Effect of a survivorship care plan on resilience in a multi-cultural population of female primary caregivers of patients with advanced oral cavity cancer: trajectory, intervention model and longitudinal effects
| ISRCTN | ISRCTN15441492 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15441492 |
| Secondary identifying numbers | N/A |
- Submission date
- 15/10/2017
- Registration date
- 17/10/2017
- Last edited
- 21/11/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
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
Contact information
Scientific
261, Wen-Hua 1st Road
Kweishan
Taoyuan
33303
Taiwan
| Phone | +886 (0)3 2118999 Ext. 3436 |
|---|---|
| shuching@gw.cgust.edu.tw |
Study information
| Study design | Prospective randomized controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| Study acronym | SCP |
| Study objectives | SCP significantly helps caregivers cope with adverse events, lower feelings of distress, and increase resilience. |
| Ethics approval(s) | Chang Gung Institutional Review Board, Taiwan, 03/12/2015, ref: 103-7644B |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/08/2015 |
| Completion date | 31/07/2019 |
Eligibility
| Participant type(s) | Carer |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 80 |
| Total final enrolment | 100 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/08/2016 |
| Date of final enrolment | 31/12/2018 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
Taoyuan
333
Taiwan
Sponsor information
Government
#106, Ho-Ping Eastern Road
Taipei
106
Taiwan
| Phone | +886 (0)2 27377992 |
|---|---|
| llchen@most.gov.tw | |
| Website | http://www.most.gov.tw |
"ROR" |
https://ror.org/02kv4zf79 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Ministry of Science and Technology, R.O.C. (Taiwan), Ministry of Science and Technology of Taiwan, MOST
- Location
- Taiwan
Results and Publications
| Intention to publish date | 01/08/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The results will be published in a cancer journal. |
| IPD sharing plan | 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). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 11/04/2023 | 21/11/2023 | Yes | No |
Editorial Notes
21/11/2023: Publication reference and total final enrolment added.
19/02/2020: The intention to publish date has been changed from 01/08/2019 to 01/08/2021.
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.
