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OpenTrials
Active, Not Recruiting

NCT Number: NCT06142071

Mixed Methods Study to Assess Family Members Unmet Needs in an Oncology Setting

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

South West Wales Cancer Centre

Swansea, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telephone Questionnaire

Behavioral

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

Primary outcomes

  1. The proportion of family members who state they need more support

    Time frame: 6 months after start of study recruitment

    The proportion of family members who state they need more support

Secondary outcomes

  1. The proportion of family members who state they need more support with each of the Carer Support Needs Assessment Tool (CSNAT) domains

    Time frame: 6 months after start of study recruitment

    he proportion of family members who state they need more support with each of the Carer Support Needs Assessment Tool (CSNAT) domains

  2. Types of additional support that family members feel would be beneficial as identified via the telephone questionnaires and interviews

    Time frame: 6 months after start of study recruitment

    This will be determined by qualitative analysis of questionnaire and interview data and may include improved psychological support, online resources, information leaflets etc

Sponsors and collaborators

Lead sponsor

Swansea Bay University Health Board

Other

Collaborators

  • Swansea University

Registry information

Acronym: SALUTE

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 21, 2023
Registry last updated
Jul 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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