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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15441492

Enrollment

Registered

2017-10-17

Start date

2016-08-01

Completion date

Unknown

Last updated

2023-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary caregivers of oral cavity cancer Cancer

Interventions

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

Eligibility

Sex/Gender

Female

Inclusion criteria

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 4 7. Agreement to participate in the study after explanation of its purposes and procedures

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Countries

Taiwan

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026