivers of patients with advanced oral cavity cancer
SCP significantly helps caregivers cope with adverse events, lower feelings of distress, and increase resilience.
Chang Gung Institutional Review Board, Taiwan, 03/12/2015, ref: 103-7644B
Prospective randomized controlled clinical trial
Primary study design
Secondary study design
Randomised controlled trial
Quality of life
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Primary caregivers of oral cavity cancer
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.
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
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
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
Target number of participants
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
Recruitment end date
Countries of recruitment
Trial participating centre
Linkou Chang Gung Hospital, Taiwan
#5, Fu-Hsing St. Kweshain
Ministry of Science and Technology, Taiwan
Funding Body Type
Funding Body Subtype
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 (firstname.lastname@example.org).
Intention to publish date
Participant level data
Available on request
Basic results (scientific)