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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06142071
Other study ID # 331660
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 8, 2024
Est. completion date August 2024

Study information

Verified date April 2024
Source Swansea Bay University Health Board
Contact Sing Yu Moorcraft
Phone 01792 285292
Email singyu.moorcraft@wales.nhs.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The main questions the study aims to answer are: 1. The proportion of family members of cancer patients who say they need more support 2. What support family members feel would be beneficial Information about patients' cancer diagnosis and treatment will be collected from their medical notes. Participating family members will be asked to complete a telephone questionnaire. Selected family members may also be asked to participate in an optional follow-up interview.


Description:

When someone is diagnosed with cancer, it can be a worrying and stressful time for patients and for their family members. Family members may provide practical and emotional support to patients, and may take on a caregiver role. Family members may want more information or advice, or may benefit from emotional support themselves. The study aims to identify any gaps in the current support provided to family members so that services can be improved in the future. Oncology patients in Singleton Hospital, Swansea will be asked by their oncology team to identify one or more family members to participate in the study. If a family member agrees to participate in the study, the research team will call them to complete a telephone questionnaire. The questionnaire should take less than 20 minutes and asks them some general questions (e.g. age, gender) and some questions about how they are feeling, what support services they find helpful and what additional support they feel would be beneficial. Data regarding participating patients' cancer diagnosis and treatment will be collected from their medical notes. After the questionnaire data has been analysed, optional follow-up interviews will be conducted with some family members to explore any issues identified in greater detail. Patients and family members will be recruited during a 6 month recruitment period and all responses will be anonymised. This is a pilot study which will not change the current support provided to family members, although they may be directed to existing services if appropriate. Patients' treatment will not be changed in any way.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date August 2024
Est. primary completion date August 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria for patients - diagnosed with a solid organ malignancy under the care of the oncology team - able to identify at least one family member who may be willing to participate in the study Inclusion Criteria for family members - a family member of a patient diagnosed with a solid organ malignancy under the care of the oncology team Exclusion Criteria for patients and family members - medical or psychiatric condition impairing ability to consent - the patient's treating oncologist's opinion is that participating in the study would cause severe distress to the patient or their family

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Telephone questionnaire
Telephone questionnaire, which includes questions on participant's demographics, anxiety/depression scores, what support they find helpful and what additional support they feel would be beneficial

Locations

Country Name City State
United Kingdom South West Wales Cancer Centre Swansea

Sponsors (2)

Lead Sponsor Collaborator
Swansea Bay University Health Board Swansea University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary The proportion of family members who state they need more support The proportion of family members who state they need more support 6 months after start of study recruitment
Secondary The proportion of family members who state they need more support with each of the Carer Support Needs Assessment Tool (CSNAT) domains he proportion of family members who state they need more support with each of the Carer Support Needs Assessment Tool (CSNAT) domains 6 months after start of study recruitment
Secondary Types of additional support that family members feel would be beneficial as identified via the telephone questionnaires and interviews This will be determined by qualitative analysis of questionnaire and interview data and may include improved psychological support, online resources, information leaflets etc 6 months after start of study recruitment
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