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

Not Applicable

Completed

• Conditions: Primary caregivers of oral cavity cancer; Cancer

• Registration Number: ISRCTN15441492
• Lead Sponsor: Ministry of Science and Technology, Taiwan

Brief Summary

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37055297/ (added 21/11/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-10-17
• Study Completion: 2019-07-31
• Last Update Posted: 4 December 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 100

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
<br> 1. Physical status, measured using Karnofsky’s Performance Status Index (KPS)<br> 2. Caregiving burden measured using the Caregiver Reaction Assessment (CRA)<br> 3. Distress, measured using the Distress Thermometer (DT)<br> 4. Social support, measured using by Medical Outcomes Study Social Support Survey-modified (MOS SS-m)<br> 5. Health-related quality of life, measured using by the Medical Outcomes Study Short Form SF-12 (MOS SF-12)<br><br> Measured at baseline (before the SCP, T0) and at 1, 3, and 6 months after first receiving the SCP (T1, T2, and T3, respectively)<br>